FILE PHOTO: Syringe and vial are seen in front of displayed new Pfizer logo in this illustration taken, June 24, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

Ben Burke Producer

U.S.

In a major game changer, FDA grants Pfizer vaccine full approval

Aug 23, 2021

Ben Burke Producer

By Ben Burke (Producer)

The Pfizer vaccine received the strongest endorsement from the Food and Drug Administration than any COVID-19 vaccine had to date Monday: full approval.

According to the FDA, the vaccine will now be marketed as Comirnaty for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will still be available under emergency use authorization (EUA) for kids 12-15.

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Pfizer had originally sought full approval from the FDA back in May. Moderna joined Pfizer the following month. Earlier this month, we learned that full approval was expected to come by Labor Day.

The FDA’s initial EUA was based on a study that tracked 44,000 people 16 and older for at least two months. That’s roughly the time period when serious side effects typically arise. However, it’s also shorter than the six months of safety data normally required for full approval.

Pfizer kept that study going. According to the FDA, even after hundreds of millions of shots, serious side effects remain exceedingly rare.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” FDA Center for Biologics Evaluation and Research Peter Marks said. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.”

The U.S. becomes the first country to fully approve the Pfizer vaccine. In a tweet, CEO Albert Bourla said he hoped “this news will instill even further public confidence in our vaccine and the science that made it possible.”

Tags: Pandemic

Joe Biden, U.S. President: “Today, after a strict process, the FDA has reaffirmed its findings that the Pfizer COVID-19 vaccine is safe and effective and the FDA has given its full and final approval. So let me say this loudly and clearly: if you haven’t, if you’re one of the millions of Americans who said that they will not get the shot, when it’s, until it has full and final approval of the FDA, it has now happened. The moment you’ve been waiting for us here, it’s time for you to go get your vaccination and get it today, today.”

“The FDA approval is the gold standard. And as I just said, now it has been granted. Those who have been waiting for full approval should go get your shot now. Vaccination is free, it’s easy, it’s safe and it’s effective and it’s convenient.”

“There is no time to waste. The Delta variant is dangerous and spreading, causing a pandemic of the unvaccinated. That’s the pandemic, of the unvaccinated. And while we’re starting to see initial signs that cases may be declining in a few places, nationwide cases are still rising, especially among the unvaccinated. Across the country, virtually all the COVID-19 hospitalizations and deaths continue to be among the unvaccinated.”

“So let me say this as parents, to the parents, as you have, you have the tools, you have the tools to keep your child safer, and two of those tools, above all, are available to you. One, make sure that everyone around your child who can be vaccinated is vaccinated, parents, adults, teens. Two, make sure your child is masked when they leave home. That’s how we can best keep our kids safe. As I’ve said before, the pandemic of the unvaccinated is a tragedy that is preventable. People are dying and will die who don’t have to. So please, please, if you haven’t gotten your vaccination, if you haven’t gotten vaccinated, do it now. It could save your life and the lives of those you love.”

Dr. Albert Bourla, Pfizer Chairman and CEO: “I think it is an additional confirmation of the safety and efficacy of the vaccine. There were several people that were more skeptical than others about the vaccine being used with an emergency authorization license. And despite the fact that this is one of the vaccines that could be used in more than a billion doses right now around the world, hundreds of millions in the United States. So there is no product, medical product that has so big safety database right now. But still, for those people, that meant a lot.

“BLA (Biologics License Application) is a very comprehensive process. That’s why I take so much time, just to give you a magnitude, the file that we submitted to the FDA was 360,000 pages. So it took a lot of time and resources from our side to put it together and took a lot of and resources from FDA to review it. And I think that is why it is an important milestone that I think will unlock some of the more skeptical minds to do the vaccine.”

“We will also submit a supplemental, as they call it, application to incorporate into our full approval the license for 12 to 16.”

“I believe that the ages five to 12, we should be having the full set of data ready for submission by the end of September. And then it is up to FDA. And then I believe that younger than five years old ages, it will take us a couple of months more.”

“We are aiming to produce this year three billion doses. To give you the magnitude of the size we released in the first six months, one billion, which means that we will release in the second six months two billion doses. This is because already we were able to ramp up particularly the manufacturing of raw materials.”

“What we plan to do is focusing on producing as much as we can and focusing on the science based on monitoring every single variant but appears around the world and seeing if this current vaccine in its current form is effective against this variant or if it needed to go through a booster or if needed to go through a specific vaccine. This is what we are doing for the time being. And we don’t plan to change that.”