Anvisa authorizes the importation of raw material for the Butantan vaccine; SP says production will be delayed 20 days – 10/28/2020 – Balance and health



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Anvisa (National Health Surveillance Agency) authorized on Wednesday (28) the importation, on an exceptional basis, of raw material that must be used in the production of vaccines against Covid-19 by the Butantan Institute.

The material will be imported from the Chinese company Sinovac, which has a partnership with Butantan for the development and production of the vaccine. The decision comes after criticism from the institute about the agency’s delay in authorizing the request, which had been made on September 23.

This Wednesday (28), in a press conference at the Palácio dos Bandeirantes, in São Paulo, the director of the Butantan Institute, Dimas Covas, said that the delay in the release would cause a delay in the vaccine production coronogram, which should have started in the second half of October.

Consulted by sheet After Anvisa’s announcement, he indicated that this delay should be 20 days, which would delay the completion of the first local batch until January 2021. “Let’s run, let’s accelerate [a produção]”, He said.

Butantan’s original plan was to receive 6 million doses of the ready-made vaccine in October and then manufacture in Brazil, until December, another 40 million doses from raw material from China. The guarantee for the importation of the 6 million doses was given last week. However, there was still no authorization for the raw material, requested, according to Dimas Covas, on September 23.

Initially scheduled to take place at a meeting on November 4, Anvisa’s decision was made through a new procedure, called a deliberative circuit, a model in which directors can advance voting on certain issues.

The measure supports the importation of 120 bags, of 200 liters each, “of bulk formula used in the production of adsorbed Covid-19 vaccine.”

According to the agency, the authorization is exceptional, since the vaccine is still in the last phase of studies, and the use of the product will be conditional on the approval of its registration. President Jair Bolsonaro (without a party) has emphasized that this support also depends on a commitment to purchase the Butantan vaccine by the federal government.

In the decision, Anvisa also says that the institute “must keep the product in its facilities, and in perfect packaging conditions, until it can be used or destroyed,” and recalls that the studies “are still ongoing and there is no forecast of date of vaccination “.

São Paulo registers lower average of deaths

In this Wednesday’s interview, the state government reported that São Paulo had the lowest weekly moving average of deaths in the last six months: 91 deaths. For the second day in a row, it stayed below 100, according to the state government. In relation to the last 15 days, the reduction in deaths was 23% and compared to the last 30 days, the decrease was 44%, according to data from Doria’s management.

This Wednesday, the state counts 39,007 deaths and 1,103,582 confirmed cases of Covid-19.
ICU bed occupancy rates are 40% in Greater São Paulo and 39.2% in the state. As of Wednesday morning, there were 4,123 patients admitted to the infirmary and 3,147 to the ICU.

The Secretary of State for Health, Jean Gorinchteyn, does not rule out the possibility of a second wave of Covid-19, similar to what happens in Europe, or “another plateau at a lower level”.

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