COVID-19

Brazil health regulator sends back Sputnik V vaccine emergency use request

Reuters
Brazil health regulator sends back Sputnik V vaccine emergency use request

SPUTNIK V. A medical worker fills a syringe with the Sputnik V vaccine as she prepares to vaccinate a Russian Army service member at a clinic in the city of Rostov-On-Don, Russia on December 22, 2020.

File photo by Sergey Pivovarov/Reuters

Brazil's health regulator Anvisa says the firm failed to give adequate assurances on its Phase 3 clinical trials

Brazilian health regulator Anvisa said on Saturday, January 16, it sent back documents submitted by pharmaceutical company Uniao Quimica seeking approval for emergency use of the Russian Sputnik V coronavirus vaccine because they did not meet the minimum criteria required.

In a statement on the Health Ministry website, Anvisa said the firm’s request failed to provide adequate assurances on its Phase 3 clinical trials and issues related to the manufacture of the vaccine.

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

In its statement, Anvisa also said that any applicant requesting emergency use authorization must show its ongoing clinical trials of the vaccine will deliver long-term safety and effectiveness.

Must Read

Sinovac’s vaccine efficacy less than 60% in Brazil trial – report

Sinovac’s vaccine efficacy less than 60% in Brazil trial – report

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

Anvisa is expected to decide on authorizing emergency use of the vaccines developed by China’s Sinovac and Britain’s AstraZeneca on Sunday. – Rappler.com

Add a comment

Sort by

There are no comments yet. Add your comment to start the conversation.