The federal government’s crusade against vaccines seems to have been taken up a notch. In an unusual move, the Food and Drug Administration has refused to directly review Moderna’s promised experimental mRNA flu vaccine for potential approval.

Moderna disclosed the denial to the FDA on Tuesday night, it posted rejection letter online. In the letter, signed by senior official Vinay Prasad, the FDA admitted that Moderna’s Phase III trial data did not include an adequate control group for comparison. Moderna stated that it followed all the recommendations previously agreed to by the agency. Prasad IS reported It was decided to reject Moderna’s application unilaterally, due to the opposition of FDA scientists.

The FDA’s decision, “which did not identify any safety or efficacy concerns with our product, does not further our shared goal of promoting America’s leadership in the development of new medicines,” said Stéphane Bancel, Moderna CEO, in a statement from the company.

“No safety concerns”

The company PUBLISHED Phase III data on its standalone seasonal flu vaccine, code-named mRNA-1010, was released in March, which collectively involved nearly 10,000 participants. The vaccine appears to be, at least, as safe and effective as a standard flu vaccine for adults under 65 as well as a higher-dose vaccine used for adults over 65. Based on antibody levels, mRNA-1010 may give people greater protection on average than typical egg-based flu shots. The study authors also acknowledged “no safety concerns.”

But in Prasad’s letter to Moderna, released last week, he admitted that the control groups Moderna used did not “reflect the best available standard of care.” The letter does not define what this standard of care is. And in its response today, Moderna stated that CEBR gave its blessing to the company’s proposed study protocol for the largest phase III trial of mRNA-1010 in 2024. The agency recommended that Moderna have a comparison group of adults over 65 who were given a high-dose flu vaccine. The company conducted separate smaller Phase III trials, one of which included such a comparison, and presented that data in its submission to the FDA last year (this data was included in the study mentioned above).

At no point, the company claims, did the FDA signal that it was not satisfied with the quality of Moderna’s data before the rejection. And it seems that in normal times, the FDA would at least consider Moderna’s vaccine for approval. Quoting three anonymous FDA officials, Stat News reported Wednesday Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), overruled his staff in deciding to completely reject the company’s application.

A grudge against mRNA

The FDA’s rejection is the latest manifestation of the government’s newfound distaste for mRNA technology. It’s a shift that began with the second Trump administration and the installation of Robert F. Kennedy Jr. to head the US Department of Health and Human Services.

Last August, for example, HHS Office has partnered that it has pulled in nearly $500 million in funding for mRNA vaccine research and development. As a justification for the move, Kennedy issued misleading statements about mRNA vaccines, claiming that they failed to provide effective protection against upper respiratory infections such as influenza and covid-19 (while less effective against the disease, covid-19 vaccines saved millions of lives during the pandemic).

Prasad was appointed head of CBER in May. He was later fired in July (possibly due to pressure from right-wing voices like Laura Loomer), only to rehired less than two weeks ago. He has something similar cast doubts about the effectiveness and safety of mRNA covid vaccines. In November, he SPOKE FDA staff say these vaccines have killed at least 10 children in the US, citing unpublished FDA analysis. This data has never been released to the public, and an alleged internal memo was leaked shortly thereafter SHOW that FDA scientists have found fewer deaths linked to vaccines (possibly as little as zero) than Prasad claims.

Prasad and other officials also stated that the FDA needs more rigorous evidence to approve vaccines going forward. That’s a decent idea in theory, but in practice, it might require placebo-controlled trials for diseases for which vaccines already exist — trials that are unethical because they’re known to expose some volunteers to preventable diseases, many experts have contended.

Most likely as a result of this further investigation, Moderna delayed its application for a combination mRNA flu/covid vaccine showed promise last year, citing the need to collect more data. As such, the company’s mRNA-1010 vaccine is under review for approval in other countries, including Canada and the European Union. Moderna said it has requested a CBER meeting to better understand the agency’s decision.

This latest saga, however, may illustrate that trying to game the current FDA rules is a losing battle.