US biotech firm Moderna said yesterday its Covid vaccine was safe and produced a strong immune response in children aged 6-11, adding it would submit trial data to global regulators soon.
The news comes as a panel of government advisers was preparing to meet today on the question of whether to authorise the Pfizer vaccine in kids aged 5-11, with top infectious disease expert Anthony Fauci predicting it would be available by mid-November.
“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,” Moderna chief executive Stephane Bancel said in a statement.
An interim analysis from a mid-to-late stage clinical trial of 4,753 children showed that two doses of vaccine produced a high level of neutralising antibodies — Y-shaped proteins that bind to the coronavirus and block it from entering human cells.
The vaccine was dosed at 50 micrograms, which is half of what is used among adults, but still produced on average 1.5 times as many antibodies in children as it did in young adults given the higher dose.
The majority of adverse events were mild or moderate, including fatigue, headache, fever, and injection site pain.
These early results, released via a press statement, do not yet include a vaccine efficacy estimate, which may be expected at a later time once cases have accrued.
The Moderna news comes as the US Food and Drug Administration (FDA) is preparing to convene a panel of advisers to vote on whether to greenlight the Pfizer shot for younger children, paving the way for 28 million more Americans to be vaccinated.
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