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SÃO PAULO – A National Health Surveillance Agency (Anvisa) can relax the criteria for approval of a vaccine against COVID-19 and release an immunizer with 50% minimum efficiency. Traditionally, the standard adopted is 70%. Such a revision of the method would be a possibility in the absence of other alternatives and in agreement with international regulatory agencies, an agency representative said on Wednesday 30.
“How much minimal efficacy does it take to approve a vaccine? Traditionally, we have the 70% criterion and most studies have been designed, outlined, to show 70% efficacy. But in a pandemic situation, with a view to Given the absence of therapeutic alternatives, the global impact that this pandemic brought, it is possible to make this criterion more flexible to 50%, as long as this risk / benefit balance is very clear, ”said Gustavo Mendes Lima Santos, general manager of medicines and biological products. of Anvisa.
The statement was made during a meeting of the External Commission to Combat Covid-19, Chamber of Deputies, to understand the progress of the vaccine that has been produced by Oxford University. Immunization tests are ongoing in Brazil with 10,000 volunteers and, thus far, there has been no news of a serious adverse effect in the country. The only occurrence was of a woman in uk, which caused the temporary suspension of the study.
Santos said that although the minimum effectiveness of 70% is adopted as a standard for the approval of a vaccine, there is no regulatory device that establishes this criterion. “Traditionally we use 70%, but we are willing, in a sharing with other regulatory bodies, in a technical decision with other bodies, to make these criteria more flexible in this scenario,” he added.
The general manager pointed out that Anvisa, since the beginning of the new coronavirus pandemic, had to rethink procedures and flows to speed up responses without compromising the quality of the vaccine. She recalled that not all clinical trials should be conducted in Brazil, but when they are, they should be evaluated in four important aspects: safety, study design, quality, and good clinical practices.
“In this context where there was a need for rapid responses, we saw the need to approve phase 3 clinical trials with ongoing pre-phase trials, and this was the case for the Oxford vaccine,” he said. This led to adaptations of the study in the country, such as broadening the age range, including additional doses, and expanding the number of volunteers. Anvisa too simplified requirements for data analysis and registration of vaccines against covid-19 in Brazil.
The Anvisa representative commented that, in addition to the question of effectiveness, another challenge for the vaccine registry is regulatory convergence, which is how much the agency can reuse the work of other agencies so as not to have to repeat them in Brazil. “We don’t want to go back to work,” he said.
Mentioning the momentary halt in Oxford vaccine trials, Santos said the occurrence “is absolutely normal. Jorge Mazzei, executive director of Corporate Relations, Regulatory and Market Access of the AstraZeneca Brazil said that this small delay will not compromise the immunization schedule.
“At the moment, we have no information that this week-long delay will affect any vaccine release process. We are increasing volunteers from 5,000 to 10,000 in Brazil, so this may speed up the process. We are on schedule, we are working as closely as possible with the Ministry of Health, Fiocruz and really trying to anticipate everything possible to bring this vaccine to Brazil, “said the spokesman for the pharmacist.
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