New Delhi: 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).
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation," DCGI Dr VG Somani told a press conference here.
Somani, who did not take any questions from the reporters, later told mediapersons the vaccines are 100% but some side effects like mild fever, pain and allergy are common for every vaccine.
"We'll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine," Somani said as reporters confronted him with questions after the press conference.
When asked about rumours that it may cause impotency, Somani said, "It is absolute rubbish."
This paves the way for the roll out of at least two vaccines in India in the coming days.
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The authority also granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said.
Serum and Bharat Biotech 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, SII 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.
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 vaccine first?
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.
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.
(With agency inputs)