“The European Commission has granted marketing authorization for Abrysvo*, the bivalent respiratory syncytial virus (RSV) vaccine, to help protect newborns by immunizing the mother and the elderly.” The news was published on the website of the European Commission, being also communicated in a note from the Pfizer company.
The vaccine is indicated for “passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth to six months of age following maternal immunization during pregnancy” and for “active immunization of persons aged 60 for years and more, for the prevention of lower respiratory tract diseases caused by RSV”, reports La Repbblica, quoted by Rador.
“The approval of the Abrysvo vaccine in Europe marks an important advance in the scientific community’s efforts to provide meaningful protection against RSV, a common, potentially serious and life-threatening respiratory virus, particularly in infants and the elderly,” explains 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.
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 licensed vaccine designed and studied specifically for maternal immunization and starting today, a single dose of the vaccine can be administered in the EU between the 24th and 36th week of pregnancy. This vaccine has also been studied in adults 60 years of age and older. The marketing authorization provides for the use of a single dose in this population segment as well.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “This is our first licensed RSV vaccine that protects not only the elderly but also newborns. Looking ahead to the upcoming fall and winter seasons, this vaccine can help prevent the serious consequences of RSV for some of our most vulnerable citizens. An extremely important thing especially for our children, for whom RSV is a leading cause of hospitalization. I hope that member states will start using this first vaccine as part of their national vaccination campaigns as soon as possible”.
Respiratory syncytial virus
RSV is a contagious virus and a common cause of respiratory disease worldwide. The virus can affect the lungs and airways of an infected person, potentially causing serious illness or even 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 in 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 hospitalizations and about 20,000 deaths in people age 60 and older.
“The respiratory syncytial virus epidemic season is near and it would be extremely useful to be able to vaccinate pregnant women in time from the 24th week of pregnancy – commented Alberto Villani, director of the pediatric department at the Bambino Gesù Pediatric Hospital in Rome – No we can say how AIFA will act in this regard, but we hope that everything will be done to be able to use the vaccine from this year.”
Source: The Republic/ Rador/ Translation by Cătălina Păunel
2023-08-28 08:19:21
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