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OR The executive secretary of the Ministry of Health, Elcio Franco, admitted that there was “frustration” on the part of the portfolio with the postponement last week of the publication of the results of Phase 3 of the CoronaVac vaccine. developed in partnership with the Chinese pharmaceutical company Sinovac.
The government of São Paulo and the Butantan Institute said last Wednesday (23) that the vaccine reached the minimum level of effectiveness required by regulatory agencies (50%), but did not show the exact percentage of effectiveness of the immunizer or other data from the final study under the justification that Sinovac requested the database for a more detailed analysis.
“Unfortunately, it was a frustration for us. [O Butantan] It was going to deliver the results of Phase 3 and is in negotiations with Sinovac to deliver these studies, which would be important data to obtain authorization for emergency use and facilitate this acquisition, ”said the secretary, at a press conference.
“Butantan has been trying [procurar a Anvisa] even before starting a dialogue with the Ministry, such as AstraZeneca and other laboratories. We are interested and we have encouraged and verified everything together with Anvisa. So we were surprised by Pfizer’s response yesterday, and with Butantan it was a frustration that it was not possible to deliver Phase 3 results. “
Yesterday, the US pharmaceutical Pfizer informed that it will not send its vaccine, produced in association with BionTech, for emergency use in Brazil and must depend on the so-called continuous presentation. This, in practice, would simplify the protocol.
In a statement, Pfizer explained that it had a meeting with representatives of Anvisa (National Health Surveillance Agency) on December 14 to clarify doubts about the submission process, but that it ended up running into difficulties in the Presentation Guide for Emergency Use. prepared by the Brazilian agency itself.
