The Russian manufacturers of the Sputnik V vaccine have filed a libel lawsuit in Brazil against the country's National Health Surveillance Agency (Anvisa) for “intentionally spreading false and inaccurate information” about the covid-19 inoculator after prohibiting its import, citing lack of data, the immunizer's Twitter account (@sputnikvaccine) reported.
It added that Anvisa made their decision without having analyzed samples of the vaccine and without considering the official documents sent by the Gamaleya Institute on the absence of adenovirus.
In its press conference today, Anvisa confirmed that it did not find any replicated adenovirus (RCA) in Sputnik V but was concerned about the Russian theoretical regulatory limit for that parameter.— Sputnik V (@sputnikvaccine) April 29, 2021
Therefore, the manufacturers of the vaccine financed by the Russian Direct Investment Fund (RDIF), this information was false and inaccurate.
Sputnik V also claims that Anvisa has already admitted their error and quoted the body's Manager of Medicines and Biological Products Gustavo Mendes, who has said that ”We did not receive samples of the vaccine to test. (...) we didn't test for a replicated adenovirus.
Anvisa denied on Monday a request from several Brazilian states to import the vaccine, which is already in use in 62 countries, including Argentina and 11 other nations in Latin America and the Caribbean because technical data to verify its safety and effectiveness was lacking.
The five directors of Anvisa followed the recommendation of the agency's experts, who pointed out several uncertainties concerning the safety and efficacy of the immunizer.
From Russia, the vaccine developers responded instantly: Anvisa's delays in the approval of Sputnik V are unfortunately of a political nature and have nothing to do with access to information or with scientific aspects and insisted on the United States' influence on potential buyers against the Sputnik V vaccine to favour the ones produced by them.
Former Brazilian Health Minister under President Dilma Rousseff and current federal Deputy Alexandre Padilha claims Anvisa's refusal to approve the drug is linked to President Jair Bolsonaro's foreign policy.
Sputnik V has already received satisfactory reviews worldwide, including the renowned scientific journal The Lancet in February of 2021, rating its efficacy at 91.6%.
But Anvisa Director Antonio Barra Torres explained: In addition to other relevant issues that prevented the import authorization of the vaccine, I can mention among them the absence of information, of studies that portray effects on germ cells.”
South Korea, Egypt, India, Mexico, Nepal, Kazakhstan and Uzbekistan have acquired the rights to produce Sputnik V and Argentina is expected to become the first Latin American country to do so with agreements already signed for that matter.