Like 'Big Lebowski' Nihilists, CDC Cuts Off Your Johnson & Johnson. But Only For A Little Bit.
Federal health officials yesterday called for a pause in use of the Johnson & Johnson coronavirus vaccine, following reports of blood clots in a tiny number of people who had received the J&J vaccine. Out of nearly seven million doses of the Johnson & Johnson vaccine given so far, six cases of "cerebral venous sinus thrombosis (CVST)" have occurred in women between the ages of 18 and 48.
The Food and Drug Administration and the Centers for Disease Control and Prevention jointly recommended the pause "out of an abundance of caution" so the possible link between the vaccine and the blood clots can be reviewed, and to allow time to educate healthcare providers about the potential problem. Acting FDA Commissioner Janet Woodcock said yesterday the agency expects the pause may last only a few days. Here's Dr. Anthony Fauci explaining the pause at a White House Presser yesterday:
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, explained making sure healthcare professional know about the blood clots is particularly important. As Vox reports,
patients with these clots also had thrombocytopenia, a condition where platelets in the blood drop to very low levels, leading to bleeding and bruising. The combination of blood clots and low platelets means that patients cannot receive conventional blood clot therapies like heparin, a blood thinner. That's why health officials want to wait to resume vaccinations with the Johnson & Johnson vaccine until they can investigate the concern and come up with new guidelines if necessary.
Another factor is that these cases occurred in younger women, who normally don't face a high risk of these types of clots.
To be sure, the risk is extremely small — literally less than one in a million — but putting new vaccinations with the J&J vaccine on hold for a short time doesn't seem like an over-reaction, given the need to let doctors and others know that the rare cases where it does happen shouldn't be approached like any other blood clot. And to get good information to the public, too, which is something the CDC is very big on doing again.
As a matter of public health messaging, there's definitely a downside to halting use of one of the three approved vaccines, even temporarily, but as the New York Times reports, this is probably the kind of problem where "abundance of caution" is a far less damaging message than the alternative:
"It's incredibly challenging, but to ignore it would have been worse," said Rachael Piltch-Loeb, an expert in health risk communication at the N.Y.U. School of Global Public Health. If the public suspected that the government was concealing serious potential side effects, she said, far more people might decide against vaccination.
The other two vaccines being used in the US, from Pfizer and Moderna, use a different technology than the J&J vaccine, and have seen no problems with blot clots. But in Europe, the AstraZeneca-Oxford vaccine, which isn't yet approved for use in the US, was also paused by health officials after small numbers of patients developed blood clots. Vaccinations with the AstraZeneca vaccine resumed once European health officials determined it didn't create any additional risk.
Again, we'll hand the heavy science lifting over to Vox's explainer of what might be going on with the J&J and AstraZeneca vaccines, which both use a genetically engineered adenovirus "to deliver DNA instructions to cells for making the spike protein of SARS-CoV-2," although the research is still in the early stages:
Robert Brodsky, director of the hematology division at Johns Hopkins University, said last month that the spike proteins built using the instructions from these vaccines could, in rare cases, trigger an immune system response that interferes with the regulation of blood clots. That immune response could also damage platelets, accounting for the symptoms presented. More evidence is needed to verify that is causing the problem, but it could help scientists develop ways to treat or prevent the issue.
So what does all this mean for the pandemic in the US? Mostly, it means people who had appointments to get the J&J vaccine this week (and maybe next) will have to reschedule for one of the other two vaccines. The White House says there are sufficient doses of the Pfizer and Moderna vaccines to still reach President Biden's goal of getting 200 million Americans vaccinated by his 100th day in office, and ultimately to get vaccines to all adults who want one.
The CDC's vaccine advisory committee will be holding an emergency meeting today, and in coming days the CDC and FDA will decide whether the J&J vaccine should still be allowed to go to all adults, whether its use should be limited, and whether additional screening of patients should be added. Again, Vox notes that's already been added to the routine for the Pfizer and Moderna vaccines after a small number of people had unexpected allergic reactions:
Health officials modified the vaccine protocol to screen people with a history of severe allergies. They also added a 15-minute waiting period for recipients post-vaccination, since most allergic reactions arose in that window.
Regulators could, then, take a similar approach with the Johnson & Johnson shot to the one they used for allergies and the mRNA vaccines, adding a screening criterion for people at highest risk of these blood clots before they receive the Johnson & Johnson vaccine.
In the meantime, as Dr. Fauci noted at the presser, if you've had the Johnson & Johnson vaccine in the last month, let your doctor know if you're having symptoms, like such as:
severe headaches, abdominal pain, leg pain or shortness of breath. Officials said the most common symptom of the disorder was a persistent, moderate to severe headache that begins six days or later after the shot.
Dr. [Anne] Schuchat, the C.D.C. official, said the risk of dangerous blood clots was "very low" for people who received Johnson & Johnson's vaccine more than a month ago.
All in all, we're guessing this won't be a serious glitch in the vaccination effort, particularly since there is zero probability of the president going on Twitter to blame problems with the J&J vaccine on his political enemies.
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Doktor Zoom's real name is Marty Kelley, and he lives in the wilds of Boise, Idaho. He is not a medical doctor, but does have a real PhD in Rhetoric. You should definitely donate some money to this little mommyblog where he has finally found acceptance and cat pictures. He is on maternity leave until 2033. Here is his Twitter, also. His quest to avoid prolixity is not going so great.