As kids around the country head back to school, there has been disappointing news for parents of children younger than 12. While many health experts had hoped for an early fall approval of a vaccine for young children, two of the nation’s top public health officials said it’s not going to happen.
It’s not clear if the initial predictions for an early fall vaccine were just overly optimistic, or if officials now think the review process will take longer than expected. The revised timeline comes after the Food and Drug Administration in July asked Pfizer and Moderna to expand the size of their clinical trials for younger children to make sure they could detect potentially rare side effects.
While Offit understands that parents are frustrated with the delay in approving a COVID vaccine for young children, it also should be reassuring that the FDA is taking the time necessary to review the vaccine data, he said. The agency doesn’t just rely on the company’s summary of the data. Agency officials look at individual reports from every single child, reviewing the most mundane details of any side effects, blood tests and other data collected during the trial.