FDA Grants Approval for Moderna’s RSV Vaccine, But They Skipped an Important Step

In a significant development, the U.S. Food and Drug Administration (FDA) has given the green light to Moderna’s mRNA-1345 vaccine, now known as mResvia.

The vaccine is designed to safeguard adults aged 60 and above from lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection.

This marks only the second Moderna drug to receive FDA approval and, more notably, the first mRNA vaccine approved for a disease other than COVID-19.

However, the FDA’s decision to bypass additional levels of scrutiny has raised some eyebrows.

In the approval letter, the agency stated, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your [biologics license application], including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”

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This committee is tasked with reviewing and evaluating data related to the “safety, effectiveness, and appropriate use of vaccines and related biological products” and providing independent expert advice to the FDA.

Moderna’s approval was based on data from the Phase 3 clinical trial ConquerRSV, a global study involving approximately 37,000 adults aged 60 or older across 22 countries, with nearly 20,000 participants from the United States.

The company claimed that the vaccine remained efficacious through a median 8.6 months follow-up and prevented severe RSV disease.

The reported efficacy of the vaccine is 83.7%, although the label indicates a 79% effectiveness in preventing at least two RSV symptoms.

While Moderna’s overview of the trial data insisted on the vaccine’s efficacy and safety, it also highlighted several “systemic reactions” reported within seven days of vaccination, including headache, fatigue, muscle pain, joint pain, and chills, in addition to injection site pain.

A Moderna-funded study published in the New England Journal of Medicine also claimed that a single dose of the vaccine “resulted in no evident safety concerns.”

However, it is worth noting that Moderna’s COVID-19 vaccine has been linked to an increased risk of myocarditis and pericarditis, particularly in young men, according to various studies, including an FDA-funded one.

Furthermore, a February study in the journal Vaccine, supported by the CDC and the Department of Health and Human Services, revealed increased ratios of Bell’s palsy, febrile seizures, and generalized seizures following doses of Moderna’s mRNA-1273 vaccine.

Despite these concerns, Moderna appears confident in its RSV vaccine, and the FDA has granted its approval.

The next step is for the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to review the vaccine during its June 26-27 meeting.

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Analysts predict that Moderna could generate around $340 million in RSV vaccine sales this year, with the potential to reach $830.5 million by 2025.