The Russian COVID drug does not meet the minimum criteria for this purpose, the local regulator said.
The National Sanitary Surveillance Agency (Anvisa) rejected a request for approval of the Russian COVID-19 Sputnik V coronavirus vaccine for emergency use in Brazil. It does not meet the minimum criteria for this purpose, the regulator said on its website Saturday, Jan. 16
“The request was returned to the company (Uniao Quimica – ed.) because it does not meet the minimum criteria, in particular, due to the lack of authorization for phase III clinical trials, as well as issues related to advanced manufacturing methods,” the statement said.
The agency explains that a mere request for phase III trials is not enough. It is necessary for such trials to be conducted in the country.
The regulator specifies that as of Jan. 4, it is awaiting the missing information for the issuance of Phase III clinical trial authorization, the stage required for an emergency use authorization. In addition, it is claimed that the regulations for meetings with Anvisa and the Office of Medicines and Biological Products have not been complied with.
According to TASS, the company Uniao Quimica, which is a partner of the Russian Direct Investment Fund (RDIF) in late December, applied to Anvisa for permission to conduct the third phase of clinical trials of Sputnik V in Brazil. At that time, the agency said that based on the experience of previous applications, a decision on the Russian drug could be prepared within 72 hours, but later the agency requested additional information about the drug.
On Friday evening, Uniao Quimica and RDIF registered with Anvisa a request for temporary emergency use of 10 million doses of the Sputnik V vaccine in Brazil.
Recall that at the end of December Hungary refused to purchase the Sputnik V vaccine. And the day before it became known that Budapest reached an agreement to buy the Chinese COVID-vaccine from Sinopharm.
At the same time, the Russian COVID vaccine was urgently registered in Venezuela and Algeria.