Anvisa (National Health Surveillance Agency) again suspended this Tuesday (11) the deadline for analysis of the Butantan Institute’s request for vaccination of the public from 3 to 17 years old with Coronavac.
In a statement, the agency said it asked for “additional clarification” about a study conducted by the Chilean government on the vaccination of young people with this immunizer, as well as adjustments to the risk management plan for the application of doses.
Anvisa and Butantan scheduled a meeting for the morning of Thursday (13) to discuss the required data, in addition to “possible commitments, in case of authorization to use the vaccine”, said the agency.
Representatives of medical societies will also participate in the meeting with the laboratory linked to the government of São Paulo.
The regulatory body still collects data from a global study conducted in China, South Africa, Chile, Malaysia and the Philippines on vaccine use. In November, the Chinese laboratory Sinovac announced that preliminary data from this phase 3 trial point to safety in vaccinating the 3-17 age group.
On December 15, Butantan forwarded to Anvisa the documentation on the vaccination request for children and adolescents. On the 22nd, the agency made the first technical requirement, blocking the period of 30 days for analysis.
Sought, Anvisa reported that 16 of the 30 days of analysis period on the application of Coronavac in children and adolescents have already been used. In other words, the agency will still have 14 days to evaluate Butantan’s claim when the count is resumed.
In August, Anvisa’s board of directors denied a request for the use of Coronavac in the 3-17 age group on the grounds of lack of data.
Agency members say that the process is now more solid, but they are still awaiting data mainly from Chile and the global study. The Andean country has already immunized 1.4 million people between the ages of 3 and 17.
The same agency officials say there are several options under consideration, such as granting a use authorization because they consider that existing data show the vaccine’s safety, but requiring the submission of consolidated studies later.
Only the Pfizer Covid vaccine can be applied to minors, from 5 years old.
The Ministry of Health evaluates using Coronavac in children, if there is approval from Anvisa. As the vaccine is of the same model applied to adults, states are already planning to allocate stocked doses to the younger public.
The advantage of Coronavac is the availability of doses, due to the fact that the immunizer has stopped being used by the federal government.
The vaccination of children and adolescents is a sensitive topic in the Jair Bolsonaro (PL) government, as the president distorts data and discourages the immunization of young people.
The president is still a vector of misinformation about Coronavac, a vaccine promoted in Brazil by São Paulo governor João Doria (PSDB), a political enemy and potential adversary of the president in the dispute for the Plateau this year.
The government of São Paulo estimates that it has the capacity to vaccinate all children aged 3 to 11 in the state against Covid-19 in about ten days.
Bolsonaro even threatened to expose the names of Anvisa servers who approved the use of Pfizer vaccines in children. In response, the agency’s president, Barra Torres, told leaf that the statements of the Chief Executive stimulated threatening crimes against the regulatory body.
In a note released on the 8th, Barra Torres also refuted insinuations of Anvisa’s alleged hidden interests in vaccinating children, and demanded the president’s retraction.
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