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 Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations 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 situations," DCGI Dr V G Somani told the media New Delhi.
This paves the way for the roll out of at least two vaccines in India in the coming days.
"Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8°C," he said.
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Prime Minister Narendra Modi termed the approval a decisive turning point in India's fight against coronavirus.
'DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,' he tweeted.
'It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,' he said in another tweet.
He also saluted the frontline workers who have been leading the country's fight against the virus.
Serum Institute of India's CEO Adar Poonawalla tweeted, 'COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.'
In his media statement, Somani also said Cadila Healthcare has been granted the permission to conduct the Phase III clinical trial of its vaccine candidate in India.
Pune-based SII's shot is a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield), encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.
"The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent," Somani said.
Further, Serum was granted permission to conduct Phase-2/3 clinical trials on 1,00 participants within the country, he said.
"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 clinical trial ongoing within the country by the firm will continue," he said.
On Covaxin, Somani said, "Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country & globally."
The firm has 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, he said.
All these data have been shared by the firm with CDSCO, he said.
The Phase 1 and Phase 2 clinical trials were conducted on approx 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response, he said.
The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 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, Somani said.
"The SEC has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue," he said.
SII had applied to the DCGI for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its Covaxin on December 7.
"In terms of safety, Covishield was well tolerated...majority of solicited reactions were mild in severity and resolved without any sequelae.
"Therefore, Covishield is safe and can be used effectively for prevention of COVID-19 in the targeted population," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.
Pfizer had also applied for regulatory approval for its vaccine on December 4 but not much progress has been made on it after that.