FDA Press Conference Transcript: Pfizer COVID-19 Vaccine Authorized for Emergency Use

FDA Moderator: (00:01) Sorry. The FDA will call on reporters one at a time to ask one question to the speakers. Once selected to ask a question, you'll be prompted to unmute your mic. You must unmute your mic at this point. Your name and outlet will be announced. You will appear on the screen so that FDA speakers can see you as you ask your question. Your image will be live streamed as well during the virtual press conference if you are asking a question. Once you have asked your question, you will be muted again. Thank you. We will begin momentarily. FDA Moderator: (01:40) Good morning. We'd like to welcome you all to our virtual press conference today to discuss the FDA's emergency use authorization of the Pfizer BioNTech COVID-19 vaccines. First, we will hear from FDA commissioner, Dr. Stephen Hahn, and Dr. Peter Marks, the director of the FDA Center for Biologics Evaluation and Research. Following their remarks, we will open up for questions. With that, let's turn the press conference over to Dr. Hahn. Dr. Stephen Hahn: (02:08) Good morning, and welcome to this Food and Drug Administration press conference. I am pleased to announce that late yesterday, the FDA authorized for emergency use the Pfizer BioNTech COVID-19 vaccine. This is the first COVID-19 vaccine to be authorized in the United States. The FDA is respected worldwide, and it's considered the gold standard regulator of medical products. We applied our high standards of review in reviewing this product so that Americans can have trust and confidence that the vaccine meets FDA's rigorous standards for safety and effectiveness. Dr. Stephen Hahn: (02:46) With this authorization, we know that our federal partners are already moving to distribute the first doses of the vaccine throughout the country. The FDA's authorization for this vaccine is a significant milestone in battling a devastating pandemic that has affected so many families in the US and around the world. Our action comes as we are near the end what has been truly a year unlike any other in modern times. While this year has been marked by tragedy, sadness, and sacrifice, it is also a year that has generated unparalleled scientific achievement that will resonate for many future generations. Dr. Stephen Hahn: (03:25) Scientific processes for medical product development, including vaccines, traditionally take years. What we have seen this year is a historic partnership among the private sector, academic researchers, and the federal government to find efficiencies in our scientific processes, as well as the dedication of time and energy toward a common goal, which has led to the rapid development of truly innovative medical products. But let me be clear, efficiency does not mean any cutting of corners. Medical products are still undergoing rigorous study and clinical trials. Important safety checks remain in place. The FDA's review teams continue as they have always done to comb through the data submitted by companies regarding their medical products. Dr. Stephen Hahn: (04:13) What's different during COVID-19 is that developers, researchers, and regulators have found new and hopefully lasting ways to be dynamic and efficient. At the FDA, we have been applying a variety of resources and tools in our search for solutions and to support the nation's medical needs, which has led to this achievement. We found ways to cut the red tape and reduce regulatory burden on medical product sponsors when possible. One important tool we have used during this pandemic, including for this vaccine action, is the emergency use authorization or EUA created by Congress specifically to provide us with the means to respond rapidly during a public health emergency. Dr. Stephen Hahn: (04:54) For an EUA to be issued, the FDA's career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product. The FDA must determine that the products known and potential benefits outweigh its known and potential risks. For vaccines that have the potential to be given to millions of healthy Americans, we at the FDA have set high expectations. For yesterday's action on Pfizer BioNTech's COVID-19 vaccine, the FDA's career scientists conducted a fast, but incredibly thorough review of a complex EUA request involving manufacturing data, quality control data, safety data, effectiveness data, and more. Dr. Stephen Hahn: (05:38) Our career scientists and staff have been working around the clock, including holidays, weekends, and late nights to swiftly do this evaluation that meets our globally recognized high standards for review. I know the meticulousness of the review that the FDA has done. I will absolutely take this COVID-19 vaccine pending availability and distribution because I have complete trust and confidence in the FDA's career staff's evaluation. To ensure all Americans can have trust and confidence in the carefulness of the FDA's review, we have made this review process as transparent as possible. We held a public advisory committee on Thursday about the Pfizer BioNTech application. Dr. Stephen Hahn: (06:22) The advisory committee consists of external experts who reviewed clinical data from Pfizer and BioNTech's submission and provided their own recommendations to the FDA related to the data concerning the safety and effectiveness of the product. The committee overwhelmingly agreed that the vaccines benefits outweighs its risks. We've also made clear through two guidance documents the information a developer should provide to us for their COVID-19 vaccine, helping Americans understand exactly what data we would be looking at during our review process. Dr. Stephen Hahn: (06:56) Additionally, yesterday, we have also posted important information to help healthcare providers understand the benefits, risks, and proper use of this FDA authorized vaccine, including fact sheets for healthcare providers and vaccine recipients, instructions for use, the letter of authorization to the requester, which spells out the conditions under which the use of the product is authorized. We also intend to post the decision memorandum, which outlines the basis of our decision. All of this information helps the public understand the importance of our thorough and diligent review of the Pfizer BioNTech vaccine. It provides the necessary information to healthcare providers to understand if there are reasons certain people should not take the vaccine, such as a history of allergic reaction to any of the vaccine ingredients. Dr. Stephen Hahn: (07:51) Our transparency is arming healthcare providers with the tools they need to make decisions about what is appropriate for their patients. This transparency should also help assure the public that this vaccine met the FDA's rigorous standards for quality, safety, and efficacy. Science and data guided the FDA's decision. We worked quickly based on the urgency of this pandemic, not because of any other external pressure. This decision was based on the strongest scientific integrity, and I am so proud of the work that our career scientists have done. Dr. Stephen Hahn: (08:29) I'd like to conclude with an important reminder. While our federal partners are already taking steps to distribute this vaccine, we remind the public to remain vigilant as inoculation will take time. Wear a mask, wash your hands, and remain socially distant when possible. Protect yourself, the vulnerable, and others. Thank you for joining us today. Now I'd like to turn to Dr. Peter Marks, our director for the Center for Biologics Evaluation and Research for a few remarks. Dr. Peter Marks: (09:03) Thank you, Dr. Hahn, and thank you to all who are joining us on this historic day to discuss the FDA's action. As Dr. Hahn mentioned, yesterday, the FDA authorized the Pfizer BioNTech vaccine for individuals over the age of 16. Although this is not an FDA approval, this authorization makes Pfizer BioNTech's vaccine available in the United States and holds the promise to 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 BioNTech vaccine, because the vaccine's known and potential benefits outweigh its known and potential risks. Dr. Peter Marks: (09:49) The data provided by the sponsor have met the FDA's 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. Dr. Peter Marks: (10:29) The FDA is considered the gold standard regulator of medical products. The process that the FDA uses to review is respected worldwide because of a well-established history that the FDA has among the most rigorous and accurate review processes globally. 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. They were reviewed by experts from different disciplines, including physicians, biologists, chemists, statisticians, epidemiologists, and other professionals. Dr. Peter Marks: (11:12) 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. These data, which included nonclinical 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 robust public discussion with the independent experts the public saw this past Thursday. We also considered as part of our own review the advisory committee's recommendation with most members voting that this product's known and potential benefits outweigh its known and potential risks. Our work evaluating the Pfizer BioNTech vaccine does not end with this authorization. Dr. Peter Marks: (12:02) ... BioNTech 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 to licensure, also referred to as approval. Additionally, for the Pfizer BioNTech 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. Dr. Peter Marks: (12:41) 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 to 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. Dr. Peter Marks: (13:06) The FDA's review process means that Americans can trust and be confident in vaccines. Not just COVID-19 vaccines, but all vaccines reviewed by the FDA and available in the United States. FDA staff members are like your family. We're 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. Dr. Peter Marks: (13:44) We are humbled and privileged to be entrusted with this mission, and we're grateful to 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. FDA Moderator: (14:05) 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 unmute your line when prompted and ensure your camera is on. Our first question comes from Matt Perrone with the Associated Press. Matt Perrone: (14:22) 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 [inaudible 00:14:28] in people with a history of allergic reactions. If I am, 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 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? Dr. Stephen Hahn: (14:52) Matt, I'm going to let Dr. Marks 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 of the vaccine, that's something that uniquely America's FDA does. And it's highlighted in the question that you asked, but also the discussion at the advisory committee. Dr. Marks? Dr. Peter Marks: (15:17) So if you've had a history of allergic reactions, obviously you should tell your doctor about those. But the vaccine really is one that we're comfortable giving to patients who have had other allergic reactions besides those other than a 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 we are making sure that sites where this vaccine is being administered, have the ability to treat allergic reactions. Dr. Peter Marks: (15:57) And I just want to reassure the public that although there were these few reactions in Great Britain, these were not seen in the larger clinical trial datasets. And so we'll be monitoring very closely for them, but I think we still need to learn more. And that's why we'll be taking precautions. FDA Moderator: (16:24) As a reminder to the journalists online, please turn your cameras on when you are going to be asking a question and unmute your line. Our next question is from Laurie McGinley of the Washington Post. Laurie McGinley: (16:37) Good morning, and congratulations to you all. Thank you for calling on me. 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 that has to happen, and whether you're concerned that there may be shortages in ingredients or equipment, especially for the mRNA vaccines and what the FDA industry and the government are doing about those issues? Thank you. Dr. Stephen Hahn: (17:15) Thank you, Laurie. Really important question. As you know, FDA's role in this is as the independent regulator that reviews the science and the data behind an application. But we do work very closely with manufacturers on this issue. And we are aware that there are quite a few people in US government who are working on the issue of increasing supply. Dr. Marks, you want to talk about FDA's role with respect to supply chain? Dr. Peter Marks: (17:39) Right. So we will work with our federal partners to help them identify potential capacity, potential supply that might help in the increased production of these vaccines. And that's something that has to be a collaborative effort here. FDA Moderator: (17:58) Thank you. Our next question is from Tom Burton with the Wall Street Journal. Tom? Tom Burton: (18:17) There. Can you hear better now? FDA Moderator: (18:23) Yes, sir. Tom Burton: (18:24) All right, thank you. FDA Moderator: (18:25) Go ahead, sir. Tom Burton: (18:26) My question has to do with the blinding issue and unblinding, and the switchover 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 ensure that you get the largest set of safety data possible? Dr. Stephen Hahn: (18:50) Tom, really an important question. And as you know, at the Vaccine Advisory Committee, this was a significant topic of conversation. Dr. Marks, can you just speak to this agency's current thoughts on this? Dr. Peter Marks: (19:01) So, we obviously are 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 received placebo, to ask to potentially be vaccinated along with the group that would be appropriate as vaccines are distributed. We believe that we'll have a reasonable data set that will come from that. And obviously right now in the United States, we have to balance the amount of blinded data that we receive with the need to protect people from a pandemic that's taking thousands of lives daily. FDA Moderator: (19:49) Thank you. Our next question comes from Kiran Stacey from Financial Times. Kiran Stacey: (19:54) Thank you. I wanted to know whether you'd 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 at all? Dr. Stephen Hahn: (20:11) Dr. Marks? Dr. Peter Marks: (20:13) So we actually considered the potential allergic reactions pretty carefully here. And one has to be careful 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 some environmental aspect. And we would really not like to have that many people not be able to receive the vaccine. So we looked very closely at the databases and we feel comfortable. And 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. Dr. Peter Marks: (20:56) Now, we'll obviously be monitoring. We have very good safety surveillance systems in place, 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 piece of this is that centers will have the ability to treat allergic reactions. I think that's an extra precaution. FDA Moderator: (21:26) Thank you. Our next question comes from Anna Edney with Bloomberg. Anna Edney: (21:31) Good morning. You guys have mentioned this and obviously the FDA has worked night and day really hard to get this EOA completed. I wonder if you learned anything during the process that might change the next applications that come in for an EOA, whether anything might accelerate or change as we look forward to Moderna and other vaccines. Dr. Stephen Hahn: (21:55) This is a really important point you're making. 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 Virbac meeting. So transparency and thoroughness of scientific review, very, very important. Dr. Stephen Hahn: (22:19) We are in the process of doing a look back and hopefully we'll have some answers with that fairly soon, about what FDA's 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. Keep many of the things that worked well, learn from the challenges, and try to do absolute best job that we can for the American people moving forward. So that's our promise to everyone. FDA Moderator: (22:46) Thank you. Our next question comes from Michael Erman from Reuters. Michael Erman: (22:51) Hi. Thank you. 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 dose. What's FDA's position on this? Dr. Stephen Hahn: (23:08) So you understand what we put in the letter of authorization and the conditions of use. We stand by those recommendations. 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. Marks to answer the issue potentially about one versus two dose, so that he can certainly clarify what the FDA stance is on that. Dr. Peter Marks: (23:34) 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 only know how people were protected with two doses of vaccine, and that duration of protection that we've seen so far relates to having two doses of the vaccine. We spent so much time carefully reviewing the data- Dr. Peter Marks: (24:03) We spent so much time carefully reviewing the data and basing our decisions on science, right? That it seems pretty 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 series so we actually know that they're truly protected at the rate of approximately 95% of efficacy that was reported. FDA Moderator: (24:36) Thank you. Our next question comes from Nick Florko with STAT News. Nick Florko: (24:43) Hi, so thanks so much for doing this. Dr. Marks you had previously warned that it could take several days or even a few weeks to greenlight in an EUA, and that was, as I understand it, after the Pfizer EUA had been submitted. I guess I'm wondering what changed that this got out so quickly after the VRPAC meeting, and for Dr. Hahn, just to address the elephant in the room, did the White House's threats to fire you have any impact on the FDA's decision to get this out quickly? Thanks. Dr. Stephen Hahn: (25:13) Well, I'll answer first, Nick, first of all, the representations in the press that I was threatened to be fired if we didn't get it done by a certain date is inaccurate. So just want to put that on the record. And I've been clear with that in our response to those press reports. Secondly, Dr. Marks and I have been very clear from the beginning that we're going to maintain the integrity of the scientific process. We're going to let our scientists do their job and review and go through the thoroughness of that review, the gold standard, if you will. Dr. Stephen Hahn: (25:46) So we've done that, but we also recognize the urgency of the situation. And so we've said repeatedly, we will work as quickly as we can to come to a decision. And that's what we did. As has been reported, our team, the scientists, met after the VRPAC meeting, they did come to the conclusion that the vaccine did meet our standard for effectiveness and safety. And as you know, before 7:00 AM 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. Marks said, thousands of people are dying a day. FDA Moderator: (26:38) Our next question comes from Meg Tirrell with CNBC. Meg Tirell: (26:41) 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 immunosuppressive therapies, how did you consider the recommendations for those groups, especially considering they were not included in the trials. Dr. Stephen Hahn: (26:59) I'm going to 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. Marks, maybe the specifics? Dr. Peter Marks: (27:15) Yeah. So there were not enough pregnant women in the trials, or women who became pregnant in the trials, to actually know and make any statement about that. So for pregnant women, for that matter for children, younger children, we don't have data at this point, but for pregnant women and the immunocompromised at this point, it will be something that providers will need to consider on an individual basis for patients or for people. FDA Moderator: (27:48) Thank you. Next question comes from Carl Zimmer with New York Times. Carl Zimmer: (27:56) Yes. Hi. I would like to know, are you going to require that AstraZeneca finish its phase three clinical trial in the United States, which is only currently half enrolled, although that means according to AstraZeneca, that they can't apply for an EUA until June, and that will affect the supply of vaccines in the United States? Dr. Peter Marks: (28:18) I'm sorry, but that's one where I can't speak to a product that's under development. FDA Moderator: (28:27) Thank you. Our next question comes from Hannah Kuchler with Financial Times. Hannah Kuchler: (28:34) Hi, I just want to follow up on what Meg asked there. What advice would you give a doctor if a pregnant woman asks for the vaccine? What should they be considering? Dr. Stephen Hahn: (28:44) Dr. Marks? Dr. Peter Marks: (28:45) So, I think, this is one where, I think, you'd want to have, from a provider to an individual, a consideration 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 individual can make a decision about whether the benefits outweigh the risk because certainly COVID-19 in a pregnant woman is not a good thing. So someone might decide 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 to the individual. Dr. Stephen Hahn: (29:25) And just to follow up further on that question, 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 that they can counsel patients, and that patients are aware of the issues is so critically important. It's one thing that the USFDA uniquely does. FDA Moderator: (29:51) Thank you. Next question from Ryan Gabrielson with ProPublica. Ryan Gabrielson: (29:57) Thanks for taking my question. To what extent has the FDA done onsite inspections of Pfizer's manufacturing sites, and has the process for this vaccine differed from past reviews? Dr. Stephen Hahn: (30:08) Just to give you an overview of the inspection process, we have a lot of different tools in the toolbox to ensure the quality and 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. And Dr. Marks, I don't know if you want to give more specifics. Dr. Peter Marks: (30:29) Yeah. So for an emergency use authorization, we are 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 are very confident that these vaccines are being made in a manner that is consistent with a high quality that Americans have come to expect from vaccines taken to prevent disease. FDA Moderator: (30:58) Thank you. Our next question comes from Karen Weintraub with USA Today. Karen Weintraub: (31:05) Thanks so much for doing this. I was wondering if you could talk a little bit about the 16 and 17 year old age group. I know there was a lot of discussion the other day. What can we say to parents to reassure them that their teenager's safe getting this vaccine? Dr. Stephen Hahn: (31:17) Dr. Marks. Dr. Peter Marks: (31:18) 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 at FDA have a 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. Dr. Peter Marks: (31:44) And based on everything we saw from looking at the data, we're very comfortable that the safety profile that was observed in 17 and 16 year olds was acceptable. And although it wasn't quite as large as you might have seen in other groups, there was enough there to make us comfortable that the known and potential benefits outweigh the known and potential risks. After all, although what was said by some, 16 and 17 year olds, they don't get really sick with COVID-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. Dr. Peter Marks: (32:24) On the other hand, they are able to transmit quite easily if they're asymptomatic, as we've learned. And since some of those 16 and 17 year olds, at least that I know of, are out there as checkout people or interacting with communities, it may be wise that we are able to vaccinate them. So we think the known and potential benefits outweigh the known and potential risks. FDA Moderator: (32:54) Thank you. Our question comes from Rachel Roubein from Politico. Rachel Roubein: (33:03) 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, if they all already have the capacity to do, or could that limit the number of sites. Thank you. Dr. Peter Marks: (33:29) So I'm happy to take that one. So the Centers for Disease Control and Prevention, which is helping with the vaccine rollout is making sure that all sites have the basic supplies to take care of an allergic reaction. Those things include things like an epinephrin pen, diphenhydramine also known by the brand name of Benadryl and potentially a steroid called hydrocortisone. They'll make sure that those are available at sites giving the vaccine. They're basic equipment to have and the idea is that will be present at all of the sites in order to take care of a potential issue. Hopefully, it'll just be there as a safety precaution. FDA Moderator: (34:17) Our next question comes from Emily Kopp with Roll Call. Emily Kopp: (34:22) Hi, I'm hoping you can explain for a general audience what efficiencies in the process helped this move along so quickly. Someone referenced not doing onsite inspections, but what else did FDA do to speed this along? Dr. Stephen Hahn: (34:37) Again, let me be clear. We did not cut corners in our regulatory process. Dr. Marks and I, and his team have been talking about this since the spring and early summer. As you know, we put out guidances in June, as well as October, around this. And we've been working with developers of vaccines from the very beginning, helping them expedite the clinical and pre-clinical development process. So all hands on deck from Dr. Marks's 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 as they gathered the data and they decided to make an application. Dr. Marks and his team are to be congratulated for their heroic efforts because they had all hands on deck, had a lot of resources at their disposal, and worked night and day to get through this process and these applications. And there were a significant amount of efficiencies in those steps, including working closely with our US government partners when appropriate. So a really a major effort by all of the agency, but in particular, Dr. Marks's center. FDA Moderator: (35:53) Thank you. Our next question comes from Peter Aitken with Fox News. Peter Aitken: (35:59) Morning. Thank you for taking my question. You said there's going to be follow up with safety... Peter Aitken: (36:03) I Think my question, you said there's going to be follow up with safety and further reviews after the emergency use. If there was a potentially problematic complication that arose, what would the process be to handle that kind of issue? Dr. Stephen Hahn: (36:14) I'm going to ask Dr. Marks to talk about the specifics around the followup with respect to the EUA, the authorization, but just to put a finer point on the question, from our perspective we in our guidances really insisted upon the fact that there would be a very rigorous follow up safety surveillance system and Dr. Marks and his team have worked with other government partners, most notably the Centers for Disease Control to help institute that. But I think Dr. Marks can answer specifically what, what might happen moving forward? Dr. Peter Marks: (36:47) So the Centers for Disease Control and Prevention and the FDA, we've now launched a 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 going to communicate it. We're going to communicate it once we know enough about it, to be able to communicate coherently on it, but we will pursue finding out about such things with due diligence so that we can get the word out there as quickly as possible. So it will be a combined effort and it will be an ongoing effort and quite a large one as we see more and more people vaccinated. FDA Moderator: (37:29) Thank you. Our next question comes from Lauren Mascarenhas with CNN. Lauren Mascarenhas: (37:38) Hi, are you worried that the appearance of pressure on this process will impact people's willingness to get a vaccine, are you working to counteract that in any way? Dr. Stephen Hahn: (37:48) So the agency is very concerned about vaccine hesitancy. We are also aware that some feel that the speed with which this development and the 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. As Dr. Marks 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 Virbac meeting on the 10th of December and following through on that. Dr. Stephen Hahn: (38:27) And then being very clear after 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 providers and people who receive the vaccine would need to have. So, yes, it's a concern. We will continue, Dr. Marks and I have been meeting with many stakeholders, certainly with the press as well, 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 for the American people and FDA and this vaccine. FDA Moderator: (39:13) Thank you. Our next question comes from Alicia Ault with Medscape. Alicia Ault: (39:22) Yes, hi. I wanted to ask you, given your remark, Dr. Marks, about vaccinating teens to prevent transmission. When will we know more about how the vaccine might impact viral shedding and transmission? Dr. Peter Marks: (39:42) 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 might happen from animal studies. So we'd like to have human data as quickly as possible, but those studies are going to be conducted during the coming months. FDA Moderator: (40:10) Thank you. Our next question comes from Drew Armstrong with Bloomberg. Drew Armstrong: (40:22) Hi, I'm wondering what data transparency FDA can commit to in terms of how and when you'll be reporting any information on vaccination numbers or side effect profiles, any kind of real-time data that agency will be doing and making available to the public in addition to your study, and then reporting that you would normally do on any kind of product like this. Dr. Stephen Hahn: (40:50) Dr. Marks. Dr. Peter Marks: (40:51) So the CDC and FDA are going to work together, as I've mentioned, and we have a website here that will post the types of surveillance that we're doing, that we'll post the types of surveillance studies. We have about 20 adverse events that we'll be looking for on 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 sleeve and taking the vaccine. Dr. Stephen Hahn: (41:27) And Drew, you may have seen our statement, my statement, from a couple of weeks ago regarding transparency in the agency and EUAs, and we have made a strong commitment, our center directors and myself, to being transparent about it. We realized that is something that we will continue to need to continue to do during this pandemic because that helps build trust and confidence in our processes and our decision-making. FDA Moderator: (41:53) Thank you. Our last question is from Meg Tirrell with CNBC. Meg Tirell: (42:00) Thank you for giving too. I'm just wondering about the delicate handling requirements of this vaccine. We've dedicated a lot of airtime and ink to the cold temperatures at which it has to be stored, the fact that it can 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'll be no degradation of the vaccine? And when do you want to tell the public about that? Dr. Stephen Hahn: (42:32) So I'm going to let Dr. Marks talk about the specifics, but really important point because folks may not know this is a core responsibility of the FDA to understand the conditions under which a product might be used and how it'd be used. And so this is something that our team has spent a lot of time looking at. Dr. Marks. Dr. Peter Marks: (42:48) So we put forward the conditions that need to be adhered to, we try to make it very clear 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, there is this bit of subtlety here that the vaccine needs to be stored at very, very cold temperatures. Once it's thawed, it can be kept in a regular refrigerator for a number of days, but we're pretty convinced that we can make this happen here. We've seen cold chains maintained in locations that are pretty rural or pretty rough for instance, with vaccination campaigns in Africa. So we're hopeful that this is going to work out. Dr. Stephen Hahn: (43:54) Well, thank you for joining us here today and participating in this press conference around the FDA's authorization of the Pfizer BioEnTech COVID-19 vaccine. We invite you to visit our website at fda.gov for more information about the authorization. Thank you.