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Anvisa (National Health Surveillance Agency) confirmed that it received early today a request for the emergency use of the covid-19 Sputnik V vaccine, developed by the Gamaleya Institute in Russia.
Submitted by União Química, a pharmaceutical company that represents the immunizing agent in Brazil, the order has a period of seven business days to be evaluated by the agency. This period does not consider the time of the process in the state of technical requirement, which is when the laboratory needs to answer technical questions.
According to Anvisa, the document classification has already begun. In the first 24 hours, the agency will check that all the necessary documents are available. Otherwise, additional information will be requested from the laboratory.
União Química had already submitted an emergency use request in January this year, but Anvisa said it did not receive minimal data for analysis. The Brazilian laboratory says, now, that it has delivered all the information to open the evaluation in the agency.
Anvisa has already published definitive registries for the use of AstraZeneca / Oxford and Pfizer vaccines in Brazil. CoronaVac, on the other hand, is approved for emergency use. Last Wednesday (24), Janssen also requested the emergency use of his vaccine.
Purchased doses
Earlier this month, the Ministry of Health signed a contract to receive 10 million doses of Sputnik V, an immunizer that is 91.6% effective against symptomatic cases of Covid-19 according to a study with preliminary data published in the Lancet journal. .
The initial schedule predicts that 400,000 doses of the vaccine may arrive in Brazil by the end of April. In May, the government expects to receive another 2 million doses and, in June, 7.6 million.
The governors of the Northeast states also signed individual contracts with the Russian Sovereign Fund for the purchase of a total of 37 million doses of the vaccine.
To contract directly, the governors of the Northeast rely on the law, approved last week, which authorizes states and municipalities to import vaccines approved by authorities from other countries and blocs such as the United States, European Union, Japan, China, United States . Kingdom, Russia, India, South Korea, Canada, Australia and Argentina.
An agreement sealed between the governors of the Northeast and the former Minister of Health, Eduardo Pazuello, provides for the ministry to act as an intermediary, incorporating vaccines into the PNI (National Immunization Plan) and distributing them throughout Brazil.
The Consortium of Governors of the Amazon is also negotiating the purchase of vaccines and Pará has already announced an agreement.
Deadlines
The request for emergency use was made based on the provisions of a law approved this month, which plans to facilitate the entry of vaccines already authorized in other countries, such as Russia. As a general rule, Anvisa will have seven days to submit an opinion on the use of the vaccine.
Anvisa will use data from foreign agencies, but can still reject the request within this period. If it considers that the information is insufficient, the agency can use the “general rule”, which provides up to 30 days for the analysis of emergency use for vaccines that have not had clinical studies in Brazil.
The request for emergency use of Sputnik V must be evaluated by the Anvisa Collegiate Board.
Political lobby
As the newspaper O Estado de S. Paulo showed, President Jair Bolsonaro received an angry audio from the owner of União Química, Fernando Marques, last week. In the speech originally sent to Luciano Hang, owner of the Havan stores, the businessman accused Anvisa of stopping the vaccine for a political plot that would favor the governor of São Paulo, João Doria (PSDB), the PT and the PCdoB.
“They want to stay with Fiocruz and the Butantan Institute. Butantan in the hands of Doria and Fiocruz in the hands of the PT, PCdoB. And, damn it, there is no vaccine, people are dying,” Marques said in the audio.
To supporters, on the morning of last Thursday (18), Bolsonaro said that he received complaints from a “known” laboratory about Anvisa, but did not mention the name of União Química. “Another big and well-known company has 20 million doses to sell and they can’t do it. Then a guy spoke to me. I told him: I can’t interfere. I can’t, no, I won’t interfere. With Anvisa,” Bolsonaro said.
In a statement, the agency denied the plot. The Chemical Union confirmed the authenticity of the audio. He said the speech was delivered in a moment of “despair” on the part of the businessman.
* With information from Reuters and Estadão Content agencies.
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