Pfizer has applied to the Brazilian counterpart of the national drug agency, ANVISA, for approval to use its vaccine against coronavirus to children between the ages of 5 and 11, the independent authority in Brasilia announced.
ANVISA “received its request Pfizer to include the age group of 5 to 11 years in the indications of the Comirnaty vaccine “, it is clarified in a press release of the authority.
The request states that the dose of the vaccine “will be adjusted” and it will be “Less than that used for persons 12 years of age and older”, while it will be distributed in different vials.
For its part, Pfizer said in a note that based on its “preliminary analysis”, the “two doses of 10 micrograms of the vaccine” regimen has been shown to be “safe and capable of producing elevated levels of antibodies” in this age group.
The Brazilian regulator has 30 days at his disposal 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 how several executives are threatened with death in case of approval of vaccines against COVID-19 for children 5-11 years old.
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 almost 610,500 deaths, the Brazil With a population of 213 million, it is the country with the second highest number of victims of the new coronavirus pandemic in the world, behind only the USA. 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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