Here is what to know about clinical trials of COVID-19 vaccines involving children

Experts remain divided on whether the third wave of the COVID-19 pandemic will impact children or not. While children and teens are not spared by the COVID-19 infections, the reality is that kids rarely develop severe disease, with deaths even rarer.

It was observed, however, that some children with COVID have developed the multi-system inflammatory syndrome.

With the virus mutating, and vaccination for children and teens not yet started, most of them remain vulnerable and can even infect other age groups.

Experts say to reach herd immunity it is imperative for the children and teens to get COVID-19 vaccines.

India vaccine makers such as Bharat Biotech, Serum Institute of India and Zydus Cadila have either initiated clinical trials or are in the process of doing so for their COVID-19 vaccine for children.

The World Health Organization (WHO) says that clinical trials in children need to pass rigorous ethical evaluations and meet certain standards before being allowed to recruit patients.

Here is what to know about the ethical dilemmas of enrolling children in clinical trials, the consent process, and other connected aspects.

Why do children need separate clinical trials?

Unlike grown up adults, children's bodies are different. They undergo many changes as they grow from infancy to adolescence and adulthood. That's why it is important to test vaccines in children.

When can companies begin vaccine trials on children?

The initial safety and tolerability data of the vaccine should be obtained in adults; ideally after conducting a post marketing surveillance in adults before proceeding to test it on children. The trials are designed in such a way that the vaccines will be first tested on older children before extending it to a younger age group and then to infants. Vaccine makers initially try a range of doses to find the right measure that triggers a strong immune response without too many side effects. This will be generally done on a smaller cohort of subjects. Once the dose-range studies are done, vaccine makers will begin larger clinical trials, in which they will evaluate its safety, reactogenicity and immunogenicity.

How is consent obtained to recruit children? 

As per the New Drugs and Clinical Trials Rules, 2019 - in case of clinical trials on children, the subjects are legally unable to provide written informed consent, which should be obtained from the parent or legal guardian. However, all paediatric participants should be fully informed about the study in a language and in terms that they are able to understand.

Where appropriate, child participants should additionally assent to enrol in the study. Mature minors and adolescents should personally sign and date a separately designed written assent form. Although a participant's wish to withdraw from a study must be respected, there may be circumstances in therapeutic studies for serious or life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare of a paediatric patient would be jeopardized by his or her failing to participate in the study. In this situation, continued parental or legal guardian consent should be sufficient to allow participation in the study.

Where to approach to participate in clinical trials?

The Clinical Trials Registry- India (CTRI) website, provides details of the ongoing clinical trials, contact numbers, email ids of the principal investigators and the recruitment status.

On occasions, sponsors of clinical trials publish advertisements in local newspapers to aid recruitment of patients to a clinical trial. Sometimes, paediatricians can also help in the process.

What are the eligibility criteria for recruitment?

Those with confirmed SARS-CoV-2 at the time of screening, or running fever, or known to have allergic reactions to any ingredient of the vaccine, bleeding disorders and immunosuppressants are excluded from the trial.

Who will pay for the treatment in case there is a trial related injury?

It is the responsibility of the trial sponsor to arrange for free treatment of any injury directly resulting from exposure to the study vaccine, or any injury directly related to procedures undertaken during a clinical trial. Generally, the opinion of the investigator and, if required, that of experts appointed by the Ethics Committee may be taken to determine whether the injury is trial-related or not.

Will there be any compensation for participating in the trial?