The vaccine produced by the Butantan Institute against , now suspended by , did not receive approval from Conitec (National Commission for the Incorporation of Technologies into the Unified System of ), a technical body that carries out prior analysis of immunizers.
The measure was criticized by the CFM (Federal Council of ) and by , former Minister of Health under Jair Bolsonaro.
Queiroga, pre-candidate for the Senate for the PL in Paraíba, says that the current management failed to comply with the law by not submitting the immunizer for technical analysis. The vaccine had already been approved by Anvisa, but it is Conitec who decides whether it should be applied in Brazil.
accuracy, effectiveness and safety, in addition to the economic evaluation of cost-benefit and the budgetary impact on the Unified Health System.
At the beginning of the month, after two suspicious deaths were recorded. The deaths are still under investigation.
Queiroga says he does not question the effectiveness of the immunizer, but says that it is necessary to comply with the procedural rite.
The Ministry of Health, in turn, states that Conitec does not evaluate brand or manufacturer, but the technology used. In this specific case, he claims that Qdenga had already undergone the agency’s analysis.
“It is this principle that guarantees the expansion of supply when new products using the same technology arrive on the national market. A practice that was even repeated under the previous government,” he said in a statement.
But Queiroga uses other examples to question the argument. He says that the ACWY meningococcal vaccine had already been approved by the committee, when there was an interest in expanding the target audience.
“This is an old wives’ tale. I don’t question the technicality of the vaccine, but it is necessary to have technical support, especially when there is not a public health emergency,” the former minister told the Panel.
Queiroga intends to represent against the minister of health, in the Federal Court of Auditors, alleging administrative improbity for the purchase of the immunizer without analysis by Conitec.
The Federal Council of Medicine also warned of the lack of analysis and defended the specific evaluation of each product, as different vaccines may have different safety and effectiveness profiles.
“Conitec plays an important role related to the incorporation and implementation of technologies within the scope of the SUS, when considering aspects such as effectiveness, budgetary impact, cost-effectiveness and large-scale use strategy, requiring specific evaluation of each product, since different vaccines may have different safety, immunogenicity and effectiveness profiles”, he said in a note.
Qdenga, for example, is applied in two doses. The one produced by Butantan is just one dose.
The director of the Butantan Institute, Esper Kallás, counters. To the Panel, he said that Conitec’s role is mainly to analyze the cost-benefit of the vaccine and that the national one is much cheaper than the Japanese one already incorporated.
“There was no risk to the safety of the immunizer. We have a very robust safety profile from clinical studies that it could be incorporated into the SUS, like Qdenga, and so it was done,” he stated.
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