Omission of the condition means the vaccine can be administered without an informed consent from the recipient and also removal of compensation provision in case of adverse event under the clinical trial protocol, an official said. This, however, does not mean there will be no compensation for an adverse event, but it will be under a different set of rules.
Once the proposal gets a final nod from the Drugs Controller General of India, Bharat Biotech will have to make relevant changes to its fact-sheet and protocol, an official said. The SEC’s recommendations are based on interim findings from Phase 3 trials of Covaxin which showed that the vaccine had an efficacy of 80.6%. A more detailed study based on Phase 3 trials is awaited.
Removal of the “clinical trial mode” is expected to increase acceptance of Covaxin, which is the first locally developed and manufactured vaccine against Covid-19, for which Bharat Biotech collaborated with ICMR.
Covaxin is also the first vaccine to have come out with Phase 3 data locally. The vaccine based on whole-inactivated virus also has higher chances to be effective against mutations, experts say. Apart from its efficacy and safety, Covaxin also has other advantages. For instance, it is stable at 2-8 degree Celsius – which is normal refrigerator temperature. It also comes in a ‘ready to use’ liquid formulation that allows distribution using the existing cold chain and supply machinery.
Both Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield, developed by Oxford University and AstraZeneca, were given emergency use authorisation for restricted use in January.
While Covishield’s interim efficacy data from outside India was considered for its approval, Covaxin was criticised as the drug regulator allowed it for emergency use under “clinical trial mode” based on Phase 1 and 2 data.
Despite the government running an intensive awareness campaign to remove vaccine hesitancy and standing firm endorsing safety and efficacy of both the vaccines, states like Chhattisgarh refused supplies of Covaxin, partly, it is felt by the Centre, for political reasons.
Though the acceptance of Covaxin has improved significantly, with PM Narendra Modi himself receiving the vaccine earlier this month, removal of the “clinical trial mode” is a validation of the vaccine.
The Phase 3 results of Covaxin showing nearly 81% efficacy is seen by the Centre as a major validation of the scientific process and regulatory decision-making while granting emergency use authorisation, that helped in a timely rollout of the nationwide vaccination programme on January 16. Till Wednesday evening, over 2.52 crore doses of the two vaccines had been given to people across the country.