Lack of Data, Brazil Delays Licensing of Russian-Made Sputnik Vaccines


Suara.com – The Brazilian government has not granted an emergency use permit (EUA) for the Russian-made Sputnik vaccine, although the total number of cases continues to rise.

This is because Brazilian health regulators are looking for more data on Russia’s Sputnik V coronavirus vaccine before considering its approval for emergency use.

Documents supporting drug maker Uniao Quimica’s application for emergency use of the vaccine have been returned to the company for not meeting the minimum criteria, the watchdog said on Saturday.

In a statement on the Ministry of Health’s website, regulator Anvisa said the request failed to provide adequate guarantees for Phase III clinical trials and problems related to vaccine manufacturing.

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Uniao Quimica is seeking approval for the use of 10 million doses of Sputnik V in Brazil in the first quarter of this year.

Russia’s RDIF sovereign wealth fund, which promotes Sputnik globally, said on Sunday that Anvisa had asked for additional information to be provided soon.

In its statement, the request from the regulator is standard procedure and does not mean that the offer of registration has been rejected. He also said that legislation that would pass through the Brazilian Senate, if approved, would allow the use of vaccines approved by other countries.

Moscow has approved Sputnik for Russian domestic use, although clinical trials there are not yet complete.

Anvisa officials previously said that the Sputnik V vaccine must be submitted to Phase III clinical trials in Brazil before its use can be authorized.

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Anvisa said on Saturday that applicants seeking emergency use must demonstrate that the vaccine will provide long-term safety and effectiveness.

Regulators are expected to make a decision on Sunday on authorizing the emergency use of the vaccine developed by Sinovac China and Britain’s AstraZeneca.

RDIF said that Sputnik was registered in Serbia, Belarus, Argentina, Bolivia, Algeria, Venezuela, Paraguay and by the Palestinian Authority.

Registration in two more countries is expected next week, he said. [ANTARA]


Source: Suara.com – Informasi Berita Artikel Kesehatan Terkini by www.suara.com.

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