Brazil’s health regulatory agency has decided not to clear Covaxin for use at present

After delays in the delivery of Covishield, supplies of Bharat Biotech’s Covaxin to Brazil too have run into trouble with Brazil’s health regulatory agency, ANVISA, deciding on Tuesday not to clear Covaxin for use at present.

In a statement protesting the decision, Covaxin’s Brazilian import partner Precisa Medicamentos (PM) said it would appeal the ANVISA decision, which, diplomatic sources said, was more about “bureaucratic process” and not pertaining to the quality of the vaccine. In particular, ANVISA required a certification of “manufacturing good practices”, which needs to be submitted before the clearances can be done.

As part of its procedure, representatives from ANVISA visited Bharat Biotech’s factory in India from March 1 to 5 and “all notes raised by the agency” were recorded, said PM in the translated version of its press statement. During the inspection, the regulatory agency reportedly required more stringent “technical and documentation procedures.”

“The requirements pointed out during inspection will be fulfilled, the timelines for fulfilment is under discussion with the Brazil NRA [National Regulatory Agency] and will be resolved soon. The 20 million dose order from the Brazilian Govt is still active. The agreement with Precisa Medicamentos is based on a long term partnership and will continue,” a spokesperson from Bharat Biotech told The Hindu, reacting to the ANVISA decision.

Tight deadlines

Bharat Biotech said it had agreed to the conditions laid by ANVISA but found the deadlines for compliance too tight, offering to complete procedures by June, rather than April, which may have led to the denial of clearances, the sources said.

“The fulfillment of ANVISA’s notes in the shortest time would only be possible by interrupting Covaxin’s production completely, consequently affecting the supply to countries that have already received the product and have already authorised its emergency use, which is extremely inconsistent and imprudent in this current world situation,” the PM statement said, pointing out that Brazilian laws allow the vaccine to be authorised nevertheless for emergency and exceptional use, even without the certification.

The development follows weeks after Serum Institute of India (SII) had informed Brazil’s state-owned vaccine importer Fiocruz that supplies of further Covishield (AstraZeneca) doses could not be guaranteed due to a number of reasons.

“Regrettably a fire at one of our buildings has caused obstacles to the expansion of our monthly manufacturing output,” Adar Poonawala, CEO, SII, wrote to Nisia Trindade Lima, President, Fiocruz on March 4. The latter — a state agency — was to produce and distribute Covishield in Brazil. The Hindu has seen this letter. “We ask for your understanding that under these circumstances supply to you cannot be guaranteed in the foreseeable months due to this force majeure … we can update you on the status of supply by mid of April,” Mr. Poonawala said.

Consignment delayed

Covishield was given emergency approval by ANVISA in January and two million doses were shipped to Brazil as part of a commercial consignment, which itself was delayed by several weeks after the government held up clearances for the shipment and the special plane originally meant to carry the doses, pending the rollout of the vaccine in India, which began on January 16. Thanking Prime Minister Narendra Modi personally for the shipments at the time, Brazilian President Nair Bolsonaro, who is under considerable criticism domestically for his handling of the coronavirus crisis, had likened the vaccines to the life-giving “Sanjeevani booti” plant in the Ramayana.

Brazil has the second highest number of coronavirus deaths in the world and is adding nearly 1,00,000 fresh cases a day. It has recorded 12.7 million cases, just behind the United States and above India. While there are five vaccines approved, it has struggled to make available adequate doses. Only 2% of Brazilians have got two vaccine shots and about 7% have got one shot.

In comparison, India has administered two shots to 0.7% of its population and 4% have got at least one shot. Bharat Biotech has reported an interim efficacy of 81% of its vaccine in a phase 3 trial involving about 25,000 volunteers.

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