FDA Approves Pfizer-BioNTech COVID Vaccine for 12 to 15 Age Group

The FDA said the Pfizer vaccine should not be given to anyone with a known history of a severe allergic reaction.

Pfizer-BioNTech COVID-19 vaccine.

(Photo: iStock)

The US Food and Drug Administration (FDA) on Monday, 10 May, authorised the emergency use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15 years.

In a news release posted on its website, the FDA determined that the Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria to amend the emergency use authorisation (EUA), which was originally issued on 11 December 2020, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks.

Acting FDA Commissioner Janet Woodcock said, “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.”

How Was Safety Data Evaluated?

The available safety data to support the EUA included 2,260 participants aged 12 through 15 years old who enrolled in an ongoing randomised, placebo-controlled clinical trial in the US.

Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were observed for safety for at least two months following the second dose.

What Are the Common Side Effects?

The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1 to 3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.

With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose. The side effects in adolescents were consistent with those reported in clinical trial participants aged 16 years and older.

The FDA further noted that while some individuals experienced side effects following any vaccination, not every individual's experience will be the same, and some people may not experience side effects.

The FDA stressed that the Pfizer-BioNTech vaccine should not be given to anyone with a known history of a severe allergic reaction, including anaphylaxis, to any component of the vaccine.

The EUA amendment for the Pfizer-BioNTech COVID-19 vaccine was issued to Pfizer Inc., who as per the original EUA request, submitted a plan to continue monitoring the safety of the vaccine.

The issuance of an EUA is not an FDA approval (licensure) of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, the news release said.

Dr Craig Spencer, director of global health and emergency medicine at the Columbia University Medical Center, said there doesn’t need to be an either-or choice between vaccinating kids and distributing shots to the rest of the world, CNBC reported.

He added that the US could do both and expressed frustration on why there hasn’t been more focus from the US on getting the rest of the world vaccinated.

Spencer was quoted as saying, “If I were to ask you, if a 12-year-old with no medical issues or a 57-year-old healthcare worker who takes care of COVID patients every day should get vaccinated, the answer is very clear, right? Why does that calculus change when it’s a health worker from a different country?”

The Pfizer-BioNTech COVID vaccine has also been determined to be more than 91 percent effective in preventing symptomatic COVID-19 at least six months after the dose, ANI reported.

(With inputs from CNBC and ANI)