The KEM Hospital and Research Centre at Vadu, Maharashtra is all geared up to start enrolling minors and children for the phase II and III clinical trials of Covid-19 vaccine Covovax from Monday.
In 2020, US-based vaccine maker Novovax Inc had announced a licence agreement with the Covishield manufacture- Serum Institute of India (SII) for the development and commercialisation of its Covid-19 vaccine candidate NVX-CoV2373, or Covovax, in low and middle-income countries, including India.
Covovax is the fourth vaccine to undergo clinical trials in children in India. In July, the drug regulator had granted permission to SII for conducting phase II and III trials of Covovax on children aged 2-17 years with certain conditions. The decision was announced on the basis of the recommendations of the Subject Expert Committee on Covid-19, an Indian Express report stated.
The study is aimed at checking the safety and immune response of Covovax in the age group of 2 to 17 years, as per the Clinical Trials Registry, India.
On August 29, the Hamdard Institute of Medical Sciences and Research in New Delhi began enrolling volunteers for clinical trials on children, the effort will initially involve a few other trial sites and recruit 100 participants.
India’s drug regulator in July had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trial of Covovax on children aged 2 to 17 years with certain conditions on the basis of the recommendations of the Subject Expert Committee (SEC) on COVID-19.
In the application submitted to the Drugs Controller General of India (DCGI), SII’s director (government and regulatory affairs) Prakash Kumar Singh and director Prasad Kulkarni had stated that globally, all adults aged 18 and above are being vaccinated and after this population is protected against COVID-l9, children will remain the most susceptible group.
Reportedly, 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, India Express reported.
The two sites in Pune- KEM Hospital and Bharati Hospital both will be involved in the paediatric clinical trials.
Dr Ashish Bavdekar, the principal investigator at KEM Hospital and Research Centre, told IE that they were expecting to start recruiting volunteers from Monday and their ethics committee has given the go-ahead recently.
Among adults, the process of vaccination of Covovax in adults during clinical trials has been completed, but other requirements, such as the collection of immunogenicity data, are pending.