India’s Biological E. Ltd poised to roll out new Covid vaccine in August

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Indian pharmaceuticals major Biological E. Ltd will soon start Phase III trials of its COVID-19 vaccine and plans producing 75 million to 80 million doses a month from August, the company’s managing director Mahima Datla told <em>Reuters</em> on Friday.</p>
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The company has developed the vaccine in collaboration with Baylor College of Medicine in Houston and Dynavax Technologies Corp. It had received approval last month from the Drug Controller General of India (DCGI) to carry out a Phase III clinical trial which will begin soon.</p>
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Government officials have said the vaccine, which uses the recombinant-protein technology in which a harmless agent is used to stimulate an immune response in cells, is likely to be manufactured in the country from August.</p>
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Datla said Biological E. would apply for emergency use authorisation (EUA) for the drug based on government advice.</p>
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Production "from August but EUA depends on the government. Will follow  their advice and directives," she said in a text message. "75-80 million doses a month from the time of launch."</p>
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However, she did not divulge any information on how the company’s plan to contract-manufacture the single-shot Johnson & Johnson vaccine was progressing. She had said in February that Biological E. had chalked out plans make about 600 million doses of the J&J vaccine annually.</p>
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J&J said last month it was in talks with India's government to begin a clinical trial of its single-dose shot.</p>
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The contract also figured in the Indo-Pacific summit convened by US President Joe Biden. It was decided at the meeting that India’s manufacturing facilities would be used to produce Johnson & Johnson and Novavax Covid vaccines with the help of finance from the US and Japan. Australia the fourth member of the Quad was expected to pitch in with logistical support.</p>