FDA authorizes Pfizer booster for 16 and 17 year olds

The Food and Drug Administration (FDA) Thursday authorized booster shots of Pfizer and BioNTech’s coronavirus vaccine for 16- and 17-year-olds, a move meant to bolster protection against the delta and emerging omicron variants.

The announcement comes a day after Pfizer said preliminary evidence shows a booster shot provides the most protection against infection from the omicron variant, though two doses still offer protection against severe disease.

“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” acting FDA Commissioner Janet Woodcock said in a statement.

“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19,” Woodcock said.

Boosters will be available for anyone in that age group who received the initial dose at least six months ago, as soon as Centers for Disease Control and Prevention Director Rochelle Walensky endorses the authorization. 

Pfizer is currently the only vaccine authorized for people under the age of 18. The vaccine has been authorized for children as young as 5, but boosters were only available for adults.

However, many states have decided to open eligibility for boosters to all ages, regardless of FDA action.

“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group. A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups,” said Peter Marks, head of the FDA’s vaccine division.

The FDA said the decision to authorize boosters for 16- and 17-year-olds was based on safety and efficacy data for people aged 18 to 55. 

But the agency did not convene its outside expert advisory panel, which has previously raised questions about the risks of myocarditis and pericarditis — rare but serious cases of inflammation of the heart muscle and surrounding tissue, respectively — associated with the vaccine.

In a statement, the FDA said it determined that “the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age.”

Scientists are divided about the need for widespread booster shots among younger people, and the decision to authorize boosters for teenagers will likely raise further questions. Federal officials and some public health experts believe younger children will eventually need boosters, though others think children respond well enough to the primary series.  

“While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two dose series and a booster dose as recommended,” Pfizer CEO Albert Bourla said in a statement.

Updated at 12:08 p.m.