FDA approves Pfizer’s RSV vaccine for older adults
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Key takeaways:
- Pfizer’s shot is the second RSV vaccine approved for older adults.
- The vaccine is also being evaluated for use in pregnant people to protect infants.
The FDA this week approved Pfizer’s respiratory syncytial virus vaccine for adults aged 60 years or older — the second RSV vaccine approved for this population in the last month.
“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century,” Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer, said in a press release. “[This] approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher risk populations, which includes older adults.”
The approval of the vaccine, which Pfizer has branded as Abrysvo, came after the FDA’s Vaccines and Related Biological Products Advisory Committee recommended it in a 7-4 vote in March.
The approval was based on data from the phase 3 RENOIR trial — a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity and safety of the vaccine in adults aged 60 years or older.
Approximately 37,000 people were enrolled in the trial and randomly assigned in a 1:1 ratio to receive the vaccine or placebo. Although the study is ongoing to allow researchers to collect additional data from a second RSV season, initial findings published in The New England Journal of Medicine showed that the vaccine was 66.7% effective (96.66% CI, 28.8%-85.8%) at preventing lower respiratory tract illness with two or more symptoms and 85.7% effective (96.66% CI, 32%-98.7%) at preventing illness with three or more symptoms in people 60 and older.
Last month, GSK’s Arexvy became the first ever RSV vaccine to gain approval — the result of an increased focus on RSV vaccine research in recent years following a long delay in activity after a deadly vaccine trial in the 1960s.
GSK and Pfizer are also studying their vaccines in other populations. GSK is testing its vaccine in people aged 50 to 59 years, including those with underlying comorbidities, and is expecting results from that trial later this year. Pfizer’s vaccine is under review for use in pregnant people, with an FDA decision expected in August.
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