Indian drugmaker Zydus Cadila (CADI.NS) 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 authorized for use in India. The country has already approved vaccines from Moderna (MRNA.O), AstraZeneca (AZN.L) 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.
If it gets approval this would be the one of the first vaccine in India for children below 12 years of age.