BELGIUM —Pfizer has secured a pivotal marketing authorization from the European Union for its groundbreaking respiratory syncytial virus (RSV) vaccine, Abrysvo (RSVpreF).
This milestone heralds a crucial step forward in safeguarding both vulnerable infants and older adults against the severe impacts of RSV infections.
The distressing surge of hospitalizations among newborns, children, and adults throughout Europe in the preceding year has underscored the compelling need for potent defense against the specter of severe RSV cases. Pfizer’s Head of Vaccine Research and Development, Annaliesa Anderson, heralds this EU approval as “a triumph for public health.”
At the heart of this advancement lies Abrysvo, Pfizer’s innovative RSV vaccine. It serves a dual purpose: shielding infants through maternal immunization and fortifying older adults against RSV’s menacing grasp.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recently issued a favorable opinion, paving the way for the EU’s decision.
Tackling RSV’s dual threat
RSV, often triggering cold-like symptoms, transforms into a potent adversary, causing pneumonia in toddlers and posing significant threats to the elderly, resulting in numerous hospitalizations and fatalities annually.
The EU’s endorsement finds its foundation in comprehensive Phase III trials. The ongoing RENOIR study showcases Abrysvo’s efficacy, registering at 66.7% against RSV-associated lower respiratory tract disease in older adults, alongside an impressive 85.7% potency against severe RSV illness.
The MATISSE trial resonates with promising results, spotlighting Abrysvo’s ability to thwart RSV’s assault.
The vaccine demonstrates a remarkable 81.8% efficacy in preventing medically attended lower respiratory tract illnesses in infants, while also marking a 69.4% success rate against severe infantile cases necessitating hospitalization or respiratory support.
Just days before the EU’s decisive move, the U.S. Food and Drug Administration (FDA) granted approval for Abrysvo’s use during pregnancy to shield newborns and infants.
The vaccine’s trajectory is steadfast, having received clearance for safeguarding adults aged 60 and above in the United States earlier in May.
Pfizer alongside GSK have already established their footprints in the United States, earning approvals for RSV protection among older adults.
As the frontrunners in a burgeoning market estimated to exceed US$10 billion by 2030, their combined efforts fortify the global defense against RSV’s relentless encroachments.
Countering RSV’s toll
Within the European Union, approximately 245,000 yearly hospital admissions are attributed to RSV in children below five years old, while the virus claims around 20,000 lives annually among the elderly.
The European Commission in June approved British drugmaker GSK’s vaccine Arexvy to protect older adults.
Sanofi and partner AstraZeneca’s long-acting therapy against RSV infections was approved last year by the European Commission for use in infants.
These approvals emerge as a beacon of hope, striking at the core of these alarming statistics, and ushering in a future fortified against RSV’s shadow.
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