PUNE: Vaccine major Serum Institute of India (SII) is all set to start phase 2 and 3 paediatric trials of Covovax on 920 children — 460 each in the 12-17 and 2-11 age groups — from next month.
The recombinant nanoparticle protein-based vaccine —NVX-CoV2373 — developed by American biotechnology firm Novavax has been branded as Covovax in India.
It will be the fourth Covid-19 vaccine to undergo clinical trials for children in India.
SII, partnering with Novavax, expects to launch Covovax for adults in India by September and for children by the end of this year.
“We plan to begin the paediatric trials in 920 children across 10 sites next month after seeking permission from the DCGI (Drug Controller General of India),” SII’s owner and chief executive officer Adar Poonawalla told TOI.
Bharati Hospital and KEM Hospital’s Vadu branch in Pune are among the10 sites where the children will undergo advanced trials.
They would be followed up for six months after inoculating with two doses of Covovax, given 21 days apart.
According to the trial design, enrolment of children in the 12-17 age group would be done first, followed by the 2-11 age group, Poonawalla said.
“We shall commence the trials in the reverse order of age.
Children in the 12-17 age group will be given the shots first and later the 2-11 age group,” he said.
SII will submit the interim trial findings on safety and immunogenicity after three months of the advanced clinical trial for licensure.
According to the latest guidelines of the Drug Controller General of India (DCGI), the company can apply for a licence of the vaccine before the completion of the trials, based on the global test results.
The primary objective of the study is to assess the safety and immunogenicity of the vaccine among children.
Healthy volunteers will receive two doses of Covovax 21 days apart.
Seven days after the first dose for 25 participants (12-17 age group), safety data would be reviewed by the Data Safety Monitoring Board (DSMB).
Based on its recommendation, the study would progress by recruiting the remaining participants.
The same process would be repeated for the 2-11 age group.
Niti Aayog (health) member V K Paul said during the briefing of the health ministry on Friday, “We have to understand that the child cohort is not a small one.
My rough guess is that if it is between 12 to 18 years, this itself is about 13 to 14 crore population, for which we will need about 25-26 crore doses.
We can’t have some getting the vaccine and others not.
We will have to take this into account when we strategize and make a decision based on how many doses of which vaccines are available.” Covid-19 vaccine makers are conducting trials for children at a fast pace.
An approved candidate vaccine for kids is likely by September-October.
In the US, Pfizer’s Covid vaccine has been approved for use in children as young as 12 years.