2023-08-25 09:40:57
“The European Commission has granted marketing authorization for Abrysvo*, the bivalent respiratory syncytial virus (RSV) vaccine, to help protect newborns through maternal immunization and the elderly.” This was underlined by a note from the Pfizer company. The vaccine is indicated for “passive protection against RSV-induced lower respiratory tract disease (LRTD) in neonates from birth to six months of age following maternal immunization during pregnancy” and for “active immunization of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV”.
“Abrysvo’s approval in Europe marks an important advance in the scientific community’s efforts to provide meaningful protection against RSV, a common, potentially serious and even life-threatening respiratory virus, especially for infants and the elderly,” he said. said Annaliesa Anderson, senior vice president and head 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. the elderly that for newborns through maternal immunization is a triumph for public health and we hope it will have a major impact in the coming seasons”.
The marketing authorization follows the recent positive opinion of the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein and Norway. Abrysvo is the first authorized vaccine designed and studied specifically for maternal immunization and from today 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 60 years of age and older. The marketing authorization foresees the use of a single dose also in this population.
RSV is a contagious virus and a common cause of respiratory disease worldwide. The virus can affect the lungs and airways of an infected individual, potentially causing serious illness or death. In Europe, approximately 245,000 annual hospital admissions have been associated with RSV in children under the age of five, with the majority of cases occurring among children under the age of one. The impact of the disease is also significant in the elderly. Each year, the virus causes more than 270,000 hospital admissions and about 20,000 deaths in people aged 60 and over.
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