The U.S. Food and Drug Administration (FDA) on Wednesday approved Pfizer Inc.'s respiratory syncytial virus (RSV) vaccine for older adults, making it the second shot against the common respiratory disease that can be fatal for seniors.
The approval comes less than a month after the FDA approved a similar shot by rival GSK PLC. 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% effective among those aged 60 and older with two or more symptoms of RSV, and 85.7% effective against severe illness defined by three or more symptoms.
Pfizer and GSK have said they expect a multibillion-dollar market for RSV vaccines.
Vaccine available in third quarter
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 also can lead to serious illness and hospitalization. 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.
Seeking OK for pregnant women
Pfizer also is 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 seek approval for its RSV vaccine this quarter for those aged 60 and older.
Sanofi and partner AstraZeneca PLC in November gained European marketing authorization for their antibody treatment nirsevimab for preventing RSV in newborns and infants. It is currently under FDA review.