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Anvisa (National Health Surveillance Agency) granted the certification of good manufacturing practices to Sinovac for the production of vaccines and medicines. The Chinese is a partner of the Butantan Institute in the production of Coronavac.
The vaccine, in the final testing phase, could be used for immunization against the new coronavirus and is a weapon against Covid-19. The certification was awarded on Monday (21).
The stage is one of the prerequisites for the continuity of both the Sinovac vaccine registration process and an eventual request for authorization for emergency use that can be submitted to the regulatory agency. The certification is valid for two years.
A commission from Anvisa traveled to China to inspect the Coronavac plant from December 2 to 13. On Wednesday (16), the Butantan Institute presented an action plan to the regulatory agency, which allowed the process to conclude.
As a result, the technical evaluation of the inspection team and the analysis review were carried out and concluded by Anvisa on Sunday (20).
According to the agency, it was possible to anticipate the initial forecast for the publication of the certification decision in about 10 days.
Confident of a high Coronavac effectiveness rate, the São Paulo government changed its tactic to pressure Anvisa to approve the Covid-19 vaccine later this year.
Instead of revealing the effectiveness of a preliminary phase 3 study, which would be done on Tuesday (15), the state will wait until Wednesday (23) and present the full trial to request the final registration of the Chinese immunizer in Anvisa.
In addition, according to the Chinese manufacturer Sinovac, the vaccine will have the registration requested at the same time with NMPA (National Administration of Medical Products), Anvisa of the Asian country.
The expectation in the state government is that China will grant the definitive registration of Coronavac in about three days.
This will put Anvisa in a difficult position, since the legislation approved in February on the subject requires that any drug against Covid-19 that has the approval of a US, European, Japanese or Chinese surveillance agency be analyzed within 72 hours.
In China, there is already an emergency approval for the use of Coronavac.
