Policy Shift: FDA Clears Moderna COVID Vax for Children As Young As 6 Months

In what many view as a sharp departure from the Make America Healthy Again (MAHA) agenda and priorities of people like Food and Drug Administration (FDA) Commissioner Marty Makary and Health and Human Services (HHS) Secretary Robert F. Kennedy, the FDA approved Moderna’s COVID-19 vaccines for children, aged six months through 11 years who are at increased risk for the virus.

The FDA has approved the Spikevax vaccine for that age bracket who are at increased risk of COVID-19 disease. The approval applies to a supplemental Biologics License Application (sBLA), which means that the FDA is requesting updates or changes to an already approved biological license for a product such as a vaccine. It’s often used for new indications, changes in dosing, new formulations or, in this case, to transition the vaccine from Emergency Use Authorization (EUA) to full approval. Spikevax is a brand name used by Moderna for the vaccine.

Under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, the FDA says it “may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, and nuclear threats.”

The information sheet included in the packaging tells users or physicians that “SPIKEVAX does not contain SARS-CoV-2, the virus that causes COVID-19. SPIKEVAX cannot give you or your child COVID-19.” It also says that the use is appropriate for patients aged 6 months through 64 years of age who are at high risk of severe COVID-19.