‘Concerning and Bewildering’: FDA Grants Full Approval of Moderna COVID Vaccine for ‘At-Risk’ Infants and Children

The U.S. Food and Drug Administration (FDA) today granted full approval of Moderna’s Spikevax COVID-19 vaccine for infants and children ages 6 months to 11 years who are at “increased risk” from the virus.

The vaccine was previously available to children ages 6 months through 11 years under emergency use authorization. It is now fully approved for all adults age 65 and older, and children and adults between 6 months and 64 years who are at higher risk of COVID-19.

Writing on Substack, epidemiologist Nicolas Hulscher called the FDA’s decision “gravely worrisome.”

“It shows, once again, that our regulatory agencies remain fully captured by the Bio-Pharmaceutical Complex,” he wrote.

Dr. Larry Palevsky, a pediatrician, said the approval raises several questions:

“I haven’t seen any data related to the use of this injection in the pediatric population. Has anyone? On what legitimate basis did the FDA approve this injection?

“What clinical criteria qualify children to be ‘at risk?’ Who decides these criteria, or are they up to the random opinion of the physician administering and selling this injection?”