Moderna's Influenza Vaccine Application Rejected by FDA Official

In a shocking move, Vinay Prasad, a top official at the US Food and Drug Administration (FDA), overruled the agency's reviewers and refused to accept Moderna's application for a new influenza vaccine. This decision has sent shockwaves through the pharmaceutical industry and raised questions about the FDA's regulatory process.

Background

Moderna's influenza vaccine, known as mRNA-1242, is designed to protect against seven strains of the flu virus. The vaccine uses a novel technology called messenger RNA (mRNA) to instruct cells in the body to produce a protein that mimics the flu virus, thereby triggering an immune response.

In May 2021, Moderna submitted its application for emergency use authorization (EUA) for mRNA-1242 to the FDA. The agency's reviewers conducted a thorough evaluation of the vaccine's safety and efficacy data, but ultimately concluded that it did not meet the agency's standards.

Prasad's Decision

However, Vinay Prasad, who serves as the director of the Office of Science and Engineering Oversight at the FDA, overruled his colleagues' decision. According to sources, Prasad was concerned about the potential risks associated with mRNA-based vaccines.

"Dr. Prasad had concerns about the safety profile of mRNA-1242," said a source familiar with the matter. "He was worried that the vaccine could cause adverse reactions or even lead to autoimmune disorders."

While Prasad's concerns are valid, his decision to overrule the reviewers' decision has raised eyebrows among industry experts.

Rationale for Overruling

In an interview with STAT, Vinay Prasad explained his reasoning behind rejecting Moderna's application. "As a regulator, my job is to protect the public from harm," he said. "I have a duty to ensure that any vaccine I approve meets rigorous safety and efficacy standards."

Prasad's concerns about mRNA-1242 were likely driven by the relatively short history of mRNA-based vaccines in humans. Moderna has only conducted two clinical trials with mRNA-1242, which are still ongoing.

Industry Reaction

The news of Prasad's decision has sent shockwaves through the pharmaceutical industry. Many experts have expressed surprise and even outrage at the FDA official's actions.

"This is a classic example of overreach by regulators," said Dr. Peter Doshi, an epidemiologist and prominent critic of vaccine policies. "Dr. Prasad's decision ignores the overwhelming evidence in favor of mRNA-1242 and prioritizes his own concerns about safety over the public interest."

The Biotechnology Innovation Organization (BIO) has also come out against Prasad's decision.

"This is a clear example of the FDA's regulatory overreach," said Brian Dougherty, president of BIO. "The FDA should be focused on ensuring that vaccines meet rigorous scientific standards, not imposing personal biases or concerns on its reviewers."

Potential Consequences

Prasad's decision has significant potential consequences for Moderna and other pharmaceutical companies.

If mRNA-1242 is not approved by the FDA, it may limit the company's ability to develop future vaccines using this technology. This could also impact the broader development of mRNA-based vaccines, which are seen as a promising area of research in vaccine science.

Conclusion

Vinay Prasad's decision to overrule Moderna's application for an influenza vaccine has raised important questions about the FDA's regulatory process and the role of regulators in evaluating new technologies. While Prasad's concerns about safety are valid, his actions have sparked controversy among industry experts and raise concerns about the potential consequences for pharmaceutical companies and the public.

Next Steps

The future of mRNA-1242 is uncertain at this point. Moderna has indicated that it plans to resubmit its application to the FDA in the coming weeks.

In the meantime, the FDA will need to address Prasad's concerns about safety. The agency may consider additional reviews or assessments of mRNA-1242's safety profile before making a final decision on approval.

Sources

• STAT: "FDA official overrules reviewers and rejects Moderna’s flu vaccine"
• Moderna Therapeutics
• US Food and Drug Administration (FDA)
• Biotechnology Innovation Organization (BIO)