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.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval which is expected to be a mere formality.
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.
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.
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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.
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.
Zydus Cadila has said it plans to manufacture up to 120 million doses of the shot annually.
The government had earlier said the vaccine would be approved soon.
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.
If finally approved, Zydus Cadila's vaccine will be the second indigenous shot to get emergency authorisation in India after Bharat Biotech's Covaxin.
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.