Six months ago, Pfizer and BioNTech secured emergency use authorization for their COVID-19 vaccine in 12- to 15-year-olds. Now, the companies have provided long-term data that could bring a full approval in the age group.
In a follow-up study of 2,228 children, the vaccine was 100% effective in preventing infection seven days to four months after the second dose. There were no serious safety concerns observed in those with at least six months of follow-up.
With the results, the companies will file for full FDA approval in the age group. In August, the shot won an FDA nod in people 16 and older.
Meanwhile, Moderna, maker of the world’s other highly successful mRNA COVID-19 vaccine, still has not received an emergency authorization for its shot in children ages 12 to 17. The FDA revealed in late October that it was delaying its decision on Spikevax, saying it needed more time to assess the risk for myocarditis.
Last week, the FDA endorsed both the Pfizer and Moderna COVID-19 shots to be used as boosters for people 18 and older. The boosters are interchangeable and to be administered no sooner than six months after the original series.
The positive data and approvals come amid increased concern in the U.S. over the recent rise in COVID-19 cases, primarily in the mountain states and now spreading to the Midwest and Northeast.
“These additional data provide further evidence in our vaccine’s safety and effectiveness profile in adolescents,” Pfizer CEO Albert Bourla said in a statement. “This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed.”