On Wednesday (28 Sep), the Health Sciences Authority (HSA) announced the authorisation of Pfizer’s Comirnaty Covid-19 vaccine for young children.
Source: Pharmaceutical Technology
The vaccination regimen for children between the ages of six months and four years will comprise three doses.
HSA said they had carefully considered the clinical data and consulted experts.
They have assessed that the vaccine benefits outweigh the risks even in young children.
Previously, HSA authorised Moderna’s Spikevax vaccine for children aged six months to five years old.
Now, the authority has approved the use of Pfizer’s Comirnaty vaccine for young children too.
For this age group, the vaccination regimen will consist of three microgram doses.
Children would have to receive the first two doses three weeks apart. Their third dose should then come at least eight weeks after the second.
HSA said the Ministry of Health (MOH) and Expert Committee on Covid-19 Vaccination will give their official vaccination recommendations when ready.
HSA’s clinical data was based on an ongoing Pfizer study involving 1,800 participants aged between six months and four years.
Source: Health Plus
Researchers found the immune response of young children with a three-dose primary to be comparable to that in adults between the ages of 16 and 25 who received higher doses of the primary series vaccine.
HSA thus inferred that three doses of the vaccine will grant young children a similar level of protection as two doses in adults.
Occurrences of adverse events were also similar to those in adults according to safety data.
Adverse events were largely mild-to-moderate. Many were common childhood vaccination side effects including injection site pain, fever, fatigue, and headache.
HSA assured that these reactions are part of the body’s natural response to build immunity.
These typically resolve on their own within a few days.
Though the clinical study didn’t report any cases of serious adverse events such as inflammation of the heart muscle, HSA still recommends that children’s caregivers monitor them.
Signs and symptoms of myocarditis include chest pains and breathing difficulties.
Caregivers should also take precautions to minimise rigorous physical activity after vaccination.
HSA assured that they will continue to actively monitor the safety of the vaccine.
Should there be any significant safety concerns, they will take the necessary actions and provide updates.
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Featured image adapted from Medpage Today.
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