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Bharat Biotech said that it will continue to work with Brazilian drug regulatory body to complete the regulatory approval process for Covaxin.

Dr Krishna Ella, founder of Bharat Biotech, addressing a gathering at a summitImage courtesy: Bharat Biotech/Twitter
news Controversy Saturday, July 24, 2021 - 09:25

Hyderabad-based vaccine manufacturer Bharat Biotech on Friday said that it had terminated the Memorandum of Understanding (MoU) with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for the Brazilian market, with immediate effect. The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine for $320 million (Rs 2,375 crore) landed in controversy and attracted investigation by authorities in that country.

An investigation was launched in Brazil after Covaxin, which had allegedly not cleared all regulatory hurdles, was sold comparatively for higher prices than Pfizer’s vaccine, which had regulatory approval. Each dose of Covaxin was sold for $15. Precisa Medicamentos is Bharat Biotech's partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.

"The company has terminated the said MoU with immediate effect. Notwithstanding such termination, Bharat Biotech will continue to work diligently with ANVISA, the Brazilian drug regulatory body to complete the regulatory approval process for Covaxin," it said. Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country, it said.

Bharat Biotech signed a MoU with Precisa Medicamentos and Envixia Pharmaceuticals LL.C on November 20 for the purpose of introducing Covaxin in the territory of Brazil. The global pricing of the vaccine has been set between $15-20 and accordingly, the jab was offered to the Government of Brazil at the rate of $15 per dose, Bharat Biotech said. It is further stated that the company has not received any advance payments from, nor has it supplied any vaccines to the Ministry of Health in Brazil.

The vaccine maker stressed that all its actions, including its global dealings, are done in accordance with local laws and the company employs and follows the highest standards of ethics, integrity and compliance at all times.

 
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