The company said its RSVpreF vaccine prevented RSV-associated lower respiratory tract illness and acute respiratory illness in adults over the age of 60 without evident safety concerns. The vaccine had a reported efficacy of 67%, according to the article.
Additionally, Pfizer said its vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, again without any evident safety concerns identified. The vaccine had a reported efficacy of 82%, according to the article.
The data publication comes just over a month after the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 7 to 4 on both safety and effectiveness in support of RSVpreF. The recommendation was based on the company’s Phase III clinical trial data released in August.
The treatment remains under FDA review ahead of a vote in the coming summer months.
Unlike Pfizer, GSK’s vaccine received unanimous support from VRBPAC for its effectiveness and also received a 10 to 2 vote in support of its safety profile. The British drugmaker had already published its Phase III results in NEJM by the time of the vote, showing a vaccine efficacy of 94% against severe disease.
Meanwhile, Moderna is pacing ahead of both companies with the Breakthrough Therapy Designation that mRNA-1345 received from the FDA in January. The designation applies to the prevention of RSV-associated lower respiratory tract disease in adults over the age of 60.
Prior to receiving the Breakthrough Therapy Designation, the treatment received Fast Track designation in August 2021. In Phase III trial data released at the start of the year, mRNA-1345 was found to have an efficacy of 84%.
The biotech said it plans to file a license application for regulatory approval during the first half of 2023.