Bharat Biotech on Wednesday, 5 January, tweeted that no painkillers or paracetamol are recommended for teenagers, after being vaccinated with its COVID-19 vaccine Covaxin.
Starting Monday, 3 January, children aged 15-18 were eligible to receive Covaxin to protect themselves against the novel coronavirus.
At present, Covaxin is the only vaccine that is being administered to children in India.
How effective is the vaccine for children? Here is all we know.
Are there any reported side effects of Covaxin in children?
The most common side effect reported, is soreness or pain at the site of inoculation.
In a statement, Bharat Biotech said that a total of 374 subjects reported either mild or moderate severity symptoms, with 78.6 percent getting resolved within a day. Pain at the injection site was the most commonly reported adverse-effect, the statement said.
Should I give my child paracetamol or painkillers?
According to Bharat Biotech, neither paracetamol or painkillers should be given to teenagers experiencing mild side-effects after vaccination.
"Through our clinical trials spanning 30,000 individuals, approximately 10-20 per cent individuals report side effects. Most of these are mild, resolve within 1-2 days, and do not require medication. Medication is only recommended only after you consult a physician," the company said.
Is Covaxin safe for children?
There were no deaths or concerning adverse effect reported after administering Covaxin in children. No cases of blood clotting or myocarditis were reported.
Why did DCGI decide the cut-off age to be 12 years?
It is not known why the DCGI set the cut off age to be 12 years even though the clinical trails were successfully conducted on children from 2 to 18 years. Watch out this space for more information.
How was Covaxin approved for children?
Bharat Biotech’s Covaxin was approved for emergency usage in children by the Drugs Controller General of India (DCGI) after:
Bharat Biotech reportedly submitted results of Phase-III clinical trials on children aged 2-18 years.
The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation’s (CDSCO) recommended its usage on children.
When was the clinical trail conducted?
The clinical trials were conducted between the months of June and September 2021.
On how many children were the trials conducted?
The clinical trials were conducted on 525 volunteered aged 2-18 years.
They were divided in three groups of 175 children each, between age groups of:
12-18 years
6-12 years
2-6 years
What is the dosage of Covaxin in children?
Children of all three age groups were given 0.5 ml of Covaxin at an interval of 28 days, which is the same dose that was administered to adults.
Does Covaxin improve immune response in children?
Comparing immune response in children before and after being inoculated in Covaxin were as follows:
Antibody response in children was more than that in adults.
On an average, children developed 1.7 times more neutralising antibodies than adults.
No cases of myocarditis or blood clots were reported.
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