Pune: The Indian Serum Institute has expanded Covovax pediatric trials in seven to 11 years with age bracket at 10 sites in India, including Pune, after ensuring vaccine security in adolescents.
Covishield makers aim to measure further pediatric trials by including children in the age group of two to six years in the next trial phase.
Pediatric phase 2 and 3 test trials from Covovax which began in August will have a total of 920 children – 460 in 12 to 17 years, 230 in 7 to 11 years and 230 in 2 to 6 years of age group.
“According to the trial design, we expanded the trial after ensuring vaccine security in 100 children from each group in an inverse order of age.
We aim to include children in the bracket aged 2-6 years a month, after vaccine security is confirmed at 100 Children in the age group 7 to 11 years, “said the trial investigator.
Recombinant nanoparticle protein-based vaccines – NVX-COV2373 – developed by the American biotechnology company Novavax has branded Covovax in India.
The Indian Serum Institute (SII), partnering with Novavaks, is expected to launch Covovax for adults in India in November this year and for children early next year.
Bharati Hospital and the Vadu Branch of KEM Hospital in Pune are among the 10 sites where children are undergoing further trials.
They will be followed up for six months after being inoculated with two covovax doses, given 21 separate days.
Confirming Development, Medical Director of Bharati Hospital and Child Doctor Head Sanjay Lalwani said, “Parents who are willing to be able to register their ward by visiting the Pediatric Department of Hospital.” Head of the Branch Branch of Vadu Branch and Gastroenterologist Ashish Bavadekar said, “Children who meet the requirements especially living in Vadu in the country’s rural part are being registered for the trial.” Vadu Village in Shirur Taluka Pune is 32 km from the city.
“We prefer children who qualify from Vadu Village because they will facilitate their monitoring post-inoculation,” said Bavadekar.
SII will submit temporary trial findings on safety and immunogenicity after three months of advanced clinical trials for licenses.
According to the latest guidelines from the drug controller General India, the company can file a license for vaccines before the trial settlement, based on the results of global tests.
Child cohort consists of around 13 to 14 crore populations.
India will need around 25-26 crore doses for them, experts said.