Invion: Revolutionizing Photodynamic Therapy (PDT) for Cancer, Infectious

• Active immunization of individuals 18 years of age and older for the prevention of LRTD caused by RSV
• Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy

“We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.”

The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving ABRYSVO in this age group. ^1,2,3,4 The results of MONeT and other studies have been published in peer-reviewed journals.

ABOUT RSV
Respiratory Syncytial Virus (RSV) is a contagious virus and a common cause of respiratory illness worldwide. ⁵ The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. ^6,7,8 There are two major subgroups of RSV: RSV-A and RSV-B. ⁹ Both subgroups cause disease and can co-circulate or alternate predominance from season to season. In total, RSV causes approximately 158,000 hospital admissions annually among adults aged 18 and older across the EU, with an estimated 13,000 hospitalizations in those aged 18 to 64 years. ¹⁰

ABOUT ABRYSVO
ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer‘s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies.

In August 2023, Pfizer  announced that the European Commission granted marketing authorization for ABRYSVO for…