Pfizer and BioNTech File for Full FDA Approval of Vaccine in Ages 12-15

A Pfizer COVID-19 vaccine is transferred into a syringe at a mobile vaccination clinic in Worcester, Mass., on Dec. 2, 2021. Steven Senne/AP Photo

Vaccine manufacturers Pfizer and BioNTech have submitted an application to the Food and Drug Administration (FDA) seeking to expand the approval of their COVID-19 shots to individuals aged between 12 and 15, citing trial data, the company announced on Thursday.

In a statement, the companies said their application to the FDA includes updated longer-term follow-up data from their Phase 3 clinical trial of the vaccine focusing on 2,228 participants ages 12 to 15 years.

The companies said their two-dose series of the Pfizer-BioNTech COVID-19 vaccine had been 100 percent effective during the trial and had a “favorable safety profile”. The results of the trial participants were measured seven days through to four months after they had received the second shot.

“Among 30 confirmed symptomatic cases of COVID-19 in the trial with and without evidence of prior infection with SARS-CoV-2, all cases of COVID-19 were in the placebo group (n=1,129) and no cases were in the Pfizer-BioNTech vaccine group (n=1,131),” the companies said.

Adverse events were “generally consistent with other clinical safety data for the vaccine, with a favorable safety profile observed in individuals with at least 6 months of safety follow-up after the second dose,” the companies said.

The companies noted that side effects that have been reported in some individuals who have received the vaccine include: severe allergic reactions and non-severe allergic reactions, myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); fever, muscle pain, among others.

The FDA granted Pfizer’s and BioNTech’s vaccine Emergency Use Authorization (EUA) for those between 12 and 15 on May 10, declaring that the shot is safe and offers strong protection for younger teens, based on clinical trials. Two days later, the CDC officially recommended the shot for the age group.

A child receives the Pfizer-BioNTech COVID-19 vaccination at the Fairfax County Government Center in Annandale, Virginia, on Nov. 4, 2021. Chip Somodevilla/Getty Images

Marketed as Comirnaty, the Pfizer vaccine is currently approved for use in all U.S. residents ages 5 and up. For children 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart.

In children 12 years of age and older, a third primary series dose is administered at least 4 weeks after the second dose, if they are immunocompromised.

The FDA granted full approval for the mRNA-based COVID-19 shot in August for individuals ages 16 and up. Shortly after, an advisory group of the CDC unanimously endorsed its full approval for U.S. citizens who are over the age of 16.

Under its EUA, Pfizer’s and BioNTech’s vaccine can be administered during the current COVID-19 pandemic, so long as the FDA determines that the known and potential benefits outweigh the known and potential risks of the vaccine.

Full approval is granted once the FDA has amassed enough scientific evidence to support the use of the COVID-19 vaccine and which shows that its benefits outweigh the risks. This would allow the companies to continue producing the shots even after the COVID-19 pandemic is declared over, and market them.

Pfizer and BioNTech also intend to file this data with other international regulatory authorities in the coming weeks, including the European Medicines Agency (EMA), the companies said.