The FDA is holding a press conference to discuss the COVID-19 vaccine emergency approval
Show Transcript
D A. Authorized the Pfizer bio and tech vaccine for individuals over the age of 16. Although this is not an FDA approval, this authorization makes Pfizer bio and text vaccine available in the United States and holds the promise toe alter the course of this pandemic. It's a truly remarkable achievement of vaccine development made in less than a year's time, with science guiding our decision making the available safety and effectiveness data support the authorization of the Pfizer bio and tech vaccine because the vaccines known in potential benefits, outweigh its known a potential risks. The data provided by the sponsor have met the FDA is expectations conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. In making our emergency use authorization determination, the FDA can assure the public and medical community that we have conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information. This achievement is ultimately a testament to the commitment of our career review staff who worked tirelessly to thoroughly evaluate the vaccine. The FDA is considered the gold standard regulator of medical products The process that the FDA uses to review respect is respected worldwide because of AH well established history that the FDA has among the most rigorous an accurate review processes globally. And this is reflected in our outstanding record for getting things right in promoting and protecting public health. The amount of data submitted to the FDA included many hundreds of pages of written technical information and additional reams of tables. Figures and listings there were reviewed by experts from different disciplines, including physicians, biologists, chemists, statisticians, epidemiologists and other professionals. In doing our review, we found efficiencies where we could without sacrificing our standards. Normally, the review process for a vaccine studied in tens of thousands of people takes months. We conducted this review in just a few weeks. Thes data, which included non clinical data on the development of the vaccine in the laboratory manufacturing data and clinical trial data, were reviewed ahead of the public advisory committee meeting to ensure a robust public discussion with the independent experts the public saw this past Thursday. We also considered it's part of our own review, the advisory committee's recommendation, with most members voting that this products known and potential benefits outweigh its known and potential risks. Our work evaluating the Pfizer bio and tech vaccine does not end with this authorization. As we noted in our October emergency use authorization guidance, we expect vaccine sponsors to continue studying their vaccines to move toe licensure also referred to his approval. Additionally, for the Fighter Bio n Tek vaccine, the FDA is requiring that the sponsor conduct active follow up for safety, including monitoring for any significant adverse events to inform the ongoing benefit, risk review and assessment of the vaccine. The FDA and the Centers for Disease Control and Prevention will also collaborate to conduct extensive safety surveillance on an ongoing basis. Before we turn to the question and answer portion of this press conference, I want to end by noting that because of the suffering caused by this pandemic, FDA staff felt the responsibility toe work through the review process with a sense of urgency while doing their jobs to ensure that any vaccine that is authorized meets our rigorous standards for safety and effectiveness that Americans and the world have come to expect. The FDA is review process means that Americans can trust and be confident in vaccines not just Cove in 19 vaccines, but all vaccines reviewed by the FDA and available in the United States. FDA staff members are like your family were a diverse organization reflective of this country, including mothers, fathers, daughters, sons, sisters, brothers and more. We know the pain that this country has gone through during the past year of the pandemic. That said, we also know that Americans put the utmost trust and confidence in our review process. We're humbled and privileged to be entrusted with this mission, and we're grateful toe have helped in this achievement. We look forward to advancing additional vaccine candidates over the coming months. Thank you. And now I'll turn back to the moderator to begin questions and answers. Thank you, Dr Hahn and Dr Marks. We will now turn to the question and answer portion of the call as a reminder to journalists on the line, please. Um, meet your line when prompted and ensure your camera is on. Our first question comes from Matt Perrone with the Associated Press. Hi, doctors. Thanks for taking our questions this morning. I want to see if you could talk to us just a bit more about the Contra indication in people with a history of allergic reactions. If I am you know, for example, one of the millions of Americans who say I have a food allergy, I carry an EpiPen with me. Can I still go ahead and and get this vaccine? Or do I need to research all the ingredients, get more information about what's in it? And if so, how exactly would I do that? Matt, I'm gonna let Dr Marx answer the technical part of that question, but you've highlighted a really important point, which is that the thoroughness of our scientific review, The delving into these issues, the line by line assessment of potential reaction side effects, the vaccine. That's something that uniquely America's FDA does and is highlighted in the question that you asked, but also the discussion of the advisory committee, Dr Marks. So if you've had a history of allergic reactions, obviously you should tell your doctor about those. But the vaccine, um, really, um, is one that we're comfortable giving Thio patients who have had other allergic reactions besides those other than severe allergic reactions to a vaccine or one of its components. So obviously you'll need to tell your doctor if you've had allergic reactions, they'll help determine knowing what's in the vaccine if you might be allergic to one of those components. But, um, we're making sure that, um, sites where this vaccine is being administered have the ability to treat allergic reactions. Andi. I just want to reassure the public that you know the although there were these few reactions in Great Britain. Thes were not seen in the larger clinical trial data sets, and so we'll be monitoring very closely for them. But I think we still need to learn mawr, and that's why I will be taking precautions as a reminder to the journalists online. Please turn your cameras on when you are going to be asking a question and on meet your line. Our next question is from Laurie McGinley of The Washington Post. Good morning, and congratulations to you all. Thank you for calling on May um, it seems at this point that there are now some increasing supplies about the supply of the vaccine and getting enough vaccine shots out there to change the course of the pandemic as quickly as possible. Can you talk to us a bit about the challenges of ramping up production. The big scale of that has to happen. And whether you're concerned that there may be shortages in ingredients or equipment, especially for the m r n a vaccines and what the FDA industry and the government are doing about those issues. Thank you. Thank you, Laurie. Really important question. A zoo. You know, FDA is rolling. This is as the independent regulator that reviews in science and the data behind on application. But we do work very closely with with manufacturers on this issue, and we are aware that there are quite a few people in U. S. Government who are working on the issue of increasing increasing supply. Dr. Mark, you wanna talk about FDA s role with respect to supply chain, right. So we will work with our federal partners to help them identify potential capacity, competitive potential supply that might help in the increased production of these vaccines on bats. Something that has to be a collaborative effort here. Thank you. Our next question is from Tom Burton with The Wall Street Journal. Tom there. Can you hear bed here? Better now. Wait. Yes, sir. All right, go ahead. Sir. My question has to do with the blinding issue and un blinding and the switch over issue. What's the current plan? Both for how patients who got the placebo may be allowed to switch over. Will they all be allowed to switch over? And if so, how do you all, um, ensure that you get the largest set of safety data possible, Tom? Really? Um, important question. And as you know, at the vaccine advisory committee, this was a significant topic of conversation. Dr. Marx, what's the Can you just speak to the agency's current thoughts on this? So, uh, the way obviously discussing with each manufacturer their plans in this case for Pfizer, the plan, I think, is to allow those who received the vaccine to find out what they received. And if they receive placebo, uh, to asked to potentially be vaccinated along with, uh, the group that would be appropriate as vaccines are distributed. Um, we believe that will have a reasonable, uh, data set that will come from that on. Obviously. Right now in the United States, we have to balance three amount of blinded data that we receive with the need to protect people from a pandemic that's taking thousands of lives daily. Thank you. Our next question comes from Karen Stacey from Financial Times. Thank you. I wanted to know whether you considered attaching additional warnings regarding allergies. Obviously, you have these warnings regarding the particular ingredients in the vaccine itself. But did you consider putting other allergic warnings on the fact sheet metal? Dr Marks? So we actually considered the potential allergic reactions pretty carefully here on Day one has to be careful based on. And look at the data that one has in hand because it turns out about 1.6% of the population has had a severe allergic reaction of some sort or another to a food or, uh, some environmental aspect. And we would really not like toe have that many people not be able to receive the vaccine. So we looked very closely at the databases. Andi, we feel comfortable. And that that we're telling people that unless they've had a severe allergic reaction to the vaccine or one of its components, they can receive it now, we'll obviously be monitoring. We have very good safety surveillance systems in place, uh, in conjunction with the Centers for disease control and Prevention, and we may have to modify things as we move forward. But for right now we're comfortable with this and the extra. The extra piece of this is that centers will have three ability toe treat, allergic reactions. I think that's an extra precaution. Thank you. Our next question comes from an enemy with Bloomberg. Good morning. You guys have mentioned this, and obviously the FBI has worked night and day and really hard to get this EU a completed. I wonder if you learned anything during the process that might change the next, um, applications that come in for anyway, whether anything might accelerate or change as we look forward, Thio, Madonna and other vaccines, This is a really important point you're making. Um, I can assure the American public that one thing that won't change is the thoroughness of our scientific review. As you can see by some of the questions around allergies, the thoroughness of our review really got to the heart of that issue. We had a very vigorous discussion at the the verb back meeting. Eso transparency and thoroughness of scientific review very, very important. We are in the process of doing a look back on, but hopefully we'll have some answers with that fairly soon about what FDA is response has been like, including the use of emergency use authorizations. And our intention is to learn the lessons because FDA is a learning organization. Uh, keep many of the things that worked well, learn from the challenges on dry to do absolute best job that we can for the American people moving forward. So that's our promise to everyone. Thank you. Our next question comes from Michael Erman from Reuters. Hi, thank you with with supply constraints. There's been discussion about possibly maximizing the number of people who can receive their first dose rather than holding back doses to guarantee a second dosed. What's What's FDA is position on this? So you understand what we put in the letter of authorization and the conditions of use. We stand by those recommendations. Um, the question that you're asking the heart of that question really should be referred to those who are distributing and making recommendations about prioritization. But I would like Dr Marx to answer the issue potentially about one versus two does so that he can certainly clarify what the FDA stances on that. So, thanks. There has been a lot of noise in the press about one versus two doses. And the way the regimen was studied was that everyone ultimately or almost everyone, received two doses of the vaccine. So we Onley know how people were protected with two dose of the vaccine and that that duration of protection that we've seen so far relates toe having two doses of the vaccine. We spent so much time carefully reviewing the data and basing our decisions on science, right, That it seems pretty, uh, foolhardy to just conjecture that one dose might be okay without knowing. And so, at least from the FDA perspective, we would be recommending that people complete the two dose Siri's. So we actually know that they're truly protected at the rate of approximately 95% um, of efficacy that was reported. Thank you. Our next question comes from Nick Floor Co. With stat news. Hi. So thanks so much for doing this. Doctor Marks you had previously said previously warned that it could take several weeks Are several days or even a few weeks to green light in the U A. On that was, as I understand it, after the fighter you have been submitted, I guess I'm wondering what changed that this got out so quickly after the verb pack meeting Andi for Dr Han just to address sort of the elephant in the room. Did The White House is threats to fire. You have any impact on the FDA is decision to get this out quickly. Thanks. Well, I'll answer first. Nick. Um, first of all, the representation in the press that I was threatened to be fired if we didn't get it done by a certain date is inaccurate. Eso just wanna put that on the record. And I've been clear with that in our response to those press reports. Secondly, um, I Dr Marx and I have been very clear from the beginning that we're gonna maintain the integrity of the scientific process. We're gonna let our scientists do their job and review and go through the thoroughness of that review the gold standard, if you will. So we've done that, but we also recognize the urgency of the situation. And so we've said repeatedly we worked as quickly as we can to come to a decision, and that's what we did, um, has been has been reported our team. The scientists met after the verb back meeting. Uh, they did come to the conclusion that the vaccine did, uh, meet our standard for effectiveness and safety. And as you know, before 7 a.m. On Friday, we issued a statement saying that we were working with the sponsor to move toward authorization and again, our incredible team, Heroic efforts night and day worked to get this done and out the door and I think did a superb job. And I'm really proud of their efforts because we understand the urgency of the situation. As Dr Mark said, thousands of people are dying a day. Okay, Our next question comes from Meg Carroll with CNBC. Well, thank you. I was wondering if you guys could talk a little bit more about the special groups and considerations for people like pregnant and breastfeeding women and people who are on immuno suppressive therapy is how did you consider the recommendations for those groups, especially considering they were not included in the trials. I'm gonna start off and sound like a broken record, but this gets to the heart of the thoroughness of our review, the line by line assessment of the safety and the effectiveness of the vaccine because these questions are very important to providers and all Americans. Dr. Marx, maybe the specifics. Yeah. So there were not enough pregnant women, uh, in the trials or women who became pregnant in the trials, Uh, toe actually know and make any statement about that. So for pregnant women, for that matter, for Children younger, uh, younger Children don't have data at this point, but for pregnant women and the immuno compromised at this point, um, it will be something that providers will need to consider on an individual basis for patients or for for people. Thank you. Next question comes from Carl Zimmer with New York Times. Okay. Uh, yes. Hi. Uh, I would like to know, Are you going to require that AstraZeneca finish its face through clinical trial in the United States, which is only currently half enroll, Although that means, according to AstraZeneca, that they can't apply for anyway until June. And that will affect the supply of vaccines in the United States. Yeah, I'm sorry, but that's one where I can't speak to a product that's under development. Thank you. Our next question comes from Hannah culture with financial times. I just want to follow up on what May gas there. What advice would you give a doctor if a pregnant woman asks for the vaccine? What, that should they be considering Dr Marks? So I think this is one where I think you'd want to have a from a provider to an individual. Ah, consideration of the of the potential benefits and the potential risks. What we don't know about the vaccine versus what we do. And I think then, if that conversation happens, I think the provider and that, uh, individual can make a decision about whether the benefits outweigh the risks, because certainly covert 19 and a pregnant woman is not a good thing. So someone might decide, um, that they would like to be vaccinated. But that's not again. That's not something that we're recommending at this time. That's something we're leaving up thio the individual. And just to follow up further on that question, um, it's again getting back to our review and what we put in the documents out for the American people and providers that level of detail to provide as much information supported by data and science to providers so they can't counsel patients. And the patients are aware of the issues is so critically important. It's one thing that that the U. S FDA uniquely does. Thank you. Next question from Ryan Gabrielson with ProPublica Thanks for taking my question. To what extent has the FDA done on site inspections of fighters, manufacturing sites and has the process for this vaccine differed from past reviews to sort of give you an overview of the inspection process? We have a lot of different tools in the toolbox to ensure the quality on safety and the fact that every lot of a vaccine, for example, or any medical product would meet our incredibly high standards. So we have a lot of tools at our disposal, which we have used on Dr Marx. I don't know if you want to get more specifics. Eso, for an emergency use authorization were not required to do the type of site inspections that we would for a biologics license application and a fully approved vaccine that said we relied on a combination of tools to ensure that we're are very confident that these vaccines are being made in a manner that is consistent with the high quality that Americans have come to expect from vaccines taken to prevent disease. Thank you. Our next question comes from Karen Weintraub with the U. S A. Today I thanks so much for doing this, I was wondering if you talk a little bit about the 16 and 17 year old age group. I know there's a lot of discussion the other day. What can we say to parents to reassure them that that that their teenager is safe getting this vaccine? Dr. Marks, Yeah, thank you so much for that question because there was, as you might realize, as you might have noted, some debate about that at our advisory committee meeting. And that's one of those places where we had FDA have, ah, fair amount of history, some of which hasn't been in the public domain because we approve a lot of vaccines in the pediatric age range, and we're very used to extrapolating from adults or from older Children into younger Children and based on everything we saw from looking at, the data were very comfortable that the safety profile that was observed in 17 and 16 year olds, UM was acceptable on. Although it wasn't quite a large as you might I have seen in other groups, there was enough there to make us comfortable that the known and potential benefits outweigh the known and potential risk. After all, although what was said by some 16 and 17 year olds, they don't get, you know they don't get really sick with co vid 19 very often, although I think if you're the parent of a child who does get sick and die from it, that you might be pretty upset. On the other hand, um, uh, they are able to transmit quite easily if they're asymptomatic, as we've learned on since. Some of those, uh, 16 and 17 year olds, at least then I know of are out there as check out people or are interacting with communities. It may be wise that we are able thio vaccinate them, so we think the known and potential benefits outweigh the known and potential risks. Thank you. Our next question comes from Rachel Robing from Politico. Hi, thanks so much for taking my question. I wanted to follow up on the allergic reactions. I think you mentioned that those sites would be able to handle an allergic reaction. Is there any specific equipment that's required of them? And is that something that they already have the capacity thio you? Or could that limit the number of thank you? So I'm happy to take that one s o. The Centers for Disease Control and Prevention, which is helping with the vaccine rollout, is making sure that sites all sites have the basic supplies to take care of an allergic reaction. Those things include things like an epinephrine pen, um diphenhydramine, also known by the the brand name of Benadryl on board, potentially a steroid called hydrocortisone. They'll make sure that those are available. ATT's sites giving the vaccine their basic their basic basic equipment toe, have Andi ideas that will be present in all of the sites in order to take care of potential issue. Hopefully, it will just be there as a safety precaution. Our next question comes from Emily Cop with roll call. Hi, I'm hoping you can explain for a general audience what efficiencies in the process helped this move along so quickly. Um, someone reference not doing on site inspections, but what else um Did FDA dio speed this along? Well, again, let me be clear. We did not cut corners in our regulatory process. Uh, Dr Marx and I and his team have been talking about this since the spring and early summer. As you know, we put out guidance is in June a swell as October around this, and we've been working with developers of vaccines from the very beginning, helping them sort of expedite the clinical on DPI clinical development process. So all hands on deck from Dr Marks, his team and the agency with respect to this from the very beginning allowing for a seamless development process which helped in the development of the vaccine and then working very closely with the manufacturers and sponsors. Um, as they gathered the data and they decided to make an application, Dr Marx and his team are to be congratulated for their heroic efforts because they had all hands on deck, had a lot of resource is at their disposal. Onda worked night and day to get through this process in these applications, and there were a significant amount of efficiencies in those steps, including working closely with our U. S. Government partners when appropriate, appropriate. So really a major effort by all of the agency, but in particular Dr Marx's Center. Thank you. Our next question comes from Peter Aitken with Fox News. Good morning. Thank you for taking my question. You said there's gonna be follow up with safety and further reviews after the emergency use. Um, if there was a potentially problematic complication that arose, what would the process be to handle that kind of issue? I'm gonna ask Dr Marx to talk about the specifics around the follow up with respect to the EU A the authorization. But just to put a finer point on the question from our perspective, we, in our guidance is really insisted upon the fact that there would be a very rigorous ah follow up safety surveillance system. And Dr Marx and his team have worked with other government partners, most notably the Centers for Disease Control Toe help Institute that. But I think Dr Marks can answer specifically what, what might happen? Moving forward. So So the Centers for Disease Control and Prevention and the FDA will be essentially now we've now launched ah, continual process where we would be looking at safety events. And if we see something that rises to the place where the public needs to know about it, we're gonna communicate it. We're gonna communicate it once we know enough about it to be able to communicate. Um, coherently on it. Um, but we will. We will pursue finding out about such things with due diligence so that we can get the word out there as quickly as possible. Um, so it will be a combined effort, and it will be an ongoing effort on quite a large one As we see more and more people vaccinated. Thank you. Our next question comes from Lauren Mask Arness with CNN. Hi. Are you worried that the appearance of pressure on this process will impact people's willingness to get a vaccine? And are you working to counter act that in any way? So the agency is very concerned about vaccine hesitancy. We are also aware that some feel that the speed with which this development and then regulatory process took place might give them concerns about the vaccine. But it's why we were very transparent. And Lauren, the way we've addressed this is to number one. Be very clear about the data and the science we would need is, Dr Mark said in his opening remarks, to make a decision be very clear from the beginning what our processes would be, including having an open and transparent discussion, as we did with the verb back meeting on the 10th of December. And they're following through on that and then being very clear after a decision was made about the data and the science and the rationale behind the decision, as well as giving a very detailed description of what would what providers and pay and been people who receive the vaccine would need to have. So yes, it's a concern. We will continue. Dr. Marx and I have been, ah, meeting with many stakeholders, certainly with the Presas. Well, uh, to address any concerns that arise and to be very clear and transparent about the processes and the science and the data. We believe that that transparency, as well as the rigorous scientific review that we've done, goes a long way to providing confidence and trust the American people in FDA and this vaccine. Thank you. Our next question comes from Alicia Ault with Medscape. Yes. Hi. Um, I wanted to ask you, given your remark, Dr Marks about vaccinating teens to prevent transmission. Um, when will we know Maura? About how the vaccine might impact viral shedding and transmission. So it may take a few months before we start to have those data. Additional studies will be done. Both clinical trials and observational studies. That will help give us those data. Right now, we have to extrapolate What? What might happen from animal studies. So we like to have human data as quickly as possible. Um, but those studies are going to be conducted during the coming months. Thank you. Our next question comes from Drew Armstrong with Bloomberg. Yeah. Hi. I'm wondering what data transparency FDA can commit to in terms of how and when you will be reporting any information on vaccination numbers or side effect profiles any kind of real time data the agency will be doing and making available to the public. Um, in addition to your study and then reporting that you would normally dio on any kind of product like this, Dr Marks. So the CDC and FDA, we're gonna work together, as I've mentioned, and we have ah website here that will post the types of surveillance that we're doing that will post the types of surveillance studies. We have about 20 adverse events that will be looking for in an ongoing basis. If there's any signals in those we will post those. Our goal here is to make sure that people know that we're doing our jobs to make sure that we look out for possible adverse events, that they feel comfortable rolling up their sleeves and taking the vaccine. Andrew, you may have seen our statement, my statement from a couple weeks ago regarding transparency in the agency in the US, and we have made a strong commitment, our center directors and myself to being transparent about it. We realized that that, um, eyes something that we will continue and need to continue to do during this pandemic, because that helps build trust and confidence in our processes. In our decision making. Thank you. Our last question is from Meg Carol with CNBC. Thank you for giving me Thio. I'm just wondering about the delicate handling requirements of this vaccine. We've dedicated a lot of air time and ink to the cold temperatures with which it has to be stored the fact that it could only be out of the freezer for a minute, transferring it from the box to the deep freezer. Personally, my own doctor has even said she's nervous about this vaccine because it requires such delicate handling. So how convinced are you that every site will do this perfectly every time? There will be no degradation of the vaccine on what do you want to tell the public about that? So I'm gonna let Dr Marx talk about the specifics, but really important point because it folks may not know this is a core responsibility of the FDA to understand the conditions under which a product might be used on and how it be used. And so this is something that our team has spent a lot of time looking at, Dr Marks. So we we put forward the conditions that need to be adhered to. We try to make it very clear, uh, in the labeling in this case, in the provider information sheet, how the vaccine will be handled. And I know that our colleagues at the Centers for Disease Control and Prevention and the Operation Warp Speed folks are making sure that things are in place to make sure that the cold chain is maintained. Now, once the vaccine there there is this bit of subtlety here that that the vaccine needs to be stored at very, very cold temperatures. Once it's thought it can be kept, uh, in a regular refrigerator for a number of days. Um, but, uh, we're pretty convinced that we can We can make this happen here. We've seen cold chains maintained, um, in in locations that are pretty, uh, pretty rural. Um, are pretty rough, for instance, with vaccination campaigns in Africa. So we're hopeful that this is gonna work out. Well, thank you for joining us here today and participating in this press conference around the FDA s authorization of the fighter bio in Tech Cove in 19 vaccine, we invite you to visit our website at FDA dot gov from or information about the authorization. Thank you. Ah,