Marketing authorization for Vax conditional on the submission of data: Ministry of Health

New Delhi, Jan. 28 (IANS): The marketing authorization of two Covid vaccines – Covaxin and Covishield, granted by the drug regulator Drug Controller General of India is subject to the submission of ongoing clinical trial data and vaccine safety data , the Union Health Department said on Thursday.

He said the company will submit data from ongoing overseas clinical trials of the product with appropriate analysis every six months or as it becomes available, whichever comes first. According to the ministry, the vaccine will be provided only for the programmatic framework and all vaccinations in the country will be registered on the CoWIN platform.

“Adverse Event Following Vaccination (AEFI) and Adverse Event of Special Interest (AESI) should continue to be monitored. is earlier under the NDCT Rules, 2019,” a ministry statement said.

Following the recommendation of the Central Drugs Standard Control Organization’s expert committee to upgrade the status of the vaccine from restricted use in emergency situations to the granting of a new drug authorization with conditions in the adult population on January 19, the DCGI gave the green light to the marketing authorization for Covaxin and Covishield under certain conditions on Thursday.

“Conditional marketing authorization is a new category of marketing authorization that has emerged during the current global Covid-19 pandemic. Approval pathways through this pathway are expedited with certain conditions to improve access to certain pharmaceuticals to meet emerging needs for medicines or vaccines,” the ministry said.

Maria J. Book