FDA Backs Pfizer Booster for 12- to 15-Year-Olds
[ad_1]
Jan. 3, 2022 — The FDA on Monday authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.
Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.
The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.
What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
A Lower Risk of Myocarditis?
Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Woodcock said they expect it would be “extremely rare with the third dose.”
“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.
The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.
The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.
“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.
Marks also pointed out that most cases of myocarditis clear up quickly.
“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.
“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Marks said. “We can look at that risk-benefit and still feel comfortable.”
He said that “the really overwhelming majority of these cases, 98%, have been mild” — shown by a 1-day median hospital stay.
Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.
Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.
Reducing the time between primary vaccination with the Pfizer vaccine — two initial doses — and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.
The 5-month interval was evaluated in a study from Israel published Dec. 21 in The New England Journal of Medicine.
Mixing and Matching Vaccines
Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.
“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Marks said.
Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
‘It’s Not Too Late’
No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.
“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.
“We know from our previous studies that even a single dose of the vaccine — and probably two doses — can help prevent the worst outcomes from COVID-19, including hospitalization and death.”
[ad_2]
Source link
casibom guncel giris: casibom giris – casibom giris
casibom giris adresi
farmacia online envГo gratis: Cialis sin receta – farmacias online seguras en espaГ±a
farmacias online seguras: farmacia envio gratis – farmacia online espaГ±a envГo internacional
farmacia en casa online descuento: gran farmacia online – farmacias online baratas
acquistare farmaci senza ricetta: Farmacie on line spedizione gratuita – acquistare farmaci senza ricetta
acquistare farmaci senza ricetta: Farmacie on line spedizione gratuita – Farmacie online sicure
alternativa al viagra senza ricetta in farmacia: viagra generico – viagra naturale
farmacia online: Cialis generico 20 mg 8 compresse prezzo – farmacia online piГ№ conveniente
Farmacia online miglior prezzo: Farmacie che vendono Cialis senza ricetta – farmacie online affidabili
Farmacie on line spedizione gratuita: Brufen 600 senza ricetta – top farmacia online
proventil ventolin: buy Ventolin – buy ventolin online cheap
furosemide: lasix medication – buy lasix online
neurontin 1800 mg: neurontin capsules 600mg – cost of neurontin 600 mg
prednisone canada prices: average cost of prednisone – prednisone canada prices
furosemida 40 mg: buy furosemide – lasix furosemide 40 mg
mexico pharmacies prescription drugs: mexican pharmacy – medicine in mexico pharmacies
best online pharmacy india: Indian pharmacy international shipping – online pharmacy india