FDA Underwhelmed by Johnson & Johnson Appeal for Booster Shot Approval

The FDA suggested that Johnson & Johnson had not conducted an appropriately thorough test to prove its vaccine requires a six-month booster.

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 New York Times.

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 previously reported that a booster dose 56 days after the initial vaccine was 94% effective in preventing symptomatic COVID-19 in the US, and 75% effective worldwide. The FDA focused their report on the worldwide results, which only showed a modest increase from the 66% worldwide efficacy offered by the first dose.

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 Pfizer-BioNTech vaccine booster for certain populations, the other major vaccine providers have been racing to keep up. The FDA appears to be withholding further approval until there is more trial data on the efficacy of boosters against the Delta variant.