As a primary care physician, I take care of many patients with idiosyncratic attitudes toward risk. Some smoke cigarettes, a known lethal habit, but eat only organic foods. Others avoid all vaccines despite centuries of evidence validating their substantial benefits. We can expect such idiosyncrasies from individuals, but it was a surprise and a disappointment to see such irrationality from the FDA/CDC. On April 13, those agencies decided to halt the administration of the life-saving Johnson and Johnson (J&J) COVID vaccine. They rescinded the decision ten days later.
The decision to halt J&J vaccination was based on six cases of blot clots (in the veins that drain the sinuses of the head) among nearly seven million individuals who have received the vaccine. Six out of seven million means the risk of this serious but generally nonfatal condition is less than one in a million. That risk pales in comparison to remaining unvaccinated.
Look at the risk in Michigan, which is now experiencing a horrendous resurgence of COVID-19. At the time of the FDA action, Michigan’s population of ten million was experiencing nearly 10,000 infections each day. The fatality rate for COVID-19 is roughly one in 200. So, about 50 unvaccinated individuals would die each day from the COVID-19 they acquired at the time of the FDA decision. For the unvaccinated in Michigan, that translates into a one in 200,000 chance of acquiring a fatal infection every day, versus a less than a one in a million one-time risk of a clot from the J&J vaccine.
Although COVID-19 is less prevalent elsewhere in the United States, the virus’s risks are still far greater than the chance of harm from the vaccine. And the FDA chose to preempt this negligible risk: The J&J vaccine had originally been approved under an “Emergency Use Authorization” (EUA). The FDA grants EUAs for vaccines addressing “serious or life-threatening diseases or conditions” when there are “no adequate, approved, and available alternatives.” Because the Pfizer and Moderna vaccines are also used under EUA and remain in short supply, the basis for J&J’s EUA was still valid when the FDA halted distribution.
The FDA/CDC joint statement cited “an abundance of caution” as their reason for halting the EUA of J&J. The agencies understandably want to demonstrate their vigilance in protecting the public. They likely assumed that pausing the EUA, then reapproving it alongside a set of warnings would allow J&J vaccinations to proceed as before.
The FDA and CDC’s pause on J&J may have bolstered vaccine hesitancy.
But their pause may have bolstered vaccine hesitancy. As I have seen in my experience as a practitioner, reluctance to vaccinate reflects “gut level” concerns rather than FDA-style risk-benefit analysis. Although the FDA rescinded the moratorium, the fear generated won’t simply dissipate. In addition, the concerns generated by the halt in THE J&J vaccine may affect willingness to take the Pfizer and Moderna vaccines as well. Vaccine skeptics anticipating that “the other shoe may drop” on the rest of the vaccines may elect just to wait and see.
We could already be seeing the fallout. I volunteer in a “Pop Up Vaccination Clinic” in the Watts/Willowbrook area of South-Central Los Angeles. The week prior to the moratorium, we administered the J&J vaccine to 121 patients. The week after the moratorium, we administered the first doses of Pfizer to only 64 patients. Although there may be other reasons for the fall-off, both the absence of the popular “one and done” vaccine and more general concerns generated by the moratorium may have accounted for the reduced demand.
Fortunately, the FDA and CDC’s reversal frees up over two million J&J vaccine doses. For the future, the FDA should overcome its “overabundance of caution” narrative and shift to the “minimize the harm” standard that practitioners employ. The correct message never changed: All the available vaccines for COVID 19 are safe and effective. I tell my patients that the best vaccine is the one they can get today.
Like people, vaccines and vaccination programs can be defamed. Once harmed, a reputation can be hard to rejuvenate. In the wake of the FDA’s J&J misstep, we should all do everything we can to encourage reluctant friends, colleagues and relatives to overcome their resistance and get vaccinated. As the national vaccination program evolves, we can only hope that the damage can be overcome.
Daniel Stone is Regional Medical Director of Cedars-Sinai Valley Network and a practicing internist and geriatrician with Cedars Sinai Medical Group. The views expressed in this column do not necessarily reflect those of Cedars-Sinai.
