The Food and Drug Administration (FDA) has called for a halt to use of the Johnson & Johnson “one-shot” coronavirus vaccine in the United States. Around 6.8 million Americans have already received it, and blood-clotting in only six recipients caused the FDA to postpone its use indefinitely — that’s .000088 percent of cases. From the FDA’s statement:
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.
The argument for shutting it all down for the time being is that the kind of clots being observed — cerebral venous sinus thrombosis (CVST) — are extremely rare and require unique treatment. Administering heparin, the anticoagulant used in most cases of blood-clotting, may be dangerous. However, while the condition is rare, it is not occurring in recipients at a greater rate than in the general population. According to Johns Hopkins, five out of every million people are afflicted with CVST a year.
There are, I think, two conclusions to be reached:
- The FDA is acting out of an overabundance of caution, and that’s a mistake. Without a causal link between this negligible case count of CVST and the vaccine, calling for a complete halt to use of the vaccine is going to hurt distribution numbers in the short and long-term. Not only will it wipe out a great many appointments made by willing recipients, it will provide anti-vaxxers with a new talking point and likely discourage many Americans from ever signing up for any of the coronavirus vaccines. Even if the clots are related to the vaccine, this halt will assuredly cost more lives than the Johnson & Johnson vaccine ever could. Why wouldn’t authorities simply issue guidance to providers to be on the lookout for cases of CVST so as to head off the immediate use of heparin as a remedy?
- Looking at it another way, this should be a devastating development for the professional anti-vaxxers, and persuade coronavirus vaccine skeptics to feel safe scheduling an appointment to receive one of the other two vaccines right away. For those who believe there’s a massive conspiracy at work to cover up the vaccines’ deleterious side effects, this is the ultimate proof otherwise. A mere six cases of (not deaths caused by) CVST caused the FDA to slam the brakes and begin a review of the Johnson & Johnson products anew. If even the smallest whiff of a serious side effect caused the FDA to overreact as it has, it’s hard to believe that it’s hiding others.