Covaxin trials on kids at five locations in India

Five medical institutions across India have so far received institutional ethics committee approvals for Covaxin’s clinical trials in children aged two years to 18 years.

A total of 525 children will be part of the trial in three age groups where safety, reactogenicity and immunogenicity of the vaccine in children will be assessed.

To put things in perspective, Pfizer’s trial enrolled 2,260 children aged 12-15 years in the United States. Moderna will enrol approximately 6,750 children in the US and Canada between the age of six months and 11 years.

The three age groups in India are 2-6 years, 6-12 years, and 12 years-18 years, with 175 children required to be inoculated in each age group. Currently, each site has a target of inoculating at least 35 children in each age group starting with the oldest age group.

Read more: Karnataka rejects Sputnik V vaccine bids made by two firms

According to the Clinical Trial Registry of India, the five institutions include Prakhar Hospital, Kanpur, All India Institute of Medical Sciences (AIIMS), Patna, Mysore Medical College and Research Institute (MMCRI), Mysuru, Pranaam Hospital, Hyderabad, and Meditrina Institute of Medical Sciences, Nagpur.

MMCRI dean Dr C P Nanjaraj told DH, “Apart from these five sites, five more sites pan-India are under consideration. All geographic conditions have been considered. The Centre selected MMCRI, we did not apply for it. We may inoculate 40 children in various age groups but the Centre has not finalised the numbers.

“We are in the process of site identification after our ethics committee gave approval. We are awaiting standard operating procedures for the identification and mobilisation of children.”

“We have done a number of clinical trials before, including for BCG vaccine on senior citizens.”

A paediatrician with four decades of experience and a member of the 13-member committee with eight paediatricians set up by Karnataka for advising the state on the third Covid wave, said life-long coverage of medical expenses should be provided to children in the likelihood of side effects, including compensation for adverse events.

“Allowing vaccine trials in children aged two years to 12 years is flawed. Most ethical trials in children start with 12-18 years age group. The older age group results should have been analysed first and based on that, we should inoculate smaller children. The US and all European countries did the same. In smaller children, the dose should be different.

“Here, it is 0.5 ml for all age groups. A sample of 500 is suitable only for bridging studies. They are only looking at whether antibodies are developed,” the doctor said.

“Five hundred is too small a size to compare the vaccine arm and placebo arm. All paediatric vaccines currently available have undergone rigorous efficacy trials abroad and we did bridging studies before rolling them out here. Covaxin hasn’t been studied anywhere in the world. No published phase 3 data for adults is available. It does not have full licensure even for adults.

“Informed parental consent and vaccine factsheet is most important for those who want to participate,” he added.

Yogesh Jain, a physician in rural Chhattisgarh and co-founder of Jan Swasthya Sahyog said, “No vaccine approval should be given for use in children till the results are available in a peer-reviewed journal. There is a ‘no-fault’ compensation system for vaccine adverse events in the US where compensation is provided notwithstanding who’s to blame.” Jain, a paediatrician formerly with AIIMS Delhi, added, “In the past, those who died due to DPT vaccine or pentavalent vaccine were never compensated. But the Centre for Disease Control in the US does,” he added.