The U.S. Food and Drug Administration (FDA) quietly granted full approval to Moderna's mRNA COVID-19 injection for children while Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. was on vacation—and without his knowledge or consent.

As head of the department overseeing the FDA, Kennedy should have been directly informed of any decision involving pediatric mRNA shots—especially one as politically and medically sensitive as full approval for children as young as six months.

On July 10, Moderna, Inc. announced the FDA approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID shot, in "children 6 months through 11 years of age who are at increased risk for COVID-19 disease."

The approval was made despite Moderna's own scientists' admission that there are "unacceptable toxicity" levels in mRNA vaccines, and that "lipid nanoparticle structural components, production methods, route of administration and proteins produced from complexed mRNAs all present toxicity concerns."

It was also made without Secretary Kennedy's knowledge.

According to multiple sources, neither Kennedy nor his Deputy Chief of Staff Stefanie Spears were briefed or consulted ahead of the decision, raising alarm over internal operations at one of the nation's most powerful health agencies.

Only July 16, White House correspondent and media host Emerald Robinson reported on Twitter/X that FDA Commissioner Dr. Marty Makary "did not inform @RobertKennedyJr (who was on vacation) or his office that FDA was going to approve the mRNA shots for children," citing sources familiar with the matter.

On July 17, CNN reported that Secretary Kennedy had fired two of his top aides "in an abrupt shakeup of the leadership at the nation's sprawling health department," also citing unnamed sources.

"Kennedy's chief of staff, Heather Flick Melanson, and deputy chief of staff for policy Hannah Anderson left HHS after only a handful of months on the job, following internal clashes that culminated in both of their removals this week," the report explained.

The CNN article didn't connect the firings to the FDA's decision to approve Moderna's jab for kids.

However, the MAHA PAC (Make America Healthy Again Political Action Committee)—a pro-Trump super PAC founded by RFK Jr.'s former staff to promote his health-focused agenda—corroborated Robinson's account and connected the firings to the FDA's Moderna decision.

On July 20, MAHA PAC cited Dr. Robert Malone—now serving on the newly restructured ACIP vaccine panel—as confirming that neither Kennedy nor Spears were informed of the FDA's decision regarding Moderna and that a major HHS leadership purge unfolded upon their return.