Abrysvo trial win could extend Pfizer's RSV vaccine to all adults
09 Apr 2024
Clinical ResultVaccineDrug ApprovalPhase 3
Pfizer announced positive top-line results from a Phase III trial testing its respiratory syncytial virus (RSV) vaccine Abrysvo in adults aged 18-59 at increased risk of severe infection, setting the stage for the company to pursue an expanded approval to prevent RSV-associated lower respiratory tract disease.
The MONeT study achieved its primary goals, with Abrysvo demonstrating a non-inferior immune response compared to results observed in older adults, where the jab is already approved, and meeting safety objectives as well. Pfizer plans to submit the data to regulators to request an approval covering all adults 18 and up.
Substudy A of the MONeT trial included 681 participants ages 18 to 59 with chronic conditions who received a single Abrysvo dose or placebo, while substudy B enrolled around 200 immunocompromised adults aged 18 and older who received two doses, one month apart.
There are currently no RSV vaccines authorised for adults under 60 in the US, where Abrysvo carries approvals in the 60-plus population and for maternal immunisation to protect infants up to six months old. An expanded age indication could give Pfizer a head start over rivals in the heated RSV vaccine market.
Abrysvo's rival landscape
Last May, GSK's Arexvy became the first approved RSV vaccine for older adults, gaining a short lead over Pfizer. Sanofi and AstraZeneca's antibody Beyfortus (nirsevimab) followed in July for protection of newborns and very young children.
While Arexvy and Beyfortus covered distinct populations, an Abrysvo approval spanning all adults could position Pfizer's shot as the first with a comprehensive label across high-risk groups. According to Pfizer, nearly 10% of US adults aged 18-49 have chronic conditions that increase their risk for severe RSV; the rate rises to around 24% for those in the 50-64 age bracket.
"This represents a real opportunity for an expansion to an age population in a risk population that wouldn't normally see the availability of this vaccine so soon," said Iona Munjal, executive director of clinical vaccine R&D at Pfizer.
However, GSK's Arexvy is so far easily the dominant player in the RSV market, despite having been approved within weeks of Pfizer's vaccine. The UK pharma reported £1.2 billion ($1.5 billion) in 2023 revenue for Arexvy, compared to $890 million for Abrysvo (see – Vital Signs: RSV and pharma’s fastest drug launches).
GSK is looking to broaden the age range for its vaccine and has already submitted data for adults ages 50 to 59 to the FDA, where a decision is due by June 7, potentially allowing the company to offer its shot in the younger age group later this year. Pfizer did not say whether it expects to be able to expand Abrysvo's label in time for the 2024-2025 respiratory virus season.
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