New Delhi: Brazil has cleared the proposal to import Bharat Biotech’s COVID-19 vaccine, Covaxin into the South American country.
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.
The approval for the “distribution and use under controlled condition” has been granted only for 4 million doses of Covaxin initially and that too under specific conditions, said a loosely translated version of Anvisa’s announcement.
“After using the 4 million authorized doses, the Agency will analyse the data for monitoring the use of the vaccine in order to assess the next quantities to be imported,” the Anvisa website said.
Brazil’s health ministry had placed an order for import of 20 million doses of Covaxin with Bharat Biotech.
“For the partial authorization, Anvisa considered the pandemic scenario in Brazil, the adjustments and new data presented in the new import order, as well as the information gaps that still exist in the analysis of Covaxin’s data and the mitigation actions proposed by the technical areas,” Anvisa said.
“In the case of Covaxin, the director rapporteur Alex Campos highlighted the improvements made in the line of manufacturing (at) Bharat Biotech after the inspection by Anvisa held at the factory in India, in April this year, in addition to the approval of the Phase 3 clinical trial of the vaccine in Brazil,” it explained.
One of these special conditions laid down by Anvisa for the exceptional import of Covaxin is that all the consignments for Brazil should have been manufactured after the adjustments of GMP implemented by Bharat Biotech.
In March this year, Anvisa had turned down the first import request of the Brazilian health ministry after which the ministry had approached Anvisa again in the last week of May.
Bharat Biotech too had approached Anvisa in May end seeking approval for two GMP certifications for Covaxin’s production line as well as its biological input, after Anvisa had, in March end, refused to grant a GMP certification to the company’s facilities in India citing non-compliance with GMP standards after an inspection in early March this year.