Zydus Cadila’s India-made 3-dose Covid vaccine approved for use by expert panel

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The subject expert committee of India's central drug authority has recommended granting emergency use authorisation to Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D, a senior official confirmed.</p>
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The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval which is expected to be a mere formality.</p>
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The Ahmedabad-based pharmaceutical company had applied for emergency use authorisation to the DCGI for the ZyCoV-D vaccine on July 1. The vaccine has on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide which included about 1,000 subjects in the 12-18 year age group.</p>
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ZyCoV-D is the first Plasmid DNA-based vaccine for human use to be administered intradermally using a needle-free injector, Cadila Healthcare MD Sharvil Patel.</p>
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He had also said that the vaccine, when approved, would help not only adults but also adolescents in the 12 to 18 years age group.</p>
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The trial for the vaccine was carried out "during the peak of the second wave of COVID-19 in India, reaffirming the vaccine's efficacy against the new mutant strains, especially the Delta variant," Zydus had informed the stock exchanges.</p>
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Zydus Cadila has said it plans to manufacture up to 120 million doses of the shot annually.</p>
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The government had earlier said the vaccine would be approved soon.</p>
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The committee, which met on Thursday, added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine, CNBC-TV18 said in a tweet.</p>
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If finally approved, Zydus Cadila's vaccine will be the second indigenous shot to get emergency authorisation in India after Bharat Biotech's Covaxin.</p>
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It would also be the sixth vaccine to be approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson.</p>