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With the delay in releasing the importation of supplies, it is “very unlikely” that Anvisa (National Health Surveillance Agency) will register the CoronaVac vaccine in 2020, according to the director of the Butantan Institute, Dimas Covas. At this point, according to Covas, only a change in protocols could speed up the process.
“The production schedule that Butantan had for this vaccine … With this delay that occurred in the import authorization, we will only be able to start this schedule in mid-November. Therefore, the validation part of the product will be available at the end of the year. year, in the first half of January, “he explained in an interview with CNN Brazil.
Even if Butantan manages to deliver the complete dossier to Anvisa in December, Covas added, the agency would have up to 60 days – that is, February 2021 – to issue the record. “I think it is highly unlikely that this schedule will allow the registration of this vaccine later this year, unless there is a change in the registration protocols,” he said.
CoronaVac is the covid-19 vaccine produced by the Butantan Institute in association with the Chinese pharmaceutical company Sinovac Life Science. The authorization to import the raw material necessary for its production was announced today by Anvisa.
The order had been placed on September 23 by Butantan, which is expected to use inputs from China to produce 40 million doses at its São Paulo factory. Until then, the institution believed that it was possible that the doses would be available until December.
In addition, the importation of 6 million doses produced by Sinovac, which should arrive in São Paulo next week, was also released.
In a note, Anvisa confirmed that it granted the release of inputs on an “exceptional” basis. The decision was made in the Agency’s Deliberative Circuit, which allows directors to vote on issues of great relevance. The group met yesterday and today.
Trust Butantan
Shortly after the authorization was delivered, the general manager of Anvisa, Antônio Barra Torres, showed confidence that Butantan will be able to meet the requirements requested by the agency, in addition to saying that he believes in the institution’s competence to attend to material that requires additional security.
“Ready-to-use vaccines were authorized and now we are authorizing the arrival of raw materials to Brazil, which, of course, will have all the safety certificate for the handling of this material assumed by the Butantan Institute, which has conditions so that it can start the adjustments to the production phase, ”Torres said in an interview with CNN Brazil.
Of course, we must remember that we are dealing with the material, in this case the inactivated virus, but it is a biological material that needs a very well done and rigorous control. And he will certainly not have major difficulties for the Institute. [Butantan] do it this way, “he added.
Torres said that the demands made by the agency, “in general, are details that speak of security, transportation, packaging of this material, its handling, the conditions it must have to be in perfect condition.
