And it is considered the Gold Standard regulator of medical products. We applied our high standards to review this product so that americans can have trust and confidence that the vaccine meets our rigorous standards for safety and effectiveness. Americans can have trust and confidence that the vaccine meets our rigorous standards for safety and effectiveness. With this authorization, we know our federal partners are moving to distribute the first doses of the vaccine throughout the country. The fdas authorization for this vaccine is a significant milestone in battling a devastating pandemic that has affected so many families in the u. S. And around the world. Our action comes as we near the end of what has been truly a year unlike any other in modern times. While this year has been marked by tragedy and sadness, it is also a year with unparalleled Scientific Achievement that will resonate for many future generations. Scientific processes for Product Development for vaccines traditionally take years. What we have seen this year is a Historic Partnership among the private sector 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 innovative medical products. But let me be clear. Efficiency does not mean any cutting of corners. Medical products are still undergoing rigorous study in Clinical Trials. Important safety checks remain in place. The fda review teams continue to comb through the data submitted by the Companies Regarding medical products. What is different is that developers, researchers, and regulators have found lasting ways to be dynamic and efficient. At the fda, we are applying a variety of resources and tools in our search to support that medical needs of the nation. We have found ways to cut the red tape and reduce Regulatory Burden on medical products sponsors when possible. One tool we have used for this pandemic is the emergency use authorization created by congress specifically to provide us with the means to respond rapidly during a Public Health emergency. For an eua to be issued, the career scientists conduct evaluations of currently available Scientific Evidence about a medical product. The fda must determine the product benefits outweigh its risks. For vaccines that have the potential to be given to millions of all the americans, we have set high expectations. For yesterdays action on pfizers covid19 vaccine, our career scientists conducted a fast but incredibly thorough review of a complex request involving manufacturing data, Quality Control data, safety data, effectiveness data, and more. Our career staff has been working around the clock including holidays and weekends and late nights to swiftly do this evaluation that meets are our recognized high standards for review. I know the meticulousness of the review and i will take this covid19 pending availability and distribution because i have complete trust and confidence in the career staff evaluation. To ensure all americans can have have in the review, we made this review process as transparent as possible. We held a Public Advisory Committee on thursday about the Pfizer Biontech application. The Advisory Committee consists of experts who reviewed Clinical Data from pfizer and biontech submissions and provided their own recommendations related to the data concerning the safety and effectiveness of the product. Agreed that the vaccines benefits outweigh its risks. We have also made clear through two guidance documents, the information a developer should provide to us for their covid19 vaccine, helping americans understand what data we would be looking at during our review process. Yesterday, we have posted Important Information to help Health Care Providers understand the benefits, risks, and proper use of this vaccine, including fact sheets for Health Care Providers and vaccine recipients. Instructions for use, the letter of authorization to the requester, which spelled out the conditions under which use of the product is authorized. We also intended to post the decision memorandum, which outlines the basis of our decision. All of this information helps the public understand the importance of a thorough and diligent review of the vaccine. It provides the necessary information to Health Care Providers to understand if there are reason certain people should not take the vaccine, such as a history of other degree action to any of the vaccine ingredients. Our transparency is arming Health Care Providers with the tools they need to make decisions about what is appropriate for their patients. This transparency should help assure the public that this vaccine met the fdas standards for quality, safety, and efficacy. Signs and data guided the fdas decision. We worked quickly based on the urgency of this pandemic, not because of any external pressure. This decision was based on the strongest scientific integrity and i am proud of the work our career scientists have done. I would like to conclude with an important reminder. While our federal partners are taking steps to distribute this vaccine, we remind the public to remain vigilant as inoculation will take time. Hands,mask, wash your and remain socially distant when possible. Protect yourself, the vulnerable, and others. Thank you for joining us today and now i would like to turn to dr. Peter marks, our director for the center a Biologics Research for a few remarks. Dr. Hahn, and thank you to all who are joining us on this historic day to discuss the fdas action. As dr. Hunt mentioned, yesterday, the fda authorized the vaccine for individuals over the age of 16. Although this is not in fda approval, this authorization makes pfizer and biontechs vaccine available in the United States and holds the promise to alter the course of the pandemic. It is a remarkable achievement of Vaccine Development in made them less than a year. With science guiding our decisionmaking, the safety and effectiveness data support the authorization of the vaccine because the known benefits outweigh its potential risks. That data provided by the sponsor have met the fdas expectations conveyed in our guidance documents. The developer and has not sacrificed the standards of our evaluation process. In making our emergency use authorization determinants, the fda can assure the public and medical community that we have conducted a thorough in valuation of the safety, effectiveness, and manufacturing quality information. Testamentvement is a to the commitment of our career review staff who work tirelessly to thoroughly evaluate the vaccine. The fda has considered is considered the Gold Standard of medical products. The process the fda uses is respected worldwide because of a wellestablished history that the fda has among the most reviews it accurate processes globally and this is reflected in our record for getting things right in promoting and protecting Public Health. The amount of data submitted to the fda included hundreds of pages of written Technical Information and additional reams of tables, figures, and listings that were reviewed by experts by different disciplines including physicians, chemists, epidemiologists, and other professionals. Found deficiencies where he could without sacrificing our standards. Normally, the review process for a vaccine spans tens of thousands of people takes months. We conducted this review in a few weeks. These data, which included nonClinical Data on the development in the laboratory, manufacturing data, and Clinical Trial data, where reviewed ahead of the Public Advisory Committee meeting to ensure robust discussion. We also considered as part of our own review the recommendation with most members voting that this products benefits outweigh its potential risks. Evaluating the vaccine does not end with this authorization. As we noted in our emergency authorization guidance, we expect vaccine sponsors to continue studying their vaccines to move to licensure, also referred to as approval. For the Pfizer Biontech vaccine, the fda is requiring that the sponsor conduct active followup for safety, including monitoring for significant adverse events to the benefit risk view you and assessment of the vaccine. Cdc will also collaborate to conduct extensive safety surveillance on an ongoing basis. Question turn to the and answer portion of this conference, i want to end by noting that because of the suffering caused by this pandemic, fda staff tell 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 standards for safety and effectiveness, that americans and the world have come to expect. Process meansew that americans can trust and be confident in vaccines. Vaccines, but19 all vaccines reviewed by the fda and available in the United States. Fda Staff Members are like your family. We are a Diverse Organization reflective of this country, including mothers, fathers, daughters, sons, and more. We know the pain that this country has gone through during the last year. Thatsaid, we also know americans put the most trust and confidence in our review process. We are humbled and provision to be entrusted with this mission and we are grateful to have helped in this achievement. We look forward to advancing additional vaccine candidates over the coming months. I will turnnd now back to the moderator to begin questions and answers. You, dr. Hahn and dr. Marks. We will now turn to the question and answer portion of the call. As a reminder to journalists, please unmute your line when prompted and ensured the camera is on. Our first question comes from the associated press. Thanks for taking our questions this morning. I want to see if he could talk with about People History of allergic reactions. If i am one of the millions of americans who cannot say i have a food allergy, can i go ahead and get this vaccine or do i need to research all the ingredients, get more information about what is in it, and how what i do that . Im going to let dr. Marks answer the technical part of that question, but you have highlighted an important point, which is that the thoroughness of our review, delving into ofse issues, the assessment potential reactions and side effects, that is something that americas fda does and is highlighted in the question you asked but also the discussion at the Advisory Committee. Ofif you have a history allergic reactions, you should tell your doctor about those, but the vaccine is one that we are comfortable giving to patients who have had other allergic reactions besides those then allergic reactions to a vaccine or one of its components. You will need to tell your doctor if you had had if you have had an allergic reaction. That sitesng sure with this vaccine is being administered have the ability to treat other degree actions and i want to reassure the public that although there were these few reactions in great britain, these were not seen in the larger Clinical Trial data sets, so we will be monitoring closely for them, but i think we need to learn more and that is why we will be taking precautions. As a reminder, please turn your cameras on when you are going to be asking a question. And unmute your line. Our next question is from the washington post. Good morning and congratulations to you all. Thank you for calling on me. It seems at this point that there are some increasing supplies about the supplies of. He vaccine can you talk to us about the challenges of ramping up production, the scale up that have to happen, and whether you are concerned that there may be shortages in ingredients or equipment, especially for the . Rna vaccines thank you. Thank you, really important question. In this is reviewing the signs and data behind an application but we do work closely with manufacturers on this issue and we are aware that there are quite a few people who are working on the issue of increasing supply. Dr. Marks, do you want to talk about fdas role . We will work with our federal partners to help them identify helpity, supply that might in the increased production of these vaccines and that is something that has to be a collaborative effort. Thank you para our next question is from tom burton with the wall street journal. Tom . Can you hear better now . Yes, sir. Go ahead. My question has to do with the blinding and on blending and the switchover issue. What is 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 geico if so, switchover . If so, how do you make sure you get the largest set of safety data possible . Really an important question and as you know, this was a significant topic of conversation. You speak to the agencys current thoughts on this . We are discussing with each manufacturer their plans. In this case for pfizer, the plan is to allow those who receive the vaccine to find out what they received and if they received placebo, to ask to be vaccinated along with the group that would be appropriate as vaccines are distributive. We believe that we will have a reasonable data set that will come from that, and right now in the United States, we have to balance the amount of blended data that we receive with the need to protect people from a pandemic that is taking thousands of lives daily. Thank you. Our next question comes from financial times. Thank you. I wanted to know whether you have considered attaching additional warnings regarding allergies. You have these warnings regarding the singler ingredients in the vaccine itself, but did you consider putting other allergic warnings on the fact sheet at all . Dr. Marks . Thee actually considered potential allergic reactions pretty carefully here and one has to be careful, based on at the data look at the data one has in hand because some of the population has had a severe allergic reaction of some sort someother to a food with environmental aspect and we would not like to have that many people not be able to receive the vaccine. We looked closely at the databases and we feel comfortable that we are telling people that unless they have had a severe allergic reaction to the vaccine or one of its components, they can receive it. We will obviously be monitoring. We have 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 are comfortable with this and the extra piece of this is that sensors will have the ability to treat other degree actions. That is an extra precaution. Thank you. Our next question comes from bloomberg. Good morning. You guys have mentioned this and the fbi has worked night and day to get this completed. I wonder if you have learned anything in the process that might change the next applications that come in, whether anything might accelerate or change as we look forward to moderna and other vaccines. This is an important point. I can assure the American Public that one thing that wont change is the thoroughness of our review. As you can see by some of the questions, the thoroughness of our review got to the heart of that issue, we had a vigorous discussion at the meeting. Transparency and thoroughness of scientific review, every important. We are in the process of doing a look back and hopefully we will have some answers fairly soon about what fdas response has been like. Our intention is to learn the lessons because fda is a learning organization. Keep the things that worked well , learn from the challenges, and try to do the best job we can for the American People moving forward. That is our promise. Thank you. Our next question comes from writers reuters. Constraints,y there has been a discussion about maximizing the number of people who can receive the first dose rather than holding back doses to guarantee a second dose. What is fdas position on this . You understand what we put in the letter of authorization and the conditions of use, we stand by those recommendations. The question you are asking should be referred to those who are distributing and making recommendations about prioritization but i would like dr. Marks to answer the issue about one versus two doses so he can clarify what the fdas stance is on that. Thanks. There has been a lot of noise about one versus two doses and the way the regiment 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 and that that duration of protection that we have seen so far relates to having two doses of the vaccine. We spent so much time carefully reviewing the data and basing our decisions on science that it seems pretty foolhardy to conjecture that one does might be ok without knowing, so at least from the fda perspective, we would be recommending that people complete the two dose series so we actually know that they are truly protected at the rate of approximately 95 of efficacy that was reported. Thank you. Our next question comes from stat news. Thank you for doing this. Dr. Marks, you previously warned that it could take several weeks or several days or even a few weeks to greenlight any eua and that was after the Pfizer Vaccine had been submitted. What changed that this got out so soon after the meeting . And dr. Hahn to address, did the white houses threat to fire you have any impact on the decision to get this out quickly . I will answer first. First of all, the representations in the press that ith was threatened to be fired is inaccurate, just want to put that on the record and i have been clear with that in our response to those press reports. Secondly, dr. Marks and i have been clear from the beginning that we are going to maintain the integrity of the process. We are going to let our scientists do their job and review and go through the fairness of that review, the Gold Standard. So we have done that. We also recognize the urgency of the situation so we have said, we will work as quickly as we can to come to a decision and that is what we did. Team, the scientists met after the meeting, they did come to the conclusion that the vaccine did meet our standard for effectiveness and safety and as you know, we issued a statement saying that we were working with the sponsor to move toward authorization. Our incredible team, heroic efforts, night and day worked to get this done and out the door and they did a superb job and i am proud of their efforts because we understand the urgency of the situation. Thousands of people are dying a day. Our next question comes from c mpc. I was wondering if you could talk about the special groups and considerations for people like pregnant and breastfeeding women and people on a middle depressive therapies. How did you consider the recommendations from those groups, considering they were not included in the trial . Im going to sound like a broken record but this gets to the heart of the thoroughness of adverb review, the assessment of the safety and effectiveness of the vaccine, because these questions are important to providers and allamericans. Dr. Marks, maybe the specifics . There were not enough pregnant women in the trials or women who became pregnant in the trials to know and make any statement about that, so for pregnant women, four children for younger children, we dont have data but for pregnant women and the immuno compromise, it will be something that providers will need to consider on an individual basis for patients. Or for people. Thank you. Next question comes from carls a mayor with new york times. With new york times. I would like to know, are you going to require the astrazeneca Clinical Trial in the united ,tates, which is half enrolled although that means according to astrazeneca that they cant apply for an eua until june and that will affect the supply of vaccines to the United States . Im sorry, but that is one there i cant speak to a product that is under development. Thank you. Our next question comes from financial times. Just want to followup. What advice would you give a doctor if a pregnant woman asked for the vaccine . What should they be considering . Dr. Marks. I think this is one where you would want to have, from a provided to an individual, a consideration of the potential benefits and risks. What we dont know about the vaccine versus what we do. If that conversation happens, i think the provider and that individual can make a decision about whether the benefits outweigh the risks, because covid19 in a pregnant woman is not a good thing so someone might decide that they would like to be vaccinated, but that is not something we are recommending at this time, that is something we are leaving up to the individual. Further,o follow up again getting back to our review and what we put in the documents for the American People and providers, that level of detail to provide as much information supported by data and science are provided to providers so patients are aware of the issues is critically important. It is one thing that the fda does. Thank you. Next question from propublic up. To what extent has the fda inspections of manufacturing sites . To give you an overview of the inspection process, we had a blot of tools to ensure the quality a lot of tools to ensure the quality and safety and make sure any medical product would meet our high standards. A lot of tools at our disposal which we have used. I dont know if you want to get more specifics. For emergency use authorization, we are not required to do the site inspections that we would for a biologics license application and fully approved vaccine. That said, we relied on a combination of tools to ensure that we are 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 usa today. Thanks for doing this. I was wondering if you would talk about that 16 and 17yearold age group. There was a lot of discussion the other day. What can we say to parents to reassure them that their teenager is safe getting this vaccine . Thank you so much for that question because there was, as you might realize, some debate about that in our meeting. That is one of those places where we at fda have a fair amount of history, some of which has not been in the Public Domain because we approve a lot of vaccines in the pediatric age range and we are used to extrapolating from adults or from older children to younger children. Based on everything we saw from looking at the data, we are very comfortable that the safety profile that was observed in its and 16yearolds in 17 and 16yearolds was acceptable. Though it was not 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. What was said by some, 16 and 17yearolds come out they dont get really sick with covid19 very often, though i think if you are the parent of a child who does get sick and die from it, you might be pretty upset. On the other hand, they are able to transmit quite easily, if they are asymptomatic, and since some of those 16 and 17yearolds, at least that i know of, are out there as to cut people out of there as check out people, we may be able to vaccinate them there at vaccinate them. Thank you. Our next question comes from politico. Thanks for taking my question. I wanted to follow up on the allergic reactions. You mentioned that some sites would be able to handle it. Is there any specific equipment that is required of them in is that something that they do or could that limit the number of thank you. I am happy to take that one. The cdc, which is helping with the vaccine rollouts, is making sure that all sites have the basic supply to take care of an allergic reaction, those things , divee an epinephrine pen benadryl known as and a steroid, they will make sure those are available at sites giving the vaccine. Haveare basic equipment to in the idea is that will be present at all the sites to take care of potential issues. Hopefully, these will just be there as a safety precaution. Our next question comes from roll call. Im hoping you can explain for a general audience what efficiencies help this move along so quickly. Someone mentioned onsite inspections, but what else . Notet me be clear, we did cut corners in our process. Dr. Marks and i and his team have been talking about this since the spring and early summer. June asut guidances in well as october around this and we have been working with developers of vaccines from the beginning on helping them expedite the clinical and Preclinical Development process. All hands on deck from dr. Marks team and the agency from the beginning, allowing for a seamless developing process which helped in the development of the vaccine and working very closely with the manufacturers and sponsors as they gathered the data and 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, and worked night and day to get through this process. There were a significant amount of efficiencies in those steps, including working with our government partners when appropriate. Of the effort by all agency, but in particular dr. Marks center. Thank you. Our next question comes from fox news. Thank you for taking my question. You said there is going to be followup and further reviews after the emergency use. If there was a problematic complication that arose, what with the process be to handle that kind of issue . Im going to ask dr. Marks to talk about the specifics around the followup, but to put a finer point on the question, from our perspective, in our guidances, we insisted upon the fact that there would be a rigorous followup safety Surveillance System and dr. Marks and his team have worked with government partners, notably the cdc, to help institute that. I think dr. Marks can answer specifically what might happen moving forward. The centers for Disease Control and prevention and the fda, we have now launched a continual process where we will be looking at safety events and if we see something that rises to the place where the public needs to know about it, we are going to communicate it once we know enough about it to be able ,o communicate coherently on it but we will pursue finding out about such things with Due Diligence so we can get the word out as quickly as possible. It will be a combined effort and an ongoing effort and quite a large one, as we see more people vaccinated. Thank you. Our next question comes from cnn. There you worried that appearance of pressure on this process will impact peoples willingness to get a vaccine in are you working to counteract that in any way . Concernedncy is very about vaccine hesitancy. We are also aware that some feel that the speed with which this development and process took place might give them concerns about the vaccine. But it is why we were transparent. The way we address this is to be clear about the data and the said, toas dr. Marks make a decision. Be clear from the beginning what our processes would be, including having a transparent discussion as we did with the meeting on the 10th of december, and following through on that. Then being clear, after a decision was made, about the data and science and rationale behind a decision as well as giving a detailed description of what providers and people who receive the vaccine would need to have. So it is a concern, we will continue we have been meeting with stakeholders, certainly with the press as well, to address any concerns that arise and to be clear and transparent about the processes and the science and the data. We believe that transparency as well as the scientific review we have done goes a long way to providing confidence and trust in the American People and this vaccine. Card our next question thank you. Hi. I wanted to ask you, given your remark about vaccinating teens to prevent transmission, when will we know more about how the vaccine might impact viral transmission . Monthst may take a few for we start to have those data. Additional studies will be done, 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 would like to have human data as quickly as possible. Those studies are going to be conducted during the coming months. Thank you. Our next question comes from bloomberg. I am wondering what data transparency the fda can commit to in terms of how and when you will be reporting any information on vaccination numbers or side effect profiles, any Realtime Data you will be doing and making available to the public, in addition to your study that you have been reporting that you numeral he do normally do. The cdc and fda are going to Work Together and we have a will put the types of surveillance we are doing, we will post the types of surveillance studies, we have about 20 adverse events we will be looking for on an ongoing basis, if there are any signals in those, we will post those. Our goal is to make sure that people know that we are doing our jobs to make sure that we look out for possible adverse events, that they feel comfortable taking the vaccine. Seen myay have statement from a couple weeks ago regarding transparency in the agency and we have made a strong commitment to being transparent about it. That isze that something that we will continue to do during this pandemic because that helps build trust and confidence in our decisionmaking. Thank you. Our last question is from cnbc. Thank you for giving me two. I am wondering about the delicate handling requirements of this vaccine. We have dedicated a lot of airtime to the cold temperatures , the fact that it can only be out of the freezer for a minute, transferring it from the box to the deep freezer. My own doctor has even said she is nervous about this vaccine because it requires such delicate handling. How convinced are you that every site builder this perfectly every time, there will be no degradation of the vaccine . What do you want to tell the public about that . Im going to let dr. Marks talked about the specifics but folks may not know, this is a core response ability of the fda to understand the conditions under which a product might be used and how it would be used. This is something our team has spent a lot of time looking at. We put forward the conditions that need to be adhered to, we try to make it clear in the labeling, in the provider information sheet how the vaccine will be handled and i know that our colleagues at the centers for Disease Control and the operation warp speed folks are making sure that things are in place to make sure that the cold chain is maintained. There is this subtlety here that the vaccine needs to be stored at very cold temperatures. Once it is thaw we are pretty convinced we can make this happen. We have seen cold chains maintained in locations that are pretty rural, or pretty rough. For instance, with vaccination campaigns in africa. We are hopeful this is going to work out. Well, thank you for joining us today and participating in this press conference around the fdas authorization of the biontech covid19 vaccine. We invite you to visit our website for more information about the authorization. The first vaccine shipments from pfizer expected to start moving up sunday morning, and be sential shipment around the United States over the next week according to the new york times. Pfizer has said it will be able to supply up to 25 million doses before the end of this year, and 100 million total vaccines by march, 2021. Gus perna chief , operation officer, of operation warp speed, says he expects the Coronavirus Vaccine first shipments will arrive at 145 sites across the country on monday. The Pfizer Vaccine will begin moving to ups hubs within the next 24 hours to go out to locations nationwide, with more going out on tuesday and wednesday. Gov. Perna for seven months, we have realized the greatest Publicprivate Partnership in modern times. Doctors, scientists,