Vax market authorisation conditional on data submission: Health Ministry

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New Delhi, 28 Jan 2022: The market authorisation of two Covid vaccines – Covaxin and Covishield, given by drug regulator Drug Controller General of India is the subject to the condition of submission of ongoing clinical trial data and safety data of the vaccines, the Union Health Ministry said on Thursday.


It said that the firm shall submit data of overseas ongoing clinical trials of the product with due analysis on a six monthly basis or as and when available, whichever is earlier. As per the ministry, the vaccine will be supplied for programmatic setting only and all vaccinations in the country will be recorded on CoWIN platform.


“The Adverse Event Following Immunisation (AEFI) and the Adverse Event of Special Interest (AESI) shall continue to be monitored. The firm shall submit the safety data including AEFI and AESI with due analysis on six monthly basis or as and when available, whichever is earlier as per NDCT Rules, 2019,” a Ministry statement said.


After the Central Drugs Standard Control Organiation’s Subject Expert Committee recommendation for upgradation of vaccine status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population on January 19, the DCGI gave its nod to market authorisation of Covaxin and Covishield subject to certain conditions on Thursday.


“Conditional Market Authorisation is a new category of market authorisation that has emerged during the current global pandemic of Covid-19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines,” the Ministry said.



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