Days after the U.S. Government announced its plans to begin a Covid booster vaccine roll-out, the Washington Post has revealed that American health officials are reviewing reports that the Moderna vaccine may be linked to a higher risk of a heart condition in younger adults than was previously thought – especially in young men. Reuters has the story.
The review was focused on Canadian data that suggests a higher risk from the shot than the Pfizer vaccine, especially in men below the age of 30, according to paper.
The Washington Post report quoted a source saying it was too early for the regulators to reach a conclusion, and that additional work was needed before any recommendation was made.
“While we won’t comment on internal meetings or discussions, we can say that FDA is absolutely committed to reviewing data as it becomes available to us,” the U.S. Food and Drug Administration said. Moderna did not immediately respond to Reuters’ requests for comment.
The possible review comes just two days after U.S. health officials said that Covid vaccine booster doses will be available to Americans from September 20th, over concerns that initial vaccinations may offer lower protection in the face of rising infections due to the Delta variant.
Health regulators in June had added a warning to the literature that accompanies mRNA vaccines produced by Moderna and Pfizer to flag a rare risk of heart inflammation seen primarily in young males.
Data from a Government agency’s safety monitoring system in that month suggested a rate of 12.6 cases of heart inflammation per million in 12 to 39 year-olds. …
If new information changes the risk-benefit profile of Covid vaccines, the FDA will update the public accordingly, the agency said in an email. …
Roughly 142 million shots of the Moderna vaccine have been administered in arms, according to U.S. Government data as of Thursday.
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