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Explained | Will the 2-18 age group in India get COVID-19 vaccines soon?

The story so far: The Subject Expert Committee, which is advising the Drugs Controller-General of India (DCGI), has recommended that it grant emergency use authorisation (EUA) for Covaxin among children aged 2-18. The final approval for the vaccine for children aged 2-18 is under expert opinion and evaluation. The DCGI will hold discussions with the Health Minister, the Prime Minister’s Office, and Bharat Biotech before granting EUA to Covaxin, according to reports. Earlier, the DCGI had granted EUA for Zydus Cadila vaccine candidate ZyCoV-D for use in children.

Is Covaxin for children different than the dose for adults?

The Covaxin that will be rolled out for children in India is of the same product and presentation as the adult vaccine, according to sources in the company that makes the vaccine, the Hyderabad-based Bharat Biotech. The company got the green light to conduct trials among children in May. Subsequently, they tested the adult version of Covaxin on 525 children, in two doses 28 days apart. Interim data from the trials, submitted by October, suggested that safety and immunogenicity were studied, and it was found to be safe among children. A longer follow-up will also be done among study participants. Data from Covaxin is not available publicly.

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Is there a need for a separate vaccine for children?

Children, experts argue, need their own regimen of care and treatment including vaccinations. While most vaccines cater to children, it is also necessary to calibrate vaccines for specific use in children when they have first been developed for the adult population, as in the case of COVID-19. It is not simply a case of sizing down an adult dosage for children, experts argue. Working on vaccine or drug regimens with children is very challenging. Children have distinct developmental and physiological differences from adults, and as they grow, they tend to have changing needs. The World Health Organization (WHO), therefore, recommends that clinical trials in children are necessary to develop age-specific, empirically verified therapies, and interventions to determine the best possible treatments for them. Dr. Moshe Arditi, academic director of the Division of Pediatric Infectious Diseases Allergy and Immunology at Cedars-Sinai, says on the Cedars Sinai website: “Their bodies work differently, and they undergo changes as they grow from infancy toward adolescence and adulthood.”

He further explains that as children grow and change, their immune systems do, too. A 6-year-old is not the same as a 16-year-old. To account for these differences, researchers do “age de-escalation” studies with participants placed in different groups. For example, 6-to-12-year-olds, 2-to-6-year-olds and 6-months-to-2-year-olds. Doses start at the lowest safest level and researchers increase them in different groups to determine whether a larger dose is more effective or whether a lower dose provides a complete response. “It’s a bit like the Goldilocks effect.”

Do children need COVID-19 vaccination?

Gavi, the Vaccine Alliance, commenting on the value of COVID-19 vaccines for children, says that considering that children under the age of 18 form a large proportion of the population (32% globally), ensuring protection for them is a move towards pandemic control. Protection is urgently needed when the disease risk is high, it says. However, for children, it adds, there is a relatively low risk of disease. Although they account for one in nine SARS-CoV-2 infections, they constitute only 2% of all hospitalisations. Most infections in children are mild and they recover fully. Serious illness is rare, but well-described; this includes the inflammatory and potentially deadly condition, Multisystem Inflammatory Syndrome in Children.

 

Recently, speaking at a seminar, Soumya Swaminathan, Chief Scientist, WHO, said, “Children have the same percentage of antibody exposure that adults have. We had shut schools saying children should not be exposed to the virus, but there has been community exposure since they have been doing other activities. Children have been going to malls, they have been playing outside, and are around their family.” However, making a case for reopening schools is vastly different from children getting a COVID-19 vaccine, while one discusses the continuation of life as it is lived, the other is a deeply ethical question. The Gavi paper says evoking the ethical principle of distributive justice that the benefits and burdens should be distributed among society’s members in a just manner makes the case that children should be included in COVID-19 vaccine trials.

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What is next?

The DCGI will have to approve the vaccine before it can be administered to children and decide whether the safety and immunogenicity data among the 500-odd cohort suffices for EUA.


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Printable version | Nov 27, 2021 5:27:31 PM | https://www.thehindu.com/sci-tech/health/explained-will-the-2-18-age-group-in-india-get-covid-19-vaccines-soon/article37144219.ece

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