Moderna Starts Vaccine Trials in Children: What Does This Mean?

Why is this trial important? When will children start getting the vaccine? FIT breaks it down for you.

(Photo Courtesy: iStock)

Moderna, on Tuesday, 16 March, announced it has begun testing its COVID vaccine in young children between the ages of 6 months and 12 years, in the US and Canada.

This comes nearly a month after Moderna, along with Pfizer in the US, and Oxford University in the UK had announced they were kicking off pediatric clinical trials in older children between the ages of 12 and 17.

What does this mean? Why is this trial important? When will children start getting the vaccine? FIT breaks it down for you.

Do young children need COVID-19 vaccine?

While it is true that most children are relatively unaffected by coronavirus and are unlikely to become unwell with the infection, “it is important to establish the safety and immune response to the vaccine in children and young people as some children may benefit from vaccination,” said Andrew Pollard, PhD of the chief investigator for the trial and a professor of pediatric infection and immunity at Oxford, said in a statement.

Apart from allowing healthy children to get back to some semblance of their past life, the vaccine would particularly be vital to children who suffer from other serious illnesses, that make them more vulnerable to serious complications from COVID-19.  

Moreover, children are often asymptomatic, and generally less likely to follow strict social distancing norms, making them spreaders who could then infect the more vulnerable adults around them like their teachers, parents, and grandparents.

The vaccines for children being approved would mean they could potentially benefit from inclusion in vaccination programmes in the near future.

Why does the vaccine need to be tested on children?

Although there isn’t much difference between a teen and a young adult, different vaccine doses are sometimes needed to achieve a similar safety profile and immune response in children as in adults.

This is especially true in the case of toddlers and infants whose immune systems haven’t fully developed yet.

For this reason, Moderna’s latest pediatric trials are especially significant, as the results could give us valuable information about a previously unchartered territory when it comes to the COVID vaccine.

The tests are also important to make absolutely sure the vaccine is as safe in babies and teens as it is in adults.

Is this a safe process?

The vaccines being tested on children are the same vaccine – at the same dose and at the same intervals – as the ones that have cleared adult trials and proven safe for use.

That being said, there is still scope for side effects and allergic reactions, which is essentially what these trials will be focusing on, and will be closely monitored during the trial period.  

How are the tests being conducted?

The sample sizes in all the pediatric trials are much smaller than those of the adult trials. The samples are also likely to be less diverse as compared to the adult trials, as the latter did not show any correlation between factors like race, ethnicity, gender, and the effectiveness of the vaccine.

Pfizer and Moderna started testing on around two to three thousand children between the ages of 12 and17. The latter’s study on children below the age of 12 is expected to to enroll 6,750 pediatric participants.  

The Oxford trial will give the actual COVID vaccine to 260 of the 300 volunteers, and the rest – the control group – will receive controlled meningitis shots.

Apart from written consent by the parents of the volunteers, in the case of the older children, they too have to give assent to participate in all the trials.

Who is eligible to volunteer?

• Should have never tested positive for COVID-19
• Should be in good health
• Shouldn’t have traveled outside of the United States in the past month
• Shouldn’t have participated in another trial in the past month
• Shouldn’t be a current smoker or have a history of smoking
• In the case of other pediatric trials conducted before, the participants were also required to be between the ages of 12 and 17

Will there be clinical trials for children in India?

Bharat Biotech, the producers of the indigenous Covaxin has been given permission to conduct clinical vaccine trials on children between the ages of 12 and 18, and is likely to start doing so by the end of February, or early March, in Nagpur, reported India Today.

Bharat Biotech had been given permission to conduct clinical trials on children over the ages of 12 back in January, after it cleared an efficacy trials.  

In January, Dr Krishna Ella, Chairman and MD Bharat Biotech had said, "We have completed our Phase-3 efficacy trials on children above the age of 12, and will soon present a protocol to the regulators for children between two to 12 years of age for permission to conduct a clinical trial."

As per international regulations, only vaccines based on inactivated viruses can be administered to children under the age of 16 years, making Covaxin the only indigenous vaccine safe for children as of now.  

When will vaccines be available for children?

The results of Moderna’s previous study on children above the age of 12 are yet to be declared. Depending on how the clinical trials go, COVID vaccines for children and teens are expected to roll out as early as in the summer, or mid-2022.

(This article was first published on FIT and has been republished with permission.)