Pfizer ready to launch RSV vaccines for older adults, pregnant women in US, Europe

[March 09, 2023]  By Maggie Fick

PUURS, Belgium (Reuters) -U.S. drugmaker Pfizer is ready to launch its respiratory syncytial virus (RSV) vaccine for both older adults and pregnant women in the U.S. and Europe later this year, executives said on Thursday.

Both Pfizer and British drugmaker GSK have RSV vaccines they hope to launch in the U.S. and Europe this year, pending regulators’ approval.

“We are anticipating approval in both the U.S. and Europe in time for rollout in the fall,” Kena Swanson, Pfizer's head of viral vaccines research & development, told a media briefing at the company's biggest manufacturing and packaging site globally.

RSV is a leading cause of pneumonia in infants and the elderly, and decades of research have finally resulted in the two successful vaccines that Pfizer and GSK are racing to introduce.

Some 14,000 people die annually in the U.S. of the lower respiratory tract disease caused by the virus, and analysts see a multi-billion dollar market for the vaccine by the end of the decade.

GSK told Reuters on Wednesday that it is also ready to launch its RSV vaccine for older adults in the U.S. this year without supply constraints.

The U.S. Food and Drug Administration (FDA) is scheduled to make an approval decision on both vaccines by May.

Pfizer company logo is seen at a Pfizer office in Puurs, Belgium, December 2, 2022. REUTERS/Johanna Geron

Annaliesa Anderson, Pfizer's head of vaccines research & development, told the same briefing that the company anticipates a population of about 4 million pregnant women annually in the U.S. who could eventually receive its RSV vaccine, though the market will take time to shape.

Given how contagious RSV is, the best way to protect infants from contracting the virus and becoming severely ill is by vaccinating their mothers during pregnancy, said Anderson.

GSK last year voluntarily stopped its clinical trial of its own RSV vaccine on pregnant women and is currently only pursuing the use of its vaccine on older adults, a company spokesperson told Reuters on Thursday.

(Reporting by Maggie Fick; editing by Jason Neely and Jane Merriman)

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