Federal buyout of Coronavac stalls and Butantan tries to donate 15 million stranded doses

The Butantan Institute, responsible for the production in Brazil of the Coronavac vaccine, has 15 million doses stopped at its factory, in the west side of São Paulo. The immunizers, which would be destined for the vaccination campaign against Covid-19, were refused by the Ministry of Health and are stuck without a certain destination.

The federal decision was released last Monday night (6). The institute’s director, Dimas Covas, said he was surprised by the refusal of the government of Jair Bolsonaro (PL) to incorporate the amount into the current vaccination campaign and into the next cycle.

With this, the institute and Sinovac, the manufacturer of the immunizing agent in China, are now trying to negotiate the donation of vaccines to other countries. The doses are valid until August 2022.

According to Covas, Butantan is negotiating with the Pan-American Health Organization, an arm of the WHO (World Health Organization) in the Americas, for the inclusion of these doses in the Covax consortium.

“Many countries in Latin America cannot afford the costs to acquire these doses via direct commercial negotiation with Butantan, so we are asking Sinovac [que permita] If this happens, provide the doses via Covax. We are free to trade with other countries, but we are having difficulty in assigning a destination to these doses,” said Covas at Butantan headquarters on Tuesday (7).

He also said that, given the pandemic situation in Africa, he is also trying to negotiate the donation of doses to countries on the continent. Recently, researchers have identified a new variant, omicron, from sequencing done in South Africa.

The variant has already been identified in more than 20 countries, including Brazil, and seems to have a higher transmissibility compared to other strains of the virus known to date.

Butantan provided, via an agreement with the Ministry of Health, 100 million doses for the National Immunization Plan (PNI), whose delivery ended in September. However, the São Paulo laboratory was expecting an agreement of 30 million additional doses with the Ministry of Health.

For Covas, the reasons for the Ministry of Health to deny these vaccines are not clear and change every moment. “One time they say it’s the problem of efficacy, another time it’s because there’s a lack of conclusive studies on immunogenicity, then because there’s no definitive record. These are excuses,” he said.

Coronavac was at the center of the dispute between the governor of São Paulo, João Doria (PSDB) and Bolsonaro. The president made several attacks on the immunizer, considered by the toucan as a possible trump card in next year’s presidential election — in which both must be candidates.

The 15 million doses found at the institute were produced until October. Since then, production at the factory has been stopped. According to the institute’s director, this amount should not increase as production will only resume if there is a demand for doses.

In a statement, the Ministry of Health informed that the Butantan Institute has already complied with the entire contract for the delivery of 100 million doses of Coronavac.

“For 2022, the Ministry of Health will have a remaining balance of 134 million immunizers from 2021, added to the acquisition of 100 million doses from Pfizer and 120 million from AstraZeneca. These two vaccines were chosen [para o próximo ciclo de vacinação] for having definitive registration at the National Health Surveillance Agency (Anvisa) and approval by the National Commission for the Incorporation of Technologies in the SUS (Conitec)”, the text said.

Coronavac is an inactivated virus vaccine and was the first used in the country. Its efficacy found in a phase 3 clinical trial with more than 12,000 healthcare professionals showed 50.38% protection against symptomatic Covid cases, 78% against hospitalization and high protection against deaths, although this result was not statistically significant. significant.

In subsequent effectiveness studies in Chile and Serrana, in the interior of São Paulo, the vaccine showed protection of more than 86% against hospitalizations, 93% against severe cases and 96% against death. The vaccine’s immunogenicity profile, that is, its ability to form antibodies after vaccination, is high both in people over 60 years of age and in people aged between 18 and 59 years.

Recently, data on the safety and production of antibodies in children aged 3 to 17 were also released by the company, which is awaiting approval from Anvisa for use in this age group.

“Coronavac’s contribution to combating Covid-19 was essential, because this was the vaccine that faced the pandemic in the most dramatic period, which was the beginning of this year, saving millions of lives,” said Covas.

Zijie Zhang, medical director and spokesman for the Sinovac company in Brazil, said that Coronavac is the most used vaccine in the world, with around 2 billion doses distributed in several countries.

For him, the Brazilian government expanded its portfolio and left Coronavac aside, but it does not rule out a political dispute. “What I can say is that the Brazilian government bought, in mid-2021, other vaccines and this is the main reason for choosing to use others. But maybe there are other factors, political, maybe other issues that we cannot say,” he said .