New Delhi: India’s drug regulator Drugs Controller General of India (DCGI) will consider giving emergency use authorisation (EUA) to Zydus Cadila for its Covid-19 vaccine ZyCoV-D in a few more days, sources told ANI.
“Subject Expert Committee (SEC) is expected to meet this week and will review the data. However, final approval for EUA will be given only after a few meetings,” sources said. Sources further informed that the DCGI’s SEC will examine data submitted by Zydus Cadila for children above 12 years.
But if data found to be satisfied then final approval from DCGI may be granted in few days.
ZyCoV-D, a DNA Covid vaccine, carries the genetic code for that part of a virus that triggers the immune system of the body. According to sources, the continuous and rolling review of data is ongoing and even if SEC meeting takes place this week then final approval will take few more days.
On July 4, Union Health Minister Mansukh Mandaviya had visited the Zydus Biotech Park at Ahmedabad where production of covid-19 vaccine ZyCoV-D takes place. ZyCoV-D is a three-dose Covid shot, the world’s first Plasmid DNA vaccine.
— Mansukh Mandaviya (@mansukhmandviya) July 4, 2021
Later on Friday, Dr VK Paul, Member (Health) of the NITI Aayog told ANI that a decision on the approval of Zydus Cadila’s Covid-19 vaccine is expected soon, adding that the data and evaluation would determine the outcome.
NITI Aayog member (Health) Dr V K Paul on July 9, in response to a question on the vaccine of drug firm Zydus Cadila, said the company had submitted its third phase trial results to the Drugs Controller General of India (DCGI) last week. “Zydus Cadila has submitted its phase-3 trial results to the DCGI last week and scientific evidence is being probed and the process of exchange of information is actively going on,” he said.
In this trial, Paul said children were also included and “we are hoping that after all this data gets evaluated through scientific process then recommendations will be followed, and if there is enough evidence to support vaccination by this vaccine for children between 12-18 years then that will also be provided at that time depending upon the robustness of the data and scientific evidence”. “We should wait for that process to be over and for a decision to be made by the scientific system in the DCGI,” he had informed.
India has so far approved SII’s Covishield, Bharat Biotech’s Covaxin, Gamaleya’s Sputnik-V, and most recently Moderna’s Covid-19 vaccine. The government said on Friday that it is working actively with COVID-19 vaccine manufacturer Moderna to see how its vaccine can be imported and made available in the country.
(With inputs from PTI and ANI)