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Anvisa (National Health Surveillance Agency) announced today that it authorized the importation of raw materials for the start of the local production of CoronaVac, the vaccine against covid-19 developed and tested by the Butantan Institute in association with the Chinese laboratory Sinovac.
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. The institution believes that the doses may be available until December.
In addition, the import of 6 million doses produced by Sinovac has already been released, which should arrive in São Paulo next week.
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.
Anvisa also clarified that the CoronaVac not yet registered in Brazil. “Studies are still ongoing and there is no scheduled date for vaccination,” the note reports.
Testing before registration
CoronaVac is in the final phase of testing (called Phase 3), in which massive testing is done on volunteers. The final report should include 61 volunteers infected with the virus. These people are tested to see if they have taken the vaccine or the placebo, which allows the effectiveness of the immunizer to be measured.
The control is carried out by an international body and only this body knows if the dose applied is placebo or immunizing. If the immunizer reaches the necessary levels of efficacy and safety, it will be subjected to an evaluation by Anvisa for its registration and only then will the vaccine be released for application in the population.
Public collections
Last week, the Butatan Institute, linked to the state government, made public the charges for the release of imports. Anvisa responded by saying that there were “discrepancies” in the import order.
Dimas Covas, director general of the institution, accused Anvisa today, saying that the delay was delaying CoronaVac’s production schedule. According to Butantan, the São Paulo factory has the capacity to produce 1 million doses per day.
Early at night, on social media, Governor João Doria (PSDB) thanked Anvisa for the release of the importation of supplies. “In this way, we will be able to produce CoronaVac here in São Paulo, at the Butantan Institute, which for 120 years has served the country and produces vaccines for Brazilians,” says the publication.
Trust Butantan
Shortly after the authorization was released, the director of Anvisa, Antônio Barra Torres, showed confidence that Butantan can comply with the requirements imposed by the agency, as well as said that he believed in the competence of the São Paulo institution to process material that it requires greater 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, ”Barra 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] so proceed ”, completed the director of Anvisa.
Barra Torres said that the demands made by the agency, “in general, are details that speak of safety, transportation, packaging of this material, its handling, the conditions it must have in order for it to be in perfect condition.”
Distribution lock
While the local production of CoronaVac has gone a step further, the distribution of the immunizer against covid-19 still remains under uncertainty. Last week, the Minister of Health, Eduardo Pazuello, even announced a commitment to purchase the first 46 million doses of the vaccine, but it was dismissed the next day by President Jair Bolsonaro (no party), who ordered the cancellation of the purchase.
At a press conference today, Governor João Doria stated that if the federal government does not decide to include CoronaVac in the PNI (National Immunization Program), which would mean its distribution by the SUS (Unified Health System) throughout the country, The São Paulo government will pay for 46 million doses, will run a state vaccination campaign and will be able to supply the immunizer to other states.
