Pfizer Asks FDA To Approve Its Covid Vaccine For Younger Teenagers

TOPLINE

Drugmakers Pfizer and BioNTech asked U.S. regulators on Friday to make their Covid-19 vaccine the first authorized for Americans under the age of 16, after preliminary data suggested the shot is 100% effective at staving off illness in teens ages 12 to 15.

KEY FACTS

New York City-based Pfizer and Germany’s BioNTech are asking the Food and Drug Administration to expand their vaccine’s emergency use authorization to include Americans between the ages of 12 and 15.

The vaccine is currently only approved for people 16 and older, and the other two coronavirus vaccines to have received emergency use authorization in the United States so far—made by Moderna and Johnson & Johnson—are approved only for adults.

Pfizer and BioNTech released early trial data last week showing younger teens who took the vaccine developed “robust antibody responses” and experienced roughly the same side effects as young adults.

The FDA did not immediately respond to a request for comment.

CRUCIAL QUOTE

“These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts,” the two companies said in a statement Friday.

WHAT TO WATCH FOR

If the FDA approves the vaccine for younger teenagers, Pfizer CEO Albert Bourla said he hopes to start immunizations before the start of the next school year. 

TANGENT

Moderna and Johnson & Johnson also plan to test their vaccines on teenagers, possibly broadening eligibility for shots as the percentage of the U.S. adult population that has received at least one shot approaches 50%.

KEY BACKGROUND

The mortality rate for children from Covid-19 is much lower rate than for adults, but the Centers for Disease Control and Prevention says at least 251 children have died from the disease, and vaccinations for teens could help prevent the virus from spreading. Plus, teenage vaccinations could make it easier for schools to fully reopen, though the CDC says vaccines aren’t absolutely necessary for schools to safely restore in-person instruction.