FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

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By edhat staff

Today, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include adolescents 12 through 15 years of age.

The FDA amended the emergency use authorization originally issued on Dec. 11, 2020, for administration in individuals 16 years of age and older.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” said Acting FDA Commissioner Janet Woodcock, M.D. 

From March 1, 2020 through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC). Children and adolescents generally have a milder COVID-19 disease course as compared to adults. The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older, according to the news release.

The FDA determined the vaccine has met the statutory criteria to amend the emergency authorization, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use in this population. 

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”

The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) and for Recipients and Caregivers with information to reflect the use of the vaccine in the adolescent population, including the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine.

Read the complete news release here.


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a-1620708015 May 10, 2021 09:40 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

A feeble attempt at paltering, 9:23. COVID is more serious in older adults, so to prevent deaths on a scale even more massive than we did, its use in that demographic was prioritized at first. That doesn't mean we should just let younger people suffer death and serious disability now, does it? Maybe in your politically warped sensibilities, it does.

LooseCannon May 11, 2021 06:04 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

My 14-year-old daughter will be getting her first Pfizer shot on Friday. I have absolutely no doubt that this is right decision, and I encourage all parents to get their kids vaccinated. The chances of a vaccine mishap for anyone is far less than the deadly consequences of contracting COVID. We need to get the kids vaccinated so they can return to school safely, full time, go to summer camps, and resume life as it used to be. Failing to vaccinate kids will delay herd immunity and increase the possibility of deadly mutations. Get your freaking kids vaccinated. Don't delay.

LooseCannon May 11, 2021 04:43 AM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

I am a bit confused. The FDA has approved the Pfizer vaccine for younger teens, but the CDC hasn't issued a ruling yet. So are the kids good to go now? Or do we have to wait for the CDC announcement?

bosco May 11, 2021 08:52 AM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

It's not surprising but sad that we keep having the same debate. Just about every comment here is self centric. Everyone continues to look at the vaccine as protecting the individual. Apparently we need better public health education in schools because it's been a year and no one seems to understand this is a PUBLIC health emergency and requires a community response. Getting vaccinated is about reducing the spread of the virus, reducing the chances the virus mutates, and protecting the vulnerable elements of our population. That means minimizing hosts and opportunities for transmission. It's not about the individual. But, again, that is lost among people on both sides of the argument.

Ahchooo May 11, 2021 09:48 AM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

Unvaccinated people could act as reservoirs for the virus. Children may not suffer as badly as older people, but if the virus is still circulating (even asymptomatically) it will continue to endanger the vulnerable.

SB_TAHOE May 11, 2021 11:39 AM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

The point is, it is time sensitive. If everyone gets vaccinated in a short period of time, it almost eradicates the virus. If herd immunity is not reached quickly the virus has a chance to mutate to resist the vaccine and we have to start all over again.

bosco May 11, 2021 12:27 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

SAC, you missed my point. My point is that vaccination is important to reduce the risk of mutations. Mutations that may eventually pose a risk to vaccinated people. I am very pro vaccine.

Chip of SB May 11, 2021 03:26 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

There are billions of unvaccinated people who are reservoirs for the virus all over the world. Even if we vaccinated every American, it would make little difference. There has also been some concern that animals could be reservoirs for the virus too, which would make it even more difficult to eradicate the virus. There are already reports that some of the mutant strains are becoming resistant to the existing vaccines, and the vaccine manufacturers are talking about producing annual booster shots. It seems unlikely the existing vaccines will be able to eradicate covid in this country, let alone globally. It will be interesting to see how the virus mutations evolve and how long the vaccines remain effective.

LCP112233 May 11, 2021 01:53 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

I'm thrilled that the vaccine around the country is working to stop the spread. And I am happy to do my part for the greater good. Thanks Trump and Operation Warp speed for making this happen.

Voice of Reason May 11, 2021 02:23 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

What action did Biden actually taken? Vaccine distribution was in full swing already, he signed a partisan $1.9 TRILLION covid relief bill with only about 1/2 going to actual covid relief and no requirement for schools to open fully to get funding, and doesn't exactly set a good example to the vaccine hesitate by wearing masks on zoom calls and outside with other fully vaccinated people. Oh, he ordered more shots... but of course my wife gives me no credit for "getting the groceries" when I just place an instacart order.

Chip of SB May 11, 2021 04:43 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

Kind of reminds me of this article. Funny how things have changed.


a-1620778325 May 11, 2021 05:12 PM
FDA Approves Pfizer COVID-19 Vaccine for Ages 12 to 15

Hilarious, right Chip?! To think that someone might threaten and fire scientists if they don't push through a vaccine for a virus that never existed but then did exist and wasn't that bad and then that person caught it and almost died from it but the election was a hoax and scientists are all democrats so don't get the vaccine but then get it secretly and not tell anyone. Inconceivable, no sane person would ever do or say those things. You're hilarious! hahaha.

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