Brazil rejects emergency purchase of Russian Sputnik V vaccine

The Russian drug COVID does not meet minimum criteria for these purposes, the local regulator believes.

The National Sanitary Inspection Agency (Anvisa) has rejected a request for approval of a Russian vaccine against the coronavirus COVID-19 Sputnik V for emergency use in Brazil. It does not meet the minimum criteria for these purposes, the regulator said on its website on Saturday, January 16.

“The application was returned to the company (Uniao Quimica – ed.) Because it does not meet the minimum criteria, in particular due to the lack of approval for the third phase of clinical trials, as well as in relation to issues related to the methods of advanced manufacturing “, – said in the message.

The agency explains that it is not enough to send a request for a third phase of investigation. It is essential that these tests are carried out in the country.

The regulator clarifies that as of January 4, it is waiting for the missing information to issue an authorization for the third phase of clinical trials, the stage required for authorization for emergency use. Furthermore, it is argued that the schedule of meetings with Anvisa and the Administration of Medicines and Biological Products has not been followed.

As clarified by TASS, Uniao Química, which is a partner of the Russian Direct Investment Fund (RDIF), at the end of December requested permission from Anvisa to carry out the third phase of clinical trials of Sputnik V in Brazil. A decision on a Russian drug can be prepared in 72 hours, but the agency later requested additional information about the drug.

On Friday night, Uniao Química and RDIF filed a request with Anvisa for a temporary emergency use in Brazil of 10 million doses of the Sputnik V vaccine.

Recall that at the end of December, Hungary refused to buy the Sputnik V vaccine. And the day before it became known that Budapest had reached an agreement on the purchase of a Chinese COVID vaccine from Sinopharm.

At the same time, the Russian COVID vaccine was urgently registered in Venezuela and Algeria.

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