[ad_1]
Anvisa (National Health Surveillance Agency) granted the certification of good manufacturing practices for the CoronaVac vaccine factory. The resolutions that attest to the measure were published on Monday (21) in the Official Gazette of the Federation.
According to the agency, the technical evaluation of the inspection team, which went to China to visit the Sinovac factory, and the technical review took place this weekend (12/20). “Thus, the publication of the certification decision was advanced approximately 10 days from the initial forecast,” Anvisa said in a note.
The final stage is one of the prerequisites to continue with the Sinovac vaccine registration process and an eventual request for authorization for the emergency use of that vaccine that will be presented to Anvisa.
“It is also part of the Agency’s ongoing efforts to make vaccines available to the population with quality, safety, and efficacy in the shortest time possible,” the agency said. The certification, according to the text published in the Official Gazette, is valid for two years.
This Monday (21), the American newspaper Wall Street Journal declared that CoronaVac, a vaccine developed in partnership by the Butantan Institute and the Chinese laboratory Sinovac, against covid-19, proved to be effective in the phase 3 test, carried out in Brazil. .
São Paulo expects more lots
Also on Monday, the São Paulo government indicated that next Thursday the state will receive a batch with raw materials for another 5.5 million doses of CoronaVac – with that, the expectation of the São Paulo authorities is that until December 31 the state has 10.8 million doses available.
Despite vaccine production, the São Paulo government has yet to present studies on CoronaVac phase 3 trials for Anvisa. The effectiveness rate of the immunizer was also not disclosed. For the vaccine to be administered, registration with the regulatory agency is required.
According to the São Paulo government, the results of phase 3 of CoronaVac’s tests should be sent to Anvisa on the 23rd, at the same time that they will be presented to the Chinese agency. The delivery date for these studies has already been postponed twice.
