Drug regulator okays Zydus Cadila's three-dose Covid vaccine, first in India to be given to kids above 12

The Indian drug regulator has given emergency use authorisation (EUA) to Zydus Cadila's three-dose Covid-19 vaccine, the ministry of science and technology said. The world’s first DNA-based vaccine approved for use against Covid is also the first in India that can be administered to adolescents—those 12 years and above.

The approval was granted following the recommendation of the Subject Expert Committee (SEC), which advises the drug regulator on applications seeking approval for vaccines, new drugs and clinical trials.

• Zydus vaccine is an intradermal jab and will be applied using a needle-free injector
• It has shown 66.6% efficacy in an interim study on more than 28,000 volunteers
• This includes nearly 1,000 in the 12-18 age group
• The doses will be administered 28 days apart
• Co asked to submit more data for two-dose regimen of its vaccine
• Zydus MD had earlier said co would launch vax in 45-60 days after regulatory nod

The SEC had reviewed the Zydus filing at a meeting on Thursday, people in the know told ET.

“Zydus Cadila has received approval for Emergency Use Authorization (EUA) from the Drug Controller General of India for ZyCoV-D,” the ministry said in its release on Friday. “It’s the world’s first and India’s indigenously developed DNA-based vaccine for Covid-19 to be administered to children and adults 12 years and above.”

Sixth to Get EUA in India
All the other vaccines administered in India are for people 18 years and above.

"It is a matter of great pride that today we have the EUA for the world’s first DNA Covid-19 vaccine ZyCoV-D by Zydus developed in partnership with the Department of Biotechnology (DBT) and supported through Mission Covid Suraksha," said Renu Swarup, secretary, DBT, and chairperson, Biotechnology Industry Research Assistance Council (BIRAC).

The SEC has asked the company to submit additional data for the two-dose regimen of its vaccine, said the people cited above.

Zydus had applied for EUA on July 1.

Ahmedabad-based Zydus developed the vaccine, ZyCov-D, with the support of the DBT and the Indian Council of Medical Research (ICMR). It has shown 66.6% efficacy in an interim study on more than 28,000 volunteers, including nearly 1,000 in the 12-18 age group.

The Zydus vaccine becomes the sixth to get EUA in India, after Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Russia’s Sputnik V, and the vaccines of US companies Moderna and Johnson & Johnson.

Zydus managing director Sharvil Patel had earlier said it would launch the vaccine in 45-60 days after regulatory approval. The vaccine has a needle-free application system—it uses a spring-powered applicator that delivers the shot.

It plans to join hands with third-party manufacturers to increase production.

While the company hasn’t disclosed the price of the vaccine, it is expected to be within the range of the currently available vaccines. Private hospitals charge Rs 780 per dose of Covishield, Rs 1,410 per dose of Covaxin and Rs 1,145 per dose of Sputnik.