FDA approves Pfizer’s RSV vaccine for older adults

Earlier in May, the agency approved the world’s first RSV vaccine for older adults, made by GSK. The vaccines could be available for seniors by fall, pending recommendations from the US Centers for Disease Control and Prevention and its vaccine advisers, who are scheduled to meet in June.

Respiratory syncytial virus, known as RSV, is a highly contagious virus that causes flu-like illness in people of all ages. Although RSV is often associated with babies and young children, it can also be dangerous for seniors. In the US, an estimated 159,000 adults 65 and older are hospitalized each year with RSV, and an estimated 10,000 to 13,000 die as a result of their infection.

In a clinical trial, the Pfizer vaccine – which will be marketed under the brand name Abrysvo – was 66.7% effective at preventing moderated lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing illness with three or more symptoms in people 60 and older, according to Pfizer.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted 7-4 with one abstention in February that there was adequate data to support the vaccine’s safety and effectiveness.

The FDA is also reviewing Pfizer’s maternal vaccine to protect infants and is expected to make a decision by the end of August.

More RSV vaccines may be on the way, too. Moderna is finishing its Phase 3 trial for an mRNA vaccine for RSV in older adults and expects to submit results to the FDA within the next few months. Bavarian Nordic also said it will report results from a Phase 3 trial of its RSV vaccine for older adults this year.

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