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COVID-19 Vaccine for Kids in India: What Is the Hold Up?

Covaxin COVID-19 vaccine for children is expected to get DCGI's approval by the end of November.

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<div class="paragraphs"><p>Neither is ZyCoV-D available yet, nor has Covaxin for children received DCGI approval.</p></div>
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Zydus Cadila received approval from the Drug Controller General of India (DCGI) in August for their COVID-19 vaccine, ZyCoV-D, meant for children aged 12 years and above.

Apart from this, the Subject Expert Committee had recommended the approval of Bharat Biotech's Covaxin for kids between 2 and 18 years last month.

But, neither is ZyCoV-D available yet, nor has Covaxin for children received DCGI's approval.

With the opening of schools and colleges, what should be our policy in this matter, and what are the challenges before India?

COVID-19 Vaccines for Kids

Opinions of different countries are divided about whether children should need to be vaccinated against COVID-19.

Some countries like the US have started vaccinating children between 5 years and 11 years. Others including Colombia, Argentina and China have approved vaccines for kids as young as 3 years old.

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But many countries around the world do not want to rush into approving COVID vaccination of children, especially since many of them countries are still grappling with the challenge of fully vaccinating the adult population.

Health Minister Mansukh Mandaviya, at a Times Now program on 11 November, regarding the introduction of COVID-19 vaccination for children, said that this decision needs to be taken very carefully.

"We don't want to rush to introduce COVID vaccine for children. The government will consult expert opinion and take a call accordingly."
Mansukh Mandaviya, Health Minister

What is Causing the Delay?

Should we be fast tracking COVID-19 vaccines for kids, the same way we did vaccines for adults?

In response to this question, Dr. Gautam Menon, Professor of Physics and Biology at Ashoka University, tells FIT, "there is much less data for vaccines in children than there is for adults at the moment."

"Given that, caution is advisable and a hasty rollout should not be done," he adds.

"There is as yet no clear data on the advantages of vaccinating children in terms of preventing adverse outcomes, since infections in children are very largely mild ones."
Dr Gautam Menon, Professor of Physics and Biology, Ashoka University

In an interview with FIT last month, virologist Dr. Gagandeep Kang, who is also a member of the National Technical Advisory Group on Immunization (NTAGI), said that she does not think that healthy children need the corona vaccine right now.

Where is India at?

Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D was approved by India's drug regulator for people aged 12 and above on 20 August, but on 14 November, according to a report by a news agency PTI, it was clarified that for the time being the vaccine will only be given to adults.

On 9 November, The Times of India quoted a senior official as saying that the Zydus Cadila vaccine for kids would be rolled out only when official guidelines for the vaccination of children in released in India.

Moreover, Government officials are concerned that the Zydus Cadila vaccine supply may not be enough to cover both adults and kids.

For these reasons, the Zydus Cadila vaccine is said to be rolled out only when the Covaxin vaccine for kids is approved.

Apart from this, the ZyCoV-D vaccine is administered using an applicator gun without a syringe, for which training of healthcare workers is also necessary before it can be rolled out.

Covaxin for Kids: Approval Status

The Subject Expert Committee, on 12 October, recommended granting emergency use authorisation to Bharat Biotech's Covaxin for age group 2-18, but it may take a few weeks to get emergency use authorisation from the Drug Controller General of India.

Unlike other approvals for the COVID-19 vaccine, an official approval from the DCGI didn't follow the evaluation of the data and recommendation of the Subject Expert Committee as is common practice.

Instead, it is independently conducting a detailed examination of the submitted data from the paediatric Covaxin trial.

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The Indian Express in its 15 November report quoted a top government source as saying that DCGI has sought additional information on two subjects related to clinical trials of Covaxin on children,

  1. The number of participants in each age groups.

  2. Details of the adverse events that occurred after vaccination in these age groups.

According to sources, in response to this, Bharat Biotech has recently submitted data to the drug regulator, and Covaxin for Children is expected to get DCGI's approval by the end of November.

The National Technical Advisory Group on Immunization (NTAGI) will issue guidelines for the use of Covaxin in children in the National Immunization Campaign only after the drug regulator takes a final decision.

What Should Be the Strategy for COVID Vaccination of Children?

According to Dr Gautam Menon, "this (vaccines for kids) can wait till we achieve at least second dose coverage of about 70-80 percent or so (among adults), as well as a third dose, if seen to be required, in the vulnerable adult population."

Speaking to FIT for a previous article, Dr Kang also said the same thing, adding that by the time the vaccination of adults is completed, we will have better real world data regarding the vaccines for children from other countries as well.

As for reopening schools, Dr Menon says data from India and other countries suggests, "schools are potential sites where children can get infected but continues to support the idea that it is in adults that the impact of vaccines in preventing serious disease and death can be most clearly seen.

"Given this, continuing with adult vaccinations, perhaps prioritizing families of school-going children, should continue to be our strategy in the immediate future."
Dr Gautam Menon, Professor of Physics and Biology, Ashoka University

According to Dr Kang, we should think about vaccinating high-risk children already suffering from any disease because it can provide some protection, but it should be done with great monitoring.

(Written with inputs from the Wallstreet Journal, Times of India, Indian Express, and Times Now.)

(Subscribe to FIT on Telegram)

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