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EU Approves Bivalent Pfizer Respiratory Syncytial Virus Vaccine

EU Approves Bivalent Pfizer Respiratory Syncytial Virus Vaccine

It is indicated for infants through maternal immunization and the elderly.

The European Commission has granted marketing authorization for Abrysvo*, the bivalent vaccine against respiratory syncytial virus (RSV), to help protect infants through maternal immunization and the elderly,” notes a statement from Pfizer.

The vaccine

The vaccine is indicated for “passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth up to six months of age following maternal immunization during pregnancy” and for “active immunization of individuals aged 60 years and older for the prevention of lower respiratory tract disease caused by RSV.”

“The approval of Abrysvo in Europe marks a significant advancement in the scientific community’s efforts to provide meaningful protection against RSV, a common respiratory virus that can be potentially severe and even life-threatening, especially for infants and the elderly,” said Annaliesa Anderson, Senior Vice President and Head of Vaccine Research and Development at Pfizer.

“The significant number of infants, children, and adults hospitalized in Europe last year demonstrated the need for protection against severe cases of RSV. Approval of the vaccine for both the elderly and infants through maternal immunization is a triumph for public health, and we hope it will have a significant impact in the coming seasons.”

Abrysvo – Authorized Vaccine

The 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, as well as Iceland, Liechtenstein, and Norway. Abrysvo is the first authorized vaccine designed and studied specifically for maternal immunization, and now a single dose of the vaccine can be administered in the EU between the 24th and 36th week of gestation.

This vaccine has also been studied in adults aged 60 and older. The marketing authorization allows for the use of a single dose in this population as well.

RSV Virus

RSV is a contagious virus and a common cause of respiratory illnesses worldwide. The virus can affect the lungs and airways of an infected individual, potentially causing severe illness or death. In Europe, approximately 245,000 annual hospitalizations have been associated with RSV in children under five years of age, with the majority of cases occurring in children under one year.

The impact of the disease in the elderly is also significant. Each year, the virus causes more than 270,000 hospitalizations and about 20,000 deaths in individuals aged 60 and older


Original source: This information was Initially covered by Adnkronos and has been translated for our readers.

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