By Robert Malone at Brownstone dot org.

Outdated package labeling for Moderna Spikevax 24-25 updated product. New FDA-approved labeling will indicate "for 6 months through 11 years who are at increased risk for severe COVID-19 disease."

What Happened on July 10?

I have had many requests to clarify what happened with the recent July 10, 2025, FDA general (non-EUA) marketing authorization of Moderna's SpikeVax for children. The truth of the matter is that I do not really know what happened at the FDA to lead to this outcome. Like many, I was shocked and disappointed. Moderna was overjoyed. Their stock value and market capitalization surged, with the climb beginning four days before the announcement, suggesting that someone had insider knowledge.

If true, that would likely constitute insider trading. This would precisely be the type of rule-breaking that many have come to expect from this company and sector. You can consider that a hypothesis, for purposes of this discussion.

Moderna's Spikevax Covid-19 vaccine received full US FDA approval for children aged 6 months through 11 years who are at increased risk for severe Covid-19 disease, as announced on July 10, 2025. This approval transitions the vaccine from its prior availability under Emergency Use Authorization (EUA) for this age group. Spikevax was previously approved for adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for severe disease.

Moderna's Spikevax was first granted FDA approval in January 2022 for adult use. The vaccine has since undergone updates, including targeting the KP.2 variant of SARS-CoV-2, and has been expanded to cover broader age groups. Moderna plans to make the updated Spikevax vaccine available for eligible populations in the U.S. ahead of the 2025-2026 respiratory virus season.

The approval was based on the FDA's scientific review, with Moderna's CEO, Stéphane Bancel, emphasizing the continued threat of Covid-19 to children, particularly those with underlying medical conditions. Despite the approval, critics have raised concerns about the lack of pediatric safety data and the potential for serious adverse events, including myocarditis and pericarditis.

The Spikevax package insert lists several adverse events, such as trouble breathing, swelling of the face and throat, rapid heartbeat, dizziness, and weakness.

The FDA and Moderna have acknowledged these risks, and updated package inserts now include stronger warnings about myocarditis and pericarditis. The vaccine is intended for individuals who are at increased risk for severe disease, and vaccination may not protect all people who receive the vaccine.

Moderna also has other vaccines in its portfolio, including mNEXSPIKE (mRNA-1283), which was approved in June 2025 for adults aged 65 years and older and individuals aged 12 to 64 years with at least one risk factor for severe disease. This approval was based on data from the Phase III NextCOVE trial, which showed that mNEXSPIKE was non-inferior to Spikevax.

There Are Several Unresolved Questions Related to This Action.

1. Why approve Moderna's Spikevax for this indication and not provide similar approval for the Pfizer product?

2. Did FDA Commissioner Dr. Marty Makary know and endorse this decision, or was it decided and acted upon at the level of FDA Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad?

3. Was the timing of this decision occurring while both Secretary Kennedy and his Deputy Chief of Staff Stephanie Spear were on vacation coincidental?

4. Was this decision made in the context of a broader strategic plan within HHS?

5. What are the pre-existing conditions that FDA considers as placing "children aged 6 months through 11 years at increased risk for severe COVID-19 disease." In other words, using plain language, what are the specific diseases of childhood that your child may have that would make them eligible for this FDA-licensed product?

6. What and where are t...