Anvisa allows import of Covaxin, Sputnik V into Brazil, but conditions apply

Brazil has given clearance to the proposal to import Bharat Biotech’s COVID-19 vaccine Covaxin with some conditions. The National Health Surveillance Agency of Brazil- Anvisa – had earlier denied permission to import Covaxin after authorities found that the Indian plant in which the jab was being made did not meet the good manufacturing practice (GMP) requirements. The Brazilian health regulator also approved another proposal to import Russia’s Sputnik V vaccine into that country. According to Anvisa’s approval, Brazil is expected to receive four million doses of Covaxin initially. After using the authorised doses, the agency will analyse the data for monitoring the use of the vaccine in order to assess the next quantities to be imported.

“Anvisa authorised this Friday the exceptional import of the Covaxin vaccine by the Ministry of Health for distribution and use under controlled conditions. The authorisation defined the amount of 4 million doses, which can be used only under specific conditions. The decision was taken at the 9th Extraordinary Public Meeting of the Collegiate Board,” it said in a statement in Portuguese.

All batches to be destined for Brazil must have been manufactured after the adaptations of the GMP implemented by the manufacturer Bharat Biotech, according to the corrective and preventive action report (Corrective and Preventive Action – CAPA) presented to Anvisa, the regulator said narrating a slew of conditions for the importing of Covaxin.

On February 26, Bharat Biotech had signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of 2021. BharatBiotech presented an adequate action plan and fulfilled all the pending issues related to the certification of GMP request, Anvisa said.

Bharat Biotech, on May 25, filed new requests with Anvisa on the issues of GMP. Anvisa recently authorised the conduct of clinical trials of Covaxin in Brazil. Approval for tests on the immuniser developed in India will serve to assess the efficacy, safety and consistency between vaccine batches.