Moderna’s mResvia is now the third FDA-approved RSV vaccine and the first one based on mRNA technology. It will compete for market share against RSV shots from GSK and Pfizer that won their FDA nods last year.
AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax's pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults.
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GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.
AstraZeneca and Sanofi drug Beyfortus is now FDA approved for preventing respiratory problems from RSV infection in infants and toddlers. Antibody engineering enables the drug to last longer in the body, providing protective effects for potentially the entire RSV season.
An FDA advisory committee voted in favor of supporting a respiratory syncytial virus therapy designed to protect newborns and infants. The antibody drug developed by partners Sanofi and AstraZeneca is currently under regulatory review.
Pfizer’s Abrysvo is now approved for preventing illness caused by respiratory syncytial virus, or RSV, in adults 60 and older. The regulatory decision comes weeks after GSK won approval for its RSV vaccine, Arexvy.
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The antibody drug, nirsevimab, is designed with a long half-life intended to protect infants from respiratory syncytial virus infection through the entire season. The drug, co-developed by AstraZeneca and Sanofi, is under FDA review.
FDA approval of GSK’s respiratory syncytial vaccine Arexvy covers adults age 60 and older—an age group at particular risk of developing severe complications from infection. GSK plans to launch Arexvy in time for the 2023/2024 RSV season.
The FDA will decide this summer which strains the next Covid-19 vaccines should address. But companies are also taking a longer view, developing shots for the future that offer different features than the current ones and potentially broader protection against a wider range of pathogens.
Johnson & Johnson’s pullback from RSV research thins the pack of companies aiming to develop a vaccine for the pathogen. GSK and Pfizer have vaccines under FDA review and a shot from Moderna could soon follow.
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AstraZeneca already has a respiratory syncytial virus antibody drug on the market for premature babies. But the approval of Beyfortus, which was developed with Sanofi, covers all infants broadly and it protects during the entire RSV season with just a single shot.
Pfizer’s respiratory syncytial virus vaccine candidate infants has clinical data showing it helped prevent severe infections in infants. It’s a maternal vaccine that produces antibodies in the mother that confer temporary protection to a baby.
Respiratory syncytial virus has no approved vaccines anywhere in the world, but the chase to bring the first one to the market is heating up. GSK reported Phase 3 data that position it for regulatory submissions the pharma giant is planning for later this year. Pfizer is also on track to seek regulatory approvals for its RSV vaccine candidate.
An antiviral that Enanta Pharmaceuticals is developing for respiratory syncytial virus infection failed to beat a placebo in its first Phase 2 test. But the biotech notes that these study participants weren’t very sick and may have recovered on their own, so it’s now pinning its hopes on ongoing studies in higher-risk groups, such as transplant patients.
Pfizer is already in the mix of companies pursuing vaccines for respiratory syncytial virus. The pharma giant is now broadening its scope with a deal to acquire ReViral Therapeutics, a biotech with two clinical-stage antivirals, each taking a different approach to stopping the potentially deadly pathogen.