RSV Vaccine Approved For Older Adults By FDA

(CTN News) – Wednesday, the FDA approved the RSV vaccine from drugmaker GSK to protect seniors against the virus that causes thousands of hospitalizations and deaths every year.

“The FDA’s approval of the first RSV vaccine today is a significant public health achievement to prevent a potentially life-threatening disease, and reflects the FDA’s commitment to facilitating the development of a safe and effective RSV vaccine for use in the United States,” Dr. The Center for Biologic Evaluation and Research’s director, Peter Marks, said in a statement.

Following an advisory meeting in March, the FDA voted overwhelmingly in favor of GSK’s Arexvy vaccine’s safety and efficacy.

Centers for Disease Control and Prevention’s vaccine advisers will meet in June to discuss recommendations for the vaccine, a key step toward ensuring insurance coverage.

As of 2022, GSK’s ongoing trial has been found to be effective against severe disease in 94% of adults 60 and older, and against infection in 71.7% of adults 60 and older.

Compared to other RSV Vaccines, Arexvy is adjuvanted, which means it contains an additional ingredient to increase immune response.

This antigen builds on work by researchers at the National Institutes of Health that was hailed as one of the top 10 breakthroughs of 2013. The COVID-19 vaccines used today were also developed from that work.

Known as AS01, its adjuvant is derived from the Chilean soapbark tree and is also used at a higher dose in Shingrix.

After last season’s “tripledemic” between COVID-19, RSV vaccine, and influenza, officials are pressing for an immediate vaccine rollout.

Statistics presented to the CDC’s advisers in February showed that the virus causes 10,000 deaths and 160,000 hospitalizations annually among seniors 65 and older, despite the fact the disease is largely underdiagnosed.

Aspects of the future

Axvy is still being studied by GSK in the coming seasons, which could provide more data about whether seniors should receive RSV vaccine boosters annually.

While acknowledging the positive data on the shot so far, some FDA advisers paused when asked about that and other outstanding questions.

It is also likely that CDC advisers will vote only on recommendations related to Arexvy for this season, allowing long-term decisions about the shot to be delayed. There is also a possibility that the panel may decide to narrow the age limit for the shot.

According to Michael Melgar, CDC’s director on vaccine policy, majority of the agency’s work group favored recommending GSK’s vaccine for adults 65 and older but not for those as young as 60.

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