Zydus Cadila vaccine gets EUA for adolescents: A look at scientific, ethical concerns in inoculating minors for COVID-19

With indigenously developed Zydus Cadila's COVID-19 vaccine receiving emergency use authorisation (EUA), another landmark in India's vaccination drive has been achieved: that of providing a vaccination option for the adolescent population (12-18) in the country of 1.3 billion people.

Covishield, Covaxin and Sputnik V, which are currently available in Indian markets, are being administered only to those above 18 years of age. On the other hand, ZyCoV-D, which is a three-dose vaccine, has been okayed for all those aged 12 and above.

However, the fact that the vaccine candidate is approved for use in children does not automatically mean that it will be available right away. A report in Hindustan Times said the jabs can be rolled out for those under the age of 18 only after the inoculation drive is officially expanded to cover children; at present, India covers only its adult population under its vaccination drive.

Furthermore, in previous communications, the company had indicated that it would need 45 to 60 days after getting EUA to roll out the vaccine.

On Saturday, Johnson & Johnson submitted an application to the Indian drug regulator to conduct a study of its COVID-19 vaccine in adolescents aged 12-17 years. The single-dose vaccine was approved for adults in India earlier this month

With the possibility of minors receiving the shot now one step closer to reality, questions regarding the safety, ethics and necessity of inoculating children also resurface.

There is a scientific question: will vaccinating children save actually lives? Then, there is also a moral and ethical dimension: will doses meant for children would save more lives if they were given to other more vulnerable groups in poor countries that are short of vaccine supply?

We look at some critical aspects of inoculating children, especially given the fact that the law keeps the burden of consent with their parents or legal guardians.

Arguments in favour of vaccinating children

• Parents had long found comfort in the fact that COVID-19 is not causing much harm to the younger population. But recent studies, surveys and on-ground data suggest that it's not only possible for children to contract the infection, but some some of them do get severely sick. Vaccines provide a safer and effective way to minimise that risk.
• Secondly, children are the future of the nation. And it's the responsibility of both parents and the government to keep them safe from the viral disease.
• Thirdly, it is important to consider to what extent children might transmit COVID-19 to others, and therefore their contribution in  community transmission -- even if their own health is not at risk with the virus. A study published in the Lancet journal recently pointed out that "living with 11-17-year-olds increases the risk of infection by 18-30 percent".
• Even if the direct benefit of inoculating children is not as visible as in vulnerable groups, it can have indirect benefits, such as schools remaining open and children being able to return to playgrounds -- all of which remain an integral part of their holistic growth.
• Given that fears of a possible future waves of COVID-19 looming, vaccinating children early can also help contain the spread of the virus.

Arguments against vaccinating kids

Before starting vaccination in children, some experts aak governments to consider broader collective interests with limited supply. Till vaccine stocks become abundant to the point it does not matter how we use them, the simple question remains: can supplies intended for children be redirected to more vulnerable adult groups in other countries to save lives?  As Julian Savulescu, a medical ethicist, tells The Conversation, "Uncontrolled global spread means more variants. So at this point, it might be more pressing to send doses elsewhere than to vaccinate children."

Secondly, some experts still b​elieve that the fine balance between risk versus benefit from the vaccine, is still slightly skewed in favour of a 'not yet' rather than a hard 'no'. Serious COVID-19 vaccine side-effects appear extremely rare. However, in the race to find the vaccine, clinical trial in adoloscents have mostly involved a very small pool of volunteers.

Pfizer’s trial enrolled 2,260 children aged 12-15 years in the United States, while Moderna will enrol approximately 6,750 children in the US and Canada between the age of six months and 11 years.

As other countries vaccinate children over 12, we can learn from their safety data. A small risk of myocarditis has emerged, particularly in boys and young men, in case of Pfizer. Even a very small chance of a significant side effect needs to be carefully weighed against the likely small direct benefit for children.

Which countries are vaccinating children?

The US rolled out a vaccination drive for children aged 12-15 on 14 May, and Canada had approved the Pfizer shots for the same age group on 5 May.

The United Kingdom has also approved the Pfizer/BioNTech vaccine for this age group. China too authorised the emergency use of CoronaVac, a COVID-19 vaccine manufactured by Chinese firm Sinovac, for children aged between 3 and 17 years.

France began offering Covid vaccinations to all over-12s on 15 June and more than 2 million children, roughly 40% of the 12-17 age group, have so far received a first shot

Other countries include Israel, Chile and Malta that have achieved one of the highest COVID-19 vaccination rates in the world.