The approval comes less than a month after the FDA approved a similar shot by rival GSK. Pfizer’s vaccine was approved for people aged 60 and older, the company said, the same age group as GSK’s shot.
In a late-stage study, Pfizer’s vaccine, to be sold under the brand name Abrysvo, was 67 per cent effective among those aged 60 and older with two or more symptoms of RSV, and 85.7 per cent against severe illness defined by three or more symptoms.
Pfizer and GSK have said they expect a multibillion-dollar market for RSV vaccines.
The company expects to make the vaccine available during the third quarter, ahead of the next RSV season, once the U.S. Centers for Disease Control and Prevention (CDC) signs off on its use.
The CDC’s advisory committee is expected to meet in June to discuss the vaccines, including who should receive them and how often.
Pfizer did not disclose a price for the vaccine. It said the price would be value-based to support routine vaccination for the recommended age group for the shots.
If the vaccine is recommended by the CDC for routine use, it will be widely available at no out-of-pocket cost for most older Americans covered by the government Medicare health plan, the company said.
RSV usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalisation. It is estimated to be responsible for 14,000 deaths in adults aged 65 and older in the United States annually, according to government data.
Pfizer is also seeking FDA approval for its RSV vaccine to prevent the disease in infants by inoculating pregnant women. It could become the first RSV vaccine available to protect babies, who are among those at greatest risk for severe illness.
The shot received backing by the agency’s panel of outside experts earlier this month for use in pregnant women.
The company has said it is ready to launch its RSV vaccine for both older adults and pregnant women in the United States and Europe this year.
Moderna Inc has said it expects to file seeking approval for its RSV vaccine this quarter for those aged 60 and older.
Sanofi and partner AstraZeneca in November gained European marketing authorization for their antibody treatment nirsevimab for preventing RSV in newborns and infants. It is currently under FDA review.
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