Moderna’s COVID-19 vaccine appears safe and effective for use in children aged six months to 17 years old, analysts for the US Food and Drug Administration say, as scientists prepare to vote on whether to recommend its authorisation.
The FDA’s reviewers said in briefing documents published on Friday evening the vaccine had generated a similar immune response in the children as observed in adults in previous trials.
“Available data support the effectiveness of the Moderna COVID-19 vaccine in preventing symptomatic COVID-19 in pediatric age groups from six months through 17 years of age,” the FDA staff said.
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The FDA staff said the vaccine generally had a similar side-effect profile in children as adults, although younger users experienced more frequent fever.
The messenger RNA-based COVID-19 vaccines made by Moderna and Pfizer have been linked to rare instances of a type of heart inflammation called myocarditis, particularly in young men.
Some countries in Europe have limited the use of Moderna’s shots for younger age groups after some studies showed it was tied to a higher risk of the heart inflammation.
The FDA said myocarditis is a known risk associated with the vaccine, but that the drugmaker’s pediatric trials were not large enough to quantify the frequency of the inflammation in relevant age groups.
The pediatric Pfizer vaccine is already authorised in the US and Australia for people aged five and older.
In Australia, those aged six and over can already be given a pediatric Moderna vaccine, while the Therapeutic Goods Administration is evaluating an application to extend its use to children aged six months to five years old.