CDSCO panel approves Bharat Biotech's Covaxin for emergency use
A regulatory expert panel on Saturday accorded its stamp of approval on the emergency use of a second Covid-19 vaccine - a home-grown one this time - in India in as many days, providing the administration with more options to vaccinate 30 crore Indians by July.
The second vaccine cleared by the subject expert committee of the Central Drug Standards Control Organisation is Bharat Biotech's Covaxin, developed in collaboration with the National Institute of Virology, Pune, which isolated the vaccine strain.
The SEC granted permission to the Bharat Biotech's vaccine for restricted use in an emergency situation in the public interest, the Union Health Ministry said in a statement.
As a matter of abundant precaution in the backdrop of infections by the mutant strain, the emergency use of the Bharat Biotech's vaccine will happen in a clinical trial mode.
A ministry spokesperson, however, didn't clarify what exactly the SEC meant by the "clinical trial mode."
The company is now carrying out third and the largest phase of the clinical evaluation of the indigenous vaccine. During the trial, the efficacy of the vaccine would be compared to an unvaccinated group of people who are also part of the trial.
Out of 26,000 volunteers that it plans to recruit for the trial, 13,000 plus have been enrolled for the study.
The approval comes a day after the same expert panel cleared Serum Institute's Covishield vaccine, which is based on exactly the same technology and master-seed as used in the Oxford University-AstraZeneca vaccine that received approval from the UK regulator.
The Serum's vaccine was recommended for emergency use subject to multiple conditions. While the ministry is silent on these conditions, the Drugs Controller General of India is likely to clear the air in an media interaction on Sunday.
The final approval for both vaccines would come from the DCGI, who would take the decision on the basis of the SEC recommendations.
"While vaccines will help protect the vulnerable, we have to be mindful that the vaccine alone without continued public health measures and individual level precautions is not going to dramatically improve the risk of being infected overnight," Comment John, a senior public health specialist at the George Institute for Global Health, Delhi told DH.
Meanwhile, more than 75 lakh Indians have registered as the willing takers of the Covid-19 vaccines so far.
The vaccines would be given free of cost to one crore healthcare workers and two crore front line workers, Union Health Minister Harsh Vardhan said here on Saturday. The Centre is yet to decide whether the remaining 27 core would also get it free.
A dry run of the vaccination campaign was undertaken all over the country to undertake any logistical challenges that may crop up when the vaccination would commence.
The SEC has also permitted Cadila Healthcare to conduct a phase 3 trial of yet another Covid-19 vaccine.
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