COVID-19 Vaccine on Human Clincal Trials | Covaxin | Bharat Biotech International Limited

Amid the rising novel coronavirus cases in the country, the Indian government today said it has started discussions on the availability of the Covid-19 vaccine to those who need it. Speaking at the health ministry press conference today, Dr. VK Paul, Member (Health), NITI Aayog said, "Discussions have already begun how will the vaccines be made available to all those who need it." Pal also added that India's two most important Covid-19 vaccines are now in phase 1 and phase 2 of their trials. The member of the country's leading thinks tank also said the government will leave no stone unturned to ensure the people of India and the international community have access to an Indian vaccine as early as possible.


Every possible facilitation will be ensured making sure trials conducted scientifically and ethically and we arrive at an affordable option. Earlier, the Drugs Controller General of India (DCGI) had permitted two vaccines; one developed by the Bharat Biotech International Limited and another one by ZydusCadila Healthcare Ltd to go in for the first and second phase of human clinical trials. Bharat Biotech's vaccine candidate Covaxin, which is India's first indigenous Covid-19 vaccine, has started human trials. In phase I, the vaccine would be tested on 375 volunteers. Covaxin, which has been developed by Bharat Biotech in collaboration with ICMR and NIV, Pune, will be tested on more than 1,100 people in phase 1 and 2 clinical trials. There are 12 places where the trial for Covaxin will take place as per the Indian Council for Medical Research (ICMR).


On Monday, AIIMS-Delhi began recruiting volunteers for conducting human clinical trials Covaxin, said Director Dr. Randeep Guleria. The institute is among the 12 sites selected by ICMR for Phase I and II randomized, double-blind and placebo-controlled clinical trials of Covaxin. Post-trials, the subjects will be followed up for 28 days and then again at a later stage, Professor at the Centre for Community Medicine at AIIMS Dr. Sanjay Rai said. The minimum time required for Phase I trial results to come out is four-to-six weeks, he added. Additionally, Pharma major Zydus Cadila has said that it is looking to complete clinical trials of its COVID-19 vaccine candidate ZyCoV-D in seven months. The company had last week started clinical trials of its COVID-19 vaccine candidate with the first human dosing. Depending on the study outcomes and if the data is encouraging and the vaccine is found to be effective during the trials, it could take a total of seven months for the trials to be completed and for the vaccine to be launched, Zydus Cadila Chairman Pankaj R Patel said in a statement.





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