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The European Medicines Agency has approved the Pfizer-BioNTech Covid-19 vaccine for the 12-15-year age group. This follows similar approvals in the United States, Canada and Singapore. The EMA’s human medicines committee recommended granting an extension of indication for the use of the mRNA vaccine in children, the agency said, adding that it was already approved for use in those 16 and above.
The development comes as countries debate sending their children back to school. In India, too, many parents are seeking a fast-tracking of vaccine approvals for children, concerned that the next surge in Covid-19 infections could be among children. The approved vaccine contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, naturally present in SARS-CoV-2, the virus that causes Covid-19, the EMA explains. The vaccine works by preparing the body to defend itself against SARS-CoV-2.
Same use as in adults
The use of the Pfizer-BioNTech vaccine in children would be the same as in adults — two injections in the muscles of the upper arm, given three weeks apart. The effects of the vaccine in children were investigated in 2,260 children aged 12-15.
The trial showed that the immune response to the vaccine in this group was comparable to that in the 16-25 age group (as measured by the level of antibodies against SARS-CoV-2), the EMA said. The most common side effects seen in children included pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever. These effects were usually mild or moderate and improved within days from the vaccination, the EMA said.
Also read: ‘India examining Pfizer’s indemnity demand’
The EMA committee noted that the study was too small to pick up rare side-effects, and it was assessing “very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart)” that occurred after vaccination, mainly in people under 30 years.
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