NEW YORK – Pfizer Inc. (NYSE: NYSE:) has released positive results from a pivotal Phase 3 clinical trial evaluating ABRYSVO, a vaccine candidate for respiratory syncytial virus (RSV), in adults aged 18 to 59 who are at increased risk of severe illness. The trial met its primary immunogenicity and safety endpoints, indicating the vaccine’s potential for broader use.
The study, known as MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), was designed to assess the immunogenicity and safety of a single dose of ABRYSVO compared to a placebo.
The vaccine elicited immune responses against RSV-A and RSV-B subgroups that were non-inferior to those observed in a previous study of older adults, where ABRYSVO’s efficacy had already been demonstrated. Participants also showed at least a four-fold increase in serum neutralizing titers for both RSV subgroups a month after vaccination.
According to Pfizer, the vaccine was well-tolerated, with safety findings consistent with previous research. The company also noted that its recruitment for the study reflected the diversity of the U.S. population, including balanced representation across various medical conditions.
Currently, no RSV vaccines are approved for adults aged 18 to 59, despite a significant portion of this demographic being at risk due to chronic conditions such as asthma, diabetes, and chronic obstructive pulmonary disease. Pfizer intends to submit the data from the MONeT study to regulatory agencies with the aim of expanding the approved age range for ABRYSVO.
Pfizer’s Senior Vice President and Head of Vaccine Research and Development, Annaliesa Anderson, Ph.D., expressed optimism about the potential impact of ABRYSVO, stating that it could become the first and only RSV vaccine for adults 18 years and older, pending regulatory approval.
ABRYSVO is already approved for use in individuals 60 years of age or older and for maternal immunization to protect infants up to six months old. The vaccine has received approvals in various regions, including the European Union, Argentina, the United Kingdom, Canada, Macau, Japan, and Australia.
The information provided is based on a press release statement from Pfizer.
InvestingPro Insights
As Pfizer Inc. (NYSE: PFE) advances its ABRYSVO vaccine, the company’s financial metrics and market performance provide a broader context for potential investors. According to recent data from InvestingPro, Pfizer’s market capitalization stands at a robust $150.51 billion, reflecting the company’s significant presence in the pharmaceutical industry.
InvestingPro Tips highlight Pfizer’s commitment to shareholder returns, with the company having raised its dividend for 13 consecutive years and maintaining dividend payments for an impressive 54 years.
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