FDA authorizes Pfizer COVID-19 vaccine for emergency use in 12 to 15-year-olds

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Posted at 5:19 PM, May 10, 2021
and last updated 2021-05-10 23:31:47-04

The Food and Drug Administration has given emergency use authorization to allow the use of the Pfizer-BioNTech COVID-19 vaccine in teens as young as 12.

The two-dose vaccine had been authorized for those as young as 16. After clinical trials and research in those aged 12 to 15, the pharmaceutical company asked the FDA to expand their emergency use authorization to allow the vaccine to be used in younger teens.

Monday morning the agency granted the request.

“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," said Acting FDA Commissioner Janet Woodcock, M.D.

Adolescents between 12 and 15 will receive the Pfizer two-dose COVID-19 vaccine the same way those 16 and older do now; the shots will be given three weeks apart with the same dosage.

The study included more than 2,200 participants ages 12 to 15. Common side effects were similar to adults, with pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. Out of more than 1,000 participants who received the vaccine, the company reported there were no COVID-19 cases detected a week after the second dose.

"I would encourage parents to ask their healthcare providers about the vaccine. The vaccine had an excellent profile in children though one can say often children don’t get terribly sick from COVID19 there are kids that do get very sick from it. In addition, they can bring it asymptomatically," said the FDA's Dr. Peter Marks.

The FDA said part of building confidence in the vaccine will be transparency.

A recent survey from the Kaiser Family Foundation looked at parent's intentions for their children 12-15 years old.

“It’s theoretical right there hasn’t been access to vaccines for children but we’re at the starting point of where we were back in December right when we started vaccine outreach and distribution for adults and so we know that there are a share of parents that are eager and willing to get their child vaccinated as soon as possible,” said Ashley Kirzinger, Ph.D., the organization’s associate director of public opinion and survey research.

The survey found around 3 in 10 parents said they’d get their child vaccinated right away once a vaccine is authorized. About 25 percent will wait to see how it’s working. More than 1 in 5 said they definitely won’t get their child vaccinated.

“It just may take some more information, some more outreach efforts conversations with pediatricians in order to increase vaccine intent among parents with younger aged children,” said Kirzinger.

Medical experts say it’s important to get as many people vaccinated as possible.

Dr. Kathleen Ryan, the associate division chief of pediatric infectious diseases at the University of Florida, pointed to the importance of school.

“Kids are losing out on school because they have to stay home during their quarantine period, if you’re vaccinated you won’t have to do that. In the older age groups, we do see this rare multi-system inflammatory disorder in kids, it’ll protect against that and it will help protect the community,” she said. “Plus from the data that we’ve seen kids mount a very good response to the vaccine and they have no more or even fewer side effects than adults do.”

Emmit Allen, 14, is excited he’ll soon be able to get a vaccine, too. His older teenage brother already received his as soon as he became eligible.

“A lot of other people have a vaccine and it’s just a good thing for me to have a vaccinate because it really enforces that herd immunity type thing especially in high schools,” he said.

“I love the fact that it has 100 percent efficacy rate. In all the studies that are very exciting I think that it will relieve a lot of concerns with him going to work and school and band and crew because then I’ll worry a little bit less about him getting it so I think it’ll give him a lot more freedom,” said his mother, Damaris Allen.

The FDA indicated vaccinations could begin as soon as Thursday, though a CDC advisory panel will meet Wednesday to discuss its recommendations.

“The counter measures acceleration group, that’s the group helping to distribute the vaccine, they understand this need for appropriate storage of this and they will be ensuring there are sufficient numbers of pharmacies, health centers able to distribute this probably by later on this week,” said Dr. Marks.

Florida has not provided details on the process for younger teens yet. Right now, minors as young as 16 can get a Pfizer vaccine if accompanied by a guardian and with a complete screening consent form.