Expert panel recommends emergency use authorization for Zydus's three-dose vaccine
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting an emergency use authorization (EUA) to ZyCoV-D, the three-dose COVID-19 vaccine developed by Zydus Cadila, on Friday. Once approved by the Drug Controller General of India (DCGI), ZyCoV-D will become the first-ever plasmid DNA vaccine in the world to be used against COVID-19. Here's more.
Zydus Cadila's ZyCoV-D is a three-dose vaccine and each dose is given 28 days apart—the second and third doses are administered 28 days and 56 days after the first dose, respectively. Moreover, the vaccine would be administered intradermally with the help of a needle-free injector. If approved for use by the DCGI, ZyCoV-D will be the second indigenous vaccine to be used in India.
To recall, Ahmedabad-based Zydus Cadila had applied for the EUA from the DCGI for its COVID-19 vaccine on July 1. Earlier on Thursday, the SEC on COVID-19 had deliberated on the pharma major's application and decided to recommend granting the EUA to its ZyCoV-D. The expert panel has further sent its recommendations to the national drugs regulator for final approval.
Once cleared for use, ZyCoV-D will become the second indigenous COVID-19 vaccine after Hyderabad-based Bharat Biotech's COVAXIN and the sixth vaccine to be approved in India. So far, India has authorized five vaccines: Covishield, COVAXIN, Sputnik V, Moderna's vaccine, and J&J's single-dose vaccine.
According to Zydus Cadila, it has conducted the largest clinical trial for ZyCoV-D in the country in more than 50 centers so far. Notably, trials were also conducted in the 12-18 years age group. Apart from adolescents, the company is also planning to conduct trials on children aged above five years. Zydus Cadila claims its COVID-19 vaccine provides protection against the Delta variant, too.
As mentioned before, ZyCoV-D is an intradermal vaccine administered using a needle-free injection system, which may also reduce several post-immunization side-effects. Usually, the needle-free injection procedure involves accelerating a fluid jet to high speeds so that it penetrates between the layers of the skin (intradermal) through a specialized fine-diameter nozzle. To note, all the vaccines currently being used in India are administered intramuscularly.
Zydus Cadila said ZyCoV-D is 66% effective against symptomatic COVID-19 cases and has shown a 100% efficacy rate against moderate cases. It can be stored at 2-8 degrees Celsius and remains stable even at 25 degrees Celsius for up to three months. ZyCoV-D has been developed by Zydus Cadila in collaboration with the Department of Biotechnology and the Indian Council of Medical Research (ICMR).