An expert panel of India's central drug authority has recommended granting emergency use authorisation to Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D, sources told PTI. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application given by Zydus Cadila on Thursday and recommended granting emergency use authorisation to its three-dose coronavirus vaccine.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval. The Ahmedabad-based pharma major had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine. The company said it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
ZyCoV-D is a three-dose, intradermal vaccine, and interim analysis has shown that the vaccine has a primary efficacy of 66.6%. It is to be stored at 2-8ºC and has shown good stability at temperatures of 25ºC for at least three months as well, the company said. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage.
If approved, ZyCoV-D will be the world's first DNA vaccine against the novel coronavirus infection, developed by an Indian company and become the sixth vaccine which has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson.
Plasmid DNA-based ZyCoV-D is to be administered intradermally using a needle-free injector.
Sharvil Patel, managing director, Cadila Healthcare had said that the vaccine, when approved, would help not only adults but also adolescents in the 12 to 18 years age group. Last month, the Union government told the Supreme Court that Zydus Cadila has concluded its clinical trial for between the age group of 12 to 18 years, and subject to the statutory permissions, the same may be available in near future for children of the age group of 12 to 18 years of age in India as well.
(With PTI inputs)