Moderna RSV vaccine shows 84% efficacy in preventing symptoms in older adults, pitting it in a race with GSK, Pfizer

USA — Moderna has announced that its experimental messenger RNA vaccine for respiratory syncytial virus (RSV) was 83.7% effective in preventing at least two symptoms, such as cough and fever, in adults aged 60 and older in a late-stage trial.

It was effective at preventing lower respiratory tract disease with three or more symptoms in 82.4% of cases.

RSV, which causes symptoms similar to a cold but can be fatal in young children and older adults, kills approximately 14,000 adults 65 and older each year.

Along with the flu and COVID-19, the disease was on the rise in the United States and Europe this fall.

According to Moderna, no safety concerns have been identified during the vaccine’s clinical trial. The trial’s safety and efficacy data will be published in a peer-reviewed journal according to the company.

The clinical trial has enrolled approximately 37,000 people from 22 different countries.

Moderna stated that it intends to file an application for FDA approval in the first half of this year. There is currently no FDA-approved RSV vaccine. Moderna, Pfizer, and GSK are racing to be the first to market with RSV vaccines.

Late last year, Pfizer and GSK submitted applications for regulatory approval in the United States. In late-stage trials, Pfizer’s RSV vaccine was found to be 66.7% effective against two or more symptoms.

Sanofi and partner AstraZeneca’s antibody treatment nirsevimab, on the other hand, has received European Commission marketing authorization for the prevention of RSV in newborns and infants.

The Food and Drug Administration in the United States is currently reviewing it.

The United States experienced an unusually severe RSV season in the fall, particularly among children and the elderly, as the public largely abandoned public health measures implemented in response to the Covid-19 pandemic, such as masking and social distancing.

The RSV vaccine from Moderna employs the same messenger RNA technology as the company’s successful Covid shots.

The Covid vaccine made Moderna a household name and generated windfall profits, but it is still the company’s only commercially available product, and demand is dwindling.

The Boston biotech firm is under increasing pressure to demonstrate that other products in its pipeline will be successful in the market. Morgan Stanley estimates a US$7 billion to US$10 billion market for an adult RSV vaccine.

The vaccine was found to be generally safe, with the most common side effects being injection-site pain, fatigue, and headache.

Moderna’s President Stephen Hoge stated that myocarditis, a type of heart inflammation linked to mRNA COVID vaccines, was not a concern.

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