Indian drugmaker Zydus Cadila said on Thursday it has applied to the country’s drug regulator for emergency use approval of its Covid-19 vaccine, which showed a 66.6% efficacy against positive cases in an interim analysis.
The candidate, if approved, would become India’s second successful home-grown Covid-19 shot and help ease the country’s severe vaccine shortage.
Coronavirus cases in India have dropped from a devastating peak in April and May, however, experts warned of a third wave and reiterated that widespread vaccination remains one of the best defences against the pandemic.
Zydus said the vaccine, which is a three-course regimen, showed safety and efficacy in a late-stage trial with more than 28,000 volunteers across the country, including about 1,000 subjects in the 12-18-year age group.
The drugmaker said it is also evaluating a two-dose regimen for the shot and the immunogenicity results of the shorter course have been found to be comparable with the three-dose regimen.
“This will further help in reducing the full-course duration of vaccination," the drugmaker said, adding that it plans to manufacture up to 120 million doses of the shot annually.
An approval for the vaccine, ZyCoV-D, would make it the fifth shot authorised for use in India. The country has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech, and Russia’s Gamaleya Institute.
Zydus said the study was carried out “during the peak of the second wave of COVID-19" in India and reaffirmed the vaccine’s efficacy against new mutant variants, especially, the Delta variant. However, it did not disclose efficacy rate against those variants.
Earlier, Dr NK Arora, Chairman, COVID working group, was quoted as saying: “Trial for Zydus Cadila vaccine is almost complete. By July end or in August, we might be able to start administering this vaccine to children of 12-18 age group."
Further, citing an ICMR study, he said the country has 6 to 8 months to inoculate its people before the third wave hits. “ICMR has come up with a study which says 3rd wave is likely to come late. We’ve window period of 6-8 months to immunise everybody in country. In coming days, our target is to administer 1 crore doses every day," he said.
The Union Health Ministry on Saturday informed the Supreme Court that the new vaccine developed by Zydus Cadila will soon be available for inoculation for the 12-18 years of age bracket. It said the government was aiming towards ‘vaccination-for-all’ by December this year.