Pfizer’s RSV Vaccine Gets FDA Approval for Use in Older Adults

by Ting Chu
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Pfizer announced today that their vaccine, Abrysvo, has been granted approval by the Food and Drug Administration (FDA), allowing it to be used as a preventive measure against respiratory syncytial virus (RSV) in individuals 60 years and older. 

The committee supported the safety and efficacy of Pfizer’s vaccine through two separate votes, both resulting in a 7-4 majority in favor. This recent approval brings a new level of competitiveness to the market, as RSV shots have been absent for several decades. 

Notably, it is the second authorized RSV vaccine for older adults in the United States this month, following GlaxoSmithKline’s (GSK) successful approval of its competing vaccine, Arexvy. Additionally, Pfizer’s maternal RSV vaccine, designed to protect infants against RSV by administering it to pregnant individuals, is currently being evaluated by the FDA. Furthermore, Sanofi and AstraZeneca’s monoclonal antibody treatment is currently under review. 

However, before any of these vaccines or treatments can be made accessible to the general public, they must receive approval from the Centers for Disease Control and Prevention (CDC). The CDC’s independent advisory panel is scheduled to convene twice next month to provide their recommendations regarding Pfizer’s and GSK’s products.

Related Article: GSK Wins Approval For World’s First RSV Vaccine

The Contribution of Phase 3 RENOIR Trial

The FDA’s decision to approve the vaccine is founded on the comprehensive analysis of data obtained from the pivotal Phase 3 clinical trial (NCT05035212), known as RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease). 

RENOIR is a global study that employed a randomized, double-blind, placebo-controlled design to evaluate the efficacy, immunogenicity, and safety of a single dose of the vaccine in individuals aged 60 years and above. The study enrolled a substantial cohort of approximately 37,000 participants who were randomly assigned in a 1:1 ratio to receive either RSVpreF 120 μg or placebo. 

The noteworthy results of this trial have recently been published in The New England Journal of Medicine, highlighting its significance. RENOIR, the ongoing study, aims to collect efficacy data throughout the second RSV season within its framework.

An Insight into the Regulatory Review Process of Abrysvo

Pfizer made an announcement on March 24, 2022, regarding the Breakthrough Therapy Designation granted by the FDA for Abrysvo, specifically for the prevention of lower respiratory tract disease caused by RSV in individuals aged 60 years and older. Following that, in November 2022, the FDA granted acceptance to Abrysvo’s Biologics License Application (BLA) for priority review, specifically emphasizing its utilization in the older adult population.

In February 2023, The European Medicines Agency (EMA) accepted Pfizer’s Marketing Authorization Application (MAA) for RSVpreF, initiating a thorough review under the accelerated assessment framework. During the same month, Pfizer Japan pursued the approval process by submitting an application to the Ministry of Health, Labor and Welfare for RSVpreF. The application specifically focuses on utilizing RSVpreF as a maternal immunization method to protect infants against RSV.

In April 2023, Pfizer Canada disclosed that Health Canada has initiated the review of RSVpreF, taking into account its suitability for individuals aged 60 and older, along with its potential as a maternal immunization strategy for safeguarding infants against RSV.

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