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The directors of the Butantan Institute and the São Paulo Department of Health will deliver today, at 4 pm, the final studies of the vaccine against the new coronavirus to Anvisa (National Health Surveillance Agency) and will request the CoronaVac registration. The virtual meeting will be with agency technicians and with the Director of Management of Medicines and Biological Products, Gustavo Mendes.
The meeting to present the studies and request the vaccination registry is scheduled for the same time that the São Paulo government announced an interview with journalists to talk about the study.
Governor João Doria (PSDB) will not be present at the meeting or the press conference, as he decided to take a ten-day vacation and traveled to Miami last night. The president of Anvisa, Barra Torres, will not participate in the meeting.
“We will meet with Anvisa to deliver the results of the studies and then present the data at a press conference and for everyone,” he told theTwitter The Secretary of Health of São Paulo, Jean Gorinchteyn, who will attend the meeting.
Governor João Doria promised to begin vaccination on January 25. But it depends on the approval of Anvisa to apply dose.
In addition to Anvisa, the government of São Paulo will send the studies to the Chinese health agency – National Administration of Medical Products. The expectation of the João Doria government (PSDB) is to obtain registration with the Chinese in up to three days. Thus, it is based on a law approved this year that determines a 72-hour period for Anvisa to approve the use of drugs, as long as it is registered with international health organizations. Among these agencies is the Chinese one.
CoronaVac is developed in partnership with the Chinese laboratory Sinovac
The country registers 188,285 deaths from the new coronavirus. The data was published yesterday (22) by the press media consortium, of which the Twitter It is part of.
Until early this afternoon, there was no request for emergency vaccination (for groups at risk) or registration (which allows the application of doses to the entire population) in Anvisa.
Vaccine war
Behind the scenes, Anvisa members claim that even with a guard structure in place to analyze the documents, it may not be possible to grant approval within 72 hours, as required by law. This is because, they argue, the quality of the information provided is critical.
There are still disagreements about the need or not for an endorsement from Anvisa so that the São Paulo government can even register in China. Anvisa understands that by regulating the investigation in the country where there is the largest study on CoronaVac, it is up to the agency to send information to analyze orders in China.
According to members of Anvisa heard by the report, there was a flaw in the documentation provided by São Paulo throughout the study. That is why there is fear in the agency that, amid the politicization, there will be pressure from the São Paulo government and an attempt to blame Anvisa for slowness.
Members of the São Paulo government deny that the documents of the initial phases of the studies are pending.
