Brazil's National Agency for Sanitary Surveillance (Anvisa) has cancelled the mandatory third stage of clinical trials to allow a new type of coronavirus vaccine for emergency use in Brazil.

The agency expects to receive the domestic drug in February.

In addition to the Russian vaccine, the beneficiary of Anvisa's decision will be the Indian drug Covaxin. Brazil plans to purchase about 20 million doses of the vaccine by the end of March.

Brazilian regulator decided to simplify the requirements due to continuous supply disruptions of the drug and its active ingredient, which is required for its production.

As noted by the media, the decision is temporary and does not eliminate the need to register the drug for universal vaccination in the country in the future.

In January, Anvisa rejected a request to approve the emergency use of Sputnik V in Brazil due to the fact that the drug "did not meet the minimum criteria, in particular due to the lack of approval for phase III clinical trials as well as issues related to good manufacturing practices".

The Russian trade mission in Brazil later stated that the domestic vaccine was 91.6% effective against the disease after Phase III trials.

The use of the drug has now been approved in 17 countries, including Argentina, Belarus, Serbia, Hungary and Mexico.

Made in Russia // Made in Russia

Author: Ksenia Gustova