January 3, 2022 – The FDA approved the first COVID-19 on Monday vaccine booster dose for American adolescents aged 12 to 15 years.
In addition to updating the authorization for Pfizer COVID-19 vaccineThe Agency also shortened the recommended time between the second dose and the additional dose to 5 months or more, based on new evidence. In addition, a third primary batch of doses has now been approved for certain immunocompromised children aged 5 to 11 years. All details are available at FDA news release.
The amended Emergency Use Authorization (EUA) applies to Pfizer only vaccine, said Acting FDA Commissioner Janet Woodcock, MD.
“Just to make sure everyone understands this, right away: if you have [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you have Modern, you can get a booster after 6 months or later, ”she said during a press briefing.
What’s new, she said, is “if you have Pfizer as your primary series, you can get a booster after 5 months or later.”
Lower risk of myocarditis?
Asked about concerns about the risk of myocarditis with vaccinations in the 12- to 15-year-old age group, Woodcock said they expect it to be “extremely rare with a third dose.”
“We have real-world evidence from the Israeli experience that will help us in that analysis,” she said.
Data to date consistently suggest a higher risk of myocarditis after a second dose of mRNA vaccine among men, from teenagers to 30-year-olds, peaking between the ages of 16 and 17, Peter Marks, Ph.D., director of the FDA’s Center for assessment and research of biological substances, he said during a media call.
The risk of myocarditis is about 2 to 3 times higher after the second dose of the vaccine compared to the supplementary injection, Marks said based on available data. This may be related to the closer time of the second dose compared to the third, he added.
“The conclusion here is that the risk of myocarditis with third doses ranging from 12 to 15 years is probably quite acceptable,” he said.
Marx also pointed out that most cases of myocarditis pass quickly.
“We don’t see long-term effects. That doesn’t mean we don’t care and it doesn’t matter,” he said.
“But what he says is that in the environment of the huge number of Omicron and Delta cases in this country, the potential benefits of vaccination in this age group outweigh that risk,” Marx said. “We can look at that risk and benefit and still feel comfortable.”
He said that “the vast majority of these cases, 98%, were mild” – which shows the average hospital stay of one day.
Despite this, the FDA plans to continue to monitor the risk of myocarditis “very closely,” he said.
Interesting, swollen under the armpits lymph nodes they were seen more often after a supplemental dose than after a second dose of a two-dose primary series, the FDA said.
The reduction in the time between primary vaccination with Pfizer – two starting doses – and supplementary injections from 6 months to 5 months is based on data on the reduction in effectiveness provided by the FDA.
The 5-month interval was assessed ua study from Israel published on December 21 The New England Journal of Medicine.
Vaccine mixing and evaporation
At present, the guidelines on amplifiers are less clear for people who have decided to mix and match their primary vaccine series.
“There was a study of mixing and merging that showed that in some cases, mixing and pairing … vaccines with an adenovirus transcript and mRNA vaccines seems to give a very good immune response,” Marks said.
When more data on mixing and pairing comes in, “we’ll analyze it and then potentially make recommendations,” he said.
‘It’s not too late’
No federal government media briefing on COVID-19 would be complete without asking for the unvaccinated to be vaccinated.
“We’re talking a lot about boosters right now, but it’s not too late for those who haven’t been vaccinated to get the vaccine,” Marks said, referring to the tens of millions of Americans who remained unvaccinated in early 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 of COVID-19, including hospitalization and death.”