Pune: Covishield Maker Serum Institute of India (SII) has increased the Covovax pediatric trial by including children in the two to six-year-old bracket at 10 sites in India, including Pune.
Vaccine makers began Covovax trials among children in August this year.
Initially, the trial enrolled teenagers in the 12-17 year category and were then expanded by registering children in the age group 7-11.
Phase 2 and 3 pediatric trials from Covovax will have a total of 920 children – 460 in categories 12 to 17 years, 230 in the age group 7-11 and 230 in the other 2-6 age group.
“In accordance with the trial design, we have expanded the trial after ensuring the security of vaccines among the 100 children of each group in an inverse order of age.
We first did it in teenagers and then put children in the age group 7-11.
Now, we have begun registering children in the age group 2-6 after seeking regulatory permissions maturing, “said a trial investigation.
Recombinant nanoparticle protein-based vaccines – NVX-COV2373 – developed by the American biotechnology company Novavax has branded Covovax in India.
Sii, partnering with Novavax, is expected to launch Covovax for adults in India this year and for children in April 2022.
Bharati Hospital and the Branch of Vadu Kem Hospital in Pune is between 10 sites where children are undergoing tests try further.
They will be followed up for six months after inoculating with two doses of Covovax, given 21 separate days.
Medical Director of Bharati Hospital and Child Doctor Sanjay Lalwani said, “We enrolled the first child in the age group 2-6 in Pune on November 11.
We intend to register 25-30 children in the age group (2-6 years).” Previously, Bharati Hospital had registered 35 children in the age group and 21 children at the 7-11 bracket for Covovax trials.
The trial site of the Branch of the Branch of the Head of the Branch of Investigator and Gastroenterology Ashish Bavadekar said, “Children who meet the requirements especially live in the rural part of Pune are being registered for the trial.”