Pfizer presented this Tuesday (9) data to Anvisa (National Health Surveillance Agency) required to evaluate the use of Covid vaccines in children aged 5 to 11 years.
According to the agency, the laboratory must formalize “soon” the request for approval for the application of doses in this group.
There is still no authorization in Brazil for the use of vaccines for Covid-19 in children. Only the Pfizer model can be applied to the 12 to 18 age group.
“According to the laboratory, the vaccine dose for children aged 5 to 11 years will be adjusted and will be lower than the dose for children over 12 years old due to a new formulation developed by the company”, informed Anvisa about the meeting held with to Pfizer of “pre-submission” of the application for the use of the vaccine in the youngest.
“Pfizer has indicated that the application will be submitted shortly, but the exact date depends on the laboratory,” the regulatory agency said. Anvisa expects the order to be made in November.
Anvisa will have up to 30 days to analyze the use of Pfizer’s vaccine in children, a period counted from the formal request by Pfizer. This period can be extended if the agency requires more data from the pharmacist.
The United States authorized on the last day 2 the use of the Pfizer vaccine in people aged between 5 and 11 years.
The Ministry of Health plans to vaccinate children in 2022, if Anvisa approves the use of the vaccine in this group. The forecast is that 70 million doses would be applied to younger people.
As Pfizer’s vaccine has definitive registration in Brazil, Anvisa’s decision on releasing the use of the vaccine for children is only published in the Official Gazette of the Union. , the directors vote on requests of this type in a collegiate meeting.
President Jair Bolsonaro (non-party) distorts data on the efficacy and safety of vaccines and campaigns against vaccinating younger people. The Minister of Health, Marcelo Queiroga, even proposed preventing the immunization of teenagers, but withdrew after strong negative repercussions.
The directors of Anvisa received death threats from people against the vaccination of children. The agency asked for police protection from officials and civil servants.
The Butantan Institute also states that it will file a new application with Anvisa for the approval of the use of Coronavac in children and adolescents between 3 and 17 years old. In August, the agency rejected the first request from the São Paulo laboratory.
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