Anvisa authorizes registration of vaccine that prevents bronchiolitis in babies

The National Health Surveillance Agency (Anvisa) authorized the registration of the Abrysvo vaccine, from the pharmaceutical company Pfizer. The dose combats the respiratory syncytial virus (RSV), which causes respiratory tract infections, such as bronchiolitis. The resolution was published this Monday (1st) in Official Diary of the Union.

In a note, Anvisa highlighted that bronchiolitis is an inflammation of the bronchi that affects young children and babies with great concern. The vaccine is indicated for the prevention of lower respiratory tract disease in children from birth to six months of age through active immunization in pregnant women.

“This means that, to protect children, the vaccine must be administered to mothers during pregnancy. The vaccine is not administered directly to babies”, reinforced the agency. The dose was also authorized for the prevention of lower respiratory tract disease in people aged 60 and over, a population also considered at risk for the disease.

The vaccine

The Abrysvo vaccine is described as bivalent, as it is composed of two antigens from the RSV F surface protein. Administration is intramuscular and in a single dose. According to Anvisa, the vaccine must be applied during the second or third trimester of pregnancy.

“Like all medications, some side effects were observed when administering the vaccine, the most common of which were: pain at the vaccination site, headache and muscle pain,” highlighted the agency. “Still, the totality of evidence presented to Anvisa was able to demonstrate that the benefits of the vaccine are greater than its risks.”

Anvisa had already authorized the registration of the Arexvy vaccine, from the pharmaceutical company GlaxoSmith Kline, also intended for the prevention of diseases caused by RSV, however, with indications restricted to the population over the age of 60.