Covovax trials for children to start at Pune site on Monday

Among adults, the process of vaccination of Covovax in adults during clinical trials has been completed, but other requirements, such as collection of immunogenicity data, are pending.

This vaccine is the fourth one to undergo clinical trials in children in India. The country’s drug regulator in July had granted permission to SII for conducting phase II and III trials of Covovax on children aged 2-17 years with certain conditions, on the basis of the recommendations of the Subject Expert Committee on Covid-19.

According to the Clinical Trials Registry — India, the study is aimed at checking the safety and immune response of Covovax in the age group of 2 to 17 years.

While the Hamdard Institute of Medical Sciences and Research in New Delhi has already started enrolling volunteers for paediatric clinical trials, the effort will initially involve a few other trial sites and recruit 100 participants.

After the initial lot of 100 participants are recruited and the vaccine is administered, the safety data will be sent to the Drug Controller General of India’s Data and Safety Monitoring Board. A total of 920 participants will be included in the trials across 10 sites.

There are multiple gaps in this study, as the recruitment process will take place initially for the 12-17 age group, then for the 7-11 age group and then for the 2-6 age group. As per the protocol, the safety data will be submitted to the regulatory authorities.

In Pune, there are two sites — KEM Hospital and Bharati Hospital – which will be involved in the paediatric clinical trials.

Dr Ashish Bavdekar, principal investigator at KEM Hospital and Research Centre, said that they were expecting to start recruiting volunteers from Monday. “Our ethics committee has given the go-ahead recently,” said Dr Bavdekar.

At Bharati Hospital, Deputy Medical Superintendent Dr Jitendra Oswal said the process of clearance by the ethics committee was underway. Other trial sites include Delhi, Mumbai, Wardha, Mysuru and Nagpur.