The KEM Hospital and Research Centre at the Vadhu Bukruk village in Pune district will begin enrolling children for phase 2 and 3 clinical trials of coronavirus vaccine Covovax on Monday, The Indian Express reported.
Covovax has been developed by American biotechnology company Novavax. Serum Institute of India, which is producing the vaccine, will conduct the trials in India.
The study aims to assess the safety and immune response of Covovax among children from 2 years to 17 years of age, as per information on the Clinical Trials Registry – India website.
Apart from the KEM Hospital in Pune district, the trials will be conducted at nine other sites across the country. A total of 920 children will be included in the trial, out of which 460 will be aged 12 to 17 years, and 460 will be aged 2 to 11 years.
The KEM Hospital’s ethics committee has given its clearance for recruitment, and the hospital will begin enrolling children on Monday, The Indian Express quoted Ashish Bavdekar, the principal investigator of the trial, as saying.
The Bharati Hospital in Pune city is also among the sites where the trials will be conducted. The hospital’s Deputy Medical Superintendent Jitendra Oswal told the newspaper that the process of clearance by the ethics committee was underway.
On August 29, the Hamdard Institute of Medical Sciences and Research in Delhi began recruiting volunteers among children aged 2 to 17 years for the trials, PTI reported.
The Drug Controller General of India had in July allowed the Serum Institute of India to conduct phase 2 and 3 trials of Covovax on children, the agency noted. Last month, Serum Institute CEO Adar Poonawalla said his company hoped to launch Covovax by the first quarter of 2022.
On Friday, the Union Ministry for Science and Technology said that the DCGI has granted approval to vaccine maker Biological E to conduct phase 2 and phase 3 clinical trials of its Covid-19 vaccine candidate Corbevax on children.
In August, the DCGI granted emergency use authorisation to ZyCov-D, a three-dose coronavirus vaccine developed by pharmaceutical company Zydus Cadila. This is the first Covid-19 vaccine in India that can be administered to children above 12 years of age.
The other vaccines that have received emergency use approval in India are Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, Russia-made Sputnik V and shots developed by United States-based Moderna and Johnson & Johnson.
Till Saturday, 67,72,11,205 have been inoculated against coronavirus in the country. A total of 58,85,687 people received Covid-19 vaccines in the past day, as per official figures.
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