Pharmaceutical company Moderna on Monday said that its coronavirus vaccine showed a strong immune response in children aged between six and 11 in a late-stage clinical trial.
The company said that it plans to submit the data to the United States’ Food and Drug Administration, European Medicines Agency and other global regulators for approval.
In a statement, Moderna said the interim data from the trials showed that the vaccine’s safety was comparable to that seen in the clinical trials of adults. In adults, the company had said the vaccine was 94% effective.
“The majority of adverse events were mild or moderate in severity,” it said. “The most common solicited adverse events were fatigue, headache, fever, and injection site pain.”
The study, called KidCOVE, was conducted on 4,753 participants, who were divided into three groups based on their age – 6 months to less than 2 years, 6 years to less than 12 years and 2 years to less than 6 years. The results published on Monday was for the 6 years to less than 12 years age group.
It said that the vaccine showed “strong immune response in this cohort of children one month after the second dose”.
The company said it used 50 microgram shots, which is half in strength of the doses used in the vaccine for adults and also the same as the booster dose authorised in the US.
Moderna said that it will submit the data of the study to a peer-reviewed publication.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints,” said Moderna Chief Executive Officer Stephane Bancel.
He added: “We look forward to filing with regulators globally and remain committed to doing our part to help end the Covid-19 pandemic with a vaccine for adults and children of all ages.”
The Moderna vaccine for adults has already been approved for use in the US. However, the company is waiting for a response from the US authorities to its application for approval of Covid-19 vaccine for children aged between 12 and 17, reported Reuters.
Some studies have suggested that the Moderna vaccine may increase the risk of myocarditis, an inflammation of the heart muscle, in boys and young men.
In July, the Food and Drug Administration had asked Moderna and Pfizer, which too has developed a coronavirus vaccine for children, to expand the size of their trials to detect less common side effects.
Moderna said it is still enrolling more children for trials in other age groups, adding that it has enrolled about 5,700 children in the US and Canada.
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