Covid-19: Vials for phase 3 trials of Covaxin arrive in Kolkata; NICED looking for volunteers

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 Covid-19 vaccine.

While vials for the same arrived in Kolkata on Thursday, the trial is expected to start in December. State urban development minister Firhad Hakim has offered to become a volunteer.

“We are looking for volunteers who reside preferably within a range of 10 km radius from the institute. The volunteers will have to sign an undertaking that they will not leave their present address for the next one year, as they need to be closely monitored,” said a senior NICED official.

NICED in Kolkata is one of the institutes in India which has been selected to conduct the Central Drugs Standard Control Organisation (CDSCO)-approved regulatory trials. It would be conducted in around 25 sites across 10 states. The trial has already started at a few sites.

“As of now, we have urged volunteers to contact us over phone or email. Around 1,000 volunteers would be enrolled in this trial after screening for their eligibility criteria. The eligible participants will be contacted for further details. The enrolment will continue until the target number is achieved,” said the official.

Covaxin – the first indigenously-developed anti-coronavirus vaccine – is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

As part of the trial application, a dose of 0.5 ml would be given 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.

Out of the 1,000 volunteers, while 500 will get the trial vaccine, the remaining will get placebo shots. The placebo will help researchers compare the two groups and understand how effectively the vaccine is working.

Chief minister Mamata Banerjee had on November 24 told Prime Minister Narendra Modi that Bengal is prepared for vaccination programme.

“West Bengal is fully prepared with trained man power and required infrastructure, including cold chains for the vaccination programme. We are ready to work with the Centre and other stakeholders to ensure speedy vaccination drive for every one as soon as the vaccine is available,” Banerjee had told Modi, according to a statement released by the state government.