Americans woke up this morning to the news that the FDA and the CDC have recommended a pause on the Johnson & Johnson COVID vaccine out of "an abundance of caution" while they review 6 incidences of rare blood clotting issues out of the 6.8 million J & J vaccines administered in the U.S.
Let's be super clear about the numbers here. Six out of 6.8 million. That means, of the people who have received the Johnson & Johnson vaccine since its February 27th emergency use authorization, 0.000088% of recipients have reported encountering this rare blood clotting issue. Literally less than one in a million.
On the flip side, some people are trying to compare these rare clots with the increased risk of blood clots in pregnancy and for those taking birth control pills, but this particular combination of clots and low platelets can't be treated the way clots normally are treated, which the CDC and FDA say is part of the reason for the pause—to alert doctors to treat any of these rare issues properly.
"In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia)," said a statement from Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination."
"Right now, these adverse events appear to be extremely rare," the statement added.
The problem, of course, with this responsible pause for review is that people who were already unsure about the vaccines may become even more hesitant. "See? We were right to wait! The vaccine isn't safe!" However, there are two big reasons why that's the wrong reaction.
1. Even assuming these clotting issues are truly caused by the vaccine and are wrapped into the numbers, the vaccine is still a far, far safer bet than taking your chances with COVID.
The math bears this out clearly. More Americans have received a COVID vaccine shot than have been diagnosed with COVID, with no pattern of deaths following vaccinations that would indicate a safety issue. Meanwhile, we have 562,000+ deaths from COVID. Even if you believe the COVID mortality numbers to be overcounted in some way (despite experts believing the count is likely an undercount), you would have to have practically zero COVID deaths to make the vaccines riskier.
But risk isn't just about death, right? What about side effects and long-term health effects of both? According to the WHO, approximately 10-15% of people who get COVID will develop severe illness, and about 5% will become critically ill. No one knows the long-term impact of COVID infection yet, but a WHO survey found that even among people ages 18 to 34 years in good health, 20% (1 in 5) of reported "prolonged symptoms." People with mild illness have reported months-long health issues, and we don't know yet if, when, or how people will recover fully. Meanwhile, immune system responses to the COVID vaccines can make people feel ill for a short time, and a very small number of people have experienced allergic reactions to the mRNA shots, but researchers have identified no patterns of long-term health issues with the vaccines at this point, which leads us to the second point.
2. This pause means that safety monitoring is working exactly like it's supposed to.
The FDA and CDC had to weigh the risk that pausing the J & J vaccine may cause vaccine hesitancy, but went with the pause recommendation anyway. Some people have expressed frustration with this choice, as the miniscule risk of blood clotting issue does not mathematically outweigh the risk of people not getting vaccinated, but ultimately people need to be confident that the process is thorough and transparent.
This is exactly what the safety monitoring of the vaccine rollouts is supposed to do—identify any potential risks and review them as they come up. These blood clot issues are so rare that there was no way for them to have shown up in the clinical trials, as that would have required a sample size of millions of people.
Messaging here is vital, of course. People need to know that the issues FDA and CDC are reviewing are extremely rare, that a pause is not a permanent halt, and that the reason they are pausing is because of the 6.8 million doses administered so far, these 6 very specific, very rare blood clot incidences are the only potential red flags they've seen.
(1) This is exactly the right move. All possibly concerning safety signals should be immediately & transparently in… https://t.co/8aKbjlPJ7Z— Leana Wen, M.D. (@Leana Wen, M.D.)1618325030.0
That is impressive. And as far as hesitancy about vaccines goes, people also need to know that the J & J vaccine is a different kind of vaccine than the Moderna and Pfizer vaccines. The J & J pause has zero bearing on the other two.
In addition, a pause on the J & J vaccine is not going to have a humongous impact on our country's vaccination numbers, since it only makes up about 5% of our total vaccine shot numbers. More than 100 million doses of Modern and Pfizer have been administered, with only a minuscule number of severe allergy reactions.
(4) To be sure, this is a disappointing setback, because the one-dose J&J has so much potential for easy distributi… https://t.co/DEpqdMYFi8— Leana Wen, M.D. (@Leana Wen, M.D.)1618325336.0
Statistically, the vaccines—even the J & J, despite the pause for review—are on very solid safety ground. The problem is how humans process and calculate statistical risk. (Basically, we're really bad at it.)
For some people, the idea of putting something into our bodies on purpose (a vaccine) feels riskier than taking a chance with getting the virus and the chance of having problems with it. But that's risk assessment based on feeling, not fact. People make most of their decisions based on emotion over reason, even if they think they don't.
So even though the J & J pause is actually a good thing, as it shows that the people in charge are monitoring things closely and taking any potential risks seriously no matter how small, there's a good chance that this news will lower people's confidence in the vaccines.
The key thing to remember is that nothing is 100% safe. But there is zero doubt that, overall, the vaccines are a far safer bet than COVID.
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