Under pressure, Brazil’s health regulator conditionally approves Sputnik V and Covaxin vaccine

RIO DE JANEIRO, BRAZIL – Under heavy pressure to approve the Russian Sputnik V vaccine and, to a lesser extent, the Indian Covaxin, the Brazilian health regulatory agency (ANVISA) has reached a compromise solution – an approval that will lead the country to, in practice, raise efficacy and quality information that the laboratories have not provided so far, but that is expected to please no one.

The number of conditions imposed by ANVISA for the use of the Russian and Indian vaccines to be imported by states and purchased by the Ministry of Health, respectively, virtually creates a new clinical trial in the country.

Among the requirements is the monitoring of people who have been vaccinated, restrictions on the amount and public to be immunized, strict monitoring of the effects, and the need for all batches delivered to the country to be analyzed by the National Institute for Quality Control in Health (INCQS), linked to the Oswaldo Cruz Foundation.

“It was an attempt to come up with a solution that guarantees a minimum degree of safety. Let’s see real-life data and effectiveness now,” a source involved in the vaccine analysis said.

Since April 26, when it denied the first import authorization for Sputnik, ANVISA has been the target of lawsuit threats from the Russian Direct Investment Fund (RFDI) and intense pressure from governors who had agreed to import up to 37 million doses of the Russian vaccine, and were forced to defer their plans.

During this time, Northeast Consortium governors, the main buyers of Sputnik V, took the lead in the negotiations with ANVISA, gathering documents with the Russians and compromising in order to secure ANVISA’s authorization.

The vote of rapporteur Alex Campos, ANVISA’s director, concedes that the documents submitted by both governors and the Gamaleya Institute have advanced in some points, but did not ensure the safety level typically demanded by ANVISA.

The solution was for a compromise, albeit within a strictness that is likely to displease governors. Even before the trial was over, Piauí governor Wellington Dias (PT) president of the Northeast Consortium said he found the strictness of Campos’ report strange, “different from anything else in the vaccine world.”

“I am hopeful that ANVISA will authorize an import license for the 37 million doses we bought,” Dias said.

However, that won’t be the case this time. For now, states will be allowed to import fewer than 1 million doses, amounting to 1% of the population of each state that made the import request, a number ANVISA considers capable of being monitored and tracked to follow up on potential adverse events and vaccine efficacy.

These same conditions were imposed for the Covaxin import, requested by the Ministry of Health, which intended to buy 20 million doses. Now, the Ministry will be allowed to buy only 4 million doses, equivalent to 1% of the Brazilian population.

According to the source, however, the decision should not cause the Ministry any problems. With new contracts signed and a reasonable amount of vaccines from Pfizer, Janssen and Astrazeneca expected in the coming months, interest in the Indian vaccine has decreased considerably.

This article was produced by The Rio Times’ automated newsroom system. How we use AI · Report an error