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Hours after the government of São Paulo announced the start of vaccination against Covid-19 for January, Anvisa (National Health Surveillance Agency) published a note in which it indicates that several procedures are still missing to obtain the immunizer registration. Coronavac, developed by the Chinese Sinovac in association with the Butantan Institute.
Anvisa affirms that the São Paulo entity has not yet sent data from phase 3 of the clinical trials of the vaccine, the last step before registration. In addition, it says that the inspection report at the Chinese Sinovac plant, also an important registration step, will only be ready on January 11.
With an even stronger tone than the note published by the agency, the general director of Anvisa, Admiral Antônio Barra Torres, said in an interview with Jovem Pan radio that it is not possible to determine a day and month for the launch of a vaccine against new coronavirus.
“Interested parties can request emergency use [da vacina] anytime. From there, we will try to do a well done analysis and in the shortest possible time. However, we do not set an approval month or day. To the authorities that do so, I wish them luck, “he said.” In the meantime, we will continue to work with the real world, the scientific world, “he added.
This Monday (7), Doria announced the start of vaccination in the state of São Paulo for January 25, the anniversary of the capital of São Paulo, despite the lack of registration and disclosure of efficacy data. According to him, all Brazilians can receive the doses.
In the late afternoon of the same day, the agency published a note with the current status of the vaccine registration process. The title of the official position was “Clarification on the analysis of studies of the Sinovac vaccine”; the correct name of the vaccine is Coronavac.
“The data relating to phase 3, which is the phase that confirms the safety and efficacy of the vaccine, have not been submitted. These data are essential for the evaluation of both requests for authorization of emergency use and requests for registration “, says Anvisa in the note.
The agency also claims that only one of the two sets of documents submitted by the Butantan Institute, with data from safety and efficacy studies, had its analysis completed. The second was only shipped on November 30 and is still under analysis.
According to Anvisa, the inspection at the Sinovac factory in China, the report of which is also considered essential for registration, ended only on Friday (4). The Inspection Report, says the agency, is a conclusive document regarding certification and its conclusions can lead to approval or rejection of the process.
“Adding the days presented, it is concluded that the inspection report must be completed between December 30 and January 11, 2020.”
Anvisa also indicated that there are minimum requirements, established in a guide created by the agency, to request authorization for emergency use.
Last week, the Brazilian agency said it would begin to analyze requests for authorization for the emergency use of Covid-19 vaccines. Unlike registries, which require final documents on clinical trials, emergency use authorization is an exceptional case, granted for drugs and immunizations still in the testing phase.
However, vaccines with this authorization can only be applied to specific groups of the population, and not massively. Also, these vaccines cannot be marketed and must be part of a public vaccination program.
