Brazil clears proposal to import Covaxin, Sputnik V; conditions apply

The clarification regarding GMP comes as the Brazillian health regulator had earlier denied the proposal to import Covaxin into the country, after the authorities found that the Indian plant in which the Covid-19 vaccine was being made did not meet the GMP requirements.

Brazil has cleared the proposal to import Hyderabad-based Bharat Biotech's indigenous vaccine against the coronavirus disease (Covid-19) -- Covaxin -- for the purpose of tackling the pandemic. The South Asian country's top health regulator, the National Health Surveillance Agency of Brazil - Anvisa, has also approved the proposal to import Russia's Sputnik V Covid-19 vaccine into that country.

In this file photo taken on May 09, 2021, a medical worker displays a vial of the Covaxin vaccine against the Covid-19 coronavirus at a vaccination center in Mumbai. (AFP)

Earlier in February, Bharat Biotech signed an agreement with the Brazillian government for the supply of 20 million doses of Covaxin during the second and third quarters of 2021, in which it presented an "adequate action plan" and fulfilled all the pending issues related to the certification of good manufacturing practice (GMP) request, Anvisa said.

The clarification regarding GMP comes as the Brazillian health regulator had earlier denied the proposal to import Covaxin into the country after the authorities found that the Indian plant in which the Covid-19 vaccine was being made did not meet the GMP requirements.

Brazil, as the per initial agreement, is expected to receive four million doses of Covaxin, following which it will monitor the data on Covid-19 vaccine use and decide, if required, the number of additional doses to be imported. Initially, Covaxin will only be used under specific conditions, Anvisa said on Saturday in a statement issued in Portuguese, shortly after the 9th extraordinary public meeting of the collegiate board.

Presenting a slew of conditions for the import of Covaxin, Anvisa said that 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 presented to Brazil's health regulator.