Hyderabad: The Drugs Controller General of India (DCGI) formally gave the approval to Hyderabad-based Bharat Biotech's Covaxin and Oxford-AstraZeneca's vaccine Covishield, manufactured by the Serum Institute of India, for restricted emergency use.
"The Central Drugs Standard Control Organisation (CDSCO) accepts the Subject Expert Committee reform rations on Serum and Bharat Biotech Covid vaccines," DCGI VG Somani said during a press conference.
Later, Prime Minister Narendra Modi congratulated the country for getting the COVID-19 vaccine.
"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 Narendra Modi
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met on 1 and 2 January and made recommendations in respect of a proposal for restricted emergency approval of COVID-19 vaccine of the Serum Institute of India and Bharat Biotech as well as phase III clinical trial of Cadila Healthcare Ltd.
The committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, pediatrics, and internal medicine.
Bharat Biotech has developed a whole virion inactivated coronavirus vaccine (Covaxin) in collaboration with ICMR and NIV (Pune) from where it 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 and 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. All these data have been shared by the firm with CDSCO. Phase I and phase II clinical trials were conducted in approximately 800 subjects and the results have 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 around 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.
The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended Covaxin for restricted use in an emergency situation in the public interest and to provide more options for vaccinations, especially in case of infection by mutant strains. Bharat Biotech will, meanwhile, continue its ongoing clinical trial.
The Serum Institute of India (SII), 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 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.
Further, SII was granted permission to conduct phase II and 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 overseas clinical studies.
After detailed deliberations, the Subject Expert Committee has recommended SII vaccine for the grant of permission for restricted use in emergency situations subject to certain regulatory conditions. The clinical trial ongoing within the country will continue.
Cadila Healthcare has developed a novel coronavirus-2019-nCov-vaccine using DNA platform technology. The firm initiated phase I and II clinical trials in India in more than 1,000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct phase III clinical trial in 26,000 Indian participants, which has been recommended by the Subject Expert Committee.
The vaccines manufactured by the Serum Institute of India and Bharat Biotech have to be administered in two doses. All three vaccines have to be stored at 2-8° C.
After adequate examination, CDSCO has decided to accept the recommendations of the expert committee and accordingly, the vaccines of SII and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare to conduct phase III clinical trial.