Anvisa (National Health Surveillance Agency) authorized the inclusion in the package insert of a booster dose of the Pfizer vaccine against Covid-19 for children and adolescents.
The authorization was included in the leaflet only for those over 18 years old. However, the Ministry of Health already recommended the application for adolescents aged 12 years or older.
According to the regulatory agency, clinical data sent by the company were evaluated. The conclusion was that the benefits of the change outweigh the risks of applying a booster dose in this age group.
“Vaccines against Covid-19 have generally shown a decline in antibodies over time, justifying the periodic assessment of the need to apply booster doses, with the aim of maintaining adequate levels of antibodies capable of neutralizing the virus. cause of the disease”, said Anvisa, in a note.
The use of the vaccine in Brazil has been authorized since February 23, 2021, with indication for immunization of a wide age range, starting from six months of age.
Anvisa’s collegiate board also approved last month the emergency use of two bivalent vaccines against Covid-19 produced by Pfizer.
The bivalent vaccine offers immunization against more than one strain of the coronavirus. The first version presented by the manufacturer was designed with the original strain of Sars-CoV-2 and omicron BA.1, which quickly spread throughout the world.
There was also the approval of a new version of the vaccine that has the original strain of the virus and has subvariants BA.4 and BA.5.
The CTAI (Technical Advisory Chamber on Immunizations) recommended to the Ministry of Health last Wednesday (30) that the bivalent vaccines against Covid-19 be used as a booster dose only in higher risk groups, such as the elderly, immunosuppressed and pregnant women.
For other audiences, such as young people without comorbidities, there is a lack of evidence on the advantages that a new booster would bring in avoiding the severity of the disease.
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