FDA authorizes Pfizer COVID-19 vaccine for adolescents

The Food and Drug Administration (FDA) on Monday gave the green light for the Pfizer-BioNTech coronavirus vaccine to be used in adolescents 12 to 15 years old, a move that will make millions more people eligible for a vaccine.

The highly anticipated decision is a key step toward ensuring middle and high schools can operate for full in-person learning in the fall — and a major boon to parents concerned about the safety of summer activities.

The FDA has been reviewing the amended application from Pfizer and BioNTech for more than a month. The companies cited research from their clinical trial in late March that found the vaccine was effective in the younger population and produced strong antibody responses. The side effects were also about the same as the older population.

Following the announcement, the Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee will meet Wednesday to review the data, and vote on recommendations for use of the shot in adolescents. Once the CDC director signs off, shots can be administered immediately.

Pfizer’s vaccine is currently authorized for everyone aged 16 and older. The other two vaccines on the market in the U.S., from Moderna and Johnson & Johnson, are only authorized for adults, but the companies are testing the shots in children.

Children need to be vaccinated in order to raise the overall level of immunity in the country. While herd immunity may not be within reach, getting more people vaccinated will lower the numbers of COVID-19 infections, hospitalizations and deaths. 

“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,” acting FDA Commissioner Janet Woodcock said in a statement. “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.”

While children are at lower risk of severe COVID-19 than adults, and generally have a milder disease course, older adolescents and teenagers are more at risk than the youngest children.

They also appear to be less of a risk of spreading the virus than adults, but the role of children in transmission is not fully understood, which is why experts think it’s important to get children vaccinated.

Pfizer expects to request emergency use authorization for its COVID-19 vaccine to be given to children ages 2 to 11 in September.

The nationwide vaccination push has resulted in more than 260 million doses administered, enough to cover 40 percent of the population. But the American public’s enthusiasm for taking a coronavirus vaccine has reached a plateau, and the number of doses administered each day has dropped off precipitously.  

The U.S. has a surplus of vaccine supply, with more than 68 million doses that have been delivered but not administered. Some states have lately been ordering only a fraction of the doses available to them, another sign of stagnant demand.

The Biden administration is working hard to make it as easy as possible for people to get vaccinated, and to convince a large number of hesitant adults. Expanding the authorization to children could pose another challenge.   

“This is a promising development in our fight against the virus,” President Biden said in a statement Monday evening. “If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal.”

A recent poll from the Kaiser Family Foundation, however, showed limited eagerness for parents to get their children vaccinated, and that parents’ views on inoculating their children lined up with whether they planned to get vaccinated themselves. 

Among parents who have at least one child between the ages of 12 and 15, 30 percent said they’ll get their child vaccinated right away, 26 percent wanted to wait to see how it’s working, 18 percent said they will vaccinate only if their child’s school requires it and 23 percent said they will definitely not get their child vaccinated.

Updated at 8:52 p.m.