As the race for a Covid-19 vaccine accelerates, dozens of leading medical experts are urging the Food and Drug Administration to adopt a stricter standard for tracking the safety of clinical trial participants.
In a letter to the agency, the academics and scientists cited a document the FDA posted on Tuesday in advance of an Oct. 22 advisory committee meeting to review procedures for developing and authorizing a Covid-19 vaccine. The document stated the FDA will review Phase 3 data that includes a median follow-up of at least two months after a vaccination regiment to assess safety.
The requirement, which was also stipulated in a guidance the agency later released for authorizing emergency use of a vaccine, is of “grave concern,” they wrote. Why? They noted that Peter Marks, who heads the FDA Center for Biologics Evaluation and Research, had said the standard is “not such a high bar,” because it would allow for fewer than two months of observation of some trial participants.
“We respectfully urge you to require a high bar for safety. The FDA should require a minimum of two months of safety observation for all trial participants. Trial participants are already a sample of the population. To diminish the weight of some trial participants does not make sense. Under the FDA’s proposed lower bar, a vaccine could be authorized before many trial participants have been observed through the period when most adverse vaccine events occur.”
The disclosure came amid a battle between the White House and the FDA over safety requirements for a vaccine. Fighting to keep his job, President Trump has repeatedly talked up the idea that a vaccine will be available before the Nov. 3 election. But his remarks have generated concern that a vaccine that is released too quickly may not be sufficiently safe or effective and will dissuade many Americans from getting vaccinated. And if that happens, herd immunity will be much more difficult to attain.
“There is too much at stake,” the medical experts continued. “Authorization of a vaccine before a high safety bar is met would severely erode public trust and set back efforts to achieve widespread vaccination. In short, premature authorization would prolong the pandemic, with disastrous consequences. The integrity of the Food and Drug Administration would be severely compromised, with long-term repercussions.”
The White House had initially blocked the FDA plan to formally publish the guidance due to the two-month data requirement. A key concern among some people on the Trump team is that the requirement will extend the time by which a Covid-19 vaccine would be available. Already, the timeline is being pushed back by most drug makers, with only Pfizer indicating its vaccine may be ready sooner than later. On Tuesday, though, the White House reportedly dropped its objections to the guidance.