Drug Controller General of India (DCGI) VG Somani on Sunday anunced that vaccines of Serum Institue of India (Covishield) and Bharat Biotech (Covaxin) have been granted permission for restricted use in an emergency situation. 

massive development comes a day after Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) me recommendations to Drugs Controller General of India to grant permission for restricted emergency use of Serum Institute of India (SII) and Bharat Biotech's vaccines. As per an official release, SEC met on Friday and Saturday and me its recommendations in respect of accelerated approval process request of SII, Bharat Biotech International Ltd as well as about phase-III trials of Cila Healthcare Ltd.

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Here is full DCGI statement:

Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and me recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cila Healthcare Ltd.
Subject Expert Committee consists of domain kwledge experts from fields of pulmology, immulogy, microbiology, pharmacology, paediatrics, internal medicine, etc.

M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee evirus vector vaccine (Covishield) encoding SARS-CoV-2 Spike (S) glycoprotein with techlogy transfer from AstraZeneca/Oxford University. firm submitted safety, immugenicity and efficacy data generated on 23,745 participants d ≥ 18 years or older from overseas clinical studies. overall vaccine efficacy was found to be 70.42%. Furr, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within country. firm also submitted interim safety and immugenicity data generated from this trial and data was found comparable with data from overseas clinical studies. After detailed deliberations Subject Expert Committee has recommended for grant of permission for restricted use in emergency situation subject to certain regulatory conditions. clinical trial ongoing within country by firm will continue.

M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where y received virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in country & globally.

firm has generated safety and immugenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on n-human primates (Rhesus macaques) and hamsters. All se data has been shared by firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and results have demonstrated that vaccine is safe and provides a robust immune response.   Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across country and vaccine has been found to be safe as per data available till date. 

Subject Expert Committee (SEC) has reviewed data on safety and immugenicity of 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. clinical trial ongoing within country by firm will continue.

M/s Cila Healthcare Ltd., has developed a vel Corona Virus-2019-nCov-Vaccine using DNA platform techlogy. firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. interim data suggests that vaccine is safe and immugenic with three doses when ministered intrermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by Subject Expert Committee.
M/s Serum and M/s Bharat Biotech vaccines have to be ministered in two doses. All three vaccines have to be stored at 2-8° C. 

After equate examination, CDSCO has decided to accept recommendations of Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cila Healthcare for conduct of Phase III clinical trial.

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