New Delhi: Five-year-old Pranshi Khaturia looks at the ceiling and tightly shuts her eyes as she’s injected by a needle that looks bigger than her dainty arm. But she’s not afraid. “I am scared of injections, but Covid scares me more. Mumma said this will protect me from Covid, so I said okay,” she told ThePrint.
Pranshi is one of the 175 children in the 2-6 years age group volunteering for Covaxin trials being conducted by Bharat Biotech, the Hyderabad-based pharma company that’s manufacturing the indigenous Covid-19 vaccine. Despite her very young age, Pranshi’s mother Priya Khaturia says the child fully understands what’s happening.
“She knows that there’s a disease doing the rounds which is why schools are shut and she has to study on her computer. Kids aren’t ambivalent to their surroundings. Even before bringing her to the trials, I ensured she is well-informed (about) what comes next. If I had kept her in the dark, she would’ve panicked,” Priya said.
The multi-centric study for testing the immunogenicity of Covaxin is underway at seven locations across India — AIIMS Delhi; ESI Hospital, Basaidarapur (Delhi); AIIMS Patna; Prakhar Hospital in Kanpur; Mysore Medical College and Research Institute in Mysuru; Pranaam Hospital in Hyderabad; and Meditrinia Institute of Medical Sciences in Nagpur.
The study will include 552 healthy test subjects, divided into three age-groups — 2-6 years, 6-12 years and 12-18 years.
For parents, the upside to having their children participate in these trials hinges on several reasons, among them an easy access to a vaccine.
“I enrolled both my kids in Covaxin trials because the third wave is imminent and people are saying it will disproportionately affect children. Getting a vaccine for my kid then grants them safety against the virus. mRNA vaccines have been given to kids above 12 years n other countries and have proven to be safe. Compared to them, Covaxin’s conventional formula is much more safe,” said Kapil Nema, who came with his six-year-old daughter Kanak. Nema’s 12-year-old son Kartik is also a trial subject.
Another parent, whose five-year-old daughter is part of the trial, said, “Covaxin has been administered to a huge population already, so I am confident it will be safe on my kid too. But there was so much running around after the second wave just to get vaccinated. I don’t want to run from pillar to post just to secure a vaccine slot for my kid. I think this is a better way to secure a vaccine and keep my kid safe.”
Consent and eligibility
Countries have been working towards vaccinating their youngest population amid chatter that a third wave will impact them the most. However, the trials have raised an ethical dilemma as obtaining consent, especially from the youngest test subjects, is tricky.
Dr Sanjay Rai, who is overseeing the Covaxin trials at AIIMS Delhi, says they have taken parental consent for all age groups, but individual consent is also being taken from test subjects aged 12 and above.
Kartik Nema told ThePrint he understood what he was getting into before he enrolled for the trial and that his parents had explained the process to him. His father Kapil had participated in Covaxin’s 3rd stage trials.
“I was excited to participate in the trials because it’s better to be safe than sorry. I am happy I have got the vaccine, and by volunteering, I feel like I am able to do something for the country as well. Also, I can’t wait to play for long-long hours with my friends. I really miss it,” he said.
Since these trials test Covaxin’s ability to trigger an immune response, and not how effectively it’ll work against the coronavirus, all volunteers are being administered the vaccine after testing negative for Covid-19 in both RT-PCR and antibody tests. This means no child will receive a placebo.
Priya Khaturia, whose daughter is part of the AIIMS Delhi cohort, says the hospital has been supportive of parents through the process.
“They regularly call us to check on the child’s well-being. Even before we enrolled, we were informed of the risks and kids were accepted into the trial after a long screening process. We’ve been told it’s going to be a nine-month-long process in which the child’s health will be monitored, and we’ve been told to keep a record of any side-effects or any other drugs that our kids take in this period.”
While there’s no monetary incentive to participate in the trial, subjects ThePrint spoke to said they were being given a Rs 1,000 conveyance fee.
Dr Rai said that since children from different socio-economic backgrounds are participating in the trial, “there’s no extra monetary incentive involved”.
“People who see our ad in the media come forward to volunteer their kid. Volunteers aren’t strictly from just one socio-economic background,” he added.
‘Vaccine safe for kids’
Dr Rai, who is a professor at the Centre for Community Medicine, AIIMS, said the vaccine dose being given to children was the same as the one administered to adults. So far, they have had no safety concerns.
“We faced no problems in recruitment and finished them within time. Parents are trusting in us and are happily volunteering their children.
“The vaccine has been successfully tested on adults and in all likelihood will be safe on kids as well. Mind you, most vaccines in the world are administered to small kids only. We follow ICMR’s ethical guidelines while testing on kids, and are giving them the same dose that we give to adults.”
When asked if children could be at a greater risk of more intense side effects, he said, “Covaxin in general is not resulting in severe side effects. Also, kids are the population that are most used to vaccinations. We haven’t observed any severe side effects yet, just normal fever, which after a vaccination isn’t an anomaly.”
However, researchers have expressed their reservation about conducting vaccine trials in children because their immunity levels maybe different and there isn’t enough evidence to suggest the vaccines are entirely safe.
Trials in other countries
Other trials involving children across the world include those conducted by Pfizer, Moderna (on subjects as young as six months) and Zydus Cadilla in India.
Trials by AstraZeneca were halted in April, while India denied Novavax permission to test its Covovax vaccine on children since the formula is yet to be approved in any country.
Despite reservations, it is recognised that vaccines are an important step towards bringing back some semblance of a pre-Covid life, and re-opening schools/educational institutes for children.
In the US, Moderna’s and Pfizer’s vaccines have been cleared for use on children aged 12-15 years. Pfizer was also been cleared for use in the United Arab Emirates and Canada, while the European Commission has allowed its use on children above 12 years of age.
Pfizer had formed the Pediatric Centre for Excellence in 2014 and partnered with 160 hospitals in the United States, using the insight offered by various stakeholders to make clinical trials safer for kids.
(Edited by Manasa Mohan)