Zydus Cadila's COVID-19 jab likely to receive approval before August end

A top official from the Union Health Ministry told UNI on Tuesday that the government is expecting the vaccine, named ZyKoV-D, to receive the Emergency Use Authorization status in August itself.

"The firm (Zydus Cadila) has submitted the additional data sought by the subject expert committee. They are evaluating it and we are hopeful that the vaccine will get approval within a week or two," the official mentioned above said.

If approved, the ZyCoV-D would become the sixth vaccine to be added to a large portfolio of Covid-19 vaccines cleared in the country after locally produced Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, the US-made Moderna, and Johnsons and Johnson's Janssen.

The Zydus Cadila's would also become the first vaccine in India that could be administered to children between 12 to 18 years of age.

The Ahmedabad-based pharmaceutical firm had on July 1 applied for emergency use authorization of its ZyCoV-D three-dose Covid-19 vaccine.

However, the SEC under the Drug Controller General of India (DCGI) had recommended the vaccine manufacturer to provide additional data related to immunogenicity and safety profiles of the jab.

ZyCoV-D is an intradermal vaccine, applied using a ‘needle-free injector’. The firm claims the needle-free system can lead to a  significant reduction in side effects.

Zydus has claimed to have conducted the largest clinical trial for a Covid-19 vaccine in India in over 50 centres. This was also the first time that any Covid-19 vaccine had been tested in the 12-18-year age group in the country.

The vaccine is said to have shown safety and efficacy in a late-stage trial with more than 28,000 volunteers, including 1,000 subjects in the 12-18 year age group.