FDA Considers Two Drugmakers for First RSV Vaccine

2 min read

Feb. 28, 2023 -- An FDA advisory panel is considering two drugmakers to make the first respiratory syncytial virus (RSV) vaccine.

RSV kills about 14,000 older Americans each year, Reuters reported. Pfizer and GSK seek to lead the market that could be worth between $5 billion and $10 billion.

“The FDA is scheduled to decide on approval of the vaccines for people aged 60 and above by May, and typically follows the recommendations of its independent panel of experts,” Reuters wrote.

Shots could be given in time for the winter surge.

Merck, Moderna and Johnson & Johnson are working on their own RSV vaccines.

Last year, studies showed Pfizer and GSK doses prevented diseases RSV causes. GSK's vaccine was 82.6% effective in preventing lower respiratory tract disease in people over 60, and 94.1% effective in preventing severe disease. Pfizer's was 66.7% effective in preventing RSV-related lower respiratory tract illness with over two symptoms, and 85.7% effective against those with more than three.

"RSV is the last of the great big respiratory viruses that afflict our population on an annual basis," said William Schaffner, MD, an infectious disease expert at Vanderbilt University Medical Center.

The CDC says adults at highest risk for severe RSV infection include those over 65; adults with chronic heart or lung disease; and those with weakened immune systems.

Adults typically have mild cold-like symptoms with RSV, but lung infections or pneumonia are possible, the CDC says. RSV can sometimes also lead to worsening of serious conditions such as asthma, chronic obstructive pulmonary disease, and congestive heart failure.

Schaffner said he expects the FDA advisory panel to approve both companies’ vaccines this week.