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CoronaVac has been the center of a political battle in the country – AFP / Archives
The National Health Surveillance Agency (Anvisa) reported, on the night of Monday 21, that it granted the certification of good practices to the Sinovac pharmaceutical factory in China, where the raw material of Coronavac, vaccine against covid-19, will be produced. developed by the Asian company in association with the Butantan Institute.
The certificate is mandatory for a possible vaccine registration in Brazil. The registration request, however, still depends on the publication of the results of the immunizing efficacy of Butantan, which was promised for next Wednesday 23.
“The complete stage is one of the prerequisites to continue both the Sinovac vaccine registration process and an eventual request for authorization for the emergency use of that vaccine that will be presented to Anvisa,” the agency said, in a note. .
According to Anvisa, the certification was delivered about ten days before the originally scheduled deadline. A team of technicians from the agency carried out an inspection at the Sinovac factory in Beijing between November 30 and December 4 to assess the quality of the production line. Then a report was sent to Sinovac and Butantan with the conclusions of the visit and the necessary improvements.
The certification was delivered after Butantan submitted an answer to the questions and an action plan to remedy the nonconformities. “The action plan was sent by the Butantan Institute to Anvisa last Wednesday (12/16). The technical evaluation of the inspection team and the technical peer review were carried out and concluded by Anvisa this weekend (12/20). Thus, the publication of the certification decision was advanced approximately 10 days from the initial forecast, ”said the agency.
The certification was published by Anvisa this Monday in the Official Gazette of the Federation and is valid for two years. It refers both to the Active Pharmaceutical Ingredient (API) production line, raw material for the production of Coronavac, and to the sterile products used in the formulation.
On the same trip to China, Anvisa technicians also inspected the factory that will produce the raw material that will be sent to Brazil for the local production of the Oxford / AstraZeneca vaccine. The national manufacturing stages will be in charge of the Oswaldo Cruz Foundation (Fiocruz). The result of this other inspection and the issuance of the certification should occur in early January, according to Anvisa.
Butantan is expected to have 46 million doses of Coronavac by May
According to the agreement signed between Butantan and Sinovac, the Chinese pharmaceutical company will send 6 million prepared doses to Brazil and enough pharmaceutical supplies for the local production of another 40 million doses. Adding the products shipped ready and those manufactured at the national level, the São Paulo government says it already has 3.1 million doses of Coronavac.
On Monday, Governor João Doria affirmed that the State will receive another 5.5 million doses of Coronavac on Thursday 24, Christmas Eve. New batches are already scheduled. There will be 400,000 doses on the 28th and another 1.6 million on the 30th. Considering the 3.1 million already stored at the Butantan Institute, Doria expects to add around 10.8 million doses of the vaccine against the new coronavirus for the day. 30 from December.
The governor’s forecast is to begin vaccination in the state on January 25, but the schedule depends on the confirmation of the effectiveness of the product and the approval of Anvisa. The Health Ministry said last week that it should include Coronavac in the national immunization plan as long as it obtains registration with the regulatory agency.
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