he is, a board member of the european medicines agency, the e.m.e.a., which is dealing with would earn his request for authorization here in europe. mr. not says it's good to have you on the program. we want to be clear, you're not speaking on behalf of him a but you do know the procedures there. when do you think madonna will be granted approval? thank you very much for having me. well, that remains to be seen. we've seen in recent weeks, a lot of these press releases from several pharmaceutical companies. we've seen candidates, but pharmaceutical companies press release is not necessarily science. it can be marketing but is not science. so where it is very critical point right now, where the regulators, for instance, the european medicines agency in europe, needs to look at all the data and come to its own conclusions on whether or not and when to authorize these products and to provide these and the grounds and these vaccine candidate with a condition of marketing authorization that remains to be seen. i don't have, i'm not a fortune better, so i cannot tell you exactly when. and i

an official with the european public alliance, and a board member of the europeans medicines agency, ema, we appreciate your time and insights. thank you. let's have a look at other developments in the coronavirus pandemic. turkey has further tightened its coronavirus measures announcing a curfew weekdays and full lockdowns over the weekends, after a record rise in new cases. the director general of the world health organization has urged countries not to politicize the hunt for the origins of covid-19, saying, that would create boundaries to learning the truth. yet nam reported its first -- vietnam reported its first locally transmitted case in three months. authorities introduced temporary lockdowns to curb further transmission. brazil's sÃo paulo state imposed stricter social distancing measures as the who urged the country to be very serious about what it called, very worrisome case numbers. deadly as covid-19 can be, most patients recover from the virus fairly quickly. but there is growing awareness that some patients cover a range of issues even months after getting over the in

medicines and vaccines. we believe are now the senate says, who is with the european public health alliance and a board member of the european medicines agency. thank you for joining us through. well, here in germany, rising covert infection rates have triggered tighter restrictions on public life. in some areas, residents in the bavarian town of pass out are only allowed outside if they can have a good reason, such as going to work or buying food. and a ban on public assembly is now in force in a nother hotspot. hilberg hausen in the country center. well, that's after hundreds of residents demonstrated against lockdown restrictions last week to have used on ahern and filed this report. these images have attracted nationwide attention in germany. people singing, walking side by side ignoring coronavirus restrictions of around 400 people, took part in the protest against strict pandemic control measures. in his book housing a coronavirus hotspot, district administrator to miss mina was shocked by the demonstration, cruel and seeing in its macabre that people operating through the town singing at the top of their voices, people dying in hospit

he is a board member of the european medicines agency, may, which is dealing with his request for authorization here in europe. mr. nazis is good to have you on the program. we want to be clear, you're not speaking on behalf of email, but you do know the procedures there. when do you think madonna will be granted approval? thank you very much for having me. well, that remains to be seen. we've seen in recent weeks, a lot of these press releases from several pharmaceutical companies. we've seen candidates, but pharmaceutical companies press release is not necessarily science. it can be marketing but is not science. so where this very critical point right now, where the regulators, for instance, the european medicines agency in europe, needs to look at all the data and come to its own conclusions on whether or not and when authorize these products and to provide these and the grounds that these vaccine candidate with a condition of marketing authorization that remains to be seen. i don't have, i'm not a fortune teller, so i cannot tell you exactly when. and i think that also politicians need to b

and it's much the same in the european medicines agency, and the british medicines agency will have to look at the data and make an adjudication. firstly, as they said, if and 2nd is it efficacious. now, the evidence that is efficacious is pretty strong as work. just said that 94 percent and no patients getting severe disease who got vaccinated and the safety data from that image is also looking good. and i think that's the reason the results were probably published today. because by f.d.a. regulations in the united states, they have to wait for 2 months for a certain number of patients after they've had the 2nd dose of the vaccine to make sure they don't get serious adverse effects. and so far, mcdonough saying there are no serious adverse effects from this vaccine when we should always get minor things like a saw a soul saw injection site in the arm where it's injected, you know, feeling unwell for a period of time, but no serious side effects have been documented so far, i'm to see how this would be given to burgess, the approval actually. and we believe that people can start in the

>> any medicine or is used in the european union needs market authorization from european medicine agencythis is important in terms of independent scientific assessment for safety and effectiveness. i can assure you that this will be done as quickly as possible. the european medicines agency is already looking at rollout review for this vaccine. also, it's ready to receive the application when it comes. there will be no delay. we will not be cutting corners in terms of looking at safety and efficacy issues. that was the eu commissioner for health. speaking to bloomberg's maria tadeo. our guest house this morning is martin malone, chief economic advisor at out the book. the adventure list of the triple v. good morning. we read weary headlines on the state of covid this morning. you look at markets through the triple v lens, a vaccine, victory. peace with biden and recovery. is it intact? will it enter? good morning. martin: good morning. how are you? manus: i'm good. martin: i think the triple v is still in play. i think we will look forward to a very good 2021. formost important factor po

medicines and vaccines. we believe are now the senate says, who is with the european public health alliance and a board member of the european medicines agency. thank you for trying to ask well, deadly as covert 19 can be. most patients do recover from the virus fairly quickly, but there is now growing awareness that some patients suffer a range of health issues even months after getting over the initial infection. w. met one covert 19 patient who told us about the illness she's endured for 8 months . pretty good in is battling the long term effects of coated 19. when she became sick in march, she had few symptoms, but it's now devastated her life. but a confident i only became gravely ill months later in june. but at the time i thought that everything would eventually be fine. but things didn't improve . i was extremely ill for many, many weeks, which turned into months. and i never got better. is what a nice piccy is one of 40 covert survivors here suffering from long term effects of the illness. germany's baltic sea coast symptoms are being treated at a rehabilitation center. after the virus piggie felt burnt out. she suffered from dizzy

the various vaccines must be approved by the european medicines agency before the eu can distribute vaccineso all member states at the same time. the amount each country receives will depend on its population size. there will be a limited rollout at the start before production is ramped up. until that happens, the european commission has advised member states to only give them to health care and care home workers, as well as old and vulnerable people. once mass rollouts begin, only then can life start returning to normal. >> russia says the sputnik five coronavirus vaccine is 95% effective, this comes among the latest breakthroughs. moscow scientists claiming it will be cheaper and easier to store than some of the alternatives. >> russia is throwing his hat in the ring to be a global savior. the sputnik v, a vaccine they say will be cheaper, easier to store, and more effective than its viral -- rivals. >> sputnik v is the cheapest vaccine on the market so far. it will be free for russian citizens, but international customers will have to pay to get their hands on the doses. scientists say it

the vaccine itself has to be approved by the european medicines agency. so optimistic we were looking at perhaps the 1st quarter of 2021. and that doesn't include, for example, the u.k. which is coming out of the european union at the end of this year. they've been doing that own bilateral deals with some of the vaccine manufacturers. indeed, i think the british government's got its own problems. it hasn't tried to justify how it's awarded contracts over the very controversial access to p.p. even indeed, the national audit office, which is the government spending watchdog, keeps an eye on exactly how the government is spending taxpayer money has come out with a very critical report as to how the government went about procuring items relating to the coronavirus and its prevention and protections, and in particular, p.p.a. personal protective equipment. according to the national audit office, a report that's been released the smalling, it's a catalogue of problems. i mean, basically it says more than $13000000000.00 worth of contracts were awarded directly w

regulatory agencies will need to look at it suggests that food and drug administration and european medicines agency, they need to assess the data to determine whether inspection is needed as a factor. and whether it is whether it is safe. there are a number of issues that have already come to light. for example, the fact that the vaccine, the pfizer oxy requires a very severe cold chain of minus 70 degrees celsius. that is, that is very, very deep freeze, so to speak. and that is, that is going to pose challenges. there are others, a dentist as one people who are local for, of course are looking out because how is a vaccine that is going to be rolled out in a lower middle income in india is also as the report just showed, producing $30000000.00 doses of the oxford astra zeneca vaccine every month. that is also still in trials. so with the visor in years, does that change anything for astra zeneca progress? no, i don't think so. i think oxford that services have a vaccine which was originally developed by r. for university is really is, you know, also one of the runners up and it is that model is qu

so we are now working with our colleagues from the european medicines agency to put a system in place for monitoring safety and the effectiveness of these of experience as soon as they are actually on the market. and that is to ensure the population that these 2 aspects are closely mourn it toward also our colleagues in the medicines agency are reassuring that they will not compromise the safety off the vaccine compared to the speed of the authorization. there are critics of the c.d.c. who question the purpose of the c.d.c. . they say that the c.d.c. was specifically created in order to be able to tackle a crisis like the coven 1000 pandemic. but that it has not been effective in dealing with the crisis. what do you say to that? it depends on what the expectations were compared to the mandates that we have been given. what i have seen sometimes east, that the expectations towards us were far outside the legal mandate that we have been provided with. and that of course then can lead to well disappointment in the expectations if they go beyond what we have been basically permitted in th

>> any medicine or vaccine that is used in the european union needs market authorization from the european medicine agencyportant in terms of independent scientific study for effectiveness and safety. this will be done as quickly as possible. the european medicine agency is already looking at a rollout review for this vaccine, and is ready to receive the application when it comes. there will be no delay, but we will not cut corners with safety and efficacy issues. anna: no cutting corners from the eu health commissioner. ofutes to go until the start thursday's equity session. we will get your stocks to watch next. growth picks up post pandemic. this is bloomberg. ♪ matt: anna anna: european equity futures suggest the downside. let's get into the stock specific stories with dani burger with stocks to watch. sees themselves return to growth in 2021, profit margin rising for the year. it proposed cutting its dividend, but saying it is a tough year but they don't think of a 19 will have a lasting impact on the world economy. 2021 could be better for them with a joe biden presidency. the ceo spoke to annmarie

the european medicines agency, it takes time developers 1st, have to submit testing data, and what's called a marketing authorization application that governs general approvals for medicinal products. throughout the e.u. . a board at the agency called the committee for medicinal products for human use is required to submit a scientific verdict on the application within $210.00 days. it then passes that opinion on to the european commission, which makes a decision on whether or not to grant an approval within $67.00 more days. so all in all the process can take between 9 and 10 months. but that's under ordinary circumstances. in the midst of this pandemic, the e m a has set up a special task force to help fast track covert 19 treatments and therapies. it allows for accelerated action in a number of ways for vaccines. a key change is that developers don't have to wait until all of their data is final. before submitting it for approval, but have been able to submit it instead in batches while the trials are still ongoing. a process called a rolling review. so in the end, the formal asse

and it's much the same in the european medicines agency, and the british medicines agency will have to look at the data and make an adjudication. firstly, as they said, if and 2nd is it efficacious. now the evidence that is that the case is pretty strong as work. just said that 94 percent and no patients getting severe disease who called vaccinated the safety data from that image is also looking good. and i think that's the reason there was also a public published today because by f.d.a. regulations in the united states, they have to wait for 2 months for a certain number of patients after they've had the 2nd dose of the vaccine to make sure they don't get serious adverse effects and so far to saying there are no serious adverse effects from this vaccine. when we get minor things like a saw, a soul saw injection site in the arm where it's injected, you know, feeling unwell for a period of time. but no serious side effects have been documented so far. i'm not to see how this would be given emergency approval actually, and we believe that people can start in the states, those doggo in th

meanwhile, the european medicines agency as human medicines committee said it's starting a rolling review of maternal covert $1000.00 vaccine. the regular is already reviewing vaccines from astra zeneca and pfizer, all in an effort to speed up the approval process. now to a coronavirus update over the weekend, the us are past 11000000, new code 1000 cases. this comes only one week after hitting 10000000. that's an average of about 150000 last week. positive test rates and hospitalizations are up across the country, forcing states to place even more restrictions on social gatherings and even travel . the u.s. leads global cases and deaths with more than 246000 televisa. meanwhile, countries in europe announced more lockdowns. strict measures are being placed as covert cases continue to search, and south korea saw 3 consecutive days of triple digit cases, also forcing the country to tighten restrictions. it's being called one of the largest free trade agreements in history. over the weekend 15 asian pacific nations signed the world's biggest free trade pact over the weekend 15 asian pacific

leyen said the european medicines agency is in regular contact with the u.s.synchronize the approval. ms. von der leyen: if all proceeds with no problem, that tells us that the conditional marketing authorization for biontech and moderna could happen as early as the second half of december 2020. leigh-ann: the world health organization is recommending against using gilead's remdesivir to treat covid-19 patients. the advice comes just weeks after regulators granted approval. says there is currently no evidence that the antiviral improves survival rates. gilead says it is disappointed and the guidelines do ignore the science. tesla is leading gains in ev stocks, hitting another record high. the latest vote of confidence is coming from the u.k. it is now looking at growing its fleet of electric cars as a way to create jobs and balance the power grid. companies in the sector have been confident electric cars will dominate the future of the market. and that is your bloomberg business flash. francine? francine: leigh-ann, thank you so much. now, coming up, we speak

the european medicines agency, it takes time developers 1st, have to submit testing data, and what's called a marketing authorization application that governs general approvals for medicinal products. throughout the e.u. . a board at the agency called the committee for medicinal products for human use is required to submit a scientific verdict on the application within $210.00 days. it then passes that opinion on to the european commission, which makes a decision on whether or not to grant an approval within $67.00 more days. so all in all the process can take between 9 and 10 months. but that's under ordinary circumstances. in the midst of this pandemic, the e m a has set up a special task force to help fast track covert 19 treatments and therapies. it allows for accelerated action in a number of ways for vaccines. a key change is that developers don't have to wait until all of their data is final, before submitting it for approval, but have been able to submit it instead in batches while the trials are still ongoing. a process called a rolling review. so in the end, the formal asse

regulatory agencies will need to look at it, such as the food and drug administration and the european medicines agency. they need to assess the data to determine whether inspection is needed as a factor and whether it is or whether it is safe. there are a number of issues that have already come to light. for example, the fact that the vaccine, the pfizer oxy requires a very severe cold chain of minus 70 degrees celsius. that is, that is very, very deep freeze, so to speak. and that is, that is going to pose challenges. there are others. but that is, that is one will the local for, of course are looking out because how is a vaccine that is going to be rolled out in a lower middle income in india is also as the report just showed producing $30000000.00 doses of the oxford astra zeneca vaccine every month. that is also still in trials. so with the visor nias does that change anything for astra zeneca progress? no, i don't think so. i think the oxford oxford vaccine, which was originally developed by our street university is really is you know, also one of the runners up and it is that model is quite diff

pfizer and deliveries are expected by the end of the year, following the approval from the european medicine's agencylege authorized a fourth contract with pharmaceutical company via tech pfizer. it covers preaches of up to 3 -- approaches of up to 300 million doses to be supplied once the vaccine is proven to be safe and effective against covid-19. >> the eu signed deals with astrazeneca and johnson & johnson for their candidates. the 27 member states would have the option to buy nearly 1 billion doses of a potential vaccine. >> it starts with the most vulnerable, who are people who live in care hopes and, of course, the staff who look after them. >> reporter: over the last week, europe saw roughly 280,000 cases a day, pushing the total number of infections past 12 million. france is facing the worst of this latest surge. health authorities in paris say critical care units are at 90% capacity and in britain, lockdowns remain in effect as the country averages more than 20,000 new cases a day. >> i know i few people who tested positive and so -- [ inaudible ] staying for two weeks. >> uk officials are

emergency use authorization with the fda similar filing it's going to file in europe with the european medicine's agency. now we talked with moderna ceo this morning about what he was most excited about in these results and here's what he said. >> the most exciting news to me yesterday when hi learned the data was serious cases because if we can prevent serious cases it means reduced illness and death. the. >> so moderna filing with the fda today saying that they expect a meeting of the fda's outside advisers december 17th, a week after the december 10th date for pfizer's vaccine to get that review from the fda, and here's a look at the other vaccines in development in the united states. we, of course, got those initial astrazeneca phase three results from other countries i have & j's results are expected by the end of the year and novavax updating on its u.s. trials that should begin within a few weeks. we've been hearing october for the start and then november. we spoke with their ceo this morning saying it's just sort of normal figuring out manufacturing that results in this delay and here's what he

that is when she is expecting that the european medicines agency will give the green light to the pfizerd get europeans and european countries get their hands on those vaccines by the end of the year. this does feed into reports that we had seen earlier this week that germans are interested in getting up and running vaccination centers in the second half of december. the european union has already signed a contract with pfizer and biontech for 400 million doses. they could get an additional 100 million on those contract -- on that contract. we have much more clarity now from the european union than a week ago. anna: let's talk about brexit. do we have any more clarity on that this morning, maria? maria: well, not really, other than the three sticking points which have been very well documented and that we are no, startingwith -- know, with a level playing field, have not been solved. barnier was not attending a briefing in person because a member of his team tested positive for coronavirus. given the tone coming out of this briefing, not a lot has changed, despite the positive momentum t

we are currently in communication with the fda in the united states, the european medicineal agency,. organizations, with japan. and if we get an authorization, emergency authorization maybe by the fda, we would be ready to supply and the same is true for europe. so that means the first requirement for supply is authorization. maria: okay. we'll leave it there. dr. ugur sahin, thanks very much. congratulations to you. i know the world thanks you as well. we'll be right back. stay with us. metastatic breast cancer is relentless, but i'm relentless too. because every day matters. and having more of them is possible with verzenio, the only one of its kind proven to help you live significantly longer when taken with fulvestrant, regardless of menopausal status. and it's the only one of its kind you can take every day. verzenio + fulvestrant is approved for women with hr+, her2- metastatic breast cancer whose disease has progressed after hormonal treatment. diarrhea is common, may be severe, or cause dehydration or infection. at first sign of diarrhea, call your doctor, start an anti-diar

yanis announces he is with the european a public health alliance and is a board member of european medicines agency is known as e m a, which is dealing with murder and as a request for authorization. a very good evening, sir. why do you think we're there now will be granted approval by the way. good evening. it is hard to tell and obviously i don't speak on behalf of the agency, but i will. my message would be that we need to let the regulators do their job. we need to let the regulators look at these, they that we need to make sure that we get these very promising, good news from the companies press releases. we've seen quite a few of them over the past few weeks, but now we need to make sure that there we need to cross-check this data and we need to make sure that the regulators have the time and the tools on their disposal to assess the company's claims how many doses will become available, you think of how quickly can they be rolled out? well, we will see more there now has said that europe will have to wait. we understand the scale up of the manufacturing capacity and obviously the distributio