FDA Approves Pfizer’s RSV Vaccine for Older Adults, Expanding Protection Against Respiratory Illness

Pfizer’s respiratory syncytial virus (RSV) vaccine for older adults has been approved by the US Food and Drug Administration (FDA), becoming the second vaccine against this common respiratory disease to receive approval. The FDA’s decision closely follows the approval of a similar vaccine by GSK Plc. Pfizer’s vaccine, named Abrysvo, is authorized for individuals aged 60 and older, matching the age group for GSK’s vaccine.

According to a late-stage study, Pfizer’s vaccine demonstrated 67% effectiveness among adults aged 60 and older with two or more RSV symptoms and 85.7% efficacy against severe illness characterized by three or more symptoms. Both Pfizer and GSK anticipate a lucrative market for RSV vaccines. Pfizer aims to make its vaccine available in the third quarter before the next RSV season, pending approval from the US Centers for Disease Control and Prevention (CDC). The CDC’s advisory committee is scheduled to convene in June to discuss various aspects, including the target recipients and dosing intervals for the vaccines.

Pfizer has not disclosed the price of the vaccine but has stated that it will be value-based to support routine vaccination within the recommended age group. If the CDC recommends routine use, the vaccine will likely be widely accessible at no cost for most older Americans covered by the Medicare health plan.

Although RSV typically causes mild cold-like symptoms, it can lead to severe illness and hospitalization, particularly among individuals aged 65 and older, resulting in approximately 14,000 deaths annually in the United States.

Furthermore, Pfizer is pursuing FDA approval for its RSV vaccine to protect infants by vaccinating pregnant women. If approved, it would be the first RSV vaccine available for safeguarding babies, who face a high risk of severe illness. The vaccine has received support from the FDA’s external expert panel for use in pregnant women. Pfizer plans to launch its RSV vaccine for older adults and pregnant women in the United States and Europe this year.

Moderna Inc also intends to seek approval for its RSV vaccine targeting individuals aged 60 and older later this quarter. In November, Sanofi and AstraZeneca gained European marketing authorization for their antibody treatment nirsevimab, designed to prevent RSV in newborns and infants, and it is currently undergoing FDA review.