Pfizer Inc. (NYSE: PFE) unveiled significant news regarding its bivalent RSV vaccine, ABRYSVO®, following an amended marketing authorization from the European Commission. This new indication now permits the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years, broadening the existing authorization that previously applied only to those aged 60 and older.

What This Means for Public Health

The revised marketing authorization addresses two critical components:

• Active Immunization:
  Individuals aged 18 and older can now benefit from ABRYSVO’s protection against LRTD caused by RSV, which leads to about 158,000 admissions annually for adults in the EU.
• Passive Protection:
  This vaccine also provides protection against RSV-LRTD for infants up to six months of age following maternal immunization between weeks 24 and 36 of pregnancy.

According to Alexandre de Germay, Chief International Commercial Officer at Pfizer, “We are delighted that ABRYSVO is approved in the EU for adults aged 18 and older. Additionally, with an indication for pregnant individuals to protect infants, this expanded authorization marks a major step for public health.” The revisions arise from positive phase 3 MONeT trial results (NCT05842967), which evaluated the vaccine’s safety and efficacy in at-risk adults.

Combatting RSV’s Burden

Respiratory Syncytial Virus (RSV) presents a serious health threat, resulting in severe respiratory conditions. Both RSV-A and RSV-B strains contribute significantly to health burdens, accounting for nearly 158,000 adult hospital admissions in the EU annually. The comprehensive coverage provided by ABRYSVO against both strains positions it as a pivotal weapon against this prevalent virus.

The Road Ahead for Pfizer

Pfizer’s updated approval for ABRYSVO not only widens the protective horizons within the EU but also illustrates its commitment to addressing public health concerns surrounding RSV. This move is poised to considerably lessen disease impacts in the upcoming seasons, safeguarding a broader population segment from RSV-related complications.