FDA Gives Full Approval to Pfizer COVID-19 Vaccine: Press Conference Transcript

Operator: (00:00)
… you may disconnect at this time. Now, I’d like to turn the call to your host, Abby Capobianco. You may begin. Thank you.

Abby Capobianco: (00:07)
Hello and welcome to this media briefing on FDA’s approval of the first COVID 19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty. I’m Abby Capobianco with FDA’s office of media affairs.

In a moment, I will turn it over to acting FDA commissioner Dr. Janet Woodcock for opening remarks. Following Dr. Woodcock, Dr. Peter Marks, director of the FDA center for biologics evaluation and research will also provide brief remarks. After the remarks we will then move to the question and answer portion of the call. Reporters on the phone will be in a listen only mode until we open the call up for questions.

As a reminder, this audio call is being recorded and live streamed on the FDA’s YouTube channel. When asking a question, please state your name and affiliation. Also, please ensure questions pertain to today’s announcement and limit yourself to one question so we can get to as many questions as possible. With that, I will now turn the call over to acting FDA Commissioner Dr. Woodcock.

Janet Woodcock: (01:16)
Thank you, Abby and thanks all of you for joining. Today is really an important day as the FDA has approved the first COVID-19 vaccine. And as you heard, the vaccine has been known as the Pfizer-BioNTech COVID-19 vaccine, and will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older.

This is a pivotal moment for our country in the fight against the pandemic. While this and other vaccines have met the FDA’s rigorous scientific standards for Emergency Use Authorization, as the first FDA approved COVID-19 vaccine the public can be confident that this vaccine meets the FDA’s gold standards for safety, effectiveness, and manufacturing quality that we require for an approved product.

As we continue to battle the COVID-19 pandemic, we’re acutely aware that vaccine are one of our greatest weapons against the virus, and we know that vaccine approval holds the promise of altering the course of the pandemic in the United States. And that for some, an FDA approved COVID vaccine may instill in them a confidence to go and get vaccinated.

Working around the clock, FDA staff were able to complete the evaluation of this biologics license application in just over three months. This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done. But we want to underscore that our efforts to move as quickly as possible, have in no way sacrificed scientific standards or the integrity of our process. Approving the vaccine as rapidly as possible while ensuring a rigorous and thorough review has been our top priority. Based on the results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

Now, Dr. Marks will share more information about the data the FDA evaluated to come to the approval decision. While today’s approval includes people ages 16 and older, the vaccine continues to be available under Emergency Use Authorization for individuals 12 through 15 years of age, and to provide a third dose for certain immunocompromised individuals.

Healthcare providers can continue to use the vaccine on their shelves that was provided under EUA while production of the approved vaccine is under product is underway. The FDA approved vaccine and the EPUA authorized vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccine series.

In remaining true to our commitment to transparency, information about the data that FDA evaluated to come to this decision will be posted on our website. Today’s approval means that the American public can have confidence that Comirnaty is safe and effective and meets FDA’s rigorous standards. Please get your COVID-19 vaccine if you have not and help your family and friends get theirs. Thank you, and now I’ll turn to Dr. Marks to discuss more about the FDA’s process for approving this vaccine.

Peter Marks: (04:53)
Thank you, Dr. Woodcock. It’s a pleasure being here today with all of you. First, I want to reiterate that this milestone in the fight against COVID-19 has been accomplished by a group of committed public health professionals who have been guided by science in everything that they do, and who’ve worked tirelessly over the past month for everyone’s benefit.

The FDA’s evaluation of this biologics license application was incredibly thorough and the public can trust that the data evaluated by the FDA on the vaccine safety, effectiveness and quality meet the agency’s rigorous, globally recognized standards.

We reviewed hundreds of thousands of pages of data and information about the vaccine safety effectiveness and manufacturing quality, and we concluded and conducted inspections of various facilities where the vaccine is manufactured.

I’d like to share more about our evaluation of the clinical data for this vaccine which, as Dr. Woodcock noted, is also detailed in many documents that will be available on the FDA’s website.

First, Emergency Use Authorization for this vaccine which was issued last December for individuals 16 years of age and older was based on safety and effectiveness data from a randomized controlled blinded ongoing clinical trial conducted in tens of thousands of individuals.

To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the Emergency Use Authorization and that included a longer duration of follow-up in a larger patient population. Specifically, the FDA’s evaluation of the biologics license application, the agency evaluated effectiveness data from approximately 20,000 vaccine recipients and 20,000 placebo recipients ages 16 and older who did not have evidence of COVID-19 infection within a week of receiving the second dose.

As Dr. Woodcock noted, based on the results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. The vaccine is clearly effective in preventing hospitalization and death, but may not always prevent infections, symptoms of transmission of a virus from person to person either.

The vaccine safety was evaluated approximately 22,000 people who received the vaccine and 22,000 people who received placebo 16 years of age and older. More than half of the clinical trial participants have been followed for safety follow-ups for at least four months after the second dose and approximately 12,000 vaccine recipients have been followed for at least six months.

The most common reported side effects by clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headaches, muscle or joint pain, chills and fever. Additionally, the FDA conducted a rigorous evaluation of the data pertaining to myocarditis and pericarditis events following administration of the vaccine authorized for emergency use. And it’s determined that the data demonstrate increased risks, particularly within seven days following the second dose. The observed risk is higher among males under 40 years of age, compared to females and older males.

The observed risk is highest in males age 12 through 17 years of age and available data from short-term followup suggests that most individual’s symptoms have now resolved after the occurrence of myocarditis. A warning about these risks is also included in the Comirnaty prescribing information, which is available on fda.gov.

The FDA, together with our federal partners, will continue to closely monitor the vaccine safety to ensure that any potential concerns continue to be identified and evaluated in a timely manner. The FDA is requiring the company to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty, including an evaluation of long-term outcomes among individuals who develop myocarditis.

In addition, the company is committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry to study and evaluate pregnancy and infant outcomes after vaccination during pregnancy.

We continue to work tirelessly to protect public health and are strongly committed to upholding the trust that the public has placed in us. Today’s action signifies a major achievement and challenge to end the COVID-19 pandemic. We know that working together, we will succeed in this goal. I’d like to take this opportunity to comment on one of the biggest challenges that we still face in getting the public vaccinated, and that’s the overwhelming amount of information that’s been circulating about COVID 19 vaccines.

We’ve heard false claims that COVID-19 vaccines cause infertility, contain microchips and cause COVID-19. And worse, we’ve heard false claims that thousands of people have died from the vaccine. Let me be clear, these claims are simply not true. Getting a COVID-19 vaccine can save your life. As Dr. Woodcock said a few moments ago, we know that for some people FDA approval of a COVID-19 vaccine may give them the confidence to get vaccinated.

By following our rigorous processes to evaluate this application, we hope those who have waited until now to make the choice to protect themselves and thereby also help protect their communities by reducing the spread of COVID-19, will go and get vaccinated. I urge you and your loved ones to get vaccinated and help put an end to this pandemic. I’d like now to turn the press conference back over to the moderator.

Thank you, Dr. Woodcock and Dr. Marks. At this time, we will begin the question and answer portion of the press conference. As a reminder, this call is being recorded. When asking a question, please state your name and affiliation. Also, please ensure questions pertain to today’s announcement and limit yourself to one question so we can get to as many questions as possible. Operator, we’ll take the first question, please.

Operator: (11:14)
Absolutely. Our first question comes from Sarah Karlin-Smith with the Pink Sheet.

Sarah Karlin-Smith: (11:20)
Hi, thanks for taking my question. Given this announcement, there’s been a lot of speculation that there could be off-label use of the vaccine, particularly in children under 12 where there’s no EUA yet. Does FDA have any concerns regarding this use, particularly given the myocarditis data in the older pediatric population, and just the different doses being tested and younger children?

Yes, this is Janet Woodcock. First of all, we want to reiterate it is important that the unvaccinated get vaccinated where it is indicated. But we do not have data on the proper dose nor do we have full data on safety in children younger than what is in the EUA. And so that would be a great concern that people would vaccinate children because we don’t have the proper dose and we don’t have the safety data nor do we have all the efficacy data as well.

So we believe that trials… We need to get the information and data on uses in younger children. They are not just small adults and we’ve learned that time and time again. And so, we really would have to have the data and the appropriate dose before recommending that children be the vaccinated.

And ordinarily, as you know, when a medical product is approved, physicians often do use off-label prescribing. However, this is a different situation. The vaccine is being distributed under a provider agreement by the US government through the CDC and there are many considerations that would pertain to off-label prescribing for the recipient and so forth. And so I’d refer people to the CDC for more information on that. But we are not recommending that children younger than age 12 be vaccinated with this vaccine. It would not be appropriate.

Operator, we’ll take the next question, please.

Operator: (13:47)
Our next question comes from Jeannie Baumann of the Bloomberg Law. Line is open.

Jeannie Baumann: (13:53)
Hi, thank you so much for taking my question. I was just wondering, the efficacy data that you had presented was I think before the Delta variant, so I was wondering what you could talk about and what we know about the efficacy now with the variant that is dominating?

I will refer that to Dr. Marks.

Thanks for that question. There is various real world evidence that are emerging here that suggests that the vaccine is still effective against the Delta variant. Obviously, as you probably are alluding to here, the data coming out of Israel seems to suggest that with time immunity from the vaccine does tend to wane. And so that’s something we’ll be following closely and obviously will be leading into a consideration of the thoughts regarding boosters, etc., as we move into the fall.

Operator, we’ll take the next question please.

Operator: (15:01)
Next question comes from Katherine Foley of POLITICO. Line is open.

Katherine Foley: (15:07)
Hi, thank you for taking questions. I’m wondering if you can talk about how Pfizer’s vaccine approval will change the future of boosters for those who are not immunocompromised and if off-label prescribing of this vaccine or giving of boosters of this vaccine will change the way that that boosters are given for the rest of the population?

This is Janet Woodcock. Again, we would emphasize that most important thing is that people who are currently unvaccinated get vaccinated, and we hope this approval will bolster confidence of those who’ve been wavering.

However, giving an additional dose of the vaccine other than immunocompromised is something where FDA will need to review the data, and is not part of this approval and we’d need to look at both safety and efficacy data or immunogenicity data and make a decision about that. So, we do not encourage off-label use because as I said, ordinarily clinicians can do this, but this is a circumstance where the vaccine is being distributed under a provider agreement with the CDC and so providers agree to conform to certain conditions. I’d refer you to the CDC for more information on that.

Operator, we’ll take the next question please.

Operator: (16:47)
Our next question comes from Brenda Goodman of WebMD. Line is open.

Brenda Goodman: (16:54)
Hi, thanks. I was hoping you could tell us a little bit about the magnitude of what it takes for the FDA to review a BLA like this? Because a lot of people have been wondering what took you so long. And then with Moderna, I’m wondering if you can give us any updates on where that application stands?

I’ll refer that to Dr. Marks.

So, I’m not going to be able to comment more about Moderna. You can contact the company for their plans. But I really am grateful for your question about what it takes to review a BLA, because people have been wondering what took so long. Well FDA, when we conduct a review of a Biologics License Application, we are highly rigorous in what we do. We don’t just look at what the summaries of data are. We go down to the level of the individual patients.

What took time is that we actually go and we monitor a percentage of the sites where the clinical trials were conducted in order to make sure that the data that was collected was collected accuracy and matches what was submitted to the agency. We go and we inspect the facilities that are making the product and making sure that they meet our high quality standards. And, doing those inspections in the middle of a pandemic were not trivial and that had to be done.

Then, we went through tens of thousands of patients of data to make sure we looked at adverse events, efficacy data, did our own analysis in addition to the company’s analysis. And then we also did a benefit risk assessments based on a real-world data that has emerged since the vaccine has now been used in hundreds of millions of people globally.

And so, that actually takes a lot of work and it’s actually 97 days since Pfizer completed the role of it’s BLA and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude. So there was a lot of work done and people worked day and night, and I’m very grateful to Dr. Woodcock for all of the support, with extra help in getting this done as well as to really a tireless team in our center that worked night and day to get this done.

Brenda Goodman: (19:24)
Thank you.

Operator, we’ll take the next question, please.

Operator: (19:30)
Our next question comes from Andrew Dunn with Business Insider. Your line is open.

Andrew Dunn: (19:35)
Yes. Thanks. I was wondering, does the FDA plan to convene VRBPAC to discuss booster shots? Specifically Pfizer’s EUA application for a booster?

Dr. Marks you might want to comment on that?

Yeah. Thanks very much for that question. A decision will need to be made about that in an appropriate time once we have these submissions in house and we have been able to review them.

Operator, we have time for one more question.

Operator: (20:11)
Our last question comes from Andrew Joseph with Stat. Your line is open.

Andrew Joseph: (20:18)
Hi, thanks very much. Sort of falling up on Sarah’s question earlier, I was just hoping you could give us sort of any latest timeline on getting vaccines authorized for kids 12 and under, or under 12 I should say? And I guess, if you can just tell us what information specifically you might still be waiting on, if any, from trials before FDA can make that decision? Thank you.

Sure. Dr. Mark?

Yeah, thanks very much. So there is a lot of interest, obviously, in vaccines for younger children. Currently there are still trials ongoing here and so the agency has to wait for the company to submit the data from those trials so that we have a good safety data set, because we certainly want to make sure that we get it right in the children ages five through 11, and then even in younger children after that. And so we will obviously move swiftly once those data are submitted, but first the trials have to be finished up, or at least the parts of the trials are going to be submitted to us have to be finished up, and then the data needs to be submitted to us. Thank you.

This concludes today’s FDA press conference. A replay will be available on the FDA’s YouTube page. If you have follow-up questions, please don’t hesitate to contact the FDA Press Office. Thank you and have a great day.

Operator: (21:41)
Thank you for your participation, this concludes today’s conference. You may disconnect at this time. Thank you.

FDA Gives Full Approval to Pfizer COVID-19 Vaccine: Press Conference Transcript

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