FDA amends Pfizer vaccine EUA to include children aged 12-15

Key Takeaways

On May 10, the U.S. Food and Drug Administration (FDA) amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include children aged 12-15, making it the first vaccine available to children as young as 12. The FDA determined that the benefits of the Pfizer vaccine in people aged 12 and older outweigh the risks. On March 31, Pfizer announced results from its phase 3 trial on children aged 12-15 showed the vaccine demonstrated 100% efficacy at preventing COVID-19. The FDA originally issued an EUA for Pfizer’s vaccine on Dec. 11, 2020 for people aged 16 and older.

Approximately 1.5 million COVID-19 cases in children aged 11 to 17 were reported to the Centers for Disease Control and Prevention (CDC) in March and April combined. The FDA said children generally have milder COVID-19 cases as compared to adults. The Pfizer vaccine will be administered as a series of two doses three weeks apart, just as has been done for recipients 16 years old and older.

The federal government was prepared last week to immediately respond to an updated EUA so that the newly eligible children could begin receiving the vaccination right away, said Jeff Zients, the White House Coordinator of Covid-19 Response. He said that over 15,000 local pharmacies would be prepared to vaccinate 12- to 15-year-olds, and the administration had been working to get more pediatricians and family doctors to offer vaccinations. However, a panel of experts for the Centers for Disease Control and Prevention (CDC) made the final call to recommend the vaccine for this age group, following a meeting on May 12.

On May 6, Moderna announced its phase 2/3 study of its COVID-19 vaccine in children aged 12-17 showed efficacy rate of 96 percent. Moderna and Johnson and Johnson, the two other COVID-19 vaccines with EUAs, are authorized for people aged 18 and older. Moderna also announced its phase 2 study of its vaccine in children aged six months to 11 years is ongoing. Pfizer is also in the middle of its study on its vaccine in children as young as six months. NACo will continue to monitor developments regarding vaccines and communicate relevant information with its members.

Additional Resources

• NACo’s COVID-19 Vaccine Distribution Toolkit
• NACo Analysis of the American Rescue Plan Act
• Biden Administration Adjusts Vaccine Allocations; Announces New Vaccine Funding Programs