New Delhi, Jan 3 :Eleven months after the first case of deadly coronavirus was detected in India, Drug Controller General of India (DCGI) V.G. Somani on Sunday approved Serum Institute of India's 'Covishield' vaccine and Bharat Biotech's 'Covaxin' for emergency use, paving way for its roll-out and administration to millions.
"After adequate examination, the CDSCO has decided to accept the recommendations of the Subject Expert Committee and accordingly, vaccine of Serum and Bharat Biotech are being approved for restricted use in emergency situation," the Drugs Controller General of India Dr. V.G. Somani said.
Covishield and Covaxin have to be administered in two doses and can be stored at 2-8 degree Celsius. The Drugs Controller General of India has also granted permission to Cadila healthcare for phase 3 clinical trial in India.
This is a major relief for India which has the second highest number of infections in the world after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.
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.
On Saturday, Union Health Minister Harsh Vardhan had announced that one crore healthcare workers, along with two crore frontline workers will get the vaccine for free.
The Subject Expert Committee, tasked with vetting the vaccine proposals, had recommended Oxford-Astra Zeneca's 'Covishield' and Bharat Biotech's indigenous 'Covaxin' for emergency use approval on January 1 and 2, respectively. The final call was to be taken by the DCGI.
The expert panel recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains.
The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
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 and Bharat Biotech Pfizer had applied for the accelerated approval on December 6 and 7, respectively.
Serum Institute of India had submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged more or equal to 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent.
Further, Serum was granted permission to conduct Phase-II/III clinical trials on 1,600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.
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.
Oxford-AstraZeneca vaccine will play a major role in India's plan to vaccinate its population against Covid-19 due to several factors -- low-cost, ease of storage and transport.
Serum Institute of India this week said that 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).
The firm had generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters.
All this data was shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response.
The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.