Sites in Pune to start enrolling children for Covovax trial within 2 weeks: SII – ET HealthWorld

Bharati Hospital in Dhankawdi and KEM Hospital’s Vadu branch are among the 10 sites across the country where 920 minors in this age group fitting the criterion would undergo the advanced trials. These minors would be followed up for six months after being inoculated with two doses of Covovax, given 21 days apart.

The recombinant nanoparticle protein-based vaccine — NVX-CoV2373 — developed by the American biotechnology firm Novavax, has been branded Covovax in India. It would be the fourth Covid-19 vaccine to undergo a clinical trial for children in India.

Vaccine major Serum Institute of India is partnering with Novovax to launch Covovax for adults in India by September, and for children by the end of this year. The country’s regulator, Drug Controller General of India (DCGI), has given the go-ahead to the paediatric trials for 920 minors at 10 sites across the country.

According to the trial design, enrolment of the minors aged 12-17 would be done first, followed by those in the 2-11 age group.

“Children in Pune would be the first to be enrolled within the next two weeks. Trial sites in Mumbai, Nagpur, Wardha, Mysuru, Bengaluru, Chandigarh, New Delhi and Bhubaneswar would kickstart the recruiting process thereafter,” said a senior SII official.

Confirming the development, Bharati Hospital’s medical director and chief paediatrician Sanjay Lalwani said, “We will be enrolling about 150 children initially and have obtained the hospital ethics committee’s permission. The parents can enrol their wards by visiting the hospital’s paediatrics department.”

Bharati Hospital’s medical expert Sonali Palkar will enrol the children in both age groups in Pune.

KEM Hospital’s Vadu branch trial site chief investigator and gastroenterologist Ashish Bavadekar said, “Eligible children primarily living in Vadu in the rural parts of Pune would be enrolled for the trial. We are aiming to enrol 100 children initially.”

Vadu village in Pune’s Shirur taluka is 32km from the city. “We will prefer eligible children from Vadu village as this will facilitate their monitoring post-inoculation,” Bavadekar said.

SII would 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 DCGI, the company can apply for a licence of the vaccine before the completion of the trials, based on the global test results.

The child cohort comprises about 13 to 14 crore population. India would need about 25-26 crore doses for them, experts said.

HL: ABOUT 26 CRORE DOSES NEEDED FOR CHILD COHORT

The child cohort is not a small cohort comprising about 13 to 14 crore population, and for which India will need about 25-26 crore doses

Zydus Cadila has concluded its trials for those aged between 12 and 18 years, and has applied for emergency use authorisation of its DNA-plasmid vaccine

At present, Phase II and III trials of Covaxin are going on for children in the age group of 2-18 years. The results are likely to be available very soon

“By September or just after it, India may have Covid-19 vaccines for children,” said an expert from the Indian Council of Medical Research (ICMR)

OBJECTIVE OF TRIALS IN KIDS

The primary objective of the trials of Covovax in children in India is to assess the safety and immunogenicity of the vaccine among children

Seven days after the first dose for 25 participants (children of 12 to 17 years), 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

After the completion of recruiting participants in Group 1 (12 to 17 years), the recruitment of participants for Group 2 (two to 11 years) would begin

The same process would be repeated in Group 2

TWO OUT OF EIGHT SITES IN PUNE

8 sites for Covovax paediatric trials

2 are in Pune — Bharati Hospital and KEM Hospital’s Vadu branch

3 more sites — Nair Hospital (Mumbai), Government Medical College (Nagpur) and Mahatma Gandhi Institute of Medical Sciences (Wardha) — are in Maharashtra

5 other paediatric trail sites of Covovax in the country are Kempegowda Institute of Medical Sciences (Bengaluru), JSS Medical College and Hospital (Mysuru), Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, Hamdard Institute of Medical Sciences & Research (HIMSR) in New Delhi and Kalinga Institute of Medical Sciences (Bhubaneswar)