COVID Vaccine Trials to Begin in Children: Is It Safe?
Covid vaccine trials in children to begin; FIT dissects the what, why and when of it.
Its been almost a couple of months since the first covid vaccine was green-lighted by the WHO, and since then several vaccines have entered the race and have been widely distributed. All of these vaccines are limited to use in adults over the ages of 18 and 16 (in the UK) only.
This, however, is set to change with pediatric clinical trials being kicked off by Pfizer and Moderna in the US and by Oxford University in the UK.
Why Do Young Children Need the Vaccine if They Are Safe From COVID?
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 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 at-risk children who suffer from other serious illnesses that make them more vulnerable to serious complications form 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 programs 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.
The tests are also important to make absolutely sure the vaccine is as safe in kids and teens as it is in adults.
Is It Safe?
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.
While Pfizer and Moderna are testing on around two to three thousand children between the ages of 12 and17, Oxford is starting with as few as 300 volunteers, between the ages of 6 and 17.
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, the children too have to give assent to participate in all the trials.
Who Is Eligible?
To be able to participate in the trials, the volunteer,
Should be between 12 and 17 years old
Should have never tested positive for COVID-19
Should be in good health
Shouldn’t have travelled 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
Will There Be Clinical Trials on 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.
The details of the trials are yet to be announced.
When Will the Vaccine for Children Be Available?
Depending on how the clinical trials go, covid vaccines for children and teens is expected to roll out as early as in the summer, or mid-2022.
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