Brazil's regulator delays emergency authorisation of Sputnik V, demands more data

Brazil’s health regulator has delayed the approval of Russia’s Sputnik V vaccine, citing the need for more data on the vaccine.

Drugmaker Uniao Quimica’s application for emergency use of Sputnik V have been returned to the company for failing to meet its criteria, Reuters reported on Sunday.

Regulator Anvisa in a statement on the website of the health ministry said that the request failed to provide enough promise on the Phase 3 clinical trials, along with issues in manufacturing the vaccine.

Uniao Quimica, the company in question is seeking allowing usage of 10 million doses of Sputnik V in Brazil, in the first quarter of 2021.

Russia’s RDIF is promoting the vaccine around the globe, and on Sunday claimed that Anvisa had requested more information, which it may receive soon.

Additionally, its statement claimed that such requests coming in from regulators are normal, and do not necessarily mean the rejection of the vaccine’s registration.

Also read: Russia says 1.5 million vaccinated globally with Sputnik V

A legislation is currently making its way to Brazilian Senate. If approved, it would allow the usage of all vaccine that other countries have approved for sure.

Even though clinical trials of Sputnik V remain incomplete even in Russia, the vaccine is being deployed to people on a large-scale.

Anvisa previously claimed that for Sputnik V to be registered and authorised in Brazil, data for Phase 3 trials would be necessary. Additionally, the regulator added that any company seeking emergency authorisation of vaccines must be able to prove that it is safe in the long-term, and can also provide effectiveness.

Also read: Russia to begin trials of single-dose 'Sputnik Light' coronavirus vaccine

On Sunday, Brazil’s regulator will decide whether to approve the emergency use of vaccines made by China’s Sinovac, and Britain’s AstraZenecea.

Sputnik V has already been registered in Serbia, Belarus, Argentina, Algeria, Bolivia, Paraguay, Venezuela, and by Palestinian agencies.

In addition, registrations for two more countries are expected by next week.