FDA approves new Moderna mRNA vaccine without bothering with independent advisers

The U.S. Food and Drug Administration has approved Moderna's mRNA-1345 vaccine, which allegedly protects adults aged 60 and older from respiratory syncytial virus infection-caused lower respiratory tract disease.

The agency's breakthrough therapy designation approval for the drug, which will be marketed as mResvia, is only the second Moderna drug the FDA has approved. More significantly, it is the first mRNA vaccine to have been approved to address a disease other than COVID-19.

'We did not refer your application to the Vaccines and Related Biological Products Advisory Committee.'

Even though that amounts to a big step, it appears the regulator was keen to jump past additional levels of scrutiny.

The FDA noted in its Friday approval letter, "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."

The advisory committee's job is to review and evaluate data concerning the "safety, effectiveness, and appropriate use of vaccines and related biological products," then provide independent expert advice to the agency.

According to the pharmaceutical company, the approval was based on "positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 or older in 22 countries."

Nearly 20,000 of the trial participants were based in the United States. There are at least 11 other studies under way examining the impact of the novel drug on other demographics.

The company claimed in a Feb. 29 overview of its trial data that the vaccine "continued to be efficacious through median 8.6 months follow-up" and was shown to prevent severe RSV disease "base on analysis of shortness of breath and medically attended RSV-[lower respiratory tract disease]."

The vaccine's efficacy is allegedly 83.7%. Reuters noted, however, that the label indicates the shot is only 79% effective at preventing at least two symptoms of RSV, such as fever and cough.

While the overview insisted that the vaccine was relatively effective and safe, it nevertheless highlighted a number of "systemic reactions" reported within seven days of vaccination, such as headache, fatigue, myalgia, arthralgia, and chills, besides customary injection site pain.

A Moderna-funded study published in the New England Journal of Medicine similarly alleged that a single dose of the vaccine "resulted in no evident safety concerns."

Despite similarly having been presented as a safe vaccine, Moderna's COVID-19 vaccine was linked in various studies, including in an FDA-funded study, to an increased risk of myocarditis and pericarditis, particularly in men ages 18-25.

Extra to heart inflammation, the Global COVID Vaccine Safety Project — a Global Vaccine Data Network initiative supported by both the CDC and the Department of Health and Human Services — revealed in a February study in the esteemed journal Vaccine that "Bell's palsy had an increased [observed to expected] ratio after a first dose of [Pfizer's] BNT162b2 and [Moderna's] mRNA-1273."

The study also noted that "there were also increased OE ratios for febrile seizures following a first and second dose of mRNA-1273 ... and for generalized seizures following first mRNA-1273 dose and fourth BNT162b2 dose."

Blaze News previously reported that the University of Auckland, which hosts the Global Vaccine Data Network, noted that there were safety signals for "acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after viral vector and mRNA vaccines."

Despite outstanding concerns about its only other approved vaccine, Moderna appears confident in its product and has evidently secured the FDA's confidence as well. Its next stop is the Centers for Disease Control and Prevention, whose Advisory Committee on Immunization Practices will review the vaccine during its June 26-27 meeting.

Analysts estimate Moderna will do roughly $340 million in RSV vaccine sales this year and possibly $830.5 million in 2025, reported Reuters.

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