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US health authorities are calling for a pause in the use of the Johnson & Johnson Covid-19 vaccine, after reports of extremely rare blood clotting cases. The Food and Drug Administration (FDA) said it was acting "out of an abundance of caution".

It said six cases of severe blood clotting had been detected in more than 6.8 million doses of the vaccine.

BBC 13th April 2021

John Hopkins reports of Cerebral Venous Sinus Thrombosis that :

CVST is a rare form of stroke. It affects about 5 people in 1 million each year.

Hopkins Medicine Org

[Thus, during the whole of 2021, we would expect there to be 1,663 cases of CVST in the entire population (332.5 million) of the USA. On average, that is 31 cases per week.]

If the expectation of CVST is that 5 people in a population of one million will be affected, is the incidence in vaccinated persons any higher ?

As mentioned in comment, the statistic is very similar regarding the EU's experiences regarding Astra Zeneca : 72 cases in 80 million vaccinations.

It is interesting that in both these instances the occurrence of CVST is very similar, about one in a million.

Nigel J
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  • Related: https://www.bbc.co.uk/news/explainers-52380823. The EU paused rollout of the Astra-Zeneca vaccine due to similar reports of blood clots. – ewanc Apr 13 '21 at 13:29
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    How do you determine if something is overcautious? Also it says 6 cases have been detected but does it discuss how many possible cases might have been missed? It shouldn't be hard to imanage that not every case gets detected. – Joe W Apr 13 '21 at 14:45
  • "Over-cautious" is a matter of opinion at this stage. There are many variables to take into consideration, and the situation may change as more information becomes vailable. – DJClayworth Apr 13 '21 at 14:57
  • "If the expectation of CVST is that 5 people in a population of one million will be affected," The expectation is for a full year, the J&J vaccine has been available for just over a month. I.e. the expectation is closer to 1 case per 2 million. – TimRias Apr 13 '21 at 15:05
  • @mmeent People are only being vaccinated once this year. They are not being vaccinated every two months. (No CVST has been found on second doses.) – Nigel J Apr 13 '21 at 15:11
  • @JoeW CVST is a serious disease and all cases will be reporting to a Doctor or to ER (A&E). I strongly doubt that any cases will be missed. – Nigel J Apr 13 '21 at 15:13
  • @NigelJ Yes, but you want to compare against is "background"rate of people that would have developed a CVST regardless of being vaccinated in the same period of time. – TimRias Apr 13 '21 at 15:19
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    All 6 cases were in women between 6 and 13 days after vaccination. So 6 women in a 1 week period relative to the vaccination date. – DavePhD Apr 13 '21 at 15:20
  • @mmeent Indeed. John Hopkins is stating that annual background rate as 5 per million. – Nigel J Apr 13 '21 at 15:22
  • @NigelJ, Yes, so about 0.5 per million for the observed period, or 0.1 if we factor in DavePhD's comment. – TimRias Apr 13 '21 at 15:23
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    If the incidence rate is truly no higher than the "background" rate, we would expect to see the same rate among people who received the other COVID vaccines - or any vaccine, for that matter. Presumably that is not occurring, since we've heard nothing about it. – Mark Apr 13 '21 at 15:30
  • @NigelJ You are correct but that is assuming that the person was actually diagnosed by a healthcare professional. Not all cases are going to be noticed by someone who will go into a healthcare facility to get diagnosed. – Joe W Apr 13 '21 at 16:05
  • @JoeW You are correct. I was forgetting the different circumstances of the USA to the UK, here. – Nigel J Apr 13 '21 at 16:20
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    @DJClayworth I think that if these cases had resulted in death, they would have said so. If everyone in the US were to get the vaccine and get blood clots at this rate, ~300 people would get blood clots, versus 1000x DEATHS. I don't think that "risking hundreds of thousands of deaths to prevent a few hundred blood clots is a perfectly reasonable thing to do" is an opinion deserving of any respect. And yes, there are other vaccines, but if people on average take another week to get a vaccine, the cost/benefit is still overwhelmingly in favor of not blocking J&J. – Acccumulation Apr 15 '21 at 03:10
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    @Acccumulation one of the cases has resulted in death so far. The risk the vaccine may be worth it for one age group, but not another. – DavePhD Apr 15 '21 at 15:07

1 Answers1

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Yes, the incidences of CVST following vaccination with the J&J vaccine and the AstraZeneca vaccine are higher than the background incidence of CVST.

For the Johnson and Johnson vaccine: Between March 19 and April 12, 6 cases of CVST with thrombocytopenia were reported to the Vaccine Adverse Event Reporting System (VAERS),1 a database maintained by the CDC and FDA. These 6 cases, all in women under 50, were what triggered the joint CDC and FDA recommendation on April 13 to pause vaccinations with the J&J vaccine.

An April 14 CDC presentation (a day after the federally-recommended pause) stated that, among women 20-50 years old, the observed CVST cases exceeded the expected background rate by "3-fold or greater." (Slide 24)

At the time, 6.86 million J&J vaccine doses had been administered, 1.4 million of which had been in women 20-50 years old. This is 0.87 cases of CVST with thrombocytopenia per million J&J vaccine doses administered, or 4.3 cases per million J&J vaccine doses administered in women 20-50.

Since the initial 6 reports, the CDC has confirmed 14 cases of CVST with thrombocytopenia as of April 25 (very recent April 30 article). By April 25, 8.1 million J&J vaccine doses had been administered. This is 1.7 cases of CVST with thrombocytopenia per million J&J vaccine doses administered. (The statistics for women 20-50 alone are not available.)

Going into the mathematics:

A Johns Hopkins page states CVST "affects about 5 people in 1 million each year." This means in 2 weeks, CVST affects 0.19 people per million. Out of 8.1 million doses administered, we would expect to see 1.55 CVST cases. The 14 cases reported to VAERS and confirmed by the CDC is close to 9 times the background rate of CVST.

For the AstraZeneca vaccine: On April 7, the European Medicines Agency (EMA)2 wrote:

As of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported to EudraVigilance. Around 34 million people had been vaccinated in the EEA and UK by this date.

This is somewhere between 2.5 to 5 cases of CVST per million AstraZeneca doses.3 (I am unsure where the question's figure of 72 cases in 80 million vaccinations came from.)

Going into the mathematics:

Using the same rate of 5 CVST cases per million people each year, we would expect to see anywhere between 6.54 and 13.08 cases out of 34 million people vaccinated (depending on how many had received one or two doses). The 169 cases reported to EudraVigilance exceeds both figures and is between 13 to 25.8 times the background rate of CVST.

1 The caveat with all VAERS reporting is reports do not mean a vaccine caused an adverse event.

2 You can think of them as the EU equivalent of the US FDA.

3 Unlike the J&J vaccine, the AstraZeneca vaccine requires 2 doses. It's unclear how many doses of the AstraZeneca vaccine had been administered by April 4, only that 34 million people had been vaccinated.

Barry Harrison
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  • Very surprised nobody has answered yet since the numbers are out there. Let me know any suggestions! I have not written an answer in awhile. – Barry Harrison May 01 '21 at 07:11
  • If the second sentence ("However, regulators have reaffirmed both vaccines' benefits outweigh the risks.") should be deleted because the question doesn't ask about that, let me know too! – Barry Harrison May 01 '21 at 07:37
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    _"both vaccines' benefits outweigh the risks"_ may be relevant for a government deciding on a "death minimization" strategy, but is not as relevant for an individual making a choice about different vaccines. – pipe May 01 '21 at 11:12
  • It would be instructive to explain the established causal link further or illustrate this bland authority statement of 'benefit/risk still OK' with two numbers: absolute risk increase and relative risk increase (like for the vaccines vs illness: 60%–95% RR but only 0.7%–1.2% AR) – LangLаngС May 01 '21 at 14:16
  • @LangLаngС Thanks for the comment! Can you explain that a bit further? I think a causal link is near impossible to prove and you would need to do animal experiments with a very large amount of animals. – Barry Harrison May 01 '21 at 14:44
  • @LangLаngС Is there something you think I could add to improve this answer? – Barry Harrison May 08 '21 at 00:39
  • @BarryHarrison https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html "A review of reports indicates a causal relationship between the J&J/Janssen COVID-19 vaccine and TTS." https://link.gale.com/apps/doc/A678018279/AONE?u=nysl_oweb&sid=googleScholar&xid=62552541 "All criteria for causation are met, with consistency, specificity, temporality and biological plausibility being very clearly met." (AstraZeneca) – endolith Feb 16 '22 at 02:01