In his tweet, Dr Tedors said “If we ACTogether, we can ensure effective & safe vaccines are used to protect the most vulnerable everywhere”.
NEW DELHI, Jan 5 I(BNC) - World Health Organisation Director General Dr A B Tedros has hailed India’s breakthrough in COVID vaccine research and said the country “continues to take decisive action & demonstrate its resolve to end COVID19 pandemic”.
As the world’s largest vaccine producer, he said, India it’s well placed to do so.
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) has recommended the COVID-19 virus vaccines of Serum Institute of India and Bharat Biotech for Restricted Emergency use. The committee also okayed Cadila Healthcare vaccine for phase-3 trial.
Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.
The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
In his tweet, Dr Tedors said “If we ACTogether, we can ensure effective & safe vaccines are used to protect the most vulnerable everywhere”. The tweet, tagged to PM Narendra Modi, referred to the ACT initiative of WHO for mobilising and pooling together global resources to tackle the pandemic.
Indin officials said Pune-based Serum Institute 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%.
Serum has also been granted permission to conduct Phase-II/III clinical trial on 1600 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 the overseas clinical studies. After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.
Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which 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 these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials 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 was initiated in India in 25,800 volunteers and till date, ~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 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.
M/s 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.