Medical Experts Urge FDA to Adopt Rigorous Safety Standards for COVID Vaccine Trial

Center Director Robert Truog is one of dozens of health leaders encouraging the FDA to implement more rigorous safety standards

Harvard Medical School Center for Bioethics Director Robert Truog, MD, joined upwards of 60 scientists and academics in urging the FDA to adopt higher safety standards amidst the race to produce a COVID-19 vaccine. In a letter sent to the agency on October 6, 2020, dozens of leaders in the medical field pushed for a minimum two month safety observation for all clinical trial participants, compared to the FDA's proposed median two month observational period. Under the current requirement, some trial participants would be observed for less than two months, which could allow a vaccine to be authorized before participants have been "observed through the period when most adverse vaccine events occur" according to experts.

Read the full letter below or as published online in STAT on October 6 here.

Dear Drs. Hahn and Marks:

As medical academics, scientists, and leaders, we believe the safety of a COVID-19 vaccine is paramount. As you know, a vaccine is given to healthy individuals and must adhere to the principle “first, do no harm.” The Food and Drug Administration has a duty to protect those who are vaccinated from harm.

But the FDA’s duty extends further. If the public does not have the utmost trust in the safety of the vaccine, the vaccination rate may not be sufficient to achieve herd immunity. In other words, the FDA’s decision could alter the course of the pandemic.

This is why a rigorous safety standard is so essential—and why the FDA’s standard is of grave concern. In a briefing document for the Vaccines and Related Biological Products Advisory Committee, the FDA indicated that it will require only a median of at least two months of safety observation of trial participants. Dr. Marks has explained that this 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.

There is too much at stake. 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.

We stand ready to publicly verify the safety and efficacy of a vaccine if the science and scientific process support such a determination. In that case, we look forward to working with you to promote vaccination that will help bring this pandemic to an end.