Pfizer’s ABRYSVO Receives Expanded EU Authorization for RSV Prevention

Pfizer Inc. (NYSE:PFE) announced a major update for its bivalent RSV vaccine, ABRYSVO®, as the European Commission has amended its marketing authorization. The new indication now includes the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years. This builds on the previous authorization, which was limited to individuals aged 60 and older, making ABRYSVO the broadest RSV vaccine available in the EU.

Expanded Indication and Public Health Impact

The updated marketing authorization covers two critical areas:

• Active Immunization:
  For individuals 18 years of age and older, ABRYSVO now offers protection against LRTD caused by RSV—a virus responsible for approximately 158,000 adult hospital admissions annually in the EU.

• Passive Protection:
  Following maternal immunization during pregnancy (between weeks 24 and 36), the vaccine also offers protection against RSV-LRTD in infants from birth up to 6 months of age.

Alexandre de Germay, Chief International Commercial Officer and Executive Vice President at Pfizer, stated,

“We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older... With an indication that also includes pregnant individuals to help protect infants, this expanded authorization signifies another step for public health.”

This development is a direct outcome of positive clinical results from the pivotal phase 3 MONeT trial (NCT05842967), which evaluated the vaccine's safety, tolerability, and immunogenicity in adults at risk of RSV-associated LRTD due to chronic conditions. These promising results, supported by data from thousands of vaccinated individuals, have been published in peer-reviewed journals.

Significance in the Fight Against RSV

Respiratory Syncytial Virus (RSV) is a highly contagious virus that affects the respiratory system, potentially leading to severe illness or death. Both RSV-A and RSV-B subgroups contribute to this significant public health burden, causing nearly 158,000 hospital admissions among adults in the EU annually. The broad protection offered by ABRYSVO against both subgroups underscores its importance in combating this common yet potentially life-threatening virus.

Looking Ahead

Pfizer's expanded authorization for ABRYSVO not only enhances the scope of protection available in the EU but also demonstrates the company's commitment to addressing the public health challenges posed by RSV. This milestone is expected to substantially reduce the disease burden in future seasons by protecting a wider segment of the population.

For those interested in further details on Pfizer's strategic developments and financial performance, additional insights can be explored through the Full Financials endpoint.