On Wednesday, the US Food and Drug Administration (FDA) approved Pfizer’s RSV vaccine for older adults, marking the second such vaccine approved for the common virus.
In May, the agency granted approval to the world’s first RSV vaccine for older adults, manufactured by GSK. Pending recommendations from the US Centers for Disease Control and Prevention (CDC) and its vaccine advisers, these vaccines may be available for seniors in the fall.The vaccine advisers have a scheduled meeting in June.
RSV, or respiratory syncytial virus, is a highly contagious virus that causes flu-like illness across all age groups.While infants and young children are commonly associated with RSV, seniors are also at risk. In the US, RSV leads to hospitalization of approximately 159,000 adults aged 65 and above each year, causing an estimated 10,000 to 13,000 deaths.
According to Pfizer’s clinical trial data, the vaccine, marketed as Abrysvo, showed 66.7% effectiveness in preventing moderate lower respiratory tract illness with two or more symptoms and 85.7% effectiveness in preventing illness with three or more symptoms in individuals aged 60 and above.
In February, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 7-4 with one abstention, affirming the availability of adequate data to support the safety and effectiveness of the vaccine.
Furthermore, the FDA is currently reviewing Pfizer’s maternal vaccine designed to protect infants from RSV, with a decision expected by the end of August. Additional RSV vaccines may be forthcoming, as Moderna is finalizing its Phase 3 trial for an mRNA vaccine targeting RSV in older adults and expects to submit results to the FDA in the coming months. Bavarian Nordic also plans to report results from a Phase 3 trial of its RSV vaccine for older adults later this year.