New Delhi, Jan 3: 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 VG Somani told the media here.
This clears 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 vaccines have to be stored at 2-8° C,” Somani 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.
Health Minister Harsh Vardhan termed it a “watershed moment in India’s battle against Covid-19”.
The World Health Organisation also welcomed the move, saying it will “help intensify and strengthen the fight against the pandemic in the region”.
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.”
Serum was also granted permission to conduct Phase-2/3 clinical trials on 1,600 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 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.
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.
Pfizer had also applied for regulatory approval for its vaccine on December 4 but not much progress has been made on it after that. (PTI)