Decks cleared for import of Bharat Biotech’s Covaxin into Brazil: Conditions apply

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 Preventiv Action – CAPA) presented to Anvisa, the regulator said narrating a slew of conditions for the importing of Covaxin.

On February 26, Bharat Biotech Ltd had said it 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 ofGMP. Anvisa recently authorised the conduct of clinical trials of CovaxininBrazil.

Approval for tests on the immuniser developed in India will serve to assess the efficacy, safety and consistency between vaccine batches.

Announcing the approval of Spuknik V by Brazil on its official twitter page, the Russian vaccine-manufacturer said, “#SputnikV will be used in Brazil following ANVISA’s approval. Brazil has become the 67th country in the world to authorise Sputnik V. The Sputnik V team fully answered all questions fromANVISA on the vaccine’s efficacy & safety.”