Pfizer received the authorisation for the vaccine based on data from two Phase III clinical trials. Credit: Karolis Kavolelis / Shutterstock.com.

The European Commission (EC) has granted marketing authorisation for Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, Abrysvo, for use in pregnant women and older adults. 

The single-dose vaccine is indicated for maternal inoculation between 24 and 36 weeks of gestation to offer passive protection against RSV-caused lower respiratory tract disease (LRTD) in infants from birth to six months of age. 

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In people aged 60 years and above, the vaccine is indicated for active inoculation to prevent LRTD.

This marketing authorisation is valid in all 27 member states of the European Union, as well as in Norway, Iceland, and Liechtenstein. 

The development comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion and recommended granting authorisation for the vaccine.

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The approval is based on data from two Phase III clinical trials, RENOIR and MATISSE.

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Pfizer Vaccine research and development senior vice-president and head Annaliesa Anderson said: “The approval of Abrysvo in Europe marks significant progress in the scientific community’s efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults. 

“The approval of the vaccine for both older adults and infants through maternal immunisation is a triumph for public health and we hope to see a tremendous impact for future seasons.”

The company received approval from the US Food and Drug Administration (FDA) for the vaccine for pregnant women to offer protection to their babies.