FDA expands Pfizer boosters to more teenagers when the omicrones go up

The US is expanding COVID-19 boosters to meet the surge in omicrones, 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 today that they are also suitable for 12 to 15 year olds once enough time has passed since their last dose.

But moving when classes resume after the holidays are not the last step. The Centers for Disease Control and Prevention must decide whether boosters are recommended for younger teenagers. It is expected that Dr. Rochelle Walensky, the director of the CDC, ruled later this week.

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.

FDA vaccine chief Dr. Peter Marks said in a statement that the agency made its decision because a booster “can contribute to better protection against both the Delta and Omicron variants,” especially since Omicron is “somewhat more resistant” to the vaccine-induced antibodies that help fight off infection.

Real-world data from Israel tracked more than 6,300 12- to 15-year-olds who received a booster vaccination there at least five months after their second dose of Pfizer and who found no serious safety concerns, the FDA said.

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 prescribed in the US.

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 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 human 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 – have received two Pfizer shots, according to the CDC.

For families who want to protect their children as well 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 teens should be protected for a while after their second dose. But the FDA also said today 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.

Pfizer is studying its vaccine in even lower doses for children under 5 years of age.