The Indian government has granted an in-principle approval for two vaccines against Coronavirus, setting the stage for the roll out of the first phase of mass vaccination in the country. The Subject Expert Committee (SEC) of the Central Drug Standards Control Organisation recommended grant of permission for restricted emergency use of Serum Institute of India’s (SII) Covishield vaccine as well as Bharat Biotech’s indigenous Covaxin vaccine.
The SEC’s recommendations will now be perused by the Drugs Controller General of India (DCGI), who will grant the final approval. The SEC had met on Thursday to appraise Serum Institute’s proposal seeking approval for Covishield, which has been developed and manufactured in India using a master seed from Oxford University-AstraZeneca.
SEC approved Covishield for restricted use with certain conditions, which included among others providing a factsheet to those getting the shot and an informed consent form, sources said.
On Saturday, the SEC met again to deliberate on Bharat Biotech Limited’s Covaxin. Curiously, SEC has recommended Covaxin for restricted use on grounds of “abundant precaution and in public interest”, especially in the context of the mutant strain of Coronavirus that was confirmed by authorities in the United Kingdom over two weeks ago.
Along with recommendations for these two vaccines, the SEC also recommended grant of permission to Ahmedabad-based Cadila Healthcare Ltd. for conduct of Phase-III trials of their vaccine, funded by the Department of Biotechnology.
Accelerated approval for new medicines and drugs is granted following the New Drugs and Clinical Trials Rules, 2019, framed under the Drugs and Cosmetics Act, 1940. The Rules provide a relaxation for skipping Phase III clinical trials or allow appraisal of limited data.
If the new drug or vaccine shows ‘remarkable efficacy’ with a defined dose in the Phase II clinical trial and if there are ‘unmet medical needs of serious and life threatening diseases in the country’, then the Rules provide a room to recommend approval.