RIO DE JANEIRO, BRAZIL – On Thursday, the government of Paraná State met with the National Health Regulatory Agency (ANVISA) to define the potential production of the Sputnik V vaccine, announced by the Russian government as the first able to fight the coronavirus causing Covid-19.
The meeting was attended by the president of the Paraná Institute of Technology (TECPAR), Jorge Callado, the Paraná State Chief of Staff, Guto Silva, and the director of ANVISA, Antonio Barra Torres.
The purpose of the meeting was to discuss the approval by Brazilian health bodies of the Russian vaccine trials phase in Brazil. According to the Paraná government, the document is expected to be submitted to the National Committee on Ethics in Research (CONEP) and to ANVISA within 30 days, and the trials to begin in 45 days.
Callado, TECPAR’s president, said that if the schedule is met, vaccination could be conducted in the second half of 2021.
All production, which also includes the clinical trials phase, will be under the responsibility of the Paraná institute. Ten thousand volunteers are expected to be involved in the trial.
In early August, Paraná signed a memorandum of understanding with the Russian Direct Investment Fund for producing the vaccine, which is developed by the Gamaleya Institute.
As soon as the vaccine was announced, scientists around the globe urged caution because they considered testing had been made during too short a time to have safe results. Moreover, Russia has not yet released the first trial phases.
TECPAR said it has already received the results of phases 1 and 2 of trials, required to ensure the vaccine’s efficacy. It further said that for reasons of contract confidentiality it could not provide any further details, but that everything will be reported in the final document submitted to ANVISA.
Vaccines tested in Brazil
Currently, four vaccines are under clinical trials in Brazil, conducted by Sinovac (China), AstraZeneca (England), Johnson & Johnson (United States), and another from a partnership between Pfizer (United States) and BioNTech (Germany).
The so-called phase 3 clinical trial is conducted in a large number of people to test its safety and immunization. The preceding phases are conducted in animals and humans but in a very small amount.
The Chinese and the British vaccines were the first to initiate trials around the world and are considered the most promising so far. The government of São Paulo, through the Butantan Institute, will finance the full production of the Sinovac laboratory vaccine.
The Ministry of Health is investing in the British vaccine. Almost R$2 billion have been reserved for production and population immunization. The whole process will be performed by Fiocruz in Rio de Janeiro.
Source: Exame