Covaxin pediatric trials to begin this week, experts hail move

As Covaxin phase 2-3 clinical trials are set to begin on a total of 525 children this week, experts call it a crucial step to access the safety, reactogenicity and immunogenicity of the vaccine in children of 2-18 years age group.

Indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), Covaxin is currently being used in India’s ongoing Covid-19 immunisation drive for adults.

The five institutions where the trials will be conducted are All India Institute of Medical Sciences (AIIMS) in Patna, Prakhar Hospital in Kanpur, Mysore Medical College and Research Institute (MMCRI) in Mysuru, Pranaam Hospital in Hyderabad, and Meditrina Institute of Medical Sciences in Nagpur.

Sharing details on their ongoing preparation, sources at Meditrina Institute of Medical Sciences told ETHealthworld that over 150 volunteers have been selected, with around 50 candidates in each of the three age categories ie, 2-6 years, 6-12 years and 12-18 years.

The panel regulating the trial will include one paediatrician, clinical research team and ethics committee, added the hospital source.

Impact of Covid 2nd wave VS 3rd wave speculations
The B.1.617 variant of Covid-19 continues to be a “variant of concern” as the mutations are causing the virus to be highly transmissible.

Last week the Union Health Minister, Dr Harsh Vardhan during his meeting with the group of ministers to review the Covid-19 situation had said that the B.1.617 variant has become the dominating Covid-19 mutant in India accounting for around 55 per cent of total “variant of concern” (VoC) detected in the country through genome sequencing so far.

Earlier, officials had flagged a concern that the correlation has been seen between the surge in positive cases during the second wave of Covid-19 in India with the rise in the B.1.617 lineage of SARS CoV2.

Sharing his experience of Covid-19 second wave and its impact on children, Fortis Hospital’s additional director of pediatrics Dr Ashutosh Sinha said, “The mutant B.1.167.2 has been more prevalent in the second wave. We have seen a massive number of children getting infected, and irrespective of their parent Covid status, the children were found to be positive.”

He stated that while a majority of these kids fortunately recovered well but if the infection trend continues, then children could be at risk in the third wave particularly as significant proportion of the adults' population would have been infected already or vaccinated.

Dr Sinha further highlighted the need for careful vigilance on symptoms of Multisystem Inflammatory Syndrome in children (MIS-C) as a post covid complication. MIS-C causes inflammation in multiple organs including the brain, heart, blood vessels, abdomen, kidneys or skin.

Parents need to watch for symptoms like fever, rash on the body, neck pain or swelling, fiery-red eyes, abdominal pain, vomiting, diarrhea and fatigue till 3-4 weeks after recovery from Covid-19.

Speaking on safeguarding the kids, Dr Sinha added that clinical trials in children are a good move as vaccination will be very beneficial in protecting the children against Covid-19 infection.

Recently Niti Aayog (health) member V K Paul had stated that children account for about 3-4 per cent of hospital admissions, in both India and the rest of the world.

According to the health experts, while more children are testing positive in the second wave but the infection is mostly mild and the mortality rate is low.

Commenting on speculations of children being more severely impacted by the virus, Apollo Hospitals senior consultant-pediatric gastroenterology Dr Smitha Malhotra said, “I don’t think there should be so much panic on it affecting children more severely. I am still hopeful that children will get away with milder disease. The ones who are more likely to get severely infected are the ones that have some underlying health condition like who are chronically ill or are on medicines which suppress their immunity.”

She shared similar views calling vaccine trials on children a welcome step and said Covid vaccination should be certainly be extended to children.

Preparing for 3rd Covid wave
Seeing the devastating impact of Covid second wave and the fear of a potential third wave, states have begun work on increasing infrastructure to meet the pediatric care requirements.

According to Dr K Srinath Reddy, epidemiologist and president of Public Health Foundation of India, if there is a third wave, several of the adults would have been infected earlier or would have acquired immunity through prioritised immunisation. “Since the virus always looks for susceptible individuals, young people will be much more mobile and available which is why they would get infected in larger numbers as compared to the first wave when they were mostly sheltered,” he said.

Dr Reddy stated that more children will be affected because they are more susceptible than adults but it does not mean that kids are going to be predominantly affected.

Sharing similar views, he also emphasized that the trials should be conducted on children, “I don’t see any particular risk amongst the children except that we have to make sure that the dose is appropriately calculated to see what the safety and efficacy issues are. You need to educate people about the trial as anybody below 18 has to have consent given by the parents.”

Currently, several states including the national capital have been facing shortages of vaccine to drive the Covid-19 inoculation program in India

Dr Reddy further stressed on prioritising vaccinations for groups which are at higher risk of severe disease, he said, "If there is an abundance of vaccine then you should vaccinate everybody including younger population, but if you don’t have that luxury of vaccines you still have to prioritise vaccination based on who is at an increased risk and more likely to get sick including children or young people with co-morbidities."