HYDERABAD: After dithering initially, Brazil’s health regulator Anvisa (Agência Nacional de Vigilância Sanitária) has finally given the green light to “exceptional import” of Bharat Biotech’s Covid-19 jab Covaxin.
The approval has been granted initially for “distribution and use under controlled condition” of 4 million doses of Covaxin, which can be used only under specific conditions including observation by the ministry of health, a loosely translated version of Anvisa’s announcement said.
“After using the 4 million 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,” the Anvisa website said.
Brazil’s health ministry had placed an order for importing 20 million doses.
“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 the special conditions laid down by Anvisa for the exceptional import is that all the consignments for Brazil should have been manufactured after the GMP adjustments have been implemented by Bharat Biotech.
In March this year, Anvisa had turned down the first import request of the Brazilian health ministry following which the ministry approached Anvisa again in May end.
In May-end, Bharat Biotech too submitted two applications to Anvisa seeking approval for GMP certifications for Covaxin’s production line as well as its biological input.
In March-end, Anvisa had refused to grant GMP certification to the company’s facilities citing non-compliance with GMP standards based on observations by its inspectors that visited the Genome Valley facility in Hyderabad in the first week of March.