EngineChem CMO COVID-19 Vaccine Granted Emergency Use Authorization in India as a Two-Dose Vaccine

[Asia Economy Reporter Lee Chun-hee] Zyidus Lifesciences' plasmid DNA (pDNA) COVID-19 vaccine ZyCoV-D, manufactured under contract by Enzychem Lifesciences, has received emergency use authorization in India as a two-dose vaccine.

According to Enzychem Lifesciences on the 29th, Zyidus announced, "ZyCoV-D obtained emergency use authorization from the Drugs Controller General of India (DCGI) on the 26th (local time) as a two-dose vaccine." Previously, it had received emergency use authorization from DCGI in August last year as a three-dose vaccine, and the convenience has been greatly improved with the two-dose regimen.

ZyCoV-D was originally developed as a vaccine administered in three doses of 2 mg each at 28-day intervals, but Phase 3 clinical trial results showed that subjects who received only the first two doses out of three had more than a tenfold increase in cellular immunogenicity. Based on this, tests were conducted on 3,100 healthy volunteers aged 12 and above in India, and the dosing regimen was improved to two doses of 3 mg each administered 28 days apart. This method was recognized for its efficacy by the DCGI, leading to emergency use authorization.

Shavil Patel, CEO of Zyidus, stated, "The two-dose regimen of ZyCoV-D will increase vaccine compliance and reduce the time required for vaccination, thereby enhancing immunity against the virus." He added, "This will help vaccinate a larger population in a shorter time during the pandemic." Son Ki-young, Chairman of Enzychem Lifesciences, also said, "The improved dosing regimen enhances vaccination convenience, which is expected to increase demand." He further stated, "We have completed registration with domestic and World Health Organization (WHO) authorities and will succeed in the vaccine business to prepare for a leap as a global vaccine company."