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|Articles|October 13, 2021
FDA Underwhelmed by Johnson & Johnson Appeal for Booster Shot Approval
Author(s)Nina Cosdon
The FDA suggested that Johnson & Johnson had not conducted an appropriately thorough test to prove its vaccine requires a six-month booster.
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Today, the Food and Drug Administration (FDA) questioned whether Johnson & Johnson had sufficient evidence to back its application for booster shots, according to a report by
The FDA suggested that the psVNA assay Johnson & Johnson used to measure the immune response of a six-month booster dose was not adequately sensitive. The FDA suspected that the significant observed increase in immune response from a second dose was due to the low sensitivity of the psVNA test.
In the US, 15 million people received one dose of the Johnson & Johnson COVID-19 vaccination, but if Johnson & Johnson is denied approval, they may have to look elsewhere for a booster shot.
Summaries of the data suggest a second dose of Johnson & Johnson two months after the first may provide added protection, but the FDA admitted quick turnaround prevented them from thoroughly assessing the raw data of the Johnson & Johnson booster trials.
Johnson & Johnson had
After two months, Johnson & Johnson claimed their booster prompted an antibody increase of four to six times what the lone dose provided. After six months, this grew to as high as 12-times the antibodies as a lone dose.
When this research was originally released, Paul Stoffels, MD, Johnson & Johnson Vice Chairman of the Executive Committee and Chief Scientific Officer said, “We now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”
With the approval of the
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