08:49 AM EDT, 04/09/2024 (MT Newswires) -- Pfizer ( PFE ) said key data from an ongoing phase 3 clinical trial of its Abrysvo vaccine, which the pharmaceutical giant is developing for the treatment of respiratory syncytial virus, or RSV, met endpoints and it's going to seek wider access for the shot.

The study evaluating a single dose of the vaccine in adults of ages 18 to 59 years, who are at risk of developing severe RSV-associated lower respiratory tract disease, met its co-primary endpoints and main safety endpoint, the company said. Participants who received the shot demonstrated that their immune responses were non-inferior to those seen in a previous study of people above age 60.

The vaccine was also well tolerated by patients during the trial, with the safety findings consistent with previous investigations, according to Pfizer ( PFE ). Shares of the firm edged up 0.4% in premarket activity.

Pfizer ( PFE ) now plans to submit the new data to regulatory agencies and request an expansion of the vaccine's availability to people of 18 years and above. In 2023, the Food and Drug Administration approved the use of the drug for individuals that are of ages 60 and older, as well as for pregnant women to protect their infants from the virus.

"These encouraging results provide evidence that Abrysvo can help protect adults with increased risk against RSV-associated illness," said Annaliesa Anderson, head of vaccine research and development at Pfizer ( PFE ). "We are excited to address a significant unmet need, pending regulatory authority approval."

Pfizer ( PFE ) reported in January that Abrysvo contributed $515 million in global revenue for the fourth quarter of 2023. The vaccine, which was launched in July, logged $513 million in sales in the US during the three-month period.

"With Abrysvo, we are focused on increasing overall RSV market growth and market share by establishing RSV vaccination as a year-round discussion and expanding our retail contracting and offerings," Chief Executive Albert Bourla said during a Jan. 30 earnings call, according to a Capital IQ transcript.

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