DCGI emergency use nod for Covaxin, Corbevax and ZyCoV-D across age groups

Covaxin bags approval for 6-12-year age group, Corbevax for 5-12 group, and ZyCoV-D for 12 years and above

The Drug Controller General of India (DCGI) on Tuesday granted emergency use approvals to COVID-19 vaccines Covaxin, Corbevax and ZyCoV-D.

While the emergency use authorisation (EUA) was granted to Bharat Biotech's Covaxin for the age group of 6-12 years, Biological E's Corbevax bagged the nod for 5-12 years age group and Zydus Lifesciences Ltd.'s ZyCoV-D for 12 years and above.

Despite the EUA, a final decision on rolling out the vaccines will be taken by the government's expert body. Currently, Corbevax for 12-14 years and Covaxin for adolesecents are being administered in the country.

With this approval, Zydus's ZyCoV-D vaccine will now be administered on day 0 and day 28. Earlier, the vaccine was approved in a three dose regimen to be administered on day 0, day 28 and day 56.

The approval will increase the compliance for the vaccine and reduce the overall time required for vaccination to improve immunity against the virus, said Dr. Sharvil Patel, managing director of Zydus Lifesciences. "It will also help in administering the vaccine in a larger population in a shorter time which is always desirable in the midst of a pandemic."

The two dose regimen for ZyCoV-D was tested in 3100 healthy volunteers more than 12 years of age.

Earlier, the safety and efficacy analysis data from Phase III clinical trial of its Plasmid DNA COVID-19 vaccine ZyCoV-D (three dose regimen) has been peer reviewed and published in The Lancet, a reputed and well known medical journal. The results of the Phase I part of the Phase I/II clinical trial (three dose regimen) has also been published in the EClinical Medicine Journal of The Lancet.

Being manufactured at its newly commissioned state-of-the-art, Zydus Vaccine Technology Excellence Centre at the Zydus Biotech Park in Ahmedabad, ZyCoV-D is one of the first plasmid DNA vaccines administered intradermally using a painless needle-free system in three doses.

The group had received an order from the government to supply 10 million doses of ZyCoV-D in November 2021.

The vaccine is priced at Rs 265 per dose while the PharmaJet needle free system Tropis applicator will be offered at Rs 93 per dose, excluding GST.

Drug substance for the needle-free DNA Plasmid vaccine, ZyCoV-D is being manufactured by Zydus VTEC with the manufacturing process and in process material transfers within the plant being automated.

Moreover, Zydus has also entered into a definitive agreement with Shilpa Medicare Limited, a contract manufacturer to produce mutually agreeable doses of ZyCoV-D. The company also entered into an agreement with Enzychem Lifesciences of Republic of Korea for the manufacturing license and technology transfer for the plasmid DNA Vaccine.