The Central Drug Standards Control Organization (CDSCO) on Sunday approved two vaccines developed by the Serum Institute of India (SII) and the Bharat Biotech for public use. ‘Covishield’ of serum institute of India and ‘Covaxin’ of Bharat Biotech got approvals for ‘restrictive emergency use’. Drug Controller General of India (DCGI) V.G. Somani on Sunday revealed this in a press conference.
Formal approval came after a subject expert committee (SEC) of the CDSCO recommended that permission be granted “for restricted use in emergency situation in public interest.” Somani said that Bharat Biotech’s ‘Covaxin’has 70.42 percent efficacy rate.
This is a major relief for the people who are waiting for vaccine. These approvals paving the way for their roll-out and administration to crores of people allover India. Government has conducted a dry run before the main task of vaccinating nearly 30 crore people in first phase.
The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.
India has the second highest number of infections after the US and nearly 1.5 lakh people perished with the pandemic.
Pune-based Serum Institute of India has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing ‘Covishield’, while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for ‘Covaxin’.
Serum Institute and Bharat Biotech had applied for the accelerated approval on December 6 and 7 respectively. The Subject Expert Committee had recommended ‘Covishield’ and indigenous ‘Covaxin’ for emergency use approval on January 1 and 2 respectively.
The expert panel recommended granting permission for restricted emergency use of ‘Covaxin’ in “public interest as an abundant precaution” in the context of infection by mutant strains.
The UK and Argentina have already approved the Oxford-AstraZeneca vaccine. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, Serum Institute of India. Serum Institute of India this week said it has a stockpiled 40-50 million doses of its Covid-19 vaccine. India is likely to receive a majority of these 50 million doses.
As far as Bharat Biotech’s Covaxin is concerned, it is India’s first indigenous vaccine for coronavirus. The inactivated virus vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
