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Pfizer’s RSV vaccine gets FDA nod for adults with increased risk of disease

Pfizer’s RSV vaccine gets FDA nod for adults with increased risk of disease


The US Food and Drug Administration (FDA) has approved Pfizer’s Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo) for use in persons aged 18-59 years who are at an enhanced risk of developing lower respiratory tract disease (LRTD) due to RSV.

ABRYSVO is a bivalent, unadjuvanted vaccine that was developed to offer widespread defense against LRTD caused by the highly contagious virus.

The vaccine is targeted for use in patients with underlying conditions including obesity, chronic lung disease, compromised immunity, and chronic cardiovascular disease that are predisposed to developing severe RSV-associated lower respiratory tract disease.

This latest approval positions Pfizer as the biopharmaceutical company with the “broadest” RSV vaccine coverage for adults.


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Previously, the company had secured authorization for the vaccine to be used in patients aged 60 years and above; now the jab can be used in adults with a heightened predisposition to severe RSV disease.

“RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” stated Aamir Malik, Executive Vice President, Pfizer.

Abrysvo can be used in newborns up to six months of age through maternal immunization of mothers between weeks 32 and 36 of pregnancy.

FDA’s decision in making this latest Abrysvo approval is based on positive efficacy data from a phase III clinical trial data coded MONeT whose results will be published and presented in an upcoming scientific conference.


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APR Team

African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.