FDA

Pfizer's CEO says the vaccine maker has asked federal regulators to authorize boosters for 16- and 17-year-olds. Currently, only people 18 and over are eligible for a booster in the U.S.

If the Food and Drug Administration authorizes use of the drug, called molnupiravir, it would be the first oral COVID-19 treatment that could be taken at home.

The FDA on Friday granted emergency use authorization for the Pfizer-BioNTech and Moderna booster shots. The boosters have already been available for people 65 and older and to high-risk adults.

The Food and Drug Administration has been without a permanent leader since President Biden took office in January. Califf led the agency during the last year of the Obama administration.

The companies say a study of more than 10,000 volunteers showed a vaccine efficacy of 95% or greater for people receiving the booster.

Moderna says the FDA is looking into reports of a rare side effect — myocarditis, or the inflammation of the heart muscle — in those who've gotten the shot.

There are a couple of big steps to get through before U.S. kids under 12 might be able to get the vaccine. Here's how the process works and when the shots could arrive.

After some debate, a group of scientists advising the FDA concluded that the vaccine's benefits outweigh its risks for young children.

A panel of experts voted to recommend that the Food and Drug Administration authorize a booster dose of the Johnson & Johnson COVID vaccine at least two months after the first shot.

The recommendation applies to people 65 years and older, those 18 to 64 who are at high risk of severe COVID and those whose work or institutional exposure puts them at high COVID risk.

Johnson & Johnson has asked the Food and Drug Administration to authorize a booster for people 18 and older six months after initial immunization, with an option to vaccinate after two months.

"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," the pharmaceutical giant said.