Noida: Child PGI to participate in Phase III Covaxin trial

NOIDA: The Super Speciality Paediatric Hospital and Post-Graduate Teaching Institute (SSPHPGTI) in Sector 30, also known as Child PGI, will participate in the Phase III trials of Covaxin, one of the two vaccine candidates selected for Covid-19.

The Drugs Controller General of India (DCGI) has permitted two vaccines — Covaxin, developed by Hyderabad-based Bharat Biotech International Limited in collaboration with the National Institute of Virology (NIV) of the Indian Council of Medical Research (ICMR), and another by Zydus Cadila Healthcare Ltd — for clinical trials for Covid-19. The first two phases of the Covaxin trials have been completed.

Child PGI, the only hospital from GB Nagar to participate in the third phase of trials, said it aims to begin with 1,000 volunteers, most of them healthcare workers and all over the age of 18 years. Only those who don’t have Covid will be selected.

The trials will be handled by Dr Mukul Jain, head of department, anaesthesia, who will be the principal investigator, and Dr Satyam Arora, assistant professor, research and transfusion medicine, who will be the co-investigator, under Dr DK Gupta, the hospital director. A couple of other doctors might join the team later.

“We have submitted our proposal papers to the ICMR. Once we receive its guidelines, we will process them through our ethics committee and try to start the trials in the third week of October,” said Dr Arora.

Details on the centres that will conduct the Phase III trials are not yet known, he added. “The target is to administer the vaccine to about 22,000-25,000 volunteers, so there could be more than 15 centres across India,” said Dr Arora. The institute plans to enrol an NGO to carry out the task of selecting volunteers. “We will create awareness drives for healthcare workers and the general public, and hire an NGO to help in the process,” Dr Arora said, adding that the trial will involve a follow-up for up to 12 months after the vaccine is given.

Dr BP Singh, a senior doctor at Child PGI, said, “After administering Covaxin, the volunteers will be kept under close observation and tested for antibodies at regular intervals as per protocols.”