The Food and Drug Administration’s vaccine advisory committee has recommended GlaxoSmithKline’s and Pfizer’s respiratory syncytial virus vaccine candidates for older adults, paving the way for approval of the country’s first RSV vaccine.
The Vaccines and Related Biological Products Advisory Committee, the same group that reviews COVID-19 vaccines, voted unanimously on Wednesday that vaccine efficiency data for GSK’s RSV vaccine for adults 60 years and older were sufficient. The advisory committee voted 7-4 on Tuesday to recommend Pfizer’s vaccine candidate for older adults based on its efficacy, with one abstention.
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“I think an RSV vaccine could have an immense impact on this very common respiratory pathogen. I would love to see more data, which it sounds like will be available from GSK in April, and then the following year, so I do think ongoing monitoring and data collection and evaluation will be incredibly important,” said Henry Bernstein, a member of the advisory committee and professor of pediatrics at Zucker School of Medicine at Hofstra/Northwell.
RSV is a common respiratory illness that typically causes coldlike symptoms, but it can be particularly dangerous for infants and older adults. In adults ages 65 and older, RSV causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations per year, according to the Centers for Disease Control and Prevention. There is no vaccine approved for the respiratory syncytial virus in the United States.
GSK’s RSV vaccine was found to be 83% effective at preventing lower respiratory disease caused by RSV in a late-stage trial. Pfizer’s RSV vaccine was found to be more than 85% effective at preventing lower respiratory tract illness with three or more symptoms.
Some members of the advisory committee expressed safety concerns about Guillain-Barre syndrome with the vaccines, urging the FDA to review more data before approving either shot. Two adults out of 20,000 patients in Pfizer’s Phase 3 trial developed symptoms of the rare neurological disorder within nine days of receiving the RSV vaccine.
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The vaccine advisory committee’s backing of Pfizer’s and GSK’s vaccine candidates sets the rival drugmakers up for a race to be the first to bring theirs to market. The FDA has final say over whether the two shots are approved. The agency is expected to make its decision by May 3 for GSK’s vaccine and later that month for Pfizer’s.
If the FDA approves one or both of the vaccines, then the CDC has to recommend the shot before it would be made available to the public.
