(Reuters) – The U.S. Food and Drug Administration (FDA) on Wednesday approved Pfizer Inc’s respiratory syncytial virus (RSV) vaccine for older adults, making it the second shot against the common respiratory disease that can be fatal for seniors.
The approval comes less than a month after the FDA approved a similar shot by rival GSK Plc. Pfizer’s vaccine was approved for people aged 60 and older, the company said, the same age group as GSK’s shot.
In a late-stage study, Pfizer’s vaccine, to be sold under the brand name Abrysvo, was 67% effective among those aged 60 and older with two or more symptoms of RSV, and 85.7% against a severe illness defined by three or more symptoms.
Pfizer and GSK have said they expect a multibillion-dollar market for RSV vaccines.
Their RSV shots are expected to roll out later this year after the U.S. Centers for Disease Control and Prevention (CDC) signs off on their use.
The CDC’s advisory committee is expected to meet in June to discuss the vaccines, including who should receive them and how often.
RSV usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. It is estimated to be responsible for 14,000 deaths in adults aged 65 and above in the United States annually, according to government data.
(Reporting by Mariam Sunny and Raghav Mahobe in Bengaluru; Editing by Shailesh Kuber and Bill Berkrot)
