Vaccine trial in Bihar: After first dose, no major side effect in children
Covaxin, India’s indigenous vaccine against coronavirus, could get emergency certification for use in children earliest in September as no anaphylaxis, which is a severe allergic reaction, or major adverse events following immunisation (AEFI), has been reported in children so far during the phase II/III clinical trials of the vaccine, feel experts.
“Pain at the site of the injection is the most common AEFI, with no anaphylaxis reported so far during the clinical trial of the vaccine in children of 2-18 years age group,” said a senior doctor associated with the trial who did not wish to be identified, quoting a secrecy clause in it.
One can expect the Drugs Controller General of India (DCGI) to grant emergency certification for use of Covaxin in children earliest in September. It is perceived that the regulator has to wait for a minimum of 56 days after completion of the first dose of vaccine, achieved across the seven research centres in India on July 9, said the doctor.
Dr Sanjay Rai, principal investigator of the Covaxin trial on children at AIIMS-Delhi, also professor, department of community, and president of the Indian Public Health Association, however, differed on the need to vaccinate children at this stage.
“Global evidence suggests that Covid-19 is a very mild disease in children and a majority of them pass off as asymptomatic cases. Around 60% seroprevalence (serology test for antibodies) has been found in children, as per a recent ICMR survey. This means around 27 crore of the 45 crore children in India, less than 18 years of age, have already been infected and went unnoticed. The mortality rate of children to the pandemic has also been low. This has to be assessed against vaccine-associated deaths before deciding to inoculate children. I don’t see any benefit of vaccinating children against Covid-19 at this stage,” said Dr Rai.
Dr CM Singh, the principal investigator of the trial at AIIMS-Patna, its medical superintendent and professor and head, department of community and family medicine, also felt that children should not be a priority group for vaccination against Covid-19, especially when the vaccine is scarce for adults.
“World-wide evidence suggest that children have been least affected by the Covid-19 pandemic in terms of morbidity and mortality. Despite being equally infected by the virus during the first and second waves of the pandemic, their hospitalisation was less. However, this should not be construed that the development of a vaccine system for children should stop. It has to be put in place besides strengthening infrastructure for paediatric healthcare There is certainly no need to panic about vaccinating children at this stage,” said Dr Singh.
Trial protocol suggests checking antibodies at 0, 28, 56, 118 and 208 days of vaccination. However, experts feel that natural antibody is better than vaccination.
As part of the clinical trial, a second dose of the vaccine has been administered to children in 12-18 years and 6-12 years age groups at AIIMS-Patna, Dr Singh said.
The AIIMS-Patna had selected 53 children for the clinical trial of Bharat Biotech’s vaccine. It divided the children into three sub-categories, selecting four in the 2-6 year age group; 21 in 6-12 years of age; and 28 in 12-18 year age bracket, added Dr Singh.
Altogether 525 children, with 175 in each of the three age groups, were shortlisted for the trial pan India.
AIIMS-Patna is one of the research sites for Covaxin’s clinical trials in children. The others are AIIMS-Delhi; ESI Hospital, Basaidarapur (Delhi); Prakhar Hospital, Kanpur; Mysore Medical College and Research Institute, Mysuru, Pranaam Hospital, Hyderabad; and Meditrina Institute of Medical Sciences, Nagpur.