RSV vaccine market to drop 64% post CDC decision (NYSE:PFE)

Healthcare analytics firm Airfinity cut its U.S. market forecast for respiratory syncytial virus (RSV) vaccines in older adults by as much as 64% this week after a panel of CDC experts narrowed their recommendations on RSV immunizations last month.

Airfinity revised its forecast following a CDC advisory committee meeting in June that recommended a single lifetime RSV vaccine for those aged 75 years and older. The CDC’s Advisory Committee on Immunization Practices (ACIP) also declined to recommend RSV vaccines for adults aged 60–74 who are not at an elevated risk of the disease.

The updates prompted London-based Airfinity to cut its forecast for the U.S. RSV vaccine market by 64% to $1.7B from $4.7B a year to reflect the revised guidance, which, it said, reduced the estimated eligible population by 44% to 46M.

The U.S. market for RSV vaccines comprises three players. In May, the FDA approved a messenger RNA-based RSV vaccine branded as mRESVIA from Moderna (NASDAQ:MRNA) to prevent the risk of lower respiratory tract disease caused by the disease in people 60 years of age and older.

Last year, GSK (NYSE:GSK) and Pfizer (NYSE:PFE) became the first to receive FDA nods for RSV shots when the agency approved their more traditionally developed vaccines, Arexvy and Abrysvo, for the same indication.

Additionally, the ACIP has delayed an expected recommendation for high-risk 50- to 59-year-olds, for whom the FDA expanded the Arexvy label in June.

The delayed decision can cause a roughly $300M revenue impact on GSK, which, according to Airfinity, is even more impactful for the U.K. company as it used a priority review voucher worth $20M-$100M to accelerate the label expansion.

“The ACIP recommendations will likely stunt revenue growth in the U.S. market unless new data can support the benefit of booster shots,” Airfinity’s RSV Lead Isabella Huettner said, adding that the three marker payers stand to benefit from a global rollout.

The U.K., Canada, and major EU countries are set to launch their RSV immunization programs for the first time this winter. “Nevertheless, the trend appears to be for a single lifetime vaccine recommendation for those over 75-year-olds, as was recently confirmed by the U.K.,” Huettner added.