FDA Overreacted on J&J Vaccine Pause: Ex-Official
FDA’s decision earlier this month to recommend a pause on Johnson & Johnson Covid-19 vaccinations was more a move to cover agency rear ends than to protect public health, according to an opinion piece by Pacific Research Institute senior fellow and former FDA’s Office of Biotechnology director Henry I. Miller. The pause was ordered because of concerns about potential blood clots in those getting the vaccine. So far, almost 7 million vaccines have been administered in the U.S. and six cerebral venous sinus thrombosis cases have been reported, according to an FDA release. All six occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination. One vaccine recipient died and another is in critical condition, FDA said.
“At a time when there are supply shortages of Covid-19 vaccines in much of the U.S., and the frequency of new cases remains significant, this recommendation for a pause is puzzling – or it would be, if the FDA didn’t have a long-standing pattern of excessive risk-aversion,” Miller says. He characerizes the pause recommendation as a common Type 2 FDA error — “an unwise decision that delays or prevents market approval (or emergency use) of a beneficial product. The reasons include regulators’ excessive caution regarding the level of risk they think a patient should be willing to accept, their demand for excessive proof of efficacy, and their lack of understanding or inappropriate anxiety about a new product or technology.”
With these types of errors, drug manufacturers typically “hesitate to antagonize the FDA or alarm investors by making too great a fuss over delayed approvals, and most often comply with the FDA’s demands for additional data or jumping through other hoops,” Miller explains. “The FDA’s bias toward more career-friendly, Type 2 errors systematically causes regulators to be overly risk averse about approval of new products — or, as in this case, allowing an important product to continue to be widely distributed.”
Miller believes that a “more judicious decision” from FDA and the CDC would have been to limit the vaccine to men and to women over age 60 while more data are accumulated and analyzed. “Another possibility would be simply to inform potential vaccinees of the (very low) risk of serious adverse events following administration of the J&J vaccine, and let them decide whether to take the shot,” he says.