An expert panel under India’s top drug regulator on Saturday recommended restricted emergency approval for Covaxin, Bharat Biotech’s Covid-19 vaccine candidate that is currently under testing in the country.
– The expert panel has now recommended restricted clearance for two vaccine candidates in as many days—on Friday,it recommended similar approval for Covishield,The variant of the Oxford-AstraZeneca vaccine that is being manufactured under licence in India by Pune-based Serum Institute of India.
– Covaxin, the indigenous Covid-19 vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology, became the second vaccine in India to inch one step closer to the final approval for emergency use. The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Saturday recommended Covaxin for restricted emergency use. On Friday, Serum Institute of India’s Covishield was given the recommendation. Both will now have to wait for the final approval from the Drug Controller General of India (DCGI).
The development comes on a day a nationwide dry run exercise of vaccination was conducted under the supervision of the Union health ministry. Union minister Prakash Javadekar on Saturday said India is perhaps the only country which has several vaccine candidates almost ready.
Bharat Biotech had applied for emergency-use authorisation first on December 7. The expert panel at that time asked the firm to submit its safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.
On Friday, as the expert panel looked into the details of both Covishield (Oxford/Astrazeneca vaccine) and Covaxin (Bharat Biotech), it asked Bharat Biotech to expedite volunteer recruitment for the ongoing third phase trial. A day after came the recommendation. – Both the vaccine candidates have been recommended for restricted emergency use which comes with a few riders. For Oxford vaccine, the panel has imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of four to six weeks.
Bharat Biotech’s vaccine candidate is an inactivated one which is developed by inactivating (killing) the live microorganisims that cause the disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response. There are many inactivated vaccines against Hepatitis A, Influenza, Polio, Rabies, which offer “excellent protection”, Bharat Biotech has said.