FDA Backs Pfizer Booster for 12- to 15-Year-Olds

Jan. 3, 2022 -- The FDA connected Monday authorized the archetypal COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the bureau besides shortened the recommended clip betwixt a 2nd dose and the booster to 5 months oregon more, based connected caller evidence. In addition, a 3rd superior bid dose is present authorized for definite immunocompromised children 5 years to 11 years old. Full details are disposable successful an FDA quality release.

The amended exigency usage authorization (EUA) lone applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

"Just to marque definite each everyone is wide connected this, close now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster aft 2 months. If you got Moderna, you tin get a booster astatine 6 months oregon beyond," she said during a media briefing.

What is new, she said, is "if you got Pfizer arsenic your superior series, you tin get a booster astatine 5 months oregon beyond."

A Lower Risk of Myocarditis?

Asked astir concerns astir the hazard of myocarditis with vaccination successful the 12- to 15-year property group, Woodcock said they expect it would beryllium “extremely uncommon with the 3rd dose.”

"We person the real-world grounds from the Israeli acquisition to assistance america with that analysis," she said.

The information truthful acold consistently points to a higher hazard of myocarditis aft a 2nd mRNA vaccine dose among males, from teenagers to 30-year-olds, with a highest astatine astir 16 to 17 years of age, Peter Marks, MD, PhD, manager of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The hazard of myocarditis is astir 2 to 3 times higher aft a 2nd vaccine dose, compared to a booster shot, Marks said, based connected disposable data. It whitethorn beryllium related to the person dose timing of the 2nd dose versus a third, helium added.

"The inference present is that connected the hazard of myocarditis with 3rd doses successful the 12- to 15-year property scope is apt to beryllium rather acceptable," helium said.

Marks besides pointed retired that astir cases of myocarditis wide up quickly.

"We're not seeing long-lasting effects. That's not to accidental that we don't attraction astir this and that it's not important," helium said.

"But what it is saying is that successful the mounting of a tremendous fig of Omicron and Delta cases successful this country, the imaginable benefits of getting vaccinated successful this property radical outweigh that risk," Marks said. "We tin look astatine that risk-benefit and inactive consciousness comfortable."

He said that “the truly overwhelming bulk of these cases, 98%, person been mild" -- shown by a 1-day median infirmary stay.

Even so, the FDA plans to proceed monitoring for the hazard of myocarditis "very closely," helium said.

Interestingly, swollen underarm lymph nodes were seen much often aft the booster dose than aft the 2nd dose of a two-dose superior series, the FDA said.

Reducing the clip betwixt superior vaccination with the Pfizer vaccine -- 2 archetypal doses -- and the booster changeable from 6 months to 5 months is based connected decreasing efficacy information that the drugmaker submitted to the FDA.

The 5-month interval was evaluated successful a study from Israel published Dec. 21 successful The New England Journal of Medicine.

Mixing and Matching Vaccines

Less wide astatine the infinitesimal is guidance astir boosters for radical who opted to premix and lucifer their superior vaccine series.

"There was a mix-and-match survey that was done which showed that successful immoderate cases, the mixing and matching … of an adenoviral grounds vaccine and an mRNA vaccine look to springiness a precise bully immune response," Marks said.

Once much information comes successful connected mixing and matching, "we'll analyse them and past perchance marque recommendations," helium said.

'It's Not Too Late'

No national authorities media briefing connected COVID-19 would beryllium implicit without a plea for the unvaccinated to get immunized.

"We're talking a batch astir boosters close now, but it's not excessively precocious for those who person not gotten a vaccine to get a vaccine," Marks said, referring to the tens of millions of Americans who stay unvaccinated astatine the opening of 2022.

"We cognize from our erstwhile studies that adjacent a azygous dose of the vaccine -- and astir apt 2 doses -- tin assistance forestall the worst outcomes from COVID-19, including hospitalization and death."