PULSE POINTS
WHAT HAPPENED: The U.S. Food and Drug Administration (FDA) has granted full approval for Moderna’s COVID-19 vaccine, Spikevax, for children aged 6 months to 11 years.
WHO WAS INVOLVED: Moderna, the FDA, American children.
WHEN & WHERE: Announcement made on Thursday.
IMPACT: Moderna’s shares rose 2%, and the company plans to have its updated vaccine available for the 2025-26 season.
IN FULL
The U.S. Food and Drug Administration (FDA) has given full approval to Moderna’s COVID-19 vaccine, Spikevax, for children between the ages of 6 months and 11 years who are considered at higher risk of the disease. Previously, the vaccine was only accessible to pediatric groups under an emergency use authorization. This announcement has positively impacted Moderna’s market performance, with shares rising by two percent in premarket trading.
This follows Moderna facing scrutiny in the United Kingdom earlier this year, when it was fined nearly £44,000 (~$60,000) for unlawfully using incentives such as teddy bears to encourage children to participate in coronavirus vaccine trials in 2023.
The British complaints centered around advertisements published by Bradford Teaching Hospitals National Health Service (NHS) Foundation Trust, which aimed to recruit children aged 12 and over for trials of Moderna’s updated mRNA vaccine. These ads were targeted directly at children rather than their parents, promising certificates and teddy bears as rewards for participation.
Molly Kingsley, founder of the pro-children campaign group UsForThem, criticized this approach, stating, “For any pharmaceutical company to effectively bribe children with the offer of free teddy bears to take part in a trial of a product posing a degree of risk to the child is sinister and deeply unsavoury behaviour.”
The FDA has itself recently updated the warning labels on Pfizer and Moderna’s mRNA coronavirus vaccines with new information on the risk of myocarditis and pericarditis, particularly in young males.
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