US FDA is recommending a pause in the use of the J&J #covid19 vaccine while they investigate 6 reported cases of the kind of rare clotting disorder seen after AZ vaccine too.
Should not come as a huge surprise to those of you who have been following the reporting on this.
As @GretchenVogel1 and I wrote last week, EMA is already investigating this safety signal.
Given that this vaccine (like AZ one) too uses an adenovirus to deliver the genetic instructions for #SARSCoV2 spike protein, there were worries about this.
@GretchenVogel1 There will be a press conference at 10am ET that may have more information.
But for now, think of this as a cautious approach to a safety signal, similar to what, for instance, PEI in Germany did when reports of AZ side effects emerged almost exactly a month ago.
@GretchenVogel1 The numbers:
As of April 12, more than 6,8 million doses of the vaccine have been administered in the US.
So far there are six reported cases of CVST with thrombocytopenia, all were were "women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination."
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There is an interesting new preprint out that will probably generate a lot of coverage at least in the UK. Essentially it argues that the risk of CVST is much higher from #covid19 than from vaccines.
Quick thread on this:
Here is an image from the paper that is likely to feature heavily in debates around this.
As you can see the risk of CVST here seems to be 8-10 times higher in people with CVST than in people who received mRNA vaccines or AstraZeneca.
BUT: A lot of caveats here.
First of all:
The paper really only makes a like-with-like comparison with mRNA vaccines (as authors pointed out in presser this morning too: “I think our data say actually nothing about the AZ vaccine.”).
That’s why the data on AstraZeneca is greyed out in that graph.
Most fascinating bit of ACIP meeting so far is a detail on the 25-year old male in J&J trial, who developed CVST with hemorrhage after 8 days.
J&J representative says it was retrospectively determined that he was negative for anti-PF4 antibodies before vaccination, positive after
Case reports are fascinating.
Here are some details on the case from previous tweet.
(Short sentence on anti-PF4 antibodies is a bit misleading here: he was negative at baseline, positive post-vaccination according to the presentation)
As I have said before these decisions depend a lot on context. In this case:
- infections are low
- other vaccines available and
- oldest people largely vaccinated (so future vaccinees would be younger)
Different places will come to different conclusions and that’s reasonable.
"In the midst of an epidemic, it has been a difficult decision to continue our vaccination programme without an effective and readily available vaccine against COVID-19. However, we have other vaccines at our disposal, and the epidemic is currently under control.”
“While these events are very rare, we’re recommending a pause in the use of the J&J #COVID19 vaccine in order to prepare the healthcare system to recognize and treat patients appropriately and to report severe events they may be seeing in people”, says @CDCgov’s Anne Schuchat.
@CDCgov Q how long the pause may be
“The timeframe will depend obviously on what we learn in the next few days. However, we expect it to be a matter of days for this pause”, says @DrWoodcockFDA.
@CDCgov@DrWoodcockFDA "The issue here with these types of blood clots, is that if one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm or the outcome can be fatal”, says Peter Marks.
I just don’t get it, @NateSilver538. I admire your work on polling and you clearly appreciate the complexity there.
You can argue about the FDA decision for sure, but pretending it is blindingly obvious that they are wrong, simply isn’t true or fair to this situation.
As so often in this pandemic, I agree with @angie_rasmussen here.
I don’t think vaccinated individuals need to lose sleep over this, but I certainly want people at the agency tasked with ensuring the safety of vaccines to lose a little sleep over this.
Gerade etwas verdutzt festgestellt, dass wir @pandemiapodcast jetzt schon seit mehr als einem Jahr machen. Am 13.4.2020 kam unsere zweite Folge raus, in der wir über Ebola in Liberia sprechen.
Was war eure Lieblingsfolge? Was würdet ihr gern noch hören?
Und unsere aktuelle Folge zur Situation auf den Intensivstationen liegt @nsemak, @SalmLaura und mir besondes am Herzen.
Falls ihr sie noch nicht gehört habt, hier entlang: viertausendhertz.de/pan22/
Und an dieser Stelle etwas verspätet ein riesiges Dankeschön an alle, die uns im ersten Jahr unterstützt haben! @pandemiapodcast ist ein Herzensprojekt, aber die Finanzierung ist nach wie vor schwierig und wir hätten es nicht bis hierhin geschafft ohne großartige Unterstützung: