FDA, CDC authorize Pfizer boosters for 16- and 17-year-olds

All adults have been eligible since Nov. 19 to receive a booster six months after their second shot of Pfizer's or Moderna's vaccines or two months after a Johnson & Johnson shot. Nearly 50 million Americans – or one-fourth of those fully vaccinated – have gotten the additional shots.

The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention broadened Pfizer’s authorization to cover the younger age group on an emergency basis. The other two coronavirus vaccines, Moderna and Johnson & Johnson, are authorized for use only for adults.

"I've actually been watching this really carefully because I feel like they – the 16- and 17-year-olds – have been a little bit forgotten," said Amy Friedman, who has a 17-year-old daughter. "They got their shots a long time ago, and with the focus on the younger kids and then the older adults – the adults over 18 – it's been a little bit of a gap, a little bubble. So, I'm really happy that they have done this."

“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,” said Dr. Peter Marks, who oversees the FDA’s vaccine division. A booster “will help provide continued protection against COVID-19 in this and older age groups."

Friedman noted that 16- and 17-year-olds are "generally all over the place," putting them at higher risk of infection from the virus.

"They're social. They're at school. They're going to gather. So, this is just a nice, added assurance," she said of the booster shots.

Pfizer and BioNTech said Wednesday that tests with blood samples from people who had received only two doses showed much lower levels of virus-fighting antibodies against omicron than against an earlier version of the virus. Antibodies are the immune system’s first line of defense against the virus, and the results suggest that two doses may not be sufficient to protect against infection, officials from the companies said.

With a booster, the level of antibodies working to neutralize the omicron variant were comparable to those combating the original variant after two doses, the companies said.

Senior administration health officials have said omicron, which contains dozens of mutations never seen before, is even more reason for everyone eligible for a booster to get one. More than 200 million Americans – over 60% of the population – have been fully vaccinated.

Although the U.S. vaccination rate overall is still well behind that of some other countries, the discovery of omicron has driven many people to get shots, even as much remain unknown about the variant.

According to federal data, roughly 3 million 16- to 17-year-olds in the United States got their second shot of Pfizer at least six months ago and would be eligible for a third shot this month.

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Cary pediatrician Dr. Hope Seidel said parents have been asking her for months about getting booster shots for their 16- and 17-year-old children.

"I'm quite confident we're going to have a lot of phone calls today and tomorrow, waiting for the day when we're going to open up those boosters," Seidel said.

A CVS spokesman said parents could start registering their children for boosters on Friday at the chain's pharmacies and clinics.

Dr. Albert Bourla, Pfizer's chief executive, called the expansion of booster shots “a critical milestone.”

"There's a large population of our children in this community that still haven't gotten vaccinated at all, but there's mounting evidence all over the world that, the more vaccine we have in arms, the less virus we're seeing in the community, and boosters play a large role," Seidel said.

It’s not yet clear if or when teens younger than 16 might need a third Pfizer dose. But CDC Director Dr. Rochelle Walensky said regulators would closely watch data on 12- to 15-year-olds because, if they eventually need boosters, “we again will want to act swiftly.”

Pfizer is supplying booster doses to the U.S. government under an agreement negotiated months ago. The company said Thursday that the FDA's move won't affect existing supply agreements.