Amid the surging COVID-19 cases around the world, in a piece of good news, India's first coronavirus vaccine-- COVAXIN-- developed by Hyderabad-based Bharat Biotech has already received a green signal from the Drug Controller General of India (DCGI) to start with human clinical trials. Now, AIIMS Ethics Committee has given a nod to start human trials.
For this purpose, 12 sites have been selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin. AIIMS-Delhi is among such sites.
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Human Trials at AIIMS-Delhi
On June 20, 2020, human trials begin in AIIMS-Delhi. A total of 375 people have volunteered amongst whom 100 will be selected for phase I and phase II of the trial in AIIMS-Delhi. The remaining volunteers will undergo human clinical trials at different places. The selected volunteers will undergo health screening before they are administered Covaxin.
How to participate in the human trail?
1- If you are a healthy individual, you can participate in the human trail either by sending an email on Ctaiims.covid19@gmail.com or by sending an SMS or by calling on 7428847499.
2- It must be noted that the volunteers between the age of 18-55 years with no comorbid conditions and no history of COVID-19 will only be eligible to participate in the human clinical trial.
Earlier Human Trials
Earlier, AIIMS-Patna started the human trails of Covaxin and was the first institute to start the trail. The hospital has chosen 10 volunteers and around 9 people are administered with Covaxin with a smaller dose for safety purposes, as per the officials. If the vaccine is found to be safe, more volunteers will be administered with Covaxin. In addition to this, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak have already started the human trails. Redkar Hospital in North Goa will soon be starting the human trail. The number of volunteers will be 10 and will be selected on the basis of their eligibility.
Timeline of Covaxin
The vaccine is made in collaboration with ICMR (Indian Council of Medical Research) and NIV (National Institute of Virology). The SARS-CoV-2 strain was isolated in NIV, Pune and was transferred to Bharat Biotech.
Earlier, the inactivated COVID-19 vaccine, developed at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley, Hyderabad, has got approval to begin its Phase I and Phase II human clinical trials.
The permission was granted by The DGCI, CDSCO (Central Drugs Standard Control Organisation), and Ministry of Health and Family Welfare after the company submitted the results of pre-clinical studies related to safety and immune response.
These clinical trials are designed to test whether the vaccines are safe or not. The effectiveness of the vaccine will be tested in the next phases. Volunteers across India will be immunised with 'Made in India' COVID-19 vaccine.
Prime Minister Modi in 'Man ki Baat' stated that work is being done in the labs on Coronavirus vaccine and the world is keenly observing India and the country is hopeful too.
Bharat Biotech's Chairman and MD, Dr Krishna Ella stated that the company is proud to announce COVAXIN, India's first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The company's Research and Development and Manufacturing teams have worked tirelessly to deploy the proprietary technologies towards this platform.
Bharat Biotech has a good track record when it comes to developing Vero cell culture platform technologies and has given successful vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.
Apart from this, 5 other Indian firms are working on COVID-19 vaccine. Around 120 vaccine programs in the world are underway. Pharma companies, researchers and scientists around the globe are working day and night to develop COVID-19 vaccine.
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