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<