US FDA Granted Approval to Pfizer's RSV vaccine

Pfizer Inc's respiratory syncytial virus (RSV) vaccine for older adults was approved by the US Food and Drug Administration on Wednesday, making it the second shot against the common respiratory disease that can be fatal for seniors. The approval comes less than a month after rival GSK Plc received FDA approval for a similar shot. According to the company, Pfizer's vaccine is approved for people aged 60 and older, 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 in those aged 60 and older with two or more RSV symptoms, and 85.7 percent effective in those with three or more symptoms.

Pfizer and GSK have stated that RSV vaccines will have a multibillion-dollar market. Once the US Centres for Disease Control and Prevention (CDC) approves its use, the company expects to make the vaccine available in the third quarter, ahead of the next RSV season. The CDC's advisory committee will meet in June to discuss the vaccines, including who should get them and how frequently. The vaccine's price has not been disclosed by Pfizer. It stated that the price would be value-based in order to support routine vaccination for the recommended age group. 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 typically causes mild cold-like symptoms, but it can also cause serious illness and hospitalisation. According to government data, it is responsible for 14,000 deaths in adults 65 and older in the United States each year. Pfizer is also requesting FDA approval for its RSV vaccine, which is intended to prevent the disease in infants by immunising pregnant women. It could be the first RSV vaccine available to protect babies, who are at high risk of severe illness. Earlier this month, the agency's panel of outside experts approved the shot for use in pregnant women.

The company has stated that it is ready to launch its RSV vaccine in the United States and Europe this year for both older adults and pregnant women. 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 Plc in November gained European marketing authorisation for their antibody treatment nirsevimab for preventing RSV in newborns and infants. It is currently under FDA review.