RIO DE JANIERO, April 28. /TASS/. The Brazilian Health Regulatory Agency (Anvisa), which refused to authorize imports of Russia’s Sputnik V anti-coronavirus vaccine, has completely ignored the real epidemiological situation in the country, the chief healthcare official of Brazil’s state of Bahia, Fabio Vilas-Boas, said on Tuesday.
"In our joint opinion with [local pharmaceutical company] BahiaPharma, Anvisa will require no less than six months to have all questions answered. The demands that it had voiced are absolutely detached from reality," he said in an interview with Globo TV.
According to Vilas-Boas, the watchdog’s refusal to authorize imports of the Russian vaccine is unjustified, as it failed to provide any scientific evidence to substantiate its claims about potential dangers of the Russian jab.
"One cannot simply claim that there are some potential risks, and delay [the review process], demanding for additional documents to be submitted. Since they have no such documents, they cannot assert that the vaccine is dangerous. It would be nothing but speculations," the official said.
Earlier on Tuesday, the Brazilian regulator denied permission to import and use the Russian vaccine Sputnik V in the country. The regulator’s meeting lasted for more than four hours. Experts’ conclusions and their opinions regarding the safety and effectiveness of the Russian vaccine were presented.
Sputnik V litigation
On April 13, Brazil’s Federal Supreme Court Judge Ricardo Lewandowski ruled Brazil could export Sputnik V, if the regulator failed to make up its mind by the end of April regarding the possibility of using the product. Thereby he sustained a request from the authorities of the State of Maranhao. On April 23, he issued the same order to the regulator concerning requests from the states of Amapa, Piaui and Ceara (a 30-day deadline was set for making a decision on the requests from the latter three). Earlier, the authorities of these states participated in a joint purchase of the Russian vaccine together with other northeastern states that has not received Anvisa’s permission yet.
The Brazilian regulator explains the delays in considering Sputnik V’s registration by a lack of the full set of documents. On March 26, the Brazilian pharmacological company Uniao Quimica, which represents the Russian Direct Investment Fund, filed another request with Anvisa for the vaccine’s registration. The next day the regulator said it had paused the consideration of the request indefinitely because some of the required documents were still missing. This is not the first time the agency suspends consideration of Sputnik V’s registration. Uniao Quimica’s owner Fernando Marques has reproached the watchdog of deliberate procrastinations in the interests of manufacturers of other vaccines.