Pfizer Strengthens Case for RSV Vaccine with Positive Data in Vulnerable Adults

Pfizer's RSV Vaccine Approval:
Pfizer's RSV vaccine, Abrysvo, has shown positive top-line results in a late-stage clinical trial involving immunocompromised adults. The vaccine demonstrated strong neutralizing responses and was well-tolerated in this vulnerable population.

Target Population:
The trial focused on adults aged 18 and older who are at higher risk of severe RSV infection due to immunocompromising conditions such as non-small cell lung cancer, end-stage renal disease, autoimmune inflammatory disorders, and solid organ transplant recipients.

Clinical Trial Details:
The study, part of the MONeT trial, evaluated the safety and immunogenicity of two doses of Abrysvo administered one month apart. The results indicated that a single dose of Abrysvo generated robust immune responses against both RSV-A and RSV-B subtypes across all cohorts and age groups.

Regulatory Implications:
Pfizer plans to present these findings at an upcoming scientific conference and publish them in a peer-reviewed journal. The data will also be submitted to regulatory agencies for review, aiming to extend the vaccine's approval to include at-risk adults over the age of 18.

Market Context:
The approval of Abrysvo for individuals aged 60 and older, as well as for use during pregnancy, positions Pfizer to potentially expand its market share in the RSV vaccine market, competing with Moderna and GSK.

Public Health Impact:
The vaccine's efficacy in immunocompromised adults addresses a significant unmet need, as this population faces a higher risk of severe complications from RSV. This development could provide crucial protection for vulnerable individuals.