Weaponizing the FDA Against Vaccines

By rejecting Moderna’s application for an mRNA influenza vaccine, RFK Jr.’s FDA is advancing his anti-vaccine agenda.

In April 2024, Moderna submitted a proposal to the FDA for testing its new mRNA influenza vaccine. The plan was to divide 40,000 subjects in 11 countries into two groups: one group would receive the mRNA flu vaccine and the other a standard-dose flu vaccine. At the time, the FDA reasonably pointed out that for people over 65, Moderna should compare its mRNA flu vaccine to high-dose, not standard dose, flu vaccine, as recommended by the CDC. However, if the company still planned to compare the mRNA vaccine with standard dose flu vaccine for those over 65, the CDC might choose not to recommend it for that age group. Because the clinical trial of the mRNA flu vaccine was performed in Europe, where high-dose influenza vaccine wasn’t readily available, the company moved forward recognizing that it might not get a CDC recommendation for older subjects, but that the FDA would still review the company’s submission. This was a written understanding.

In September 2024, Moderna launched its vaccine trial with 40,700 subjects, half of whom received the mRNA flu vaccine and the other half standard-dose vaccine. The mRNA vaccine was 27% more effective at preventing symptomatic cases of flu and 49% more effective against hospitalization than the standard-dose flu vaccine. In August 2025, the FDA agreed with the trial design and encouraged the company to apply for licensure based on the results, especially since Moderna had now performed an additional study in 2,200 people over 65 showing that the mRNA flu vaccine induced higher levels of protective antibodies than the high-dose flu vaccine.

On February 3, 2026, despite a previous written understanding, the FDA refused to review Moderna’s application for licensure of its mRNA influenza vaccine. The decision was made by Vinay Prasad, who now heads the FDA’s Center for Biologics Evaluation and Research (CBER). Moderna wrote that the failure to review the application was “inconsistent with previous written communications from CBER to Moderna.” Agency officials later revealed that Prasad had overruled his FDA staff. Indeed, David Kaslow, the head of the vaccine office, wrote a detailed memo explaining why the FDA should review Moderna’s application.

Moderna’s mRNA influenza vaccine appears to be an improvement on both the standard-dose vaccine given to people less than 65 and the high-dose flu vaccine given to people over 65. Nonetheless, because of RFK Jr.’s pick to head an important division in the FDA, Americans might be deprived of an influenza vaccine that appears to be better than the ones we have. On February 11, 2026, a Wall Street Journal (WSJ) headline read: “Vinay Prasad’s Vaccine Kill Shot: Does the White House Know the Harm He’s Doing to Public Health?” “This is arbitrary government at its worst.”

Vinay Prasad’s failure to honor a previous agreement with Moderna appears to be an extension of RFK Jr.’s war against mRNA vaccines. In 2021, RFK Jr. said that the mRNA COVID vaccines were the “deadliest vaccines in history.” In August 2025, RFK Jr. withdrew $500 million to fund research that included an mRNA bird flu vaccine. More recently, Robert Malone, RFK Jr.’s hand-picked Vice Chairman of the CDC vaccine advisory committee, has called for the removal of mRNA COVID vaccines from the market.

Weaponizing the FDA to make arbitrary, unsupportable decisions will only discourage companies from pursuing newer, better vaccines. Which, sadly, appears to be the goal.

Addendum: This substack was posted on February 17, 2026. The next day, Vinay Prasad changed course and agreed to review Moderna’s application for licensure of its mRNA influenza vaccine.