Hyderabad-based vaccine conglomerate 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.
Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country, the company said. The ending of the MoU came after the deal with the Brazilian government for the supply of 20 million doses of the vaccine for 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 pressures, was sold comparatively for higher prices than Pfizer’s vaccine, which had regulatory approval. Each dose of Covaxin was sold for USD15. 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.
However, 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.
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