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Brasilia (AFP) – The pharmaceutical company Pfizer requested this Friday to the National Sanitary Surveillance Agency (Anvisa) of Brazil to authorize the use of its anti-coronavirus vaccine for infants between 5 and 11 years old, the Brazilian institution reported.
Anvisa “received a request from Pfizer to include the age group from 5 to 11 years in the indication of its Comirnaty vaccine,” it said in a statement.
Pfizer’s order indicates that the dosage of the vaccine “will be adjusted and lower than that used for those over 12 years of age” and will be distributed in different packages, Anvisa said.
Pfizer, for its part, indicated in a note that, according to a “preliminary analysis”, “a regimen of two doses of 10 micrograms of the vaccine was shown to be safe and capable of generating a high level of antibodies” in this age group.
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Anvisa has a period of 30 days to analyze the request from Pfizer, whose vaccine has been applied to children between 5 and 11 years old in the United States since November 2, after the approval of health regulators.
The agency will focus especially on “data on safety and adverse events” and dose adjustment, among other elements that it will analyze to grant authorization, the Brazilian regulator explained.
European authorities are analyzing requests from Pfizer and Moderna to be able to administer their vaccines to children.
In Brazil, the Pfizer immunizer was authorized for young people between the ages of 12 and 15 on June 11, but it has been registered in Brazil since February 23, when its use was allowed in those over 16 years of age.
With 213 million inhabitants, Brazil registers more than 610,000 deaths from the coronavirus, a number surpassed only by the United States, and at least 58.1% of the population received the complete scheme of the vaccine.
Pfizer’s request was formalized after Anvisa denounced to various authorities, including the Federal Police and the Attorney General’s Office, that its directors and several officials received death threats by email due to the possibility that the entity authorizes anticovid vaccines for children from 5 to 11 years.
The police announced an investigation into the case.
© 2021 AFP
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