Drugs Controller General of India Approves COVID-19 vaccines

The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) comprising domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, pediatrics, internal medicine met on 1st and 2nd January, 2021 and made a few recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of  Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of Cadila Healthcare Ltd.

The Serum Institute of India, 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 safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies was submitted by the firm. The overall vaccine efficacy was found to be 70.42%. Further, permission was granted to conduct Phase-II/III clinical trial on 1600 participants. 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 Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions after detailed deliberations. The clinical trial ongoing within the country by the firm will continue.

Whole Virion Inactivated Corona Virus Vaccine (Covaxin) developed by Bharat Biotech in collaboration with ICMR and NIV (Pune), has 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. All the data has been shared by the firm with CDSCO. On nearly 800 subjects, Phase I and Phase II clinical trials were conducted and the results are 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 22,500 participants have been vaccinated across the country till date and the vaccine has been found to be safe as per the data available.

The Subject Expert Committee (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.

Cadila Healthcare Ltd. has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase- I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.

All the three vaccines have to be stored at 2-8° C and after adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee. Vaccines of Serum Institute of India and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare to conduct the Phase III clinical trial.