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tv   Hearingon Vaccine Safety Systems  CSPAN  April 11, 2024 8:08am-10:48am EDT

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we will taken out to capitol hill for a hearing to examine the effectiveness of vaccine safety reporting after the roll out of the covid-19 vaccine. this includes officials from the cdc and the fda. you are watching live coverage on c-span3 . >> i advised members and remind them of all the rows of corn. the issues we are debating are important. the members feel deeply about. i understand that. while vigorous disagreement is part of the legislative process, members are reminded that we must adhere to established standards of decorum and debate. this is a reminder that is a violation of house rules and the rules of this committee to
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engage in personalities regarding other members or to question the motives of a colleague. remarks about type are not permitted by the rules and are not in keeping with the best traditions of our committee. this is a very serious matter. the chair will enforce these roles of the courtroom at all times and urge all members to be mindful of their remarks today. if the chair finds the member to be in violation, remember will be suspended of speaking for the remainder of the hearing but i never organize myself for the purpose of making an opening statement. good morning. vaccines are crucial public health tools which save millions of lives as a physician myself, i have administered many doses of vaccines especially covid-19 vaccines. in 2020 i volunteer to participate in the moderna
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vaccine trials. having this hearing is not an anti-vaccination hearing and i am not anti-vaccination. i should not even have to say that. unfortunately, i do. i am sure as i sit here and there are people getting ready to use that very thing to discredit this hearing. unfortunately, in an error of sound bites and new cycle whiplash, it seems there is little time for nuance conversation about these topics. today, i hope we can have that conversation about process. sometimes we do not know and weaknesses in the system until it is truly tested. now is the time to safeguard for the future. and about how we can do better next time if there is things we recognize that could have been done better. it is not a time to look at the things we did well as well. but we need to restore trust in
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public health. i am very concerned with the hesitancy by so many today to vaccinate their children. that is a great concern of mine. testifying before us today or two senior officials who made the post marketing vaccine safety systems. these systems are absolutely critical to keeping the american people safe. also, to earning and preserving their trust. in the trust of the positions that care for patients. our witnesses will discuss how the systems work, what they can do, what they can't do and the challenges that they face. that is a bear process. their testimony is important to design better systems in the future, as needed. one such system, the vaccine adverse reporting system is perhaps the best known of the surveillance systems it has
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been the source of attention and controversy since the beginning of the covid-19 vaccine rollout. however, concerns about these data is usually does met with submissive replies but they can point to the fact that vaers is unable to prove causality. it contained reports of people being hit by a car after vaccination. they say that vaers is being misused by anti-vaccine advocates and that it is misinformation . they are all legitimate concerns of the american people, especially this seems to ignore many legitimate questions that have been raised. for example, how does the government utilize this data? we want to know during her testimony before this committee last june, director wolinsky assured us that the cdc had a responsibility to come. every single report in vaers. it is unclear if that is
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happened or that is true. people have submitted reports to vaers have told my staff that they were never contacted by the cdc or fda officials. our recent british medical journal investigation now has two. it seems that both sides agree that there is something wrong here. further, while serious injuries caused by vaccines are rare, but government has assumed the responsibility to compensate for them. in doing so, then seek -- dancing magnifiers have been shielded from liability for the government has an important duty, one that is essential in preserving trust in vaccines and how we measure completely and honestly about them appearing before us today is commander george grimes. dr. grimes is director of injury compensation programs and oversees the countermeasure injury compensation program or see icp as well as the vaccine
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injury compensation. they are covered under cicp. where as most other widely distributed vaccines are covered under vicp. as of january 2024 cicp has compensated 11 claims out of the more than 12,000 that have been filed for covid-19 vaccines. because of its design cicp payments are also smaller than vicp. an average of about $3700 compared with $500,000 in vicp. it appears that cicp may not be designed or equipped to handle a vaccine that was so widely distributed and mandated
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for many as covid-19 vaccines were. i have concerns that we would not be able to expect people to line up and get vaccinated during the next pandemic if they feel that, in some way, they are going to be abandoned. this testimony is important to design better systems for the future and establishing best practices. i hope this hearing will provide us with an opportunity to discuss what lessons were learned during the pandemic, about our vaccine safety and surveillance systems. these lessons, i believe, are critical in preparing for future pandemics, which is the mission, one of the missions of the subcommittee. i look forward to a robust and on-topic discussion about these issues and i want to thank everyone for being here, especially our witnesses for being here. i would now like to recognize
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ranking member louise for his opening statement. >> thank you and thank you to the witnesses for your participation in today's hearing. our nation vaccine safety systems play a critical role in protecting public health. every day scientists, physicians and public health officials work together as part of this is him to monitor the safety and efficacy of vaccines to ensure the best possible products reach everyday americans. their efforts have helped protect us from the threat of deadly diseases for decades. their efforts during the covid- 19 pandemic help contribute to one of the most successful vaccine rollouts in history, which under president biden's leadership, led to the country out of the depths of the pandemic. in total, these efforts saved 3.2 million lives. it prevented 18.5 million hospitalizations and save the united states an estimated $1.5 trillion in
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medical cost. as a physician who went out into underserved communities to administer vaccines during the height of the pandemic, i saw firsthand the difference these vaccines made in helping our communities overcome covid-19. at the end of the day, we were able to save so many lives, prevent so much illness and reduce a mounting of medical costs on our system because these vaccines were shown, repeatedly to be safe and effective due to extensive clinical data. since then, our nations robust vaccine surveillance systems and countless other studies have only reaffirmed the safety of these vaccines by monitoring for and evaluating serious adverse events which remain rare. this system has worked well. in
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fact, we saw it identify safety signals in vaccines during the pandemic when it detected cases of thrombosis with tts associated with the johnson and johnson vaccine. resulting in the cdc and fda releasing updated recommendations for vaccine products. i do want to be clear that while adverse events are rare, they are not impossible. that is why we must continue to invest in a strong and capable vaccine safety and surveillance system that is efficient and in assuring the best quality vaccines reach the american people. it is why we must ensure that when an adverse event does arise, people can receive the protection and compensation that they needed. there is good bipartisan work. i know we can do this on this
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front to strengthen the national vaccine injury compensation program and countermeasures injury compensation program to make them more efficient. i hope that -- i hope that we discussed those reforms here today. today's hearing does have the potential to generate forward- looking policy solutions that improve people's lives however, it only does so if we approach this topic with care. if we don't, i worry that we are opening a pandora box that i fear we will not be able to close again. right now, we are already witnessing an alarming rise in overall vaccine hesitancy, which has been fueled by disinformation spread online during the last four years. as this disinformation has pestered, immunization rates among americans have fallen for covid-19, polio, measles, mumps and rubella. this should be alarming to us
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all. we have already seen outbreaks of measles pop up and under vaccinated communities in the last year, including in philadelphia and columbus. we have already seen an additional 300,000 covid-19 deaths in the u.s. that could have been prevented if not for a growing distrust in vaccines. i worried that the liberalization of medicine, the politicalization of science and vaccines will hurt us all in the end. in the manufacturing of distrust and public health norms and institutions that we have held true for so long will make us less prepared to combat a future pandemic but republicans already 2.4 times more likely than democrats or independents to believe that covid-19 vaccines are unsafe. childhood vaccination rates are already at historic low. we are already in the process of
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undoing decades of progress in overcoming infectious diseases at unless we handle each opportunity to discuss this with email care, we are hurtling towards an even more grim future. i urge for a constructive and civil conversation among us all today but focuses on strengthening our current safety and compensation programs enhancing confidence in our public health institutions and building a brighter, healthier future for us all. i yield back. >> thank you, dr. ruiz. our witnesses today are dr. daniel jernigan. he is the director of the national center for emergency zoonotic infectious diseases at the centers for disease control and prevention. dr. peter marks. dr. marks is a
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director for center for biologics evaluation and research at the u.s. food and drug administration. dr. george reed grimes is the director of injury compensation programs at the u.s. health resources and services administration. pursuant to committee on oversight and accountability rule, the witnesses will please stand and raise their right hands. do you solemnly swear or affirm that the testimony that you are about to give is the truth, the whole truth, and nothing but the truth, so help you god? thank you. you may be seated. let the record show that the witnesses all answered in the affirmative. the slight cub -- subcommittee appreciates you all for being here today and we look forward to your testimony that me remind the witnesses that we have read your written statements and they will appear in full in the hearing record. please limit your oriole statements to five minutes.
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as a reminder, please press the button on the microphone in front of you so that it is on and the members can hear you. when you begin to speak, the light in front of you will turn green. after four minutes the light will turn yellow. when the red light comes on, your five minutes has expired and we would ask that you please wrap up. i now recognize dr. marks to give an opening statement. >> 23, chair,, and members of the select subcommittee. thank you for the opportunity to testify to talk about the covid-19 response and ongoing vaccine safety efforts. vaccines work. we know from clear and compelling evidence that vaccines save lives of millions of children and adults every year by producing immune
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responses that prevent diseases such as measles, influenza and covid-19. though they may not provide perfect protection, vaccines can often prevent the most serious consequences of disease including hospitalization and death. the american public can rest assured that vaccines that are off the ride -- authorized and approved are safe and effective. the vaccine development process and fda's stringent regulatory and scientific evaluation process and continue safety surveillance ensure about the health benefits of available, approved and authorized vaccines far outweigh any risk. regarding covid-19 vaccines, fda helped make these critical medical countermeasures available as quickly as possible without compromising our scientific and regulatory standards. during a once-in-a-lifetime pandemic that was a public health emergency, fda scientists and employees worked around the clock cooperatively,
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intensively and efficiently alongside researchers and manufacturers to minimize the time between the clinical development process, manufacturing scale up in the regulatory review process. hundreds of americans were dying from covid-19 daily at this time. and every day we can make vaccines available sooner counted. every day counted and we made them count. between december 2020 and may 2023, over 270 million people received more than 675 million doses of covid-19 vaccines in the united states, including over 650 million doses of the mrna vaccines. the covid-19 vaccines have had a tremendous positive impact over the course of the pandemic globally. ultimately saving millions of lives since their introduction. the vaccines continue to be among the most effective public health measures worker
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preventing the serious consequences of covid-19. a large part of what has made this public health success possible is the deployment of sophisticated safety monitoring in fact, covid vaccines are the most closely monitored vaccines that have ever been rolled out in u.s. history. the safety of the approved and authorized covid-19 vaccines has been monitored by the fda for both passives and active safety surveillance systems in collaboration with cdc and other governmental and nongovernmental partners. fda also participates in ongoing international vigilance efforts and these are in addition to the safety surveillance efforts required of the vaccine manufacturers. these surveillance tools work. in early 2021, days after pass of safety surveillance
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reporting through the vaccine adverse events reporting system detected that six at a more than 6 million patients who had received the hansen covid-19 vaccine had developed a rather -- where blood clotting disorder. they recommended causing the use of that until the risk to be evaluated. another example is the detection of myocarditis that followed the use of covid-19 vaccines which led fda to modify labeling and the cdc to provide advice on the mrna covid vaccines to healthcare providers about how to reduce the risk. vaccines are one of the most highly effective public health measures. they are responsible for saving millions of lives every year. the benefits of available, approved and authorized vaccines in the united states, when used appropriately, continue to far outweigh any risks. staying up to date on vaccination has been and continues to be the best way to
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reduce the risk of death and serious illness or hospitalization from various infectious diseases, including covid-19 thank you for the opportunity to testify today but i look forward to answering your questions. >> i now recognize -- to give an opening statement. >> distinguish members of the subcommittee, it is an honor to appear today to discuss edc's ongoing work to monitor the safety and effectiveness of vaccines. i serve as the director of the national center for emerging and infectious disease at cdc which includes the immunization safety office cdc works to protect against public health threats through prevention, detection and response. vaccines are a cornerstone of that work. they have played a leading role in eradicating smallpox and eliminating wild poliovirus
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from the united states and averting millions of illnesses and deaths from childhood vaccine preventable diseases. during the covid-19 public health emergency, over 676 million doses of covid-19 vaccines were administered in the u.s.. there are estimated to have prevented millions of hospitalizations and deaths. these public health successes have been made possible by shared commitment to ensuring vaccines are safe. as such, vaccine safety monitoring is a top priority for the cdc and we collaborate closely with the fda and other partners. we utilize multiple data systems in a complementary and layered approach to detect possible safety signals and investigate them rigorously and act promptly when appropriate. the vaccine adverse event reporting system or vaers is a system where individuals, healthcare providers and manufacturers can report adverse events following vaccination that may need to be investigated further.
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vaers is not designed to determine if a vaccine caused a reported event. rather it is an early warning system where we evaluate reports of serious adverse events and use complementary systems to further analyze potential safety concerns. these other systems include the vaccine safety datalink, which uses electronic health records of a robust analysis and the clinical immunization safety assessment project, which offers consultation to providers on patients adverse events. during the covid-19 response, the cdc established a smart phone app where individuals can report health impacts after vaccination and we also established a covid-19 registry to monitor pregnancy and infant outcomes over time following vaccination the cdc is committed to transparency and
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regularly shares information on vaccine safety with our federal and state partners. in addition there have been more than 30 public meetings of the advisory committee on immunization practices featuring research on covid-19 vaccine safety and effectiveness. this approach to safety monitoring works. i will share two examples with you and underscore dr. marks' comments. during the first six weeks of the j&j vaccine was authorized for use. the cdc identified six cases of a rare and life-threatening blood clot through vaers. when additional review identified a causal relation between the j&j vaccine and the blood clots, the cdc and fda acted within days to inform clinicians and the public and can be an emergency meeting of the practice and recommended a positive in the demonstration of the j&j vaccine. further investigation led to preferential recommendation for mrna covid vaccines over j&j
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and currently the j&j vaccine is not available in the united states. the second of is myocarditis. in april 2021 cdc observed high reports of myocarditis following the vaccination particularly in young men through the vaers system. after confirming these events using the vaccine safety datalink, the cdc quickly updated clinical considerations while continue to recommend covid-19 vaccinations. further research has shown that the risk of myocarditis is substantially lower following vaccination then following infection. as these examples show vaccine safety monitoring by the cdc and our partners is rigorous and transparent. the data continues to show that staying up to date on covid-19 vaccines is an effective and safe way to prevent severe illness, hospitalizations and death. the development and administration of covid-19
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vaccines is a remarkable scientific achievement. after the most robust and comprehensive safety monitoring in our history, the science shows that we would all have confidence in the covid-19 vaccines and that they are safe and effective. i appreciate the opportunity to discuss the vaccine safety efforts and look forward to your questions. we went tonic. i never can mind -- recommend dr. grimes for his opening statement. >> thank you for the opportunity to speak with you today about the work of the health resources. i am commander read grimes, director of the countermeasure injury compensation program or see icp. the public registry and emergency preparedness act of 2005 or the prep act provided compensation for injuries or death directly caused by the
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administration or use of a countermeasure. they have received approximately 13,000 claims alleging a covid-19 countermeasure injury filed with the see icp since the declaration of 2020. of these 9600 alleged covid-19 vaccines as a countermeasure. for context the program received about 500 claims over its 10 year history prior to covid-19. while injuries are rare and the claims we have received for covid-19 represent a small fraction , less than 0.001% of all covid-19 vaccine administrations in this country, the case for the cicp is higher than it was prior to 2020. when i became director in december 2021, i immediately focused on the need to increase the cicp's capacity to process claims. the prep act as a high standard
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for an individual to be compensated by the cicp . by law, we are required to establish the covered countermeasure directly caused a covered injury, which must be determined based on compelling and reliable, valid and scientific evidence. as a result the cicp conducts medical reviews of each cicp claim to determine if it meets the statutory standards. this detailed review includes an iterative process of obtaining and reviewing comprehensive medical documentation from cicp requesters as well as closely reviewing and monitoring the medical literature. for compensable claims, the cicp must also collect detailed financial information given that the program, by statute, can provide composition only after other third-party payers. at the prime of the prep act declaration, the cicp had no
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appropriation and only four staff. we requested and congress provided a direct appropriation for the first time in the history of the program in fiscal year 2022. with these funds, we have been able to increase hiring and have 35 full-time staff working to process claims. we have also implemented other process improvements to resolve claims at a faster rate. in 2023 we average more than 90 claims result each month, which is up from zero per month the year before i started in this role. additionally, we are proving information technology and other communication channels with requesters. while the program has made significant improvements, there is more to be done the president's fiscal year 2024 budget requested $15 million to operate the cicp. with these funds, we want to continue to increase our capacity to analyze and resolve claims, including through increased staffing and i.t. infrastructure improvements.
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we are committed to working with congress to meet the program's resource needs to increase the rate of cicp resolutions. the cicp is also in the process of establish and injuring table for covid-19 vaccine injuries that are presumed to be directly caused by a covered countermeasure. in order to establish this table, hhs must meet the standard set by congress. the injury table is another tool that will allow us to streamline the claims review process and more expeditiously addressed requests. finally, i wanted to address the national vaccine injury compensation program or vicp . the vicp was established under a different statute, the national childhood vaccine injury act of 1986. for a vaccine to be covered on the trend -- vicp, certain conditions must be met, including a recognition from the cicp for for routine administration to children or individuals who are pregnant. the vaccine must be subject to an excise tax.
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covid-19 vaccines currently do not qualify for vicp coverage, which would require congressional action. we at hrsa are carrying out these programs as directed by congress per thank you for the opportunity to be here today to discuss hrsa's work and we look forward to continue to work with congress on these critically important programs. >> thank you, all, very much for your testimony. i recognize myself for questions. i want to say a couple things before we start. i want everyone to understand, especially those serving on the government side, public reception -- perception becomes reality. because of that, words matter. words matter. for those of us, as members of congress, or as physicians at home, we are face to face with people.
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we are sitting face to face with somebody. we are not just looking at data on a sheet and making decisions. it needs to be done, what you are doing, but there is a difference. that is why i say words matter. let me give you an example. when you say safe and effective, that is relative in your mind. it is relative in your mind but it is not to the person at home. they hear 100% safe and 100% effective. that is what they hear. this is why words matter. dr. foutch he in his testimony would say, you can never say that any treatment is 100% safe. in essence, that is what people heard and are still hearing today. we have to change that. the doctor on the ground with a member of congress on the ground is one on one with somebody explains that to them, hopefully.
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yes, this vaccine saved hundreds of thousands of lives and i will advocate for that for any time and that is why it was for emergency use because people were dying and we knew from the trials that they could save lives and keep people out of the hospital. we also knew that you could still get covid. we never really heard that from the federal level. we just heard, it is safe and effective. now we have a society that thinks that the polio vaccine and the other vaccines are not necessarily safe and effective, the way they have been. we never explained mrna technology is different from the technology of the other vaccines that have been around forever. and you lump them together. when people come to my office to tell me i had ad adverse event of some type, i am one on one with them. it is not something on a piece of paper.
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so, words matter. that is one of the things i want to stress across the board from the subcommittee at the end of the day. early on, i will tell you that i even said to secretary a czar, america needs to be hearing from the doctors treating covid patients. not the politician who says if trump makes this vaccine, i'm not taking it. is that helpful? we need to hear from the doctors treating covid patients. the doctors administrating the vaccines and the doctors we are trying to save lives. that is what the public needed to hear from. we have to be careful with our words. i am grateful. dr. jernigan, you gave a caveat today but it kept you from being hospitalized in most cases , or dying especially if you are amongst the most runnable.
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i appreciated that. that is the type of messaging we have to have going forward. i am grateful we live in a country that has the systems in place. they are there to protect the american people and to provide for better health in america. there is ways we can do better and that is what i want to talk about today. i will start by asking this question about vaccine safety and surveillance. i want to ask each of you this question. at least dr. jernigan and dr. marks. is any pharmaceutical 100% safe ? >> thanks very much for that question, chair wenstrup . no pharmaceutical is 100% safe or even the water we drink is not 100% safe if you drink too much you can die from complications of water poisoning. >> well said. >> thanks for the question. as clinicians we all recognize that no medical integration is
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risk-free. >> i will go to dr. grimes. there is a reason we have a compensation program. >> yes, sir. there is a reason we have a compensation program and we are dedicated to diligently caring that out. i cannot say it any better than my colleague sitting next to me have. >> it is important we properly surveil for these inevitable injuries. unfortunately, inevitable, injuries. no matter how many or how few. would you agree with that, dr. marks ? >> i would agree fully with that but if we want to maintain confidence in the vaccines and the other medical products that we authorize or approve, we must have very robust safety surveillance systems in place. >> dr. jernigan. >> i agree we need those comprehensive and multiple vaccine safety monitoring systems.
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>> dr. grimes. >> i could not agree more. >> i agree with that. do you feel with what we currently has is sufficient i do not mean that in and adversarial way. what are some of the things you think we could do better. as i said at the beginning, sometimes it takes something like a pandemic to recognize where we can do better. in the bane of surveillance system being sufficient, any ideas that you can add to that? >> thanks so much for that question. i believe we had a very good safety surveillance mechanism in place that included overlapping systems and including passive and active systems. i do believe we could do better. i think there were challenges in getting data in real time
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that limited us in our ability to understand what was happening on the ground and hopefully, we can work better together with all of the individual states to have a more unified safety surveillance system should this ever happen again or, for that matter, even on an ongoing basis for our medical products. >> thank you. >> throughout the pandemic, we stood up with the most intensive vaccine safety monitoring in u.s. history. we really see the benefits of having a robust vaccine safety monitoring system and sustaining that will be a critical feature for us moving forward. >> dr. grimes. >> i would defer to my colleagues to my right. they are the experts. >> a fair enough. one of the things as i had the pleasure of meeting with you all individually. what occurred to me in hearing some of the concerns, especially during this pandemic and it came on quickly.
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you had workforce challenges, if you well, understandably, considering that. and every component of what you do. one of the ideas i had -- i am an army reservist. one of the things i had a, is we have a reserve component in each one of your categories of interest. we can call up experts in the field that can handle the increased load during a pandemic. to me, that would really aid our national security and our national health security. it is just a thought but i would love to get your opinions on it. i know you face many challenges by the overload of what took place. dr. marks. >> chair wenstrup , thank you so much for that question. i really appreciate the opportunity to reflect on this issue when the pandemic happened , we at the fda were dealing
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with our usual files that we have. there are many vaccines that are important for everyday life. we did not have a codger of people to just move over. we had to pull people to work on the covid-19 vaccines. many of them had to learn how to deal with emergency use authorization. i cannot agree with you more that if we had a codger of people ready to move over, very familiar with a major's use authorization and able to quickly move to reviewing vaccines and a pandemic setting, that would greatly help us in the future. >> you pointed out the workforce and certainly in public health with this estate territory at the cdc, we have an aging workforce but we need more public health people working in the field we at the cdc really
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having to act as a response agency to not structure it that way. having some additional ways to quickly mobilize folks to stand up systems quickly and implement innovations rapidly, that requires a robust workforce that we really need going forward. >> thank you for the question. i think we in the cicp, at the beginning of the pandemic, has a four staff , as i mentioned in my opening comments. we needed to scale up to do the volume of the work. that is one of the things we look tough for the future, are the opportunities and strategies to optimize scalability and flexibility to perform the essential functions of our critical programs. >> i appreciate that, as someone who has endured mass casualty events. you know, being able to be
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prepared for that or at least have a call up ability to do that. i think that is something i hope we can look into as a congress to consider that type of reserve work force that is ready to go on day one. as of february 2024, vaers reports for covid-19 vaccines total significant rehire than all other vaccines combined as reported. this is a surprising figure. dr. marks was the government prepared for an avalanche of report due vaers ? it kind of goes with what we just mentioned. >> thank you so much for that question. i apologize about your name before. it shows when you are nervous, things can happen. the point is extremely well taken. we tried to be prepared for that. the avalanche of reports was tremendous. it requires re-tasking people on the fly and i will let my cdc colleague speak to this. we had to usually staff up and
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had many meetings working to increase our ability to go through these reports. as you already mentioned, what the public sees on the public vaers page is just a small fraction of the information that we ultimately collect and sift through. it is very important to determine whether an adverse event is truly related to the vaccine. one of the things we often receive is that we do not make additional information available. i would say to you that it is a challenge. what we have learned is that it is very challenging to make available, essentially, protected health information. if you have a z.i.p. code that someone was pregnant -- if you have a zip code of someone in ohio that they were pregnant and they had covid, you could potentially re- identify those. this is one of the challenges that we face in making available information. i think we like to work to make
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the most of information available as possible. >> do you have any concept on that, dr. marks, as far as this number, you know, childhood vaccines, they are spaced out. this was a vaccine that was being administered -- would it be a larger swath of the population? was the number higher ? was at the same per capita, if you will ? does that make sense? >> our seasonal influenza campaigns often administer about 150 million doses over the course of a number of months. here, we had millions of doses rolled out on top of each other at a tremendously rapid rate. in addition, we encourage people , part of the emergency use authorization process, we were encouraging safety reporting
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because we thought we needed to know, at any potential adverse event so that we could try to investigate and find out if there was something we were missing. >> did you have anything to add to that, dr. jernigan ? >> i now recognize dr. ruiz for questioning. >> one of the greatest public health challenges of our time. i agree with the chairman, words matter. what we say here today will have a significant ramifications on whether millions of americans will place their trust in safe and effective vaccines, including the covid-19 vaccine. before i get to my question i would like to enter into record a letter the select subcommittee received for more than 50 medical and public health organizations and experts ahead of today's hearing. here you go.
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this letter, which was led by vaccinate your family and signed by a broad coalition that includes the american academy of pediatrics, the association of state and tory alto -- territorial health officials, state and city health officials, the american public health association, the american heart association, doctors for america and many more warns us of the potential damage that could be dumb if today's hearing fails to handle the subject of vaccine safety carefully and without advice. just this morning a group of six leading medical societies representing more than a 560,000 physicians issued a joint statement. they wanted to acknowledge the overwhelming evidence based science and
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recognize how covid-19 vaccines protect and save millions of lives. i would also like to enter the statement into the record. >> without objection. >> as a position and as ranking member of the select subcommittee, i want to ensure that today's conversation remains rooted in the facts. the facts are that while delivering effective covid-19 vaccines to the american people at a historic pace, our federal public health officials went to painstaking links to evaluate their safety and they are continuing to do so. dr. marks, your division of the fda is responsible for evaluating data to authorize and approve products, including the covid-19 vaccine. could you explain for us the rigorous standards of the fda has followed in its authorization and approval processes for the covid-19 vaccines >> thanks so much for the question. the covid-19
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vaccines, before we even started to receive data, we put forth guidance, first in april and then in october of 2020 which described our expectations for the safety and efficacy of these vaccines. that is the standard that we would use before we can issue an emergency use authorization. for the initial amusing -- we had data which was equal to what we have or equal to what we would have required for a biologic license application and we required effectiveness data that was near or equal to what we would have required for a biologic license application. we cannot speed up time. in order to get the vaccines, we actually about the safety to be authorize with just two
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months of media follow rather than the six to 12 but we would comment that would capture adverse effects. when we went to finally do the biologic license application we go through very large data sets. the pfizer vaccine had 43,000 people involved in clinical trials with about 21 or 22,000 had received the vaccine initially and then thousands more received it after six months. we went through tremendous amount of data and looked at the adverse events and looked at the effectiveness data. that plus looking carefully at the manufacturing. >> what has the data shown a guarding the safety? >> it includes that there are some initial discomfort, potentially in the arm, fatigue that could occur. there are rarely more serious side effects that we identified that we identified myocarditis
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and where allergic reactions. thankfully, by putting mitigation strategies in place, both of those have been decreased in occurrence. >> dr. jernigan, your division is responsible for operating surveillance systems that detect adverse health effects. mild or serious. could you please explain the multitiered system that the cdc has in place to monitor for safety concerns regarding vaccine that have been brought to market? >> thanks for the question. like i said, we have been putting through the most intensive vaccine safety monitoring in u.s. history. that includes five different systems at the cdc. the first of those is the vaccine adverse event reporting system, that we talked about. it is an open door to get the reports in the second is the vaccine safety datalink. it is
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a large health record, about 13.5 million records in it. we look for trends. we have a pregnancy monitoring system but we have the smart phone enabled app called v-safe . we have a clinician immunization safety assessment program. we have medical experts that can provide input in this safety monitoring. that system has been tremendous with us being able to follow what is going on with vaccine issues. what we have found, so far, at least with the datalink, is that there are lower rates of death in those that are vaccinated compared to the unvaccinated. there are lower rates of cardiac complications compared to those that have been unvaccinated. what we are looking for in the vaers system is signals of th ings i think this thprocess works w we were able to find statements
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that there were six cases of a blood clot problem, a very rare problem that can be identified very early. we were able to communicate that and follow a science-based process where the science is evaluated, it is provided to the advisory committee and we know that the committee advises and provides it to the director to decide. that science-based process is what we have been following utilizing the data. >> that is a system where individuals can report their systems that they believe are associated with the vaccine. how do you determine if it is associated with the vaccine or it is not associated with the vaccine? >> it is essentially a front door where anyone can put in
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anything that they think might be associated with that vaccine. we have a lot of reports that might not be associated with the vaccine, there is a process for reviewing it. it is followed up, medical records are collected and autopsy records are collected too. we don't use it to look at trends about whether the vaccine is more commonly causing a problem versus what is in the general population. >> one can subscribe the data from there's to be the actual rate of death or serious illness, because that is an initial screening and then the investigation that occurs
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afterwards, will determine if it was in fact related to the vaccine or not. there are cases where death was reported where you found that it was not due to the vaccine, correct? >> correct. a hospice patient who is one of the more vulnerable people we want to get vaccinated, they might have do not resuscitate, they might die two days getting after the vaccine but is not associated with the vaccine. there is reports of vehicle injury in folks that were vaccinated and family members who died caring for a vaccinated patient but the death was not in the vaccinated patient. there are a number of those reports. what we want, is to be able to say, what is the impact of the vaccines and we have looked at other data to get us that info. >> this rigorous surveillance
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system has been successful for the covid-19 vaccines. tts among patients that receive the j&j vaccine, for example, use plain how the detection of these cases reflects the seediness of the vaccine safety surveillance system? >> these indicate that the process works. you mentioned the tss associated with the j&j vaccine. it can show that the risk is much lower among those vaccinated compared to those who were vaccinated. it is a system we have been able to pick up signals that turn out to not be signals. a stroke can occur. we picked up the signal but when we continue to follow it, it went away. we get signals that are there,
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sometimes they are, sometimes they are not. we can act quickly and change recommendations when needed. >> my understanding is that following the detection of these cases, fda limited the use of the j&j vaccine. how did they reach this decision? >> thank you for that question. we evaluated the data that came in regarding the vaccine itself, the j&j vaccine. there was another vaccine that was like that vaccine that was being used outside of the united states which had a similar issue, we look at the totality of that data and then we changed the fact sheets for providers and patients, making a recommendation that this not be a first-line vaccine to be used for a single dose vaccine was desirable rather than a two dose regimen. >> the surveillance system
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worked as designed detecting rare adverse events and creating a policy decision to best protect consumers, is that correct? what would you say to americans that say that they draw into question the safety of the broader universe of covid-19 vaccines? >> i think what we see here in vaccine safety surveillance i might be confusing for the public sometimes, i sometimes listen to very weak signals and that means i you turn up the game. we have the surveillance system turned up very high. the ability to detect signals. sometimes we hear things that turn out to not be true. we have the game turned up high. we continue to look for
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signals. we sometimes find them. as i speak, we are in the process of evaluating if there are signals that have been detected that are real, or if they turn out to be a statistical anomaly. >> i am not an amateur radio guy, i am a doctor. you are talking about specificity or sensitivity. it sounds like we want to detect as much as we can and rule out the false positives, correct? >> and doctors language, sorry. the idea here is to have a very sensitive system to pick up any signal and then, we can go back and try and make sure it is truly related to the vaccine, thank you. >> i hope my colleagues will heed the warnings we received ahead of today's hearing.
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public confidence in vaccines that have saved millions of lives and are the significant health intervention are not something that should be undermined for partisan gain. i yield back. >> i now recognize the chairman of the full committee for five minutes for questions. >> thank you, mr. chairman. i want to talk about the vaccine approval process. pfizer submitted the approval application may 18th, 2021, correct? >> that is correct. >> january 18th, 2022 was the required action due date, correct? >> that is correct. >> you worked with dr. philip crouse with this? thank you, when pfizer submitted the application, dr. crouse oversaw the approval process, they should approve the vaccine pastor then eight
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months. they proposed the end of october, 2021, you requested september 15th, 2021. they hesitated but oblige. you said that you wanted it approved even faster than september 15th and they declined. according to them, after you declined, you and janet woodcock relieved them of the roles in the approval process. they felt substantial pressure from you to approve this vaccine faster than what they thought was defensible. did anybody instruct you to speed up the approval timeline faster than september 15, 2021? >> thank you for that question, it deserves an explanation of what was going on during that summer, in the week ending july 10th, 2021 there were 1645
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deaths and in the week ending august 14, there were 9114 deaths from covid-19 and there was clear knowledge that having an approved vaccine would help americans feel more comfortable getting vaccinated. we felt speeding up the vaccine approval process -- >> let me interrupt. did anyone instruct you? did you make this decision on your own? >> this is a decision i made on my own. >> why would you pressure the doctors and remove them from the approval process when they disagree? >> the approval process was one that needed to move as rapidly as possible. >> we may go back to that. do you recall any conversations regarding the need to approve
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the vaccines, in order for it to be mandated? >> there was an acknowledgment that an approval could allow vaccine mandates to occur, they were not conversations over that. >> u.n. dr. woodcock said that it does not require mandatory vaccination, do you recall this question? >> i'm not sure what you are referring to. there is probably a statement of fact that when you have a licensed vaccine, a mandate could be placed. >> do you recall why they expressed concern about accelerating the approval of the vaccine? >> they were concerned about the workload. >> taking a thorough approach was important because of increasing evidence of association with this vaccine and a development of
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myocarditis, and your mother the safety signals regarding myocarditis? >> there are safety signals known and they were placed on the label. >> did you have a conversation about the vaccine approval with the department of defense? >> i cannot recall any conversation directly with the department of defense. >> did anyone at fda have conversations regarding vaccine approval with the department of defense? did you express your desire to approve the vaccine by august 20th? and it was proved august 23rd, correct? just for the record, the military mandate was issued on the 24th? that is interesting timing.
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thank you, mr. chairman, i yield back. >> i now recognize ms. dingle from michigan. >> thank you, i am concerned that americans confidence in the safety and efficacy of vaccines is critical to the nation's public health. for hundreds of years, dating back to 1796, vaccines have saved lives. however, we are now witnessing startling decline in immunization levels across the board and i am deeply concerned about what this means for our nation's ability to respond to public health threats in the future. we have mizzou outbreaks even in washington, d.c. i want to focus on what we can and should do to promote vaccine confidence with reforms that enhance community engagement
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and strength in the vaccine systems. one way we can go about this is approaching people with cam passion by making sure that their questions are answered honestly, trust worthily with accurate information that breaks through some of the noise, that is a lotto false information online. during the height of the pandemic, democrats passed the american rescue plan. it also invested in community- based outreach programs to increase vaccine uptake. this focused on meeting people where they were to equip them with transparent, reliable information about vaccine safety and development. i would like to get your thoughts because i have some other questions. how does the cdc work to provide people with timely and accurate information regarding vaccine safety? >> at cdc we are committed to transparency and we shared that
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information on vaccine safety through different communication methods that we have through the web, through media, et cetera. >> i think it is important that people know about the known side effects of the vaccine or adverse effects that might occur after vaccination. i was assured that it was saved and effective and it was obviously neither. i was scared to death to get this covid vaccine. i sought out accurate information from any doctor i knew walking down the street. to reassure me about the safety of the covid-19 vaccine. i did get it and prepared to die, i am still here giving everybody a hard time. ultimately, i supported the biden administration's commonsense policies to
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increase vaccine uptake. i believe we have systems in place. the systems are working to ensure that adverse events can be detected and meaningfully addressed. can you please speak to the ways in which the cdc provides transparent information regarding rare adverse events that may occur from various vaccines, including covid-19 vaccines. >> as we mentioned, there are different surveillance systems that we monitor. when we see any single there, we communicate that to the general public to provide that information to the advisory committee and recommendations can change. we are committed to transparency. we have information on risk- benefit analysis at 30 different advisory committee meetings over the last three years. we get that information out so that people can understand. >> what steps should congress
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take to strengthen these efforts? what role does comprehensive funding play in the ability to operate these surveillance programs? >> we want to work closely with healthcare providers. the decisions, from many times the information that we want to get out. we have safety systems right now that are at a very high level in terms of the activities we are doing. we do not need to go back to where we were before. we need to sustain these systems that are broad now and get the most information about safety. >> in the rare instances when something does go awry and in adverse event occurs, people need to know that there is protection and compensation available to them. how do the compensation programs work to adjudicate valid claims or compensate
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individuals as quickly as possible? >> thank you, for that question. the compensation program, we are required to make a determination based on the compelling and reliable and scientific evidence that a serious physical injury or death was directly caused by the countermeasure. we have at least three advanced practice providers that review each claim and each claim is reviewed for legal sufficiency to make sure that it meets with a statute set by congress. >> i hope we will all work together to make sure people keep confidence in vaccines, they prevent deaths, ultimately. >> good morning, thank you, mr. chairman, for holding this important hearing. i would like to extend my gratitude to all of our witnesses for taking time to share their expertise with us
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today. in march of 2020 our world experienced an undeniable shift. covid-19 brought fear and uncertainty. in a triumph of science and innovation, a vaccine was developed in record time. however, subsequent actions from overstating vaccine efficacy and sweeping mandates and the suppression of open scientific debate eroded public trust. leaving questions about vaccine safety, sparking valid concerns and unfounded fears. unfortunately, the action surrounding the covid-19 vaccine have highlighted areas where these systems may have fallen short and we can start rebuilding trust for safe and effective vaccines in the future, we do know that vaccines really are often times
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lifesavers. i do want to point specifically to the concerns about postvaccination heart issues, particularly myocarditis in young people. myocarditis is one of the injuries that have been compensated for. i would like to know from bowls, what specific monitoring , safety monitoring or research projects are currently underway by the cdc or the fda, to delve deeper into this issue. >> i am happy to start, thank you for that question. we have had multiple go arounds in the adverse event reporting systems that use active surveillance, one of them is the best system, to look among large databases and electronic healthcare records to look at the incidence of myocarditis
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in vaccinated individuals versus nonvaccinated individuals. some of that work has now been published. it leads us to understand that after the first covid-19 vaccine where they were given two doses three or four weeks apart, there was a risk in the younger age range that was one in 20,000. now with the spacing out of the vaccines, the risk is almost undetectable and there was a recent study published in 3 million+ individuals ages 5-17 years that they received the vaccine doses which only, confirmed what we had seen. there was a signal for myocarditis after the
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vaccination series in those 12- 17 years of age and now, that signal is not being seen more recently. we have learned something about how to deploy the vaccines. that is why cdc has changed their recommendations for how they be used. >> if you could quickly add to that? >> we have diverse systems that are monitoring other systems and we continue to monitor for myocarditis. >> is the fda actively conducting safety surveillance on those that receive the early covid-19 vaccines? are there health markers i you are studying that may signal trends that may require further inquiry? >> every time we go through and do the safety surveillance, it goes back to 2020. some cases where we are looking for certain things, we might
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use a different window. indeed, we have to look at the beginning of the period he can speak to max cdc in that regard. >> we certainly have been monitoring the issue with various different data systems. it is 18 times less likely to get if you are not vaccinated. >> not just myocarditis, everything. >> is the fda conducting surveillance on those who receive the early covid-19 vaccines? >> usually adverse effects are the first few weeks following the vaccination. following the lower times we do have effectiveness systems that are in place at cdc. >> we are running out of time, thank you very much. >> i now recognize ms. ross
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from north carolina. >> thank you very much, mr. chairman. thank you very much to our witnesses for being here today. i want to correct the record on some misrepresentations that we have heard here and that we have also heard in the public regarding the covid-19 vaccine and vaccine safety systems more broadly. in listening to today's hearing, one might be led to believe that reports submitted to the adverse event reporting system are the most meaningful measure of adverse health events and should be the sole purpose for evaluating if the covid-19 vaccine is safe. my understanding is that is just one surveillance program within a multilayered vaccine safety system that cdc operates and submissions to them which are unverified can be submitted
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by anyone no matter how likely vaccine is to create an adverse event. through these other surveillance programs. is that correct? >> yes. vers is a way to quickly identify trends. it cannot be used to determine causality. >> can you explain in more detail how vers prompts this deeper investigation through other safety surveillance programs at the cdc? >> after the last several years there have been 676 million doses of vaccine that have been administered. and that is an exceedingly rare number of adverse events reported. each of the serious adverse
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events does have a follow-up. they ask for medical records and autopsy records. this program can evaluate some of the findings, there other data sets that can tell us if there is an increased signal across the general population that we need to be worried about. >> thank you for that. >> for the reasons you just explained, it seems like the vers data on its own does not provide a strong basis for evaluating causality. doing so does require this multilayered approach. is that correct? how far into the multi layered approach are you for the covid vaccines? >> an ongoing basis, we have presented at each of the advisory committees on what we are seeing. >> just to be abundantly clear, using the vers data exclusively to make claims about covid
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vaccines causing adverse health effects would be flawed? >> the vers is not to be used to determine if a vaccine is causing an adverse effect. >> thank you very much. dr. marks, my colleagues have attempted to distort an email you sent regarding the authorization of the pfizer booster. this is evidence of political interference that undermined patient safety to expedite the process of this product. i would like to give you an opportunity to correct the record on the rate misrepresentations of this email that had been made. i have 1:15, it is all yours. >> thank you so much for the opportunity, at the time, that these boosters were authorized,
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just before, we had an increasing number of deaths running into the thousands per day in the united states. there was great urgency, to think about what we could do to try and reduce the number of deaths, it was clear that immunity was waning and giving a booster could restore immunity and decrease the number of deaths and so we moved with all due haste, not because of any kind of external pressure but because of internal pressure. we felt compelled to save american lives because thousands of people were dying. i had a pretty good idea of how to find efficiencies to move forward. it was critical to move as fast as we could. by the way, the data showed that introduction of the first booster was probably responsible for saving hundreds of thousands of lives as we entered the delta and omicron
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waves. >> thank you, mr. chairman, thank you all for being here. dr. marks we spoke over the phone back august 10th of 2021 and i was asking about vers because i had lots of constituents reaching out to me saying that they are were tons of adverse effects and thousands of deaths and they were very concerned. i asked how many were confirmed and then at that time, you said four, four cases that you confirmed deaths of that were caused by the vaccine and i suggested at the time that the cdc and fda do a better job of telling the public not just how many cases were reported, but how many were actually
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confirmed. and if i heard you right, recently, you said that you do not want to give out too much information because of privacy rights. certainly we can put out how many were confirms death, couldn't we? >> congressman, thank you so much for that question. i fully agree with you that we have not done a good enough job of communicating at sometimes the actual number of deaths versus what is in vers. we fell prey to it at this hearing. there are only handfuls, i will asked to comment on this again. handfuls that we can actually associate -- >> why have you not done it? this was august of 2021. it seems very logical to me that if you are saying that people in the public should not count on vers because anyone can report to that, why wouldn't you actively report to the public what we confirmed in this really low number of cases
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that were actually caused by vaccines, it has been years now, why have you not done it? >> we did present that in various settings, including at the advisory committee, it was mentioned at the vaccine advisory committee. perhaps it did not go as broadly -- >> is there an easy place for the public to find this? you gave us a link back in 2021, it was difficult to get to if i remember right. why not spend the time -- if the goal is to give confidence to people in getting vaccines, why in the world would you not say, okay, what we have done is we have investigated these deaths, we have done this and that. we have only found a handful. it does not make any sense to me. i want to continue, i'm sorry, i only have a short period of
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time. one of my constituents from arizona worked for a company that forced him and mandated him to receive the covid vaccine in may of 2021. he got the j&j vaccine and within a month of receiving the vaccine he was in the hospital, paralyzed from his neck down. he spent over three months in the hospital and was eventually diagnosed with -- syndrome, the doctor has said right on his medical stuff that it was most likely caused from the vaccine. steve continues to struggle with his injuries today, because he was forced to take an experimental vaccine at the urging of the health agencies. his injury was reported to vers and he filed a claim about two years ago, and he has not heard
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back at all. not even a form letter. i want you to know that, commander, so that maybe my office can give you his name, so you can respond that you got the claim from two years ago. also, there was a new york man that suffered from hl age, after his covid vaccine. his initial report was classified as life-threatening. his second report filed after his death was classified as hospitalized. the family requested a correction to the second report to be a fatality and was instructed to file another report that was sent a condolence letter from the cdc. the fatality was in may of 2021. the letter was received in december of 2022. the family subsequently sent an automated message at the end of 2023 to update their vers
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report on his condition, he is dead. the family has been distressed by the lack of proper investigation done and classification that he has actually died. all i am saying, i have run out of time. as you have said, you have increased the number from four personnel to 35. obviously more work needs to be done, if the person died and it says they are hospitalized. this is a huge problem. with that, i yield back. >> i recognize the ranking member of the full committee from maryland. >> thank you, mr. chairman. you said a moment ago that the vaccine booster alone saved hundreds of thousands of lives. how many lives have been saved
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by the covid-19 vaccine generally? >> it is estimated in the united states about 3.2 million lives. it is estimated that globally covid-19 vaccines have saved 14 million lives, conservatively. >> we have lost more than 1 million people to covid-19. >> that is correct. about 1.1 million. i kept a daily record which got up to about 3200, one world trade center director per day. >> a sequence of missteps and mistakes made by the prior administrations pandemic response cost hundreds of thousands of american lives. i take it, one of the points you have to make is that the public health response at the
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federal government makes a huge difference in terms of health outcomes for the american people. >> i would agree with that. >> whether it is measles, tuberculosis, covid-19, would you agree that vaccines save lives in the aggregate? >> i think that by definition, for us to approve or authorize a vaccine, there has to be overwhelming evidence that many more lives are saved then might be taken by a vaccine. the safety profile has to be by definition, excellent. >> it seems as if one of the things that has created political and social conflict around this is the fact that even when vaccines save a huge number of lives, millions of lives as dr. marks just
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testified, if in a small number of cases there are adverse results, the people who suffer them and their families are understandably very upset about that. would you agree that is a general conflict or dynamic that exists with all vaccines? >> correct. we recognize that no medical intervention is risk-free. >> if i had a family member that suffered an adverse reaction to any vaccine, measles, covid-19, i would say, i wish they had not gotten in the first place and of course, if anyone would've been able to predict it, they would've been told not to get it. on the other hand, if we just said to everyone, there is a tiny number of people that
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suffer an adverse result and no one should get it, we know a lot more people will suffer and die because of it. is that a basic problem that you wrestle with in your field? >> correct. anytime we talk about public health measures, we talked about the risks and the benefits. >> have you detected anything at the cdc, through your surveillance systems, that has caused you to doubt the safety or the appropriateness of the cdc original and continuing recommendation that people get vaccinated against covid-19? >> i dedicated my life to public health and i care deeply about protecting americans and using the best available science. i want to stress that the covid vaccine is safe and effective. we have safety monitoring
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systems in place and we have acted on those quickly. >> would you agree that the covid-19 vaccine and its rollout in the biden administration has been one of the great achievements of modern science and public health? >> over the last four years we had a once over a lifetime event that required an incredible response from all of us. the use of vaccines has been a remarkable achievement for us all. >> there is a paper that someone sent to me called access death rates for republicans and democrats from the department of public research that makes the point that there were higher access death rates for registered republicans compared to democrats and this is related to vaccine hesitancy or fears. i was wondering if you would pine on this for a second, have we seen a case like this in the past, where there is partisan
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differences in people's willingness to get a vaccine? their skepticism and death rates arising from such differences? >> you point out the importance of us getting is so that other folks can be vaccinated. >> i now recognize ms. green from georgia for five minutes of questions without objection. >> thank you, mr. chairman. i have a phd in recognizing -- when i see it. we knew early on that the people that were at risk of hospitalization and dying of covid were those that were obese, had diabetes, were over the age of 65, we also knew that children were at no risk, practically zero risk of being hospitalized or of death from covid-19, we knew that young people, healthy young people were not at risk. dr. marks you rushed through this process of authorizing
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these vaccines, even though you knew the side effects, you knew about myocarditis and you knew about the studies. let's be real about the situation that we have. here we have the reports on vers. some people on here trying to belittle these reports, these reports come from people. people that died. people that got injured. in december, in the middle of december, the first vaccine was approved and authorized under emergency use. 10,596 report in less than a month. 2021, 706,000 reports on seven four deaths. 2023, it went going down because the mandates stopped.
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let's talk a little more about the vaccines. here we have reports, deaths, 18,372, permanent disability, hospitalizations, emergency room or office visits. serious adverse events, 313,449. all kinds of injuries. miscarriages, heart attacks, myocarditis, permanent disability, neurological problems, it goes on and on. these are people being forced to take vaccines, it should not have happened. i have just told you the numbers of reports, however, under cicp only 6640 of these
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claims are pending or under review. cicp only compensated 11 of the 40. let's make that number cleared over. only 11 people have been compensated. only 11 people have been compensated. out of the for the covid-19 claims that were eligible, only 40 were determined eligible, that is amazing. the average award was only $3700. on the other hand, the average payout over the last 30 years was $490,000. if you die or get injured from a covid-19 vaccine, i would like to recognize someone in the room today, she has met
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with you, dr. marks. she has met privately with you about her vaccine injuries. she participated in a clinical trial and was injured and then was dropped from the trial for the covid-19 vaccines. her medical expenses are $443,000 per year. she filed with cicp and has gotten no response. she is right here, can you raise your hand? thank you. perhaps you can meet with her after this meeting. dr. marks, you admitted to her that vaccine injuries are real. that they are real. you rushed through the authorization and now, you have authorized that children should receive these vaccines and even babies as young as six months old. that is shameful.
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i will continue speaking, thank you, this is my time. the national institute of health, also saw her for her neurological complications that have been quite severe, they studied her and then they dropped the study and asked her to be quiet about it. these are the real stories of the vaccine injured, they were totally and completely wiped off of social media. there have been thousands of peer-reviewed medical studies. thousands of them studying vaccines injuries. they are real, people are dying and having heart attacks, strokes, blood clots and many other countries are dropping the covid-19 vaccine and saying that we should not give them to children. it is time to be honest about the vaccine injured. we need to stop allowing these vaccines to be given out to
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children. >> the young ladies time has expired. >> thank you, mr. chairman, that was a lot of conspiracy theories and wild accusations that have been debunked by medical science, vaccines work and save lives and they have saved millions of lives in this country. it is unfortunate that we are here having this hearing trying to poke holes and cause more vaccine hesitancy among the public. we know we are here, because committee members have demanded we have this hearing and we continue to cave and give those members everything that they want. we know that we have a member of this committee that just made some comments that has been on social media demanding that we hold this exact same hearing. this is the same person that we know has on countless posts spread misinformation, encourage parents to refuse vaccinations for their children
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and even compared the responses to the holocaust. i want to read something that is in the public record, i'm not saying anything that is not in the public record. a member of this committee actually said, this same person said that vaccinated employees getting a vaccination logo just like they forced jewish people to wear a gold star. that is the level of insanity and attacks that we are having is an actual debate around the lives saved from vaccinations. this is a member has held the shadow public hearings that covid is a bio weapon to target specific races. i want to read you this quote
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from the public record at a hearing. have the covid vaccines resulted in an increase in cancers and our turbo cancers real? in my opinion, this is insanity. we know that is not the case. dr. marks, can you clarify again for the american people, do the vaccines cause turbo cancers? >> i do not know what a turbo cancer is. it was used in a paper in mouse experiments is describing inflammatory response. we have not detected any increase in cancers with the covid-19 vaccines. >> thank you. >> may i add something here. i do need to apologize to the 1000 or so parents of children who are under four years of age who die of covid-19 that were
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unvaccinated, because there were deaths and there continue to be deaths in children and that is the reason why they need to get vaccinated. thank you. >> i agree with you, 100%. the fact that we are having parents that are choosing to vaccinate their kids less than before because of all the attacks on vaccinations, it is shameful that members of congress continue to put down vaccinations as an opportunity to get communities healthier. i want to thank you for the work that you did, my mom passed away from covid-19. my step father passed away due to covid-19 and both would've taken the vaccination in an instant if it was available to them. any time that folks on the subcommittee attack vaccines, it is personally insulting to all of the families that have actually lost loved ones. we have saved millions of lives because of the vaccine. it is unfortunate that we keep
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causing this harm. i just want to say, lastly, dr. marks, do you agree that additional lives would've been saved, from the folks that were not vaccinated that we lost, over 1 million, in this country, with a vast majority of those lives have been saved if they had been vaccinated? >> 85% of the deaths that occurred were in unvaccinated individuals. if we could've reached a higher vaccination rate, it is likely that we would've had fewer deaths. countries where they reached higher vaccination rates have lower deaths per capita. >> i would like everyone to encourage vaccination. with that, i yield back. >> thank you, chair and i would like to join in with the
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previous comments with members of the committee and welcome all of you again, thank you for being with us here today. mr. chair, i would also point out the members of this committee, even though i'm not the chair, there should be some sense of decorum. vulgarity should be discouraged. if i ever say that i am a phd in bs , i will not talk about what was said today. people across this nation who want and expect that congress, if no other place, will conduct itself in a way that does not insult any of them personally because of vulgarities and away that we should conduct business. as chair of the american ethics, has always been one of
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independence and self- sufficiency. as a society we see health decisions as deeply personal and deeply private. in some instances, the proclivity towards individuals is him can provide hesitancy around vaccines. in the case of the covid-19 pandemic, fear mongers amplify vaccine hesitancy and it is done without substance or fax but through fear and by way of late-night talk shows and syndicated radio shows. those talking heads, took advantage of certain communities negative experiences with the american public health system by playing on fear and mistrust and by amplifying a vaccine hesitancy across the nation.
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when you do that, you really play with fire. in this case, the fire that the gentleman from california mentioned about how we lose loved ones and how people die and how that rate of death accelerated over and over again. i really want to think god that the great virologist in 1955 did not run into the nonsense when he developed a vaccine for polio. parents were clamoring because they wanted their children to be able to walk and have a good life. there was a sense of sense and sensibility that went along with that. when it is done right, it is done right. so many children and others are vaccinated for polio successfully and were there some bad stories along the way, i'm sure there was, just have we heard that when you are dealing with science, there is
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not 100% certainty and everything. mr. chairman, my colleagues on both sides of the aisle know that covid vaccines under accelerated development timelines have proven over and over again to be safe. i would ask unanimous consent that i submitted into the record, this article, from the general interest news site entitled, will america continue to turn away from vaccines. dr. jérgen can you explain again for the committee, there are people watching this around the nation that missed some of the early discussion, can you explain for the committee again, the multilayered process of vaccine safety monitoring that the cdc implemented for
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covid-19? >> has, i have worked in public health since 1994. this is the most robust vaccine safety monitoring system that we have ever had. there are five different systems, we use all of those to determine the impact of the vaccines and the safety. all of those systems are used by cdc. >> can you also elaborate that by all standards this is an incredibly thorough process that meets all of the merits of scientific approach and rollout for such. why are these systems so crucial in strengthening vaccine competency in the united states? >> we want to make the best recommendations with the best available sciences. we use a science-based process to get to those recommendations. making sure that science is first and making sure that we
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have the data. >> i want to thank all of you for being here with us again. mr. chairman, i yield back. >> thank you, mr. chairman, i want to thank the witnesses for testifying before the select committee today. i would like to say that i am a former director of the state department of health in iowa. i was vaccinated and gave vaccines in all 24 counties of my district and i have never been for a vaccine mandate for covid-19 both when i was distributing vaccines as well as today. dr. marks, covid-19 remains somewhat of a public health challenge including declining vaccination rates. let me say, as a public health director, and as a state senator, vaccine hesitancy and
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fatigue is not new. this has been an issue, and has been enhanced through covid-19 mandates. i understand that the fda has recommended periodic updates to vaccine competency. supporting the ability of a diverse supply of covid-19 platforms heard multiple fda approved vaccine options can play a role in consumer choice of products and ensuring equity of access which can contribute to increased consumer acceptance without forcing americans to receive a specific option. can you speak to how the agency is taking steps to ensure that vaccine manufacturers have the time needed to adapt their products accordingly for new virus variants. >> thanks very much for that question.
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i would certainly agree with you that there is a need to have choice among vaccines. that will allow a greater vaccination rate because some people may not feel comfortable with certain types of vaccines, they might want a more traditional vaccine more than a newer vaccine. that is why we have been continuing to work with manufacturers to make sure that when we rollout the next update, we will have a diversity of choice, at least more than one type of vaccine that will be available. you will see, as we move into spring, as you have noted, we will go through a strain selection process and we are already having dialogue with manufacturers to help them get prepared. there is a lot of work they can do to prepare for this so that we can hopefully have the choice that you are talking about. >> thank you. as you know, covid-19 vaccines are covered over the cicp with
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fda being responsible for authorizing and approving the covid vaccines and responsible for adjudicating cicp claims for the shots, i'm concerned there is too much government involvement and overlap with covid-19 vaccine adjudication. furthermore, the cicp was not designed for a pandemic as large as the covid-19 pandemic. in addition to the rsv and genki vaccines which are also available. adding vaccines has an excise tax which will require congressional action. when a new vaccine is approved and marketed, what steps are
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required to ensure access to compensation and what happens if a new vaccine is not added to the list of taxed vaccines? >> thank you for that question, we have two measures from the national vaccine compensation program that are both in my division. with the national vaccine compensation program we work with the department of claims to do separate duties to adjudicate the claims. three criteria must be met. one is the routine recommendation by the cdc for routine administration and children or individuals who are pregnant. the second is the excise tax which is a noticing coverage that the secretary of hhs without. for a dengue or rsv or covid-
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19 vaccines to be added to the program all of those would need to be met. >> dr. grimes, what is the rate of denial for compensation for claims for covid-19 vaccines and cicp? >> i do not have the right. >> i understand there's a current backlog of claims in cicp by more than 10,000. why is there a backlog of claims for the covid-19 vaccine? >> thank you for the question. at the beginning of the pandemic we did not have a direct appropriation with the cicp. we also had only four staff. when we receive the first direct appropriation in fiscal year 2022 we were able to ramp up quickly and now we have over 35 staff assisting to adjudicate themes. >> thank you.
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my time is expired but i would like to submit additional questions to be answered after the hearing. >> so ordered. >> thank you very much. >> i am deeply concerned about some of the dangerous rhetoric we've heard through today's hearing which appears purposely aimed at undermining confidence in vaccines. i agree with you, mr. chair, words matter and so do fax. ahead of the steering we received a letter from the association of state and territorial health officials took an organization representing public health officials. this underscores the importance of, quote, informing the public truthfully about the safety and effectiveness of vaccines and to engage the topic responsibly and with the utmost integrity. mr. chair, i would like to enter this letter into the record. >> without objection. >> thank you. i'm concerned that with today's hearing my republican colleagues have failed to handle the subject with the care
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our public health officials avast were recklessly amplifying misinformation about the covid-19 vaccine. what my colleagues on the other side of the aisle may claim that this hearing is only about the covid-19 vaccine, they cannot and must not ignore the fact that the coven misinformation, intentional spread of misinformation has resulted in across-the-board decreases in immunization levels over the last few years. in fact, the world is experiencing the largest global decline in decades in the number of children receiving basic immunizations. a recent survey conducted at the university of pennsylvania found the number of americans who viewed vaccines as less than effective has increased since april 2021. most americans think it is likely safer to get covid-19 than to get the vaccine. one in six americans believe vaccines cause autism and are now less likely to consider getting the measles, mumps, and rubella vaccine.
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when we are seeing outbreaks of previously controlled diseases like polio and measles pop up not just another countries but here in the united states. measles was declared eliminated in the u.s. in 2000. we have seen consistent outbreaks mostly, especially in under vaccinated communities. these include outbreaks of eight cases in philadelphia and an outbreak of 85 cases among unvaccinated children in central ohio in 2022. the savings of vaccinations to medical cost and human life cannot be formed. the cdc estimates immunizations for children between 1994 and 2021 will prevent over 1 million deaths and save nearly $2.2 trillion in societal costs . already we know that covid-19 vaccines have saved more than three point -- 3.2 million lives has been referenced in
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the hearing. let's be clear. no parent wants to do their children harm, but many parents are sadly getting and trustingly acting upon false information like what we have heard today. i would like to discuss today how we can make sure parents get the best and most accurate information they need so we can promote confidence in long trusted life- saving vaccines and prevent outbreaks of deadly diseases. can you please explain how the fda evaluates vaccines to ensure they are safe and effective for the age groups they are intended to be used for? >> thank you for that question. every vaccine that we authorize or approve we require to have manufacturing information to show it is high quality and we have to have information on its effectiveness and safety in the specific population that it is being prescribed and or we have to be able to understand that it will function similarly in that age group that we are
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authorizing or approving it for. it is a process we take very seriously at the agency. there is a very dedicated group of people that spend their time poring over data to make sure that in the thousands of records that are submitted to us, thousands of pages over 1 million pages for one of the biologics license applications that we get that authorization or approval right. >> thank you. parents have questions about vaccines for their children. what steps do you recommend they take to get their questions answered.? >> i think we talked about this the other day. the primary thing we need is conversations between parents and their providers. that provider does not have to be a physician. it can be a nurse practitioner or someone in a doctors office that is a physician assistant. but having that conversation,
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the individual conversation where people can ask questions and have them answered, i have spent a lot of time during the pandemic doing that and it makes a huge difference. i believe in the privacy of the provider patient relationship. >> thank you. i am out of time but i would reiterate that today wally have seen republican lawmakers so distrust and life-saving vaccines, i hope this committee can correct course and focus on work that matters. keeping people alive, keeping them safe and preventing outbreaks of deadly diseases, expanding access to critical vaccines and safeguarding the health of americans. >> your time has expired. now recognize the gentleman from texas. >> thank you for being here. we hear from agencies they can fix everything if only they have more funding, more authority, more data. the covid-19 pandemic showed us we have a different problem in
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that is the structure that approach to public health. the government provided millions of dollars for vaccine development aided by taxpayer- funded scientists. that we purchased the vaccines back from the pharmaceutical companies. next the fda and cdc were responsible for evaluating the safety of the vaccines and clear them for emergency use. and not content with recommended vaccines for the american people to make their own decisions they attempted to force american people to get the vaccine blatantly disregarding constitutional evidence. at the same time they were provided special liability protections ensuring they cannot be sued for adverse effects. instead the government bureaucrat gets to decide whether or not somebody was injured. and offer them a minuscule
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amount of money as compensation if they manage to make it through an arbitrary process which is very intensive. so right now we have the same agency funding the research, approving and mandating and adjudicating the covid vaccines . it concentrates too many government functions in the same hand. so much of this misinformation was actually fostered by the federal government in the sand -- sense that we have the federal government colluding with social media companies to discourage the scientific opinion that when against what was the stated mandate at the time. to help clear the record i would like to ask a couple things. dr. marks, you stated that vaccines work at the outset. i don't think this committee is designed to question that. but there is an attempt in this conversation to throw the covid- 19 -- a very new different
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scientific approach to vaccines with a new data set that is still developing and all those kinds of things with very well- established vaccines like polio or chickenpox or meningitis for these types of things when i think americans rightly so after watching the government of the last couple years could have some concerns about covid- 19 and the information that has been presented. i want to ask you a couple of questions a simple yes or no. does the covid-19 vaccine prevent the disease from you receiving the disease? >> you cannot have a yes or no answer that question because it will reduce your risk of serious outcome such as -- >> i'm not debating whether or not it helps people mitigate some of the -- >> they do a very good job of preventing death and hospitalization. it may not prevent the infection.
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>> the mantra at the time was to stop the spread. we were understood that we either could not receive it or transmit it when it was released. could he speak to that? could you receive it or transmit it after receiving the vaccine? >> having worked at cdc for 30 years i have seen the benefits of the vaccine. we have to make the best recommendation. >> can you transmit it or receive it? >> we need to make the best recommendations we can. >> it is a yes or no western. commander, can you receive -- >> i think we make the best recommendations for the public. >> can you still get covid after getting the covid-19 vaccine? >> yes. >> that is correct. >> does it prevent you from transmitting it? >> there is data that shows earlier in the pandemic there was some reduction in transmission. the data on that is very
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challenging to pin down, but it does not absolutely prevent transmission. >> thank you very much. i would ask you, why does the cdc website list it as a vaccine preventable disease and why does it call it a recommended immunization. >> that is referring to the benefit from getting the vaccine. we know it does prevent you from getting severe disease, hospitalization and death. >> the issue right now and why we are seeing a bunch of hesitancy is because the information coming from the federal government has been murky at best on the subject. people do not know what to trust. my question is why the listless along with other very proven long set of scientific data as a vaccine that prevents disease? >> all vaccines have very different levels of effectiveness.
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this is a vaccine preventable disease. >> you have done a great job of filibustering my time. i yield back. >> i now recognize dr. joyce from pennsylvania for five minutes. >> thank you for convening this hearing for our panel today. this is an incredibly important discussion topic. as our continued work on this committee to get to the bottom of both the origins of covid-19 and also the government response. understanding how federal agencies can tract the rollout of the covid-19 vaccines and documented incidences of injury or adverse effect is critically important for any future responses. as a doctor, having accurate and up-to-date information before treating patients during a public health emergency is of utmost importance. a federal health agencies have several systems for vaccine
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safety. the most well known during the pandemic became the vaccine adverse event reporting system. the government also has two systems for adjudicating and compensating vaccine related injuries. the countermeasures injury compensation program which is cicp and the vaccine injury compensation program which is vicp. two of the key differences between the cicp which covered the covid-19 vaccines and the vicp which covers most of the vaccines are who adjudicates the claims and who covers the damages. in cicp claims are adjudicated by hrsa whereas in vicp claims are adjudicated by the court of federal appeals and in terms of who pays it as appropriated funds whereas in
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vicp the money comes from an excise tax that is levied by manufacturers on each vaccine dose. before the covid-19 pandemic, it was a very small program with a small scope? however, claims have exploded now that widely distributed and even mandated covid-19 counter measures are covered under the program. as of january 1 of this year, the total number of cicp claims ever filed was 13,406. covid-19 claims account for 12,854. that is nearly 96% of the total. because of the design and limited resources, adjudication of claims is a lake the and burdensome process. it is also reported that 3640 of these claims are currently pending or under review. commander grimes, how is the cicp structure to ensure
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accessibility and fairness to petitioners and how does this compare to traditional litigation systems. >> thank you for that question. in the cicp we administered by statute . it's a file for request a benefit and must submit medical records to show that there is compelling reliable valid medical and scientific evidence to support that it was directly caused by the use or administration of a covered countermeasure. that could be covid-19 vaccine. it could be a smallpox vaccine. >> let's stay focused on the covid-19 vaccine because that is our obligation. do you feel it is more appropriate to have petitioners, your word, for covid-19 claims to be paid by the vaccine manufacturer or by the american taxpayer?
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>> petitioners are for the national vaccine injury compensation program. those are through the routine administration with an excise tax levied on it whereas the requesters through the ci cpr paid for compensation of claims through appropriated funds and through administration of the program. it is also paid for most appropriated funds. >> as a physician i am also worried that in some cases health practitioners do not know where and how to report adverse effects which is critical to ensuring that all vaccine events are accounted for. i also have concerns of how these events and potential risks are reported to healthcare providers. for each of you, could you take turns in describing what your respective agency insures against any adverse effects that are reported and how those reports are managed and how this information is conveyed to the front-line individuals that are dealing with this? dr. marks. >> thank you for the question. each vaccine label whether it
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was the authorized vaccines or approved vaccines, it has set information on where to report adverse events. when we get those we can combine with cdc and sort through those events. we take them seriously and investigate them to sort out whether there are any there. >> we provide information through the vaccine information sheets that are provided to everybody to understand the potential risks. we also communicate to the public and take information, put that together and communicate with the advisory committee and the recommendations can be changed if needed. >> commander, did you see any faults in the system? >> i am here to testify on behalf of the director for the division of injury compensation programs and not to the cdc and fda systems. >> i now recognize dr.
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maccormack from georgia for five minutes. >> thank you. i know we are on a timeline so i will get straight to the point. i want to point out that it was president trump's operation works be that had unprecedented delivery of the vaccination in record time. i think it is ironic that this scientific achievement will forever be tainted with the government's handling of covid- 19 and the mistrust that was created and the federal programs that surround it. to avoid partisanship in this case i would like to highlight that it was democrats who touted the program that president trump not only came up with but received the vaccination himself and admits openly to getting the booster as well. there are ironies in this argument all the way around. the question is, why has america become so distrustful of vaccinations as my colleagues have pointed out. why is it that they no longer want to get a vaccination that may have potential benefit.
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i would make a couple points on this. first of all, when you when you assert yourself between a doctor and patient and some doctors contradict you and you censor them, even when you are not a doctor treating patients, people will say, why does the government have authority to do that? to censor my doctor. when you start requiring people to do something instead of encouraging, the natural resistance of a freedom loving people that we are founded on those principles will be to resist what you are requiring. it should not be any surprise to us when the people say, i'm not going to do what you are telling me i have to do when my doctor may agree with me and not you. you are the government. why do we insert ourselves in inappropriate ways? when we talk about the evolution of science when you have immunity and you are still requiring a vaccination that could cause a hyper immune response which you can admit to there is risk versus benefit on every decision when the government says we will make a carte blanche assignment. it is
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no wonder people are mistrustful of our recommendations. this is the problem we have right now so that talk about the vaccination liability and compensation program. it came to my attention last february when i heard from my constituents that claims were sent to cicp for vaccine injuries and were constantly lost or denied or caught up in bureaucracy with little or no transparent he. now march 3 of last year several of my colleagues and i wrote a letter to hrsa about our serious concerns regarding the countermeasure injury compensation program and expect to respond to constituents in a reasonable timeframe. first of all, i would say along of the government sku actually responded so i think you care. you pointed out that you have a very small -- four people working for you which was based on the pre-pandemic response
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force and you were trying to respond to 13,000 people with four employees. since then you have been blessed up with 35 people, i believe. might accurate in saying there is 13,000 claims approximately? >> there are approximately 13,000 claims about 9600 of which allege vaccine. >> of those which, how many have been closed? >> 2200 about. >> okay. the number is 35 employees handling those claims. >> yes. >> i have to be quick because we are on a timeline. how many claims are we processing per month? >> in 2023 we processed 90 claims per month over that year and that velocity increased throughout the year. >> of those claims how many had been shown to have some merit for injury?
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>> currently there are about 40 that have been found to have an injury that was directly caused by covid countermeasure. >> so a pretty small percentage. >> yes. >> so to do the math each employees handling about 2.7 cases per month and showing 40 out of 2200 cases that have been processed of the 13,000. that means we have about 10,000 cases and backlog. i know you have asked for more employees but at 2.7 per employee it would take us about 10 years to process the remaining claims. the application process to get this denial processed through some sort of appeals process has an even smaller approval rating. it is a judge jury and executioner. i do not think it is right. i think we need to streamline the process. you need to as a leader in my opinion know what paperwork is required, how it is processed
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and increase the process by 10 fold to do our job for the american people. i am out of time and i yield. >> esther chairman, i would like to ask unanimous consent to submit this to the record. it's an article from the new york times that says covert shots for children most of the world has decided most young children do not need to receive covid booster shots. the u.s. is an outlier. >> without objection. i would like to recognize ranking member weeks. >> medicine is very nuanced. the human body is so remarkably beautifully made and our physiology is a complete wonder still. taking a snapshot of a time and using it to go back and define the entire experience of covid in children is again misleading . now with rates that are low,
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with information that we have on children that are high risk, immunocompromised should get the vaccine. in certain areas where the rate is low and the risk of getting infected in an otherwise healthy child, one would reconsider whether that child would need a booster or in the situation. throwing these kind of facts out there without the context and understanding is wrong. it is very misleading. in fact, we have talked about how there is a screening, not the definitive tool to use the rate of side effects or serious side effects from getting the vaccine. these are individuals who get
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the vaccine and whatever they feel afterward they report it. we want them to do that. we want them to do that. it is a way to screen for this. we want to have high sensitivity to reduce the false- negative. then with this kind of screening test you have a high false positive. that is why we need to reevaluate more in-depth investigation on an individual basis to determine whether in fact it was caused by the vaccine. we already laid out the reason scientifically why it is not, of the five systems it is not the system to use as the definitive rate of infections. but to use it because it has the false positive is
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intentionally falsely misinterpreting the data that is causing vaccine hesitancy. people know but they intentionally still speak to it as if it is the definitive data. that is the part that gets me. that is this information. that is not misinformation it is intentionally giving false information for their own personal and partisan political gain. that is a clear example of what we have been talking about of politicizing science. let's just go back and summarize that in total covid-19 vaccines saved 3.2 million lives, prevented 18.5 million hospitalizations and saved the united states an estimated $1.15 trillion in medical cost.
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when we say that the vaccine does not prevent getting sick or does not stop the spread of disease, let's go back and talk about the nuanced aspects of the use of vaccines which is supposed to boost your immune system. if you have a high enough immune response to the virus then yes, for those individuals it does prevent them from getting sick. am i right? >> correct. >> so by lowering the risk of getting infected, yes it does prevent getting vaccines for those individuals. it is not an absolute, but when we talk about absolutes we are intentionally giving this information to the american public that they do not work. if you lower the risk of getting the illness and getting
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sick or increase your immune response enough to prevent symptomatic infection, then wouldn't you say that that reduces the risk of spreading it to other people? >> where you -- the more you can lower the viral load the more likely you are able to. >> the viral load is a medical term that is important to understand. vaccines increase your immune response and lower the viral load. people who have a small viral load decrease the risk of spreading the disease. is that correct? do i have that physiology right? >> that would be correct. >> would it be correct to say that indeed vaccines reduce the spread and for some individuals prevent the spread of the virus to other people. correct? >> i think we can say that as a
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general statement. i would not want to make it as an absolute statement in the spirit of today. >> that is my point. by and tensioning using absolute statements like that without the nuances, people should know better. they are just informing the community. what i said was not absolute. i said it reduces the risk of spread and for some people it reduces the spread. it does and can reduce the spread with that new one. it is because of the safety and efficacy of these vaccines that we are ultimately able to overcome the pandemic is because of the vaccines that we are able to change the vaccine guidelines over time or our social distancing practice or wearing a mask.
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yes there is work to be done to promote in the united states. we could agree on that it requires funding capacity, human resources. we can fix the systems to help make it better but there is no doubt that the multisystem vaccine safety apparatus surveillance systems is the best in the world. we should talk about that instead of focusing on these false positives or false narrative so we can build confidence in the american people. so misusing our platforms to spread false or disinformation does a disservice to the american people. it manufactures distrust. these accusations manufacture distrust fear mongering manufactures
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distrust. with increased distrust you increased vaccine have it is -- hesitancy. with less people taking the vaccine more people get infected the pandemic spread and more people die. how does this help us prevent or better prepare for the next pandemic? it doesn't. it makes it worse. it puts people's lives at risk and actually harms the american people. this is the opposite of helping to prepare and mitigate the harms of the next pandemic. i hope we can find a path forward in the serious work that needs to be done to save lives in the event of a future pandemic and keep people safe. as i said when we started today's hearing we are already in the process of undoing decades of progress in overcoming infectious diseases
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so we must handle each opportunity to discuss this matter with the men's care before we reach a point from which we cannot return. i hope going forward everybody can drop the outrageous false rhetoric we have heard by some today. instead identify a constructive path forward that protects the people's health. i yield back. >> thank you. this hearing should not have been political and most of it was not. i would say today fortunately. the fact that it is is further evidence that this conversation is completely necessary to take place. i can say that i have invested in all sides of the issues around the pandemic, starting in 2020 being on the intelligence committee and also researching what other countries were doing, how to try to treat people and save
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lives. as representatives we are the conduit to asking their questions. it is not easy for them to just call you and get an answer although i thank you for taking my call early on during the pandemic. perception is reality. i mentioned that at the beginning. that is what we have to face and words matter because when you say reduce, it is different than saying prevent. that happened too often. not necessarily from your voice, but it happened and that is what america heard. i think it became clear today that it is not the be all and all. it is the initial recycling can if you will pick then you decide what actually goes
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further but we did not say that it is the only one america saw. it was the only thing that was out there for the public so what do we expect. i think that that matters. we see things on some of these natural items in the drugstore it will say not approved by the fda as a legitimate treatment, but it is okay to take but it's not necessarily going to meet all of its claims necessarily. that is an honest approach to what america is out there. i think there has never been a question that vaccines save lives by anyone. i am from cincinnati. you know how much pride we take because it is the home of albert sabin and the polio vaccine? it is huge. that is in our dna in cincinnati. we grew up knowing that. we
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take pride in it but we cannot leave behind those that have been injured simply because they don't necessarily fit a narrative regarding the vaccine safety. we have to take all of that into consideration. we heard today patients and parents should have a conversation with their personal healthcare provider to assess the vaccine whether it is appropriate for their particular position, condition, whatever. dr. marks i heard you today very caring lee i feel say you have regret about those under 5 that may have died from covid. i spoke to pediatricians and some say, yes i think they should be vaccinated if they have a, b, c, d, e. that goes back to talking to your doctor and that goes back to revealing all of the data about those that may have died. these are
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children that maybe would have died if they got the common cold. i don't know. but those are things you have to take into consideration. i have learned a lot about covid-19. i think if you want to assess vulnerability maybe we should check the fear and levels -- that is another story. this committee, i think we did a good job today. we really looked at the fact and we were able to discuss openly about where the pitfalls are and i'm not just blaming the government because it is also politicians. it is politicians that drove a lot of distrust in what was coming out of public health. just go back to the beginning. president trump says we need to restrict travel.
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dr. fauci told us he recommended that we restrict travel. what happened to president trump when he said that? he is a racist and politicians say there is nothing to worry about here. that is a raisins -- racist comment come to chinatown and create a super spreader. that is a problem on our side. that is why i say we need to hear from the doctors more than anybody else. lives have been saved but we cannot ignore certain things. i mentioned before, dr. marks you are advocating on operation ward speed. but you have a politician saying in essence if it is your vaccine she is not taking. that does not help us.
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that creates vaccine hesitancy. when a politician stands up and says, if you take this you are not going to the icu and you are not going to die yet some are going to the icu and some are dying. that is a fact. there may have been a lot of of the reasons for it. china comes out and says we've got this under control. the w.h.o. parents that. dr. lane goes to china. they've got it all under control. that is the advice given to politicians. of course this there is distrust but that came from china themselves. they did not have it under control but that's what they were telling everybody. that leads to distrust so we must trust by verify especially when taking advice from an adversary. the risks have to be put out.
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no drug can run a commercial without listing the risks. it is malpractice if they do not go over the risk. we were not doing that. we issued a mandate saying you have to get it or you lose your job. they go to the drugstore and get it and get the card. i am glad to hear you all agree today, at least i think you do that it requires the best practice to have a conversation with your doctor about your personal health. the better data the doctor has the better we can treat patients. that is what we are after. saving lives, treating patients better. i mentioned before, there is a difference between saying effectiveness data is different than just saying it is effective. there's data that might say it is not 100% effective.
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we knew that, this is what the public years. so they get confused because they know, i know some people had an adverse reaction. why are we saying it is safe? it is not 100% safe. you may have done work completely 100% right but if it is not message clearly or accurately down the line, it is a problem. i often ask where is the surgeon general to be talking about this. when i grew up it was c everett coupe and people trusted. the reason i said we need to hear from doctors treating covid patients i'm reminded of general schwarzkopf during the gulf war. every night people tuned in to hear what he had to say about the war, not what a politician had to say. i think that makes a huge difference. we recognize today gratefully
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we are telling the american people when we recognize myocarditis as a problem we did something about it. that is important. that builds public trust. when we say that we are just ignoring it and mandating it anyway. i question why we quit talking about convalescent plasma as a form of treatment. especially when we knew the vaccine did not prevent you from giving -- getting covid but you just got a sick why weren't we focusing on treatments like that that were very effective? i was told that i needed a booster to go to germany. i had been vaccinated both doses of pfizer. i got covid several months later and the only reason i knew is because i could not smell garlic salt. that is the only way i knew.
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when i got my antibodies checked i wanted to do t cells as well. when i got my antibodies checked when i was told i needed a booster i got the lab report to show it. you have a conversation with your doctor about that. why did we put this aside. that is what america understood. why are we not talking about the benefits of natural immunity. why are we not saying if you have natural immunity you are less likely to get another round of covid. why are we not looking at that data? those are things i wanted to do . i wanted to do that through the military and secretary austin never responded. it was 22 physicians that signed that letter and he never responded. . never answered a question even after several attempts. so we have some things. we have people here that want
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to make a difference especially going forward, but we cannot ignore these hiccups and questions the american people have. if i only sat here in washington i can't have this discussion with you the way i am having it. you go home and you are the conduit to the government. you know what, if we are not honest. if we can't be trusted we don't get elected. they see people in washington never leave. just understand that. that is why it is important we have this conversation and it's important we do better going forward. . i thank you all for your time today. i appreciate the work you do. we want to be helpful to make it even better in the future. thank you all for being here, for your important and insightful testimony. with that and without objection
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all members will have five legislative days with which to submit materials and additional questions to be forwarded. without objection the subcommittee stands adjourned. thank you all for attending.
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>> if you miss any c-span coverage you can find it any time online at c-span.org. videos of key hearings, debates and other events guide you to interesting and newsworthy highlights. these appear on the right-hand side of the screen when you hit play and select videos. this makes it easy to get an idea of what was debated and decided in washington. scroll through and spend a few minutes on c-span's points of interest. today, fbi director christopher wray testifies on the budget request. watch at 2:00 eastern on c-span or online at c-span.org. c-span is your unfiltered view of government. we are funded by these
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television companies and more including con cast -- comcast. republican mike person has been governor of missouri since 2018. back in january he gave his final state of the state address before a joint session of the legislature in jefferson city. the governor who is in the final year of his last term highlighted policy achievements and shared his vision for the he touches on several issues including work development, education, infrastructure and the functional crisis. [applause]

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