Pfizer and BioNTech announced Thursday they have asked the Food and Drug Administration to fully approve their Covid-19 vaccine for children ages 12 to 15, citing data that showed the shot gave 100% protection against the virus in the age group among those sampled.
The companies pointed to their 2,228-person trial—the findings of which were originally released in November—that found zero cases of Covid-19 among fully vaccinated 12- to 15-year-olds when tested seven days to over four months after receiving the second Pfizer/BioNTech dose.
The vaccine is currently available for the age group, as well as children ages 5 to 11, under an FDA emergency use authorization, which requires the vaccine’s benefits to outweigh its “known and potential risks.”
The companies say they will also file the data from the trial to the European Medicines Agencies and medical authorities for other countries in the coming weeks.
The shot was fully approved by the FDA for individuals ages 16 and older in August.
Full approval means the companies will be able to continue producing the vaccine after the Covid-19 pandemic is declared over, and will be allowed to market the shot.
The Pfizer/BioNTech shot is the only Covid-19 vaccine approved, emergency or otherwise, for Americans under age 18.
A Centers for Disease Control and Prevention study released in October that examined data from June 1 to September 30—when the delta variant was the dominant strain of the coronavirus—found the Pfizer/BioNtech Covid-19 shot to be 93% effective at preventing hospitalizations in individuals ages 12 to 18.
Health officials are concerned about a drop in the vaccine’s effectiveness against the omicron variant of the coronavirus, which has spread rapidly since first being detected in southern Africa in late November. Discovery Health, a South African private health insurance administrator, releasedfindings Tuesday from a real-world study that showed the Pfizer/BioNTech Covid-19 vaccine was 70% effective at preventing Covid-19-related hospitalizations and 33% effective at preventing infection amid the omicron-driven wave in South Africa, indicating a 47-percentage-point drop in effectiveness at preventing infection from prior waves. The data analyzed 211,000 Covid-19 tests, 41% of which were from adults who had received two doses of the Pfizer shot. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Wednesday during a White House press briefing that Covid-19 booster shots, either from Pfizer/BioNTech or Moderna, offer substantial protection against hospitalization from the omicron variant.
The data from Discovery Health also showed a 29% dip in hospitalizations compared to the alpha variant after adjusting for vaccination status.
By Mason Bissada, Forbes Staff