U.S. Calls for Pause on Johnson and Johnson Vaccine After Clotting Cases
nytimes.com
nytimes.com
What I'm finding interesting is that if this has anything in common with the (AZ/)Oxford vaccine problem as we should suspect, it would not seem to be related to Oxford's unique or nearly so use of an unstabilized version of the spike protein. At this point the only things obviously in common are some version of the spike protein and using adenovirus vectors. Different ones of the latter, a chimpanzee derived one for Oxford and a normal human one that's one of the causes of "the common cold" for Janssen.
Derek Lowe has commentary from yesterday on all this here, up to date except it only mentioned Janssen in passing based on his hearing about early cases with the latter: https://blogs.sciencemag.org/pipeline/archives/2021/04/12/az... It goes into the cold risk/benefit calculations you should make for various treatments and their diseases.
And if all the people with blood clots were women, why not stop it in women only?
Why pause it? Several reasons.
The USA has tried very hard to keep vaccine confidence high. We didn't follow the UK's lead on prioritizing first doses; we're giving doses on the schedule the doses were designed for. We didn't approve AZ yet, because there's some question marks there. We didn't approve a myriad of other vaccines from other countries we don't trust. A great way to blow that trust away is to continue to let some people get J&J then watch as people continue to die.
Second, J&J has had serious supply issues. Pfizer and Moderna have been the workhorse. I haven't been able to find clear data but it looks like J&J is less than 10% of the doses injected. It would be much, much more substantial of a problem if we had to pause Pfizer or Moderna.
Third.. and this one is maybe more controversial.. J&J does have lower efficacy. Maybe the USA is better off with a two-dose-vaccinated populace.
J&J or rather Janssen's production capabilities are mostly in the EU, we in the US have been getting doses made in the Netherlands with fill and finish (bottling) in the US. Unfortunately Emergency BioSolutions, a company who's competence is all political, not production, got the initial subcontract to make Janssen doses in the US, and predictably has done a horrible job. To make a long story short their Baltimore factory has not received FDA approval and just plain shouldn't without a complete top to bottom housecleaning, everything from firing every person in it to actually keeping the equipment and rooms etc. clean and free of mold and bacteria (yes, it's that bad). Merck though has recently agreed to make doses.
So we've run out of "banked" pre-authorization supplies of Janssen doses, and are not getting a whole lot from the Netherlands. Moderna and Pfizer appear to be in much better shape because they're not depending on delicate cell cultures to make their vaccines, production is much simpler except for the microfluidics that mix the lipids and mRNA. Biologically the most complicated thing is making DNA using E. Coli, that's much easier to do correctly than cell cultures, especially in bulk.
As for total doses administered in the US, see https://covid.cdc.gov/covid-data-tracker/#vaccinations As of yesterday only 6.9 million of Janssen out of 190 million total.
And you're right about the efficacy, Janssen's objective from the beginning was to develop the single most effective one dose vaccine, which they've achieved, although they're trying two doses eight weeks apart in a separate US based Phase III trial.
From [0]:
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female.
[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
2) It's not correct to say the denominator is 7 million. So far the cases seem to be concentrated in specific demographics, and it's not clear yet if that is a matter of who has received the vaccine, or if some demographics are more vulnerable than others.
The rate is 3-4 per million adults over the course of a year. The J&J vaccine has only been administered over about 3 months, so we'd expect only about 1 per million for this sampling period. It is true we can't be certain whether we've missed cases, but there's no evidence to suggest we have. This is a rare disease and this is a time period where everyone is hyperalert for potential vaccine side effects.
> It's not correct to say the denominator is 7 million. So far the cases seem to be concentrated in specific demographics, and it's not clear yet if that is a matter of who has received the vaccine, or if some demographics are more vulnerable than others.
The rate given is for all adults. The J&J vaccine is only approved for use in adults. All reported cases are in exactly the group most commonly affected. While again we can't say with certainty that there isn't a demographic effect, there is no evidence thus far to support that hypothesis.
I'm not saying that there is no reason to investigate further, but there is absolutely no evidence that people receiving this vaccine are experiencing symptoms at a higher rate than we'd otherwise expect. If there is an effect, all evidence at this time suggests it is very small. A small increase in risk of getting a rare condition, when compared to the far more likely possibility of contracting a disease that has killed hundreds of thousands in the US alone, is not something to be alarmed by.
This syndrome has taken only 1 to 3 weeks, I read 2-12 days elsewhere, to show up in people who've received Janssen's vaccine. Six total out of 6.9 million doses administered; I have no time to do the math right now but I think it might be worse than you think, plus we have to consider this very same thing showing up in the other vaccine of roughly the same type that's been widely prescribed in open societies, AZ/Oxford's.
You are falsely assuming that they had zero risk prior to getting the vaccine and then the vaccine set off some clock of development time. In reality, there is a constant risk. Any cases from prior to the vaccine being administered would not be counted, and only so much time has passed since the vaccine was administered. What you are really measuring here is what are the odds that someone who has received the J&J vaccine did so in the past 1-3 weeks, which is in fact extremely high with nearly half administered in the past week alone. Further, the longer the delay between the vaccine being administered and the development of a clot, the less likely it is to be reported in connection with the vaccine. We should thus expect nearly all cases of background CVST to come from people who have recently received the vaccine.
> plus we have to consider this very same thing showing up in the other vaccine of roughly the same type that's been widely prescribed in open societies, AZ/Oxford's.
The AZ/oxford vaccine produces a different kind of clot, and its incidence rate is likewise not significantly above background levels. The fact AZ is being investigated with regards to blood clots is only more reason to be confident that blood clots in people who have recieved the vaccine are being accurately reported.
The number is quite low, on the other hand as a patient I expect not to die after treatment. This is particularly problematic since that cohort isn't at risk anyway. Probably the death rate from Covid-19 is 0.0% or so there.