The US pharmaceutical industry Pfizer applied to the Brazilian counterpart of the national drug agency, ANVISA, on Friday to approve the use of its COVID-19 vaccine in children between the ages of 5 and 11, the independent authority in Brasilia announced.
ANVISA “received Pfizer’s request to include the age group of 5 to 11 years in Comirnaty vaccine indications,” the authority said in a press release.
The request states that the dose of the vaccine “will be adjusted” and will be “less than that used for persons 12 years and older”, while it will be distributed in different vials.
For her part, Pfizer said in a note that based on her “preliminary analysis”, the “two doses of 10 micrograms of the vaccine” regimen has been shown to be “safe and able to generate increased levels of antibodies” in this age group.
The Brazilian regulator now has 30 days to consider the request. The use of this vaccine in the age group between 5 and 11 years has already been approved in the US since November 2.
Pfizer’s request was filed after ANVISA recently revealed that several of its executives are receiving death threats if COVID-19 vaccines are approved for children aged 5-11.
Brazilian police say they have launched an investigation.
The Pfizer vaccine for adolescents 12-15 years of age was approved on June 11. It was approved in February for citizens over 16.
With nearly 610,500 deaths, Brazil, with a population of 213 million, is the country with the second-highest death toll from the new coronavirus pandemic in the world, behind only the United States. However, as more than 58 percent of vaccinated Brazilians now die, the average number of deaths due to complications of the disease on a daily basis has dropped significantly from the nearly 3,000 recorded when the pandemic peaked in April.
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