Jan. 3, 2022 — The FDA on Monday licensed the primary COVID-19 vaccine booster dose for American adolescents ages 12 to fifteen.
In addition to updating the authorization for the Pfizer COVID-19 vaccine, the company additionally shortened the really helpful time between a second dose and the booster to five months or extra, primarily based on new proof. As well as, a 3rd major collection dose is now licensed for sure immunocompromised kids 5 years to 11 years previous. Full particulars can be found in an FDA news release.
The amended emergency use authorization (EUA) solely applies to the Pfizer vaccine, mentioned appearing FDA Commissioner Janet Woodcock, MD.
“Simply to ensure each everybody is evident on this, proper now: If you happen to received [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you happen to received Moderna, you may get a booster at 6 months or past,” she mentioned throughout a media briefing.
What’s new, she mentioned, is “in the event you received Pfizer as your major collection, you may get a booster at 5 months or past.”
A Decrease Threat of Myocarditis?
Requested about issues in regards to the threat of myocarditis with vaccination within the 12- to 15-year age group, Woodcock mentioned they anticipate it will be “extraordinarily uncommon with the third dose.”
“Now we have the real-world proof from the Israeli expertise to assist us with that evaluation,” she mentioned.
The information to this point constantly factors to the next threat of myocarditis after a second mRNA vaccine dose amongst males, from youngsters to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Heart for Biologics Analysis and Analysis, mentioned in the course of the media name.
The danger of myocarditis is about 2 to three instances greater after a second vaccine dose, in comparison with a booster shot, Marks mentioned, primarily based on out there information. It could be associated to the nearer dose timing of the second dose versus a 3rd, he added.
“The inference right here is that on the danger of myocarditis with third doses within the 12- to 15-year age vary is more likely to be fairly acceptable,” he mentioned.
Marks additionally identified that almost all instances of myocarditis clear up shortly.
“We’re not seeing long-lasting results. That is to not say that we do not care about this and that it is not vital,” he mentioned.
“However what it’s saying is that within the setting of an amazing variety of Omicron and Delta instances on this nation, the potential advantages of getting vaccinated on this age group outweigh that threat,” Marks mentioned. “We will take a look at that risk-benefit and nonetheless really feel comfy.”
He mentioned that “the actually overwhelming majority of those instances, 98%, have been gentle” — proven by a 1-day median hospital keep.
Even so, the FDA plans to proceed monitoring for the danger of myocarditis “very carefully,” he mentioned.
Apparently, swollen underarm lymph nodes have been seen extra incessantly after the booster dose than after the second dose of a two-dose major collection, the FDA mentioned.
Lowering the time between major vaccination with the Pfizer vaccine — two preliminary doses — and the booster shot from 6 months to five months relies on reducing efficacy information that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel printed Dec. 21 in The New England Journal of Medication.
Mixing and Matching Vaccines
Much less clear in the meanwhile is steering about boosters for individuals who opted to combine and match their major vaccine collection.
“There was a mix-and-match research that was finished which confirmed that in some instances, the blending and matching … of an adenoviral report vaccine and an mRNA vaccine appear to provide an excellent immune response,” Marks mentioned.
As soon as extra information is available in on mixing and matching, “we’ll analyze them after which probably make suggestions,” he mentioned.
‘It is Not Too Late’
No federal authorities media briefing on COVID-19 can be full with out a plea for the unvaccinated to get immunized.
“We’re speaking quite a bit about boosters proper now, but it surely’s not too late for many who haven’t gotten a vaccine to get a vaccine,” Marks mentioned, referring to the tens of tens of millions of People who stay unvaccinated firstly of 2022.
“We all know from our earlier research that even a single dose of the vaccine — and possibly two doses — will help forestall the worst outcomes from COVID-19, together with hospitalization and loss of life.”