FDA analysis suggests J&J submitted weak data for boosters

In a new analysis, the FDA questioned the strength of the evidence provided by J&J in its recall request. A key test used by the company was probably not sensitive enough, the agency suggested, adding that it did not have enough time to independently review much of the raw data from the tests. The document, released ahead of a meeting of the agency’s vaccine advisers on Friday, could have a significant influence on whether the 15 million Americans who received the single-dose vaccine will be allowed to receive a second injection, or whether they will instead be urged to obtain a different brand of vaccine for additional protection.
The agency’s analysis follows a report released on Tuesday, in which J&J argued for a recall, presenting data from a number of trials. “A booster dose is recommended at 6 months or later, depending on the strength of immune responses,” he writes.
But on Wednesday, the FDA said the test used by the company to measure the immune response of a six-month boost – known as the psVNA test – is not sensitive enough for the task. He also asked if the increased immune response was as large as the data suggested. “It is likely that the results observed are due to the low sensitivity of the psVNA test used,” says his report. J&J spokesperson did not immediately respond
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