CM – US FDA Expands Pfizer Boosters To More Teenagers As Omicron Rises


The US is expanding COVID-19 boosters as it meets the Omicron surge, with the Food and Drug Administration allowing additional Pfizer syringes for children 12 and older.

Boosters are already recommended for everyone aged 16 and over, and federal regulators decided on Monday that they are also suitable for 12 to 15 year olds as soon as enough time has passed since their last dose.

But moving when classes resume after the holidays are not the last step. A panel from the Centers for Disease Control and Prevention is expected to decide later this week whether to recommend boosters for younger teenagers, with a final decision from Dr. Rochelle Walensky, the director of the CDC.

The FDA also said anyone 12 and older eligible for a Pfizer booster can get one as early as five months after their last dose instead of six months.

The FDA’s chief vaccinee, Dr. Peter Marks said that while serious illnesses are rare in younger teenagers, a booster will help them avoid this risk – while also helping to reduce the spread of Omicron, or another coronavirus mutant.

« Hopefully this will be not just a call for people to get their booster vaccinations, » but for the tens of millions of unvaccinated Americans to reconsider that decision, Marks said. « It’s not too late to get vaccinated. »

The FDA based its latest booster decision largely on real data from Israel, which did not reveal any new safety concerns when 6,300 12- to 15-year-olds received a Pfizer booster five months after their second dose.

Likewise, the FDA said more data from Israel showed no problem giving someone eligible for a Pfizer booster that extra dose a month earlier than the six months previously allotted in the US.

The most important safety question for younger teenagers is a rare side effect called myocarditis, a type of heart inflammation that occurs primarily in younger men and teenagers who are receiving either the Pfizer or Moderna vaccines. The vast majority of cases are mild – much milder than the heart inflammation caused by COVID-19 – and they seem to peak in older teenagers, those aged 16 and 17.

Marks said the side effect occurs in about 1 in 10,000 men and boys aged 16 to 30 years after the second injection – but a third dose seems about a third less risky. That’s probably because more time had passed before the booster than between the first two shots, he said.

While the FDA did not consult its independent scientific advisers prior to making this decision, the CDC’s own advisory panel will surely weigh carefully how much benefit this age group is likely to receive before endorsing the additional injection.

Vaccines still offer strong protection against serious illness from any type of COVID-19. But health officials are calling for anyone eligible to receive a booster dose in order to have the best chance of avoiding lighter breakthrough infections from the highly contagious Omicron mutant.

Children tend to be less severely ill with COVID-19 than adults. But during the Omicron wave, hospital admissions of children are on the rise – most of them unvaccinated.

Pediatrician and global health expert Dr. Philip Landrigan of Boston College welcomed the FDA’s decisions, but stressed that the most important thing is to give the unvaccinated their first shots.

« Most serious illness and death from COVID will occur among unvaccinated people in the coming weeks, » he said in an email. « Many thousands of lives could be saved if people could induce themselves to get vaccinated. »

The vaccine from Pfizer and its partner BioNTech is the only option in the US for children of all ages. About 13.5 million 12 to 17 year olds – just over half of that age group – received two Pfizer shots, according to the CDC.

For families who want to protect their children as much as possible, the age limit for booster raises questions.

The older teenagers, 16- and 17-year-olds, were entitled to boosters in early December. But the original vaccinations opened as early as May for the younger teens, 12-15. That means those who come first in the spring may be millions, about as many months past their last dose as the slightly older teenagers.

As for even younger children, pediatric doses for 5-11 year olds were introduced in November – and experts say healthy children should be protected for a while after their second dose. But the FDA also said Monday that children with severely compromised immune systems will be given a third dose 28 days after the second dose. This is the same time for the third dose, which is already recommended for adolescents and adults with weakened immune systems.

What about the timing of booster vaccinations for adults who have received the Moderna or Johnson & Johnson vaccines?

The FDA said it had no new data from Moderna to support a timing change, and people who had already received two Moderna shots should continue to wait six months for a refresher. For people who originally received the single dose of J&J, the US is recommending another dose of a vaccine just two months later.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

A nurse is holding a vial of the Pfizer BioNTech COVID-19 vaccine on December 8, 2020 at Guy’s Hospital in London. (Frank Augstein / AP)

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