FDA Approves Pfizer Vaccine for Kids 12 and Up

The FDA expanded its emergency use authorization of the Pfizer vaccine on Monday, taking a huge step in the overall vaccination effort and bringing incalculable relief to many parents.

It’s the news so many have been waiting for: Children 12 and older can now safely get the COVID-19 vaccine.

The US Food and Drug Administration on Monday expanded the emergency use authorization of the Pfizer vaccine for adolescents, a huge move in the effort to vaccinate as much of the population as possible.

But, with signs that some COVID-19 variants are affecting children more than the original strain, just as significant is the collective sigh of relief from anxious parents who were able to inoculate themselves and their high school juniors against the virus, but not their freshmen or middle schoolers. (The authorization for those 16 and up was granted in December.)

It is a sign, FDA officials said, that the US is now winning the fight against the virus.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Dr. Janet Woodcock, the acting FDA Commissioner in a news release.

The vaccine is safe for children, FDA officials said.

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.

The approval was based on clinical trials of 1,131 adolescents who got the vaccine, (1,129 others got a placebo), and the most common side effects, the FDA said, were identical to those in adults – sore arms, headaches, fatigue.

Severe side effects are very rare.

The protection, however, was strong.

In adolescents who got the vaccine and had no previous signs of infection, “the vaccine was 100% effective in preventing COVID-19.”

That’s pretty good.

It is still too early to tell if the vaccine in adolescents prevents or minimizes the chances of transmitting the virus, but data for all the current vaccines in adults strongly suggests they are as effective in stopping the spread as they are in preventing illness.

It is unclear just how soon adolescents in Pennsylvania will be able to get vaccine appointments.

Pfizer is also conducting clinical studies in children 2-12 years of age and hopes to release those results soon.

Some media reports last week said the FDA could approve the Pfizer vaccine for use in that age range by September, just in time for the return to school.