Covid-19: Vials for Covaxin Phase 3 Trials Arrive in Kolkata; NICED seeks volunteers – india news
The National Institute of Cholera and Enteric Diseases (ICMR-NICED) is looking for around 1,000 volunteers to conduct the phase 3 clinical trial of the Covid-19 vaccine.
While the jars for it arrived in Kolkata on Thursday, the trial is expected to begin in December. The state minister for urban development, Firhad Hakim, volunteered to volunteer.
“We are looking for volunteers who preferably reside within a 10 km radius from the institute. Volunteers will have to sign a pledge that they will not leave their current address for the next year as they must be closely monitored, ”said a senior NICED official.
NICED in Kolkata is one of the institutes in India that has been selected to conduct regulatory trials approved by the Central Medicines Control Organization (CDSCO). It would take place at about 25 sites in 10 states. Testing has already started on some sites.
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“From now on, we have encouraged volunteers to contact us by phone or email. About 1,000 volunteers will enroll in this trial after assessing their eligibility criteria. Eligible participants will be contacted for more details. Enrollment will continue until the target number is reached, ”the official said.
Bharat Biotech, in collaboration with the Indian Council for Medical Research (ICMR), is developing Covaxin, the first indigenously developed coronavirus vaccine.
As part of the test application, a 0.5 ml dose would be administered on day 1 and again on day 28.
“We have already received a few hundred vials from Hyderabad on Thursday. The clinical trial would start soon, ”said an official.
Of the 1,000 volunteers, while 500 will receive the test vaccine, the remaining will receive placebo injections. The placebo will help researchers compare the two groups and understand how well the vaccine is working.
Prime Minister Mamata Banerjee had told Prime Minister Narendra Modi on November 24 that Bengal is ready for the vaccination program.
“West Bengal is fully prepared with a skilled workforce and the necessary infrastructure, including cold chains for the vaccination program. We are ready to work with the Center and other stakeholders to ensure a rapid vaccination campaign for all as soon as the vaccine is available, ”Banerjee told Modi, according to a statement issued by the state government.