The registration authorization for the Abrysvo vaccine, from the company Pfizer, was published this Monday (01) (link to DOU). The vaccine is intended to combat respiratory syncytial virus (RSV), which causes respiratory tract infections, particularly bronchiolitis.
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Bronchiolitis is an inflammation of the bronchi that affects young children and babies with great concern. The Abrysvo vaccine is indicated for the prevention of lower respiratory tract disease and severe lower respiratory tract disease in children from birth to 6 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.
Its use was also authorized to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older, a population also considered at risk.
About the vaccine
The Abrysvo vaccine is called bivalent, as it is composed of two antigens from the RSV F surface protein. Its administration is intramuscular and the dosage schedule involves the application of a single dose. The vaccine should be administered to pregnant women 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.
Even so, the totality of evidence presented to Anvisa was able to demonstrate that the benefits of the vaccine are greater than its risks. Its effectiveness, safety and quality were also proven under the terms of Resolution RDC No. 55/2010, which deals with the registration of biological products.
The analysis of the immunizing agent was prioritized in accordance with item II of Article 3 of Resolution RDC No. 204/2017, as it is a new medicine intended for the pediatric population.
The Agency had already authorized the registration of the Arexvy vaccine (GlaxoSmith Kline), also intended for the prevention of diseases caused by RSV, but with indications restricted to the population over 60 years of age.
Source: Anvisa
