Taking a Pause
What if we all took a pause once in a while to wonder if we might be wrong?
Openness to the possibility that you may be wrong is a hallmark of credibility and rigor in science. What happened last week with the Johnson and Johnson (J&J) COVID-19 vaccine is a great example of this rigor. Even in the midst of overwhelming evidence that these vaccines are safe and effective, scientists continue to search for new information about how our bodies respond to these new vaccines.
“Most intensive safety monitoring in US history”
While we have been waiting our turn to get vaccinated, scientists at the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been busy with what CDC calls “the most intensive safety monitoring in US history.”
As part of this monitoring, healthcare providers are required to report any seriously bad things that happen to people after a vaccine to the federal Vaccine Adverse Event Reporting System, known as VAERS. This might include death, needing to go to the hospital, or some other serious medical event, especially if it may have been life-threatening. VAERS can’t tell us whether these events are related to the vaccines, but it can give us an early and important heads up on potential issues.
A weird thing happens.
By the middle of April, there were six reports in VAERS of a rare and dangerous type of blood clot. All six reports involved women under age 50, and all six happened between 6 and 13 days after the women got the J&J vaccine. One of the women died. Considering that there had been almost 7 million doses of this vaccine administered, six reports may not seem like a lot.
But it was eerily familiar.
Reports of unusual blood clots after receiving the AstraZeneca COVID-19 vaccine have recently been investigated in Europe. It’s not just a coincidence — the AstraZeneca and the J&J vaccine use a similar type of weakened cold virus in the vaccine, unlike the Pfizer and Moderna vaccines.
Not just any blood clot.
Typically, if you have a blood clot, you might be treated with blood thinners, like heparin. But the clots that occurred after these two vaccines are unusual. If these blood clots are treated with heparin, they can get much worse.
The pause.
The reports from VAERS and from Europe’s experience with the similar vaccine seem to suggest that something extremely rare but potentially dangerous is happening. But why pause the use of this vaccine if the risk of blood clots is so vanishingly low and the risk of COVID is so high?
- One reason is to consider whether the J&J vaccine may be riskier for some people than for others. Right now, it looks like the risk of getting this rare blood clot after receiving the J&J vaccine is less than 1 in a million. But could the risk be higher for some women younger than age 50?
- Another reason is to seek more information. During the pause, CDC is working with healthcare providers across the country to make sure that all the cases of this rare blood clot have been reported to VAERS.
- Finally, we need to pause use of this vaccine to make sure that healthcare providers know how to treat these unusual blood clots. Since these blood clots need to be treated differently than most others, it is important that healthcare providers know how to treat them when they arise before resuming use of this vaccine.
What’s next?
It’s possible that we may keep using the J&J vaccine, maybe with additional warnings about the risks, or maybe with a recommendation that some people who have a higher risk of blood clots use a different vaccine. It’s also possible that we could decide not to use this vaccine. This seems unlikely because this vaccine has been extremely safe and effective overall.
What does this mean for me?
All six of the people with blood clots started having symptoms within two weeks of their vaccine. If it has been less than three weeks since your vaccine, CDC recommends that you call your doctor if you get symptoms of a blood clot like a severe headache, leg pain, abdominal pain, or shortness of breath. Remind your healthcare provider that you have recently received the J&J vaccine.
If you haven’t been vaccinated yet, now is the time to make your appointment! All Americans are now eligible for the vaccine. Make an appointment for any vaccine that is available to you.
Keep reading.
- https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html
- https://www.nytimes.com/2021/04/16/us/johnson-covid-vaccine.html
- https://www.wsj.com/articles/j-j-covid-19-vaccine-was-paused-over-blood-clot-treatment-concerns-11618777554
Think like a scientist.
Feeling sure? Pause. Consider. Look for other perspectives. Do you have all the information? Listen to others. Have you learned something that inspires you to re-think your opinion?