more than 40 free 1000 subjects were immunize mostly 18 to 85 years of age an independent data monitoring committee assessed if it can see off of ecstasy in a ficus e was assessed based on the number of confirmed covert 19 cases starting 7 days after the 2nd injection in the press evil 162 cases of covert were reported wired in. a way fx in a to sub subjects we counted 8 cases this is a vaccine if we can see off 95 percent you can see on the slide that. this high vix seen efficacy was observed across separations including you know all age groups also including older diet's off 65 years and age across ethnicities and also across gender us. independent daytime monitoring committee did not know what any serious safety concerns in fact all vaccine was whether tolerate church we are served a common reactions you would have with vaccination ink. pain adventure injection side fatigue headache must so pain most and generally these reactions were a mild to moderate and short lift a tourist events of great free or very rare we observed only a fatigue in 4 percent of participants and a headache in 2 percent o

was generally well tolerated with no serious safety concerns reported by the independent data monitoring committee. both the u.s. and canada will review maderna's vaccine in the coming weeks. >>> here in the u.s. tomorrow the fda advisors to the fda will hold a day long hearing to determine whether to give an emergency use authorization to pfizer's coronavirus vaccine. food and drug administration scientists reviewed the company's data earlier this week. federal officials say they expect to have enough dozes to vaccination 20 million americans by the end of this year. they expect the first dozes will be going out within hours of the emergency use permit being approved. >> we could then have an eua within days. and be giving vaccines to our most vulnerable next week. >> another vaccine made by maderna is also waiting for emergency fda approval. the agency will meet by thursday of next week to make a decision on the maderma vaccine. >>> contra costa county says they have purchased one of the specialized freezers to store the the maderna vaccine. because the county will be using similar freezes owned

we have ongoing safety reviews by an independent data monitoring committee. these are occurring weekly. this makes sense in the context of a rapidly enrolling trial. the dmc consists of four adults and pediatric infectious disease experts and one statistician with expertise in assessing vaccine safety, immune response, and efficacy. no safetyentified concerns during the clinical trial and recommended the study continued as planned at all of their safety reviews. datasummarizes the safety based populations submitted to the fda for this review. starting at the bottom, there are over 43,000 study participants with safety data collected in the trial as of the data cutoff november 14. moving up, nearly 38,000 of these represent a subset with median follow-up time of two months post dose substitute. this means there are over 19,000 participants for whom state follow-up data is available for at least two months post dosage. of the total safety population, there were over 8000 subjects shown at the top for whom seven days of solicited local and systemic reactions wer

data from our phase three portion of the trial. i want ed to highlight somethin for members of the committee. we have ongoing safety reviews by an independent monitoring committee of unblinded safety data. these are occurring weekly. this makes sense in the context of a enrolling trial with this new vaccine candidate. it's one status stigs. all the expertise in accessing vaccine safety, immune response and efficacy. it's identified no safety concerns during the duration of the clinical trial and is recommended that the study continue as planned that all of their safety review. this summarizes the safety databased population submitted to the fda for this review. starting at the bottom, there are over 43,000 study participant with safety data collected in the trial as of the data cutoff on november 14th. moving up the figure, nearly 38,000 of these represent a subset with median safety time of two months. meaning fda guidance. this means that there are over 19,000 participants for whom safety data is available for at least two months. it's the total safety population if there were over 8,000 subject ises shown at the top of whom seven days of local and

an independent data monitoring committee assessed the efficacy of a relaxing, the efficacy was assessedthat high vaccine efficacy was observed across all subpopulations including all age groups, also including older adults of 65 years and higher. across ethnicities and also across gender. the independent data monitoring committee did not note any serious safety concerns, and fight our vaccine was well tolerated. we observed the common reactions you would have with vaccination, including pain at injection side, fatigue, headache, muscle pain, mostly and generally these reactions we re mostly and generally these reactions were mild—to—moderate and short lived. at worst events of grade three were very real. we observed only fatigue and a small percentage and headache into percent of participants and about 98% of participants and about 98% of participants who received the first dose came back for the second shot. we will continue to follow—up with participants and our trials for efficacy and safety for two years and report on our observations. as they come up. with this i would hand over to

particularly in data monitoring committees, with actions that are good for an individual which in the current setting might be giving them a vaccine immediately, and what is best for society, which might mean holding off until a practice see -- until a placebo-controlled randomized trial can continue. resolution of ethical dilemmas always requires compromise. the balance of competing dictates and minimizes physical harms or ethical wrongs which are caused by unfairness, violations of autonomy, or actual personal or societal harm. now, to continue, our ability to conduct clinical trials, which is to experiment on each other, is something that society gives us permission to do. we don't need that permission to do chemistry or biology experiments. and because the procedures and oversights for oct's are so structured and standardized, it's easy to forget how fragile that permission to conduct rct's is. but anybody who has worked at an institution whose research enterprise has been completely shut down because of a single ethical lapse knows that this trust can never be taken for granted.

there's something called a data safety monitoring board or committee that, on a weekly basis, examines the data from therempanies to make sure are no safety signals that anything that would cause concern for the participants. that has been happening on a weekly basis. these are independent experts. they get to see the data in real sureand monitor to make there is nothing happening that should not be happening. anything that can be done to make sure that this is safe has been done. about theder messenger rna technology, because it seems to be new -- it is new to vaccine technology but not new to medicine. the first mention or first reference to mrna, as a treatment for diseases, occurred in 1992. if you go to the national library of medicine and do a search of messenger rna, you will see thousands and thousands of papers have been published on this. a is a new technology in vaccine but certainly not new in terms of clinical medicine. all of those things together should give people some reassurance that they can take the virus and not feel too concerned about it. host: let's talk to bob,

there's oversight from the data monitoring committee from day one and an unblinded team supporting the dnc review cases of severe covid-19 at least weekly to evaluate the indication splits of the number of severe cases in each treatment group in terms of the study design alert criteria and stopping rules that are outlined in the slide. neither the alert trigger was met. now i will go ahead and move on to our efficacy data analyses. the first slide here is showing the demographics of our efficacy population. subgroups listed sex, age, race, ethnicity and the presence of comorbidity. for age, you can see that the elderly population is represented with approximately 20% of the population being 65 years of age and older. for race approximately 10% of participants identified themselves as black or african-american. and there are smaller numbers of participants of american indian, alaskan native, native hawaiian, specif pacific islander. 25% of the population identified themselves as hispanic or latino and approximately 45% of the population has medical comorbidities. 35% of the population w

data and analysis providing guidance to [inaudible] ocoh oversight committee and section b committees. data requests. align data requests with the strategic planning process for ocoh funds, advise committee for monitoring and data tracking outcomes as monitored by the data oversight committee chair, and make recommendations to the committee for making data and over sight available to the public and transparent. so i can answer any questions, otherwise, i think this was reviewed last time, so it's possible for a vote. i think we do have our city attorney, jon givner on the line potentially. >> first, are there any committee members question on the bylaw in general? i think these just got posted, so is there any members that have questions or comments on the documents that just got posted and then either on the proposed language? >> this is member andrews, and i would just say it's good to have last, as all other duties assigned, because that helps outgoing forward. i just wanted to find out who helps on these activities? >> these were actually shared with myself as chair, with the vice chair. i know that member ledbetter gave some feedback and member nagendra on the item in general, and then, we had the

bodies just the way the data and safety monitoring board looked at the data a while ago and said it looks good, let's examine the data and see if we can get an eua. the advisory committee to the fda now has made that recommendation. the reason i think this is so important is that we want to make sure that we impress the american public that decisions that involve their health and safety are made outside of the realm of politics, outside of the realm of self-aggrandizement and are made in essence by independent groups. so it was a very important step

that caused a pause in the study and where we looked and evaluated it carefully the data monitoring safety committee went through all the appropriate hoops to make sure that there was no evidence that it was causally related to the vaccine and gave it a clean bill of health. that then went back to the regulators here, that allowed us to proceed with the trial. the level of trouble here is very, very low indeed. there's really very little adverse effect risk with this vaccine. >> i'm still trying to figure out why a two-dose shot would be approved by regulators, sir john, if the one dose turned out to be much more effective, and why it's sort of confusing who gets how many doses and what the east fficacy rates are. were you able to figure that out? >> yeah. so the -- the efficacy, which the mhra has approved on, 70% efficacy, the same as the efficacy that you get after a single dose. it's important to remember there are other characteristics of vaccines that are equal important as the top line news on a press release, and one of those is durability, the ability to create the best plausible antibody r

data and monitoring committees are actions that are good for an individual which in the current setting might be giving a vaccine immediately and for society which might mean holding off until a practice see bow control, randomized trial can continue. resolution of ethical dilemmas always requires compromise. the balance of competing dictates and minimizes physical harms or ethical wrongs caused by unfairness, violations of autonomy or actual personal or societal harm. now, to continue, our ability to conduct clinical trials, which is to experiment on each other is something that society gives us permission to do. we don't need it to do chemistry or biology experiments. and because the procedures and oversight are so structured and standardized it's easy to forget how fragile that permission to conduct rtcs is. but anybody who has worked at an institution whose research enterprise has been completely shut down because of a single ethical lapse knows this can never be taken for granted and it is earned and reearned through transparent processes to determine what is acceptable. that is wh

research protections, independent institutional review boards, data and safety monitoring boards, the f.d.a. verb pact, and the c.d.c. advisory committee on immunization practices, these are all there to make sure that the tuskegee -- tragedies like the tuskegee syphilis experiments or the exploitation of henrietta lacks never ever happen again. finally, we have to engage trusted voices. medical organizations like the national medical association and the national hispanic medical association, faith leaders and the minority gatekeepers like the historically black colleges and universities, the divine nine, tribal leaders, and the national conference of hispanic state legislators, all of whom ive spoken to frequently and recently as this week. because when these gatekeepers are informed and confident, their communities will be informed and confident. i want to close by saying i know the importance of representation. many of you heard me tell this story i never believed i could be a doctor, much less the surgeon general of the united states, because i never met another black doctor, even though i had straight a's. the first doctor i met o

there's something called a data safety monitoring board or committee that, on a weekly basis, examines data from therempanies to make sure are no safety signals that anything that would cause concern for the participants. that has been happening on a weekly basis. these are independent experts. they get to see the data in real sureand monitor to make there is nothing happening that should not be happening. anything that can be done to make sure that this is safe has been done. about theder messenger rna technology, because it seems to be new -- it is new to vaccine technology but not new to medicine. the first mention or first reference to mrna, as a treatment for diseases, occurred in 1992. if you go to the national library of medicine and do a search of messenger rna, you will see thousands and thousands of papers have been published on this. a is a new technology in vaccine but certainly not new in terms of clinical medicine. all of those things together should give people some reassurance that they can take the virus and not feel too concerned about it. host: let's talk to bob, cal

drug companies ecks and it is gone through an independent data and safety monitoring board and gone through the fda independent advisory committee and it has been subjected to fda guidelines publicly published stating what they would require for approval and finally it has been authorized by fda's career scientific experts as i promised. at 95% efficacy this vaccine is extraordinarily effecte at protecting you fm the virus and getting vaccinate will help keep you and your famy and ur country healthy and safe. with that, i will hand things over to the docr so he can explain more about how the ministration process is working here at gw. thank you very much. >> good afternoon everyone. thank you very much, sretary azar and surgeon general atoms. it is an honor to be part of today' event. my name is doctor bruno and the chf medical officer here at the george washington university hospital and i'm thrilledo be here today on such a historic moment in public health. as our head of ergency magement and an emergency management position myself i have seen firsthand the negative effect of covid-19. there is no dou the covid-19 has put a st

data and safety monitoring board. it's going to the aggies into an advisory committee. it subjected to fda guidelines publicly published stating that fda would require for approval. and finally it has been authorized by fda's career scientific experts as i promised. at 95% efficacy this vaccine is extraordinarily effective at protecting you from the virus. getting vaccinated will help keep you, your family, and your country healthy and safe. so with that i will hand things over so he can explain more about how the administration process is working here at gw. thank you very much. >> good afternoon, everyone. thank you very much, secretary azar, and surgeon general adams. it is an honor to be part of today's event. i am the chief medical officer here at the george washington university hospital. i am thrilled to be here today on such a historic moment in public health. as her head of emergency management and in emergency medicine physician myself, i id seen firsthand the negative affect and life-threatening effects of covid-19. there's no doubt that covid-19 has put a st

we have independent data monitoring and safety boards. you have got the committee, independent people, with people of color on those committees looking at it. and as dr. fauci has said, my good friend, dr. corbit, nih, african-american female, one of the smartest people i know, who actually developed this vaccine. we, now, have many people looking to make sure these vaccines are safe. and i want people to know that and i am working with trusted influencers. steve harvey. faith leaders, like td jakes. we want to make sure people who are trusted in the community have the facts because, if they feel confident, the people who look up to them are going to feel confident. >> if i could just follow up, with the surgeon general. this made you very emotional and, listen, you say we should talk about vaccine confidence. but there are -- this is why we are doing it. there are lots of -- many people who are black, african-americans out there, who don't have the confidence in the government. do you -- what are you hearing, when you're out there talking to people? do they become

data and safety monitoring board. it has gone through the fds independent advisory committee.en subjected to fda guidelines publicly published stating what the fda would require for approval. finally, it has been authorized by fda's career scientific experts as i promised. as covid-19 vaccines begin to receive emergency approval, the race is on to distribute the shot. now an opportunities among companies that are responsible for this global rollout. with the details is dani burger. it is where to go now in terms of investing but you see some pretty amazing returns in covid-19 exposure stocks. good morning. dani: good morning. that is right. the picture is complicated when investing in the vaccine makers themselves, will profits actually look like? and then you have companies like astrazeneca for example which has to have more global tests. still, we have seen companies like biontech rally 50% since late october. pfizer is up more than 20%. if you want to put your money in the supply chain, it is complex. it has been called the most complex distribution puzzle of our time but o

human research protections, independent institutional review boards, data and safety monitoring boards, the fda vrbpac and the cdc committee on immunization practices, these are all there to make sure tragedies like the tuskegee syphilis experiments or the exploitation of henrietta lax never ever happen again. finally we have to engage trusted voices, medical organizations like the national medical association and the national hispanic medical association. faith leaders and minority gatekeepers like the historically black colleges and universities, the divine nine, tribal leaders and the national conference of hispanic state legislators, all of whom i have spoken with frequently and as recently as this week. because when these gatekeepers are informed and confident, their communities will be informed and confident. i want to close by saying i know the importance of representation. many of you have heard me tell the story i never believed i could be a doctor much less the surgeon general of the united states because i had never met another black doctor, even though i had straight as, the first doctor i met of color was dr.

data and safety monitoring board. it's gone through the fda's independent advisory committee.ed to fda guidelines publicly published, stating what the fda would require for approval. finally, it has been authorized by fda's career scientific experts, as i promised. at 95% efficacy, this vaccine is extraordinarily effective at protecting you from the virus. getting vaccinated will help keep you, your family and your country healthy and safe. so with that, i will hand things over to dr. petino, so he can explain more about how the administration process is working here at g.w. thank you very much. >> good afternoon, everyone. thank you very much, secretary azar and surgeon general adams. it is an honor to be part of today's event. my name is dr. bruno petino and i am chief medical officer at the george washington hospital. i am thrilled to be here today on such a historic moment in public health. as our head of emergency management and an emergency physician myself, i have seen first hand the negative effects of covid-19. there's no doubt that covid-19 has put a strain on all of

drug companies' checks, it's gone through an independent data safety and monitoring brd, it's gone through the fda's independent advisory committee, it's been subjected to transparent standards that the fda has published of its requirements, and it's been authorized by fda career scientific experts. 95% efficacy, this vaccine is extraordinarily effective at protecting you from this virus. getting vaccinated will help keep you, your family and your country healthy and safe. in the meantime and in the comingonths as our country approaches full vaccination, we have to continue taking ste to keep ourselves and our loved ones and our communiti safe. wash your hands, watch your distance, wear your fe coverings wn you can't watch youristance and avoid stings where you can't do those things or where you may let your guard down. everyacrifice you make in the coming months will help save lives and insure that we emerge from this pdemic as soon as possible. each vac seen administered in these coming days is a tribute to the general rousety and genius of this country. the achievements of every american who made operation warp speed possible

through the drug company checks, gone through an independent data and safety monitoring board, gone through the fda independent advisory committeebjected to fda guidelines, publicly publish stating what fda would require for approval. finally, it has been authorized by fda's career scientific experts, as i promised. asked johns hopkins bloomberg school of health vice dean about the timeline for faxing rollout. -- vaccine rollout. >> any day now they will start vaccinating at hospitals in the u.s., a great step forward. we will get more and more vaccines, getting nursing home residents vaccinated, and then real challenges start because hospitals and nursing homes, it is easy to find the people there. once you get into community settings, even if you're talking about very high risk people, it is a bigger challenge. >> based on what you're seeing currently was supply chains and the rollout, when do you expect us to get to that all allusive can community where we live somewhat normal lives again? >> a great question and it depends partly on vaccine access and partly on what everybody else does. herd immunity is the concept for the v

bodies just the way the data and safety monitoring board looked at the data a while ago and said it looks good, let's examine the data and see if we can get an eua. the advisory committee to the fda now has made that recommendation. the reason i think this is so important is that we want to make sure that we impress the american public that decisions that involve their health and safety are made outside of the realm of politics, outside of the realm of self-aggrandizement and are made in essence by independent groups. so it was a very important step this evening late -- around 5:00 or so when the decision was made. now the fda will take under consideration that recommendation and will very likely act on it quite soon. >> okay. and look, you're now at about 60-30 of people in favor of taking the virus which is an improvement over what it had been. the more information that comes out frankly the less trump seems to have to do with it, the better it may get. but of course this has to be about science, not sentiment. now, why are things so bad right now? >> well, it's a conflation of things, chris, you and i have spoken about in the past. we have a very high baseline of in

data sharing for the purpose of ending homelessness and the monitoring of prop c funds, also responsible for transparency data monitoring and progress of outcome. there a there were a couple of different outcomes of proposed committee structures, so two proposed that were stomach but a little different. so one had six subcommittees that would include -- similar but a little different. so one had six subcommittees, and the proposal had descriptions of all of them, and we can pull them up later if we want to discuss those in more detail. the second proposal was similar but a slightly different structure. had five subcommittees in addition to the primary committee. immediate funding needs work group, system planning data subcommittee, a housing development work group, a behavioral health work group, and a communications subcommittee, so those were the various comments that we received related to the bylaws. so i'm going to stop sharing now and can turn it over, mary, if you want to give presentation back to the city attorney, that would be great. >> mr. givner: all right. thank you. so i can briefly run through these ideas just to flag a few issues, what can be done easily and what's more complicated, and then, obviou

data safety and monitoring board that oversees those trials. the drug companies' own ethical standards and checks and balances. the f.d.a.'s independent and transparent advisory committee meeting. the f.d.a.'s transparent guidance standards for emergency use authorizations for covid vaccines. finally the f.d.a.'s career scientific experts applying the standards that they have publicly shared. we have been heartened to see that americans' vaccine confidence is rising substantially. according to an abc poll this week, more than eight in 10 americans say they plan to take the vaccine. kaiser today announced 70%. vaccine confidence is surging. we still have much work to do to ensure all americans understand the value of these safety and effective vaccines, but it's clear that many americans are learning these vaccines are safe and extraordinarily effective. and as we get more and more health care workers or vulnerable seniors vaccinated and they go through the experiences i was able to see with health care workers this morning from doctors, nurses, e.r., labor, deliverry, i.c.u.'s alt medstar georgetown university hospital, i asked each of them getting vaccinated how it fe

looking at vaccine safety and effectiveness monitoring we'll hear pin input we will also hear from the company about its own data and then this commit committeeill have this discussion, they are scheduled to take their vote at around 3:15 today but of course this could happen at any point it is scheduled to go until 5:15 this afternoon so we'll hear what they discuss and of course, a big topic is likely to be these allergic reactions that we heard about in two health care workers in the uk uk regulators suggested that people with a history of severe allergies should not take these shots. so it will be very interesting to hear the fda and this committee weigh in on how to approach issues like that, which could emerge when this vaccine gets rolled out to thousands and millions of people when of course the trials were in just 44,000 so a very big day. >> meg, the hope is that the vaccines can get rolled out very quickly, but i know the cdc still has to say exactly who should be getting these first. so next week is potentially the earliest we'd see any in the united states? >> it all depends on how quickly the fda acts after the vote today. possi

data and safety monitoring board or dsmb. it was charters and convened by the national institutes of health and it is completely independent from the company. in addition an independent efficacy end point adjudication committeeas assembled. to determine if the conditions for severe covid-19 were met if adjudicated all cases for the primary end point and it continues to adjudicate cases as they accrue and it will ultimately adjudicate all covid-19 cases reported. 30,000 brackets were randomized in group one. the full analysis set was participants that received at least one dose of nrna, a modified intent to treat includes participants with noep evidence of infection. for protocol population, redefined for the primary efficacy analysanalysis. it includes those that got both planned doses and had no major deviations. more than 92% are part of this population. now let's return to the efficacy results. ensuring that we study participants most at risk for covid-19. 25% of the study pop lake would include participants over 65 years of cage with co-morbid medical conditions. we enrolled 42% of the study population in these two categories. let's review the study demography by gender and age. approximately equal propo