India's drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
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.
Who will get the vaccine first?
Based on the potential availability of vaccines the Government of India has selected the priority groups who will be vaccinated on priority as they are at higher risk.
As per the FAQs The first group includes healthcare and frontline workers. The second group to receive COVID 19 vaccine will be persons over 50 years of age and persons under 50 years with comorbid conditions
How to register to COVID-19 vaccine?
At present, data of the beneficiaries collected from the government and private health facilities and is being fed into CoWIN, a digital platform to roll out and scale up the vaccination drive.
However, the self-registration module will be made available in the later phases of the implementation.
(With inputs from agencies)