Brazil’s Covaxin order still active, clarifies Bharat Biotech after regulator denies certification

New Delhi: Bharat Biotech has said that Brazil government’s order of 20 million doses of Covid-19 Covaxin is still active and that it will fulfil certain requirements pointed out during the inspection by Brazilian health regulator Anvisa.

The Hyderabad-based vaccine maker’s clarification came after reports that Anvisa denied permission to import Bharat Biotech’s Covaxin into the country

The health regulator refused to grant a certification of Good Manufacturing Practices (GMP) to Covaxin, citing non-compliance with necessary standards. It suspended the request of Brazil’s health ministry to import the vaccine.

GMP certification by Anvisa is a must for import and sale of drugs and vaccines in Brazil.

The regulator, whose team visited Bharat Biotech’s vaccine-making facility at Genome Valley in Hyderabad last month, reportedly found certain non-conformities indicating risk to vaccine’s manufacturing and product quality assurance.

The regulator flagged the issues relating to vaccine potency, sterilisation, viral inactivation and purity. It observed that the vaccine maker has not validated the method of analysis that proves that the virus was completely inactivated during manufacture.

Bharat Biotech, however, maintained that the requirements pointed out during inspection will be fulfilled. It also clarified that the agreement with Precisa Medicamentos, its Brazilian partner, will also continue.

Sources in Bharat Biotech told IANS that seeking more information or certain clarifications is common during inspections and regulatory procedures followed by drug regulators across the world. “This is not uncommon. We will definitely be fulfilling the requirements pointed out during the inspection,” they said.

Bharat Biotech had announced on February 26 that 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. The value of the deal is estimated at around Rs 2,140 crore

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It was on January 12 that Bharat Biotech announced that it has signed an agreement with Precisa Medicamentos for the supplies of Covaxin to Brazil.

This followed the visit by a team from Precisa Medicamentos to Bharat Biotech facility in Hyderabad to discuss potential export possibilities of Covaxin, India’s first Indigenous vaccine for Covid.

The team had met Bharat Biotech Chairman and Managing Director Dr Krishna Ella. It was revealed that during the discussion, Brazil’s ambassador to India, Andre Aranha Correa do Lago joined on a virtual platform. He expressed his keen interest on behalf of the government of Brazil, towards the procurement of covaxin.

Both the parties agreed to prioritise supplies of Covaxin for the public market, through a direct procurement by the government of Brazil. Supplies to the private market would be based upon receipt of market authorisation from Anvisa, the Brazilian regulatory authority, it was stated.

“We identified highly technological, scientific and sanitary control levels. There were also excellent outcomes in clinical trials, which will be published soon. Bharat Biotech has exceeded our expectations, demonstrating quality and safety at the level of the largest vaccine suppliers in the world,” a statement by Bharat Biotech had quoted pharmaceutical director of Precisa Medicamentos, Emanuela Medrades as saying.

Bharat Biotech has developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.

Covaxin, one of the two vaccines currently being administered in India, is a highly purified and inactivated 2 dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, says the vaccine maker.

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The company claimed last month that the vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its Phase 3 clinical trial.

The Phase III human clinical trials of Covaxin began mid-November and are currently ongoing in about 26,000 volunteers across India.

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