Moderna’s Spikevax has been “Approved” by the FDA

The U.S. Food and Drug Administration (FDA) has officially granted full approval to Moderna’s controversial mRNA COVID-19 vaccine, Spikevax, for children as young as 6 months old through 11 years of age who are deemed “at increased risk” of COVID-19.

The vaccine was previously available to kids under Emergency Use Authorization (EUA), but the FDA has now handed over full approval, greenlighting the use of the experimental shot despite growing evidence of adverse events, including myocarditis, pericarditis, allergic reactions, and even seizures in young recipients.

While the media parrots talking points about “protecting vulnerable children,” the fine print tells a different story:

Myocarditis and pericarditis risks are highest in males ages 12 to 24—and Moderna wants to jab children as young as 6 months.

Adverse reactions include: seizures, chest pain, shortness of breath, vomiting, and even fainting.

Parents are told to “stay nearby for up to an hour” after their child’s injection—just in case their toddler has a severe allergic reaction or passes out.

The vaccine may not protect all recipients, yet Moderna continues pushing forward with mass vaccination.

https://www.thegatewaypundit.com/2025/07/modernas-covid-19-vaccine-spikevax-receives-full-fda/

FDA Approval Letter:

The review of this supplement was associated with the following National Clinical Trial (NCT) numbers: NCT04796896, NCT04649151, and NCT05436834.

https://www.fda.gov/media/187511/download

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SPIKEVAX safely and effectively. See full prescribing information for SPIKEVAX.

https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/263ee046-5d0f-44e4-b78b-84ce45c3fa64/263ee046-5d0f-44e4-b78b-84ce45c3fa64_viewable_rendition__v.pdf