January 4, 2020: Drugs Controller General of India (DCGI) granted permission to Bharat Biotech’s indigenous COVID-19 vaccine ‘Covaxin’ and Oxford-AstraZeneca’s ‘Covishield’ vaccine produced by Serum Institute of India. The vaccines have been permitted for “restricted use in emergency situation.” India has become the third country to approve Oxford-AstraZeneca’s vaccine.
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) recommended the Restricted Emergency Approval of COVID-19 virus vaccine by Serum Institute of India and Bharat Biotech. DCGI also granted permission to Cadila Healthcare for conduct of the Phase III clinical trial.
“A decisive turning point to strengthen a spirited fight! 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,” tweeted Prime Minister Narendra Modi.
PM Modi also lauded the efforts by doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for their efforts in a fight against COVID-19.
As per the press note released by Ministry of Agriculture & Farmers Welfare, Serum Institute of India at Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The overall vaccine efficacy was found to be 70.42%. The DCGI also granted permission to conduct Phase-II/III clinical trials of Covishield on 1600 participants within the country.
Adar Poonawala, CEO of Serum Institute of India tweeted on January 3, “Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”
Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine (Covaxin) in collaboration with Indian Council of Medical Research and National Institute of Virology (Pune). 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 conducted tests and created 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. Phase I and Phase II clinical trials of the vaccines were conducted in approx. 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial of Covaxin was initiated in India in 25,800 volunteers of which approximately 22,500 participants have been vaccinated across the country. As per the statement released by the government, the vaccine has been found to be safe based on the data available till date.
Cadila Healthcare has developed Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology.