A “Pause” to Get Neurotic About … Our Greatest Medical Triumph?
Word came down from on high, about a small problem with one of the vaccines. No need to panic, the authorities said, but we’ll just “pause” to investigate. And in the meantime, if you already got this vaccine, the CDC and FDA had some advice: “seek medical care right away” if you develop headache, chest pain, abdominal pain, back pain, shortness of breath, blurry vision, if you break out all over in tiny spots …
Emergency department physicians across the nation heard this and sighed in resignation.
Even before this official CDC cry of “danger!”, a steady stream of patients had been arriving, on foot or by ambulance, convinced they were suffering a severe vaccine reaction.
Many had offered classic accounts of anxiety-mediated events — for example, rapid breathing with tingling in hands prior to the shot, and then — “the moment I got the shot, doctor!” — becoming dizzy and fainting. One elderly patient’s chief complaint of “vaccine reaction” was an obvious herpes zoster rash. It was on the same arm where he’d received a COVID-19 vaccination — 35 days prior. I told him I doubted the events were related, but — “doctor, it’s the same arm!”
A colleague of mine saw a person who, alarmed about official pronouncements about her Johnson & Johnson vaccination, had gone to urgent care. Instead of offering reassurance, healthcare providers there checked lab work on an asymptomatic patient and, when the blood tests couldn’t rule out blood clots, sent her to our emergency department for …?
We all understand the thinking behind the 10-day pause last month of the J&J / Janssen vaccine. It is not enough for these vaccines to be highly effective and incredibly safe; the public has to agree they are effective and safe. By the same logic behind “the pause”, every American getting a COVID-19 vaccine initially found they must be observed for 15 minutes afterwards, to watch for an anaphylactic reaction. Many of us were literally handed a timer with 15 minutes on it, and told we could hand it back on the way out after it rang.
The official hope was that if they take such obvious care to keep us safe, we will tell a story of being obviously safe. But there is an alternative, parallel story: Vaccines are so dangerous, they hand you a clock to see if you’ll survive the first 15 minutes!
And so, a pause. Experts at the Centers for Disease Control and at the Food and Drug Administration used it to review what is now a total of 15 cases of thrombosis-thrombocytopenia syndrome (TTS) across nearly 7 million J&J/Janssen vaccinations. In this exceedingly rare auto-immune disorder, which predominantly affects young women, the patient’s antibodies attack her own platelets. This leads to thrombocytopenia (low platelet counts), alongside pathological thromboses (clots) anywhere from the deep veins of the leg to the central venous sinus of the brain. It has been convincingly demonstrated as a side-effect, and has also been seen in Europe with the similar Oxford-AstraZeneca vaccine.
Fifteen cases in 7 million J&J / Janssen vaccines works out to one in 450,000. In Great Britain, there was one case of TTS for every 250,000 doses of Oxford-AstraZeneca vaccine.
These numbers cry out for perspective. As the British Medical Journal recently noted, the combined oral contraceptive pill has a blood clot risk of 1 in 2,000.
In other words: A young woman is at least 125 times more likely to have a blood clot from certain birth control pills than from one of the more traditional COVID vaccines.
Post-pause, the federal government declared it safe to continue using the J&J/Janssen vaccine, but in the same breath added that younger women “should be aware of the rare risk of blood clots … and that other COVID-19 vaccinations are available;” and that “for 3 weeks after receiving the vaccination, you should be on the lookout for symptoms of a blood clot.”
Wonderful. But since oral contraceptives are at least 125 times more dangerous, for how long does the federal government recommend that a woman on birth control pills “be on the lookout”? Should young women be aware that other forms of contraception are available?
A transparently cautious process, one marked by the open exchange of ideas and information, is necessary, wonderful — and totally inadequate. Medical professionals need to step forward to interpret this information, and to do so like caring doctors, not like cagey lawyers drafting a click-to-accept internet service provider agreement.
It’s often noted that medicine is about stories; that patients interpret their medical conditions or events by telling the story. Patient gets vaccine in arm; patient develops blistering painful shingles rash in same arm. “Doctor, it’s the same arm!” Patient just knows a vaccine was developed at a reckless “Warp Speed” pace as part of an international crisis, is terrified of it but more terrified of COVID-19, accepts it and immediately — “the moment I got the shot, doctor!” — collapses.
“The pause” was meant to tell a story: We are careful and thorough; we can be trusted.
But the pause — and especially the over-the-top post-pause warnings — can tell a parallel story: Vaccines are dangerous; vaccines can cause blood clots, even deaths.
We have a much better tale to tell then either of these. It’s a full-throated epic poem, a celebration of vaccination as our greatest medical triumph. It ranges from the defeat of smallpox — history’s greatest killer of humans, the scourge of Egypt’s pharaohs and George Washington’s Continental Army, eradicated in 10 short years! — to the rout of polio — to the crushing victory underway over COVID-19. We can already see that victory on the march after having delivered hundreds of millions of highly effective, safe vaccine doses.
So let’s stop with the hand-wringing. Vaccines work. Every emergency department doctor knows this, because terrifying diseases prevalent twenty or even ten years ago are gone. Kids now get upwards of 34 vaccines each year, and the results are amazing. We used to routinely see babies choking and drooling from epiglottitis as haemophilus influenzae B closed their airways; we used to see teenagers dying from meningococcal meningitis. Such cases are now so unusual, they are fading from a working physician’s radar as an important consideration.
Dozens of young women across Europe and America developed blood clots and low platelets, with some terrible outcomes and even deaths. That’s awful. That this was a rare adverse effect of a medical intervention intended to make them safe somehow makes it feel so much worse.
At the same time — what is the rate of terrible outcomes after a course of amoxicillin? The reported anaphylaxis (life-threatening allergic reaction) case rate of about 1 in 5,000 to antibiotics is almost 20 times higher than the rate of reported COVID-19 reaction anaphylaxis. Again: You are 20 times more likely to have a severe allergic reaction to a course of Amoxicillin than to a COVID-19 vaccination.
As to fatal anaphylaxis, a simple antibiotic course is infinitely more dangerous: there has been no fatal anaphylaxis to a COVID-19 vaccine, and with 15-minute post-injection observations by epinephrine-armed professionals, none is likely.
Meanwhile, thousands die every year across our nation from clostridium difficile diarrheas, which are often caused by brief courses of antibiotics. Where is the C diff-inspired pause?
All COVID-19 vaccines — even the J&J and AstraZeneca versions — prevent blood clots. Because the vaccines themselves prevent COVID-19, which itself causes blood clots at an incredible rate — among hospitalized patients, in something like 1 in every 5 to 10 cases.
Put another way: a case of COVID-19 might be 25,000 times more likely than a J&J / Janssen vaccine to cause a pathological blood clot. Instead of sending people for emergency department evaluations because they got a COVID-19 vaccine, it would arguably be more logical to send people for evaluation if they did not.
Matt Bivens is a practicing emergency medicine physician in Massachusetts. An earlier version of this article also appeared in Emergency Medicine News.
