Production of 3rd India-made Covid vaccine starts, final nod for use likely by June

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Indian pharmaceuticals firm Cadila Healthcare has started producing its potential COVID-19 vaccine for which it will seek emergency use authorisation in May or June, the company’s managing director Sharvil Patel told Reuters news agency.</p>
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The Ahmedabad-based company eventually plans to roll out 240 million doses a year.</p>
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Patel said unlike some other pharmaceutical companies that have been adversely impacted by the US restrictions on exports of vaccine raw material, Cadila was sourcing all its ingredients domestically.</p>
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He was referring to the Adar Poonawalla-led Serum Institute of India which has been hit since the US has imposed a ban on the export of raw material for the AstraZeneca-Oxford vaccine manufactured by the Pune-based company.</p>
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Patel said, "We did anticipate those challenges. Everything for us is done in India. Our supply chain is secure. We don’t have any issues for the next 14-15 months."</p>
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"We have just started producing doses," Sharvil Patel said in a Microsoft Teams interview on Friday. "But it is not meaningfully large."</p>
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He said the company plans to produce 10 million doses a month starting from June, taking the in-house annual capacity to 120 million. The rest of the production, as required, will mainly come from third-party producers. Patel said the company was already in talks with two other manufacturers and would slowly add more to the list.</p>
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Cadila’s vaccine is a DNA plasmid product which involves the injection of a small part of the virus's genetic code (DNA or RNA) to stimulate immune response in the recipient. It is currently meant to be given in three doses but the company is also carrying out trials on a two-dose regimen.</p>
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India had exported more than 66 million Covid-19 vaccines to 80 countries but has now been forced to curtail exports because the country has been hit by a devastating second wave of the Covid-19 pandemic.</p>
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The country’s inoculation campaign is being ramped up to include all adults from May 1 which will require a much larger number of vaccine doses. </p>
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<strong>Other vaccines in pipeline</strong></p>
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India is currently using the AstraZeneca-Oxford  shot and homegrown Covaxin manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research.</p>
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Amongst the other vaccines in the pipeline, India has already given the go-ahead for the production and distribution of Russia’s Sputnik V vaccine in the country. The government has also put on the fast track approvals for foreign-produced COVID-19 vaccines that have been granted emergency authorisation in other countries. This has paved the way for Johnson & Johnson to enter the country and the US pharma giant has applied for approval from the Indian drugs regulator.</p>
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Since the J&J vaccine has been approved for use in the United States, the European Union and other nations including Thailand and South Africa it can be rolled out  under the new liberalised rules in India. </p>
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J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine while US pharma giant Novavax has an agreement with Serum Institute of India.</p>