Virtual Press Conference: First COVID-19 Vaccine – 12/12/2020

good morning we’d like to welcome you all to our virtual press conference today to discuss the fda’s emergency youth authorization of the pfizer biontech covid19 vaccine first we always hear from fda commissioner dr stephen hahn and dr peter marks the director of the fda’s center for biologics evaluation and research following their remarks we will open up for questions and with that let’s turn the press conference over to dr han 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 bioentic covid19 vaccine this is the first cova-19 vaccine to be authorized in the united states the fda is respected worldwide and is 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 and 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 u.s and around the world our action comes as that 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 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 in 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 what’s different during coven 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 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 product’s 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 bioentex covet 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 our career staff 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 coven 19 vaccine pending availability and distribution because i have complete trust and confidence in the fda’s career staffs 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 bioentec application the advisory committee consists of external experts who reviewed clinical data from pfizer and bioentex 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 vaccine’s benefits outweighs its risks we’ve also made clear through two guidance documents the information a developer should provide to us for their covet 19 vaccine helping americans understand exactly what data we would be looking at during our review process additionally yesterday we have also posted important information to health to help health care providers understand the benefits risks and proper use of this fda authorized vaccine including fact sheets for health care 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 bioin-tech vaccine it provides the necessary information to health care providers to understand if there are reasons certain people should not take the vaccine such as a history of allergic rex allergic reaction 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 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 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 and now i’d like to turn to dr peter marks our director for the center for biologics evaluation and research for a few remarks thank you dr han and thank you to all who are joining us on this historic day to discuss the fda’s action as dr han mentioned yesterday the fda authorized the pfizer bioentech vaccine for individuals over the age of 16 although this is not an fda approval this authorization makes pfizer bioentex 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 bioentech vaccine because the vaccines known and potential benefits that way it’s known in potential risks 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 the fda is considered the gold standard regulator of medical products the process that the fda uses to review is spec is respected worldwide because of a well-established history that the fda has among the most rigorous and 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 that 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 these 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 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 bioentech 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 bioentec 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 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 the fda’s review process means that americans can trust and be confident in vaccines not just covet 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 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 thank you dr han 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 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 the contraindication 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 and if so how exactly would i do that 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 a potential reaction side effects of the vaccine that’s something that uniquely america’s fda does and is highlighted in the question that you asked but also the discussion at the advisory committee dr marks so if you’ve had a history of allergic reactions obviously you should talk 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 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 are making sure that sites where this vaccine is being

administered have the ability to treat allergic reactions um and i i just want to reassure the public that you know the although there were these few reactions in great britain these 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 more and that’s why we’ll 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 unmute your line our next question is from laurie mcginley of the washington post good morning and congratulations to you all uh thank you for calling on me 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 up 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 thank you lori um really important question um as you know fda’s role in this is as the independent regulator that reviews the science and the data behind uh an application but we do work very closely with uh 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 uh dr march you want to talk about fda’s role with respect to supply chain right so we 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 thank you our next question is from tom burton with the wall street journal tom there can your bed hear better now wait yes sir all right go ahead sir um 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 tom really an important question and as you know at the vaccine advisory committee this was a significant topic of conversation dr marks what’s the can you just speak to this agency’s current thoughts on this so uh the 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 uh 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 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 stacy from financial times thank you uh 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 fat sheet at all dr marks so we actually considered the potential allergic reactions pretty carefully here and 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 some environmental aspect and we would really not like to have that many people not be able to receive the vaccine so we look very closely at the databases and 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 uh the centers for disease control and prevention and we may have to modify things as we move forward uh but for right now we’re comfortable with this and the extra the extra piece of this is that centers will have the ability to treat allergic reactions i think that’s an extra precaution thank you our next question comes from edney with bloomberg good morning um you guys have mentioned this and obviously the fdi has you know worked night and day and really hard to get this eua completed i wonder if you learned anything during the process that might change the next applications that come in for an eua whether anything might accelerate or change as we look forward to moderna 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 verbac meeting so transparency and thoroughness of scientific review very very important 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 thank you our next question comes from michael erman from reuters hi uh thank you with uh 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 uh what’s what’s fda’s 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 the question that you’re asking the heart of that question really um should be referred to those who are distributing and making recommendations about prioritization but i would like dr marks to answer the issue uh potentially about one versus two dose so that he can certainly clarify what the fda stance is on that so thanks there’s 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 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 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 um we would be recommending uh that people complete the two dose series so we actually know that they’re truly protected at the rate of approximately 95 percent of efficacy that was reported thank you our next question comes from nick florco with stat news hi so thanks so much for doing this uh dr mark’s you had previously said i previously warned that it could take several weeks or several days or even a few weeks to green light in the ua uh 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 verpack meeting um and for dr hans to address sort of the elephant in the room did the white house’s threats to to fire you have any impact on the fda’s decision to get this out quickly thanks well i’ll uh i’ll answer first nick um first of all the the representations in the press that um i was threatened to be fired if we didn’t get it done by a certain date um is inaccurate um so just want to put that on the record and i’ve been clear with that in in our response to those press reports secondly um i’ve 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 so we’ve done that but we also recognize the urgency of the situation so we’ve said repeatedly

we work as quickly as we can to come to a decision and that’s what we did um as ben has been reported our team the scientists met after the vervac meeting they did come to the conclusion that the vaccine did meet our standard for effectiveness and safety and as you know before 7 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 mark said thousands of people are dying a day 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 immunosuppressive therapies how did you consider the recommendations for those groups especially considering they were not included in the trials 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 marx maybe the specifics yeah so um there were not enough pregnant women uh 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 younger children we don’t have data at this point but for pregnant women and the immunocompromised at this point um it will be something that providers will need to uh consider on an individual basis uh for patients or for for people thank you next question comes from carl zimmer with new york times uh yes hi um uh i would like to know um are you going to require that astrazeneca finish its phase through clinical trial in the united states which is only currently half enrolled uh 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 yeah i’m i’m 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 hi i just want to follow up on what meg asked there um what advice would you give a doctor if a pregnant woman asks for the vaccine what should they be considering dr marx so i think this is one where i think you’d want to have a it’s from a provider to an individual a 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 uh if that conversation happens i think uh the provider and that uh individual can make a decision about whether the benefits outweigh the risk because certainly covet 19 in a pregnant woman is not a good thing so someone might decide um that they uh 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 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 the patients are aware of the issues is so critically important it’s one thing that the us 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 pfizer’s 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 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 um and dr marks i don’t know if you want to give more specifics 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 thank you our next question comes from karen weintraub with usa today i thank so much for doing this i was wondering if you would 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 that that their teenager is safe getting this vaccine uh dr marks yeah thank you so much for that question because there was as you might realize as you might have noted uh 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 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 a lot you know they don’t get really sick with covet 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 uh pretty upset on the other hand um 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 check out people um or or interacting with communities it may be wise that we are able to uh vaccinate them so we think the known and potential benefits outweigh the known and potential risks thank you our next question comes from rachel robin from politico hi thanks so much for taking my question um i wanted to follow up on um 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 all already have the capacity to do or could that um limit the number of thank you so i’m happy to take that one um so 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 the brand name of benadryl um and and potentially a steroid called hydrocortisone they’ll make sure that those are available um at sites giving uh the vaccine their basic their basic uh 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 will just be there as a safety precaution our next question comes from emily kopp 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 someone referenced not doing on-site inspections but what else did fda do to speed this along well 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 sort of expedite the clinical and pre-clinical development process so all hands on deck from dr marx’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 marx 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 in these applications and there were a significant amount of efficiencies in those steps including working closely with our us government partners when appropriate appropriate so a 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 um you said there’s going to be follow-up with safety and further reviews after the emergency use if there was a potentially problematic prop complication that arose what would the process be to handle that kind of issue i’m going to ask dr marks to talk about the specifics around the follow-up with respect to the eua the authorization but just to put a finer point on the question uh from our perspective we in our guidances um really insisted upon the fact that there would be a very rigorous uh follow-up safety surveillance system and uh dr marks and his team have worked with other government partners most notably the centers for disease control uh to help institute that um but i think dr marx can answer specifically what uh 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 a continual process where we would be looking at safety events and if we see something that rises to uh 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 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 thank you our next question comes from lauren muscarinis 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 counteract that in any way so um 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 as 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 verbace meeting on the 10th of december and following through on that and then being very clear after a decision was made about the the data and the science and the rationale behind the decision as well as giving a very detailed description of of what would what providers and pa and people who receive the vaccine would need to have so yes it’s a concern we will continue dr marx and i have been meeting with many stakeholders uh certainly um with the press as 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 and fda and this vaccine thank you our next question comes from alicia alt with medscape yes hi um i wanted to ask you given your remark uh dr marks about vaccinating teens to prevent transmission um when will we know more about uh 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’d like to have human data as quickly as possible but those studies are going to be conducted during the coming months thank you our next question comes from drew armstrong with bloomberg hi i’m i’m wondering uh what uh 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 um in addition to your study and then reporting that you would normally do um on any kind of product like this dr marks

so the cdc and fda are going to work together as i’ve mentioned and we have a website here uh that will uh post the types of surveillance that we’re doing uh that will post the types of surveillance studies we have about 20 uh adverse events that we’ll 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 sleeve and taking the vaccine and drew you may have seen our statement my statement from a couple weeks ago regarding um transparency in the agency and euas and we have made a strong commitment our center directors and myself uh to being transparent about it we realize that that is something that we will continue and need to continue to do during this pandemic because that helps build trust and confidence in our processes and our decision making thank you our last question is from meg terrell with cnbc thank you for giving me two i’m just wondering about the um 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 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 will be no degradation of the vaccine and what do you want to tell the public about that so i’m going to let dr marks 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 and and how it’d be used and so this is something that our team has spent a lot of time looking at dr marx 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 uh to uh make sure that the cold chain is maintained now once the vaccine there 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 uh in a regular refrigerator for a number of days um but we’re pretty convinced that we can we can make this happen here we’ve seen cold chains maintained in in locations that are pretty uh uh pretty rural um or uh uh pretty rough uh in for instance with vaccination campaigns in africa so uh we’re hopeful uh 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 pfizer bioentec covet 19 vaccine we invite you to visit our website at fda.gov for more information about the authorization thank you