FDA tells Moderna it needs ‘additional time’ to evaluate use of its vaccine for teens because of rare cases of heart inflammation

The US Food and Drug Administration has told Moderna it requires more time to rule on whether to approve its jab for children aged between 12 and 17, so it can evaluate reported risks of rare side effects, the drugmaker has said.

According to Moderna, the FDA informed it on Friday that it would need “additional time to evaluate recent international analyses of the risk of myocarditis after vaccination” with the company’s jab. 

The review may not be completed before January next year, the regulator warned. Moderna asked the FDA for emergency approval of its vaccine for adolescents back in June.

The drugmaker said on Sunday it was fully committed to working closely with the FDA on the review, while insisting that the safety of vaccine recipients was “of paramount importance” for the company.

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The European Medicines Agency (EMA) cleared Moderna’s vaccine for children aged from 12 to 17 in July. However, in early October, Sweden, Denmark, Norway, and Finland suspended the use of the US-designed jab among young men and boys. The decision was based on the findings of an unpublished study by Sweden's Public Health Agency, which sounded the alarm over “an increased risk of side effects such as inflammation of the heart muscle or the pericardium.” 

Moderna said more than 1.5 million adolescents around the globe have so far been injected with its jab, according to its estimations. It also pointed to the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), saying they had earlier stated that cases of myocarditis from mRNA vaccines have been “rare and generally mild.”

The company also announced it was going to delay its application for authorization in the 6 to 11 age group until the current FDA review is complete.  

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Rare cases of heart inflammation have been linked to both the Moderna and Pfizer-BioNTech vaccines. However, the FDA has already greenlit the use of Pfizer's jab for those aged between 5 and 11 years, saying the benefits of protecting kids from Covid-19 outweighed the risk of rare complications.

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