Covaxin for kids: While awaiting trial data, experts unpack what is known about the Covid jab for children

Parents have been grappling with fears of sending unvaccinated children to schools and colleges which are gradually reopening across the country. Now, they are likely filled with hopes and questions, after Bharat Biotech's coronavirus jab Covaxin was recently recommended for emergency use in children between 2-18 years by the subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).

At present, Covaxin is a part of the national immunisation programme for adults only. While the manufacturer awaits the final nod from the Drugs Controller General of India (DCGI) to launch the jabs for children, Mid-day invited three experts to explain the nuances of vaccination for children, especially those who are immunocompromised.

But first, here is some context about the jab's journey so far: the expert committee recommendation came last week after Bharat Biotech completed phase 3 clinical trials involving 525 children in September this year. The go-ahead for the trials was given by the drugs controller general of India Dr VG Somani in May. Covaxin is the second vaccine to be approved after Zydus Cadila's ZyCov-D, which received the green signal in August. However, the latter is only for adults and children above 12 years.

Although it is still early days and experts need to access trial data for better assessment, paediatrician Dr Nitin Shah and consultant pulmonologist Dr Lancelot Pinto of PD Hinduja Hospital & MRC, as well as Dr Dhanya Dharmapalan, consultant for paediatric infectious diseases, Apollo Hospitals, Navi Mumbai weigh some of the pros and cons based on information currently at hand.

What do we know about the vaccine and its recommendation for use in children?

Dr Nitin Shah explains, "This is a technical approval by the highest committee, which looks into new drugs. Now, it has to undergo an EUA (Emergency Use Authorisation) for that age group and then the actual rollout will be conducted."

The process itself will take time, he reckons. Following the approval, it will need to be decided whether the vaccinations will give prioritisation to children who are at risk of severe Covid or generally, who will be giving it (public or private hospitals), and whether it will be given by paediatricians or nurses. Further, the rollout will happen only after addressing if vaccines are to be booked through the same app, and if so, getting children registered on it, Shah says.

What should parents keep in mind when deciding to give their children the vaccine?

Dr Pinto explains, "Parents need to keep in mind the fact that despite children having an extremely low risk of moderate to severe Covid, they will continue to spread the virus unless they are protected."

Elaborating on this, Shah adds that immunising the child would benefit not only them personally but everybody around them too. "Children can also transmit it to people who are at high risk of developing severe Covid-19 either at home or in school. It will help the people who haven't taken the vaccine because children cannot be expected to follow Covid-appropriate behaviour."

Will the vaccine have to be given keeping in mind the current vaccine schedule for children?

Shah says there is no need to keep a gap between routine childrens' vaccines and this vaccine and they could be given simultaneously or one after another. However, he says it is advisable for parents to see if the other vaccines have any side effects and then give it to the child. He adds, "For example, if a two-year-old child has taken a typhoid vaccine today, he won't take the Covid vaccine tomorrow, he can wait for one or two weeks till the side effects of the first vaccine are gone. However, scientifically, there is no problem in giving it on the same day back-to-back and so it shouldn't be an issue."

What are the known possible side effects of the vaccine? What should parents look out for?

Covaxin hasn't shown any severe side-effects in adults and is a safe vaccine, so there shouldn't be a problem with children too, according to Shah. The paediatrician explains, "Parents are used to other side-effects like pain, fever, swelling, feeling of malaise or body ache, loss of appetite, which are seen for a day or two. They are self-limiting and may or may not need medication. If the fever is high, they can be given paracetamol." Dr Shah says that Covaxin isn't going to unusually lead to more reactions than any other child vaccine.

Pinto agrees, saying that the recommendation suggests that the vaccine is likely to be safe and well tolerated. "The reactions seen among adults such as pain at the site of the injection, fever, body ache for a short period might also be seen in children," he explains.

"Side-effects such as pain at site, fever, headache are known in adults and anaphylaxis has also been reported but no other serious adverse effects following immunisation were reported in the trials," adds Dr Dharmapalan, member of the Covid-19 Task Force of Apollo Hospitals and the Indian Academy of Pediatrics. She says that mRNA vaccines may cause transient myocarditis or pericarditis but since Covaxin is an inactivated virus vaccine, only studies will show if there is any risk.

Can the vaccine be given to children with pre-existing illnesses and conditions such as cancer, diabetes and high risk?

All three specialists believe that the vaccine will help children who have conditions that reduce their immunity and priority should be given to them. Pinto explains, "This is because studies have shown that most of the children who experienced moderate to severe Covid were more likely to have an immunosuppressive condition than children who were otherwise healthy."

"Children don't develop many symptoms with Covid," says Dr Shah, which is why there were hardly any symptomatic cases in the first wave and only mild cases in the second. "The children who got hospitalised or died were due to adverse conditions. The immunocompromised cases include those undergoing chemotherapy for cancer, other malignancies, bone marrow transplant or organ transplant, children with renal problems or diabetes and any other high-risk conditions."

The post-vaccine side effects were different for women compared to men. Will it be the same for young boys and girls?

Dharmapalan says, "The gender differences for post-vaccine side effects were noted for other type of vaccines but not for Covaxin."

Although Pinto believes that the side-effects of the vaccine will not necessarily be mirrored in children, especially among younger children, he adds that it would be ideal to wait for the clinical trial data to be released to understand this better.

Is it advisable to consult a paediatrician before giving the vaccination?

Experts differ on this. Shah says it is not necessary to ask the paediatrician once it is a part of a national rollout and can be taken because it has been approved by experts.

Pinto says that unless there are circumstances or conditions which need clarifying, parents should avoid consulting a paediatrician before getting vaccinated, as it would add another layer of complexity to the programme, which is currently already overburdened.

On the other hand, Dharmapalan believes that while it would depend on government policy, it is a good idea to visit the family paediatrician before taking the vaccination to understand how it will work for the child.

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