In era of skepticism, FDA clears Moderna COVID vaccination for children up to 11 years old

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.

The FDA also authorized the Moderna COVID-19 Vaccine (2024-2025 Formula) under EUA for all children aged 6 months through 11 years, targeting the Omicron variant KP.2 strain. 

The MAHA shakeup at the CDC

Consumers might be confused at what initially appears to be veering off the MAHA track. However, it's a much slimmer approval and recommendation than was previously approved and recommended. 

For the vaccine-hesitant, last month was a signal of optimism. Last month, Kennedy replaced all 17 members of the CDC’s Advisory Committee on Immunization Practices (ACIP) with an eight-member panel, including some individuals known for vaccine-skeptical perspectives. 

The decision sparked debate across scientific, medical and research communities, with former members and health experts warning it might erode confidence in vaccines and weaken immunization guidelines. The new committee, featuring members like Dr. Robert Malone and Vicky Pebsworth, started evaluating the childhood vaccine schedule and decided to eliminate thimerosal, a mercury-containing preservative, from flu vaccines. 

House Democrats have since called for clarification from the CDC, raising concerns about the panel’s choices, particularly the postponement of a vote on updated COVID-19 vaccine recommendations.

Moderna announced the approval via its X account, stating: "Today we announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Spikevax®, our COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. Our COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization."