On Feb. 28, 2023, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended approval for Pfizer’s RSV vaccine candidate, making it potentially the first RSV shot to be approved in the United States.
The next day, the RSV technology marked a second success: The committee recommended GSK’s vaccine for older adults on March 1, 2023. The FDA is expected to decide on approval by May.
“Today’s vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems,” said Phil Dormitzer, Global Head of Vaccines R&D at GSK. “Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications.”
GSK said that its “RSV older adult vaccine candidate is also under regulatory review by the European Medicines Agency, Japan’s Ministry of Health, Labour and Welfare, and several other regulators, with decisions expected in 2023. Additional regulatory submissions are anticipated to continue throughout this year.”
As Bio.News reported earlier, in further explaining RSVpreF (the RSV bivalent vaccine candidate) research from the National Institutes of Health (NIH) study details the crystal structure of prefusion F, a crucial form of the viral fusion protein (F) that RSV employs to enter human cells.
These findings served as the basis for Pfizer’s investigational RSV vaccine candidate. The NIH study demonstrated that prefusion-specific antibodies were extremely effective at preventing virus infection, indicating that a prefusion F-based vaccine may provide the best protection against RSV.
Following this significant finding, Pfizer tested various iterations of a stabilized prefusion F protein and discovered a candidate that in pre-clinical tests strongly stimulated an anti-viral immune response. Equal quantities of recombinant RSV prefusion F from subgroups A and B make up the bivalent vaccine candidate.
Before the fall RSV season, additional Biotechnology Innovation Organization (BIO) members, such as Bavarian Nordic, Johnson & Johnson, Merck, and Moderna, will probably also apply for the approval of their candidates.
Pfizer’s RSVpreF vaccine will be evaluated by the FDA. The FDA typically follows the recommendations of the VRBPAC. If approved, the CDC, which generally aligns with the FDA’s decisions, would need to give its approval as well.