U.S. pauses J+J Covid vaccine due to cerebral blood clots + thrombocytopenia

[NRSKarenRN, BSN, RN]

J+J Covid vaccine paused today due to cerebral venous sinus thrombosis  + thrombocytopenia - developed within 2 weeks post vaccination.  1 person has died, another in critical condition, both women less than age 48..  Six serious reactions out of almost 7 million  J+J vaccinations reported to date.  Karen

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

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As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).  All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given....

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot...

Cerebral venous sinus thrombosis (CVST) is the presence of a blood clot in the dural venous sinuses, which drain blood from the brain. Symptoms may include headache, abnormal vision, any of the symptoms of stroke such as weakness of the face and limbs on one side of the body, and seizures.

What is cerebral venous sinus thrombosis?

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Cerebral venous sinus thrombosis (CVST) occurs when a blood clot forms in the brain’s venous sinuses. This  prevents blood from draining out of the brain. As a result, blood cells may break and leak blood into the brain tissues, forming a hemorrhage.

This chain of events is part of a stroke that can occur in adults and children. It can occur even in newborns and babies in the womb. A stroke can damage the brain and central nervous system. A stroke is serious and requires immediate medical attention.

It affects about 5 people in 1 million each year...

What is thrombocytopenia?

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Thrombocytopenia (THROM-bo-sigh-toe-PEE-ne-ah) occurs when your blood platelet count is low. Platelets are also called thrombocytes. This type of blood cell clumps together to form blood clots to help stop bleeding at the site of a cut or wound. Another name for a blood clot is thrombus.....

From VIPIT to VITT: Thrombosis and COVID Vaccines

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More data support link between adenovirus vector vaccines, blood clotting, and low platelets

Journal of Clinical Medicine Article Thrombocytopenia and Intracranial Venous Sinus Thrombosis after “COVID-19 Vaccine Astra Zeneca” Exposure

Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination

[amoLucia]

As per norm, TY for the informational update.

[NRSKarenRN, BSN, RN]

My youngest son got the J+J vaccine 5 PM Saturday; 10:30PM Sunday evening walks into kitchen shivering, asking for hot tea and peanut butter + jelly sandwich. Covered up with 2 blankets, went to sleep.

Back to work 9AM next day.  Will be observing him closely next 2 weeks. One week til my 2nd Moderna shot.

[subee, MSN, CRNA]

My first thoughts is that all of these patients were young and female ....candidates for oral contraceptives which are a known risk factor for blood clots.  The journal quoted above states that it occurs about 5 times per million a year but millions more people have had the J and J vaccine and only 6 people have experienced this side effect?  I don't know how that could possible be proof that the two conditions are linked.

[NRSKarenRN, BSN, RN]

50 minutes ago, subee said:

My first thoughts is that all of these patients were young and female ....candidates for oral contraceptives which are a known risk factor for blood clots. 

That's what I thought---  any reports of men with this syndrome??

[subee, MSN, CRNA]

I haven't found any reports of this syndrome in men.  However, I came across this comparing the rate of blood clots with the AZ vaccine compared to the rate of blood clots in women on oral contraceptives.  

Blood clots - although rare - are a risk associated with both the contraceptive pill and the AstraZeneca vaccine. 

Due to reports of blood clots in the UK and a possible case in Victoria, the government updated its health advice last Thursday, recommending those under 50 to get the Pfizer jab instead of the AstraZeneca vaccine.

Speculation over the safety of the AstraZeneca jab prompted comparisons online with the contraceptive pill.  This medication remains Australia’s default contraceptive. So what does that mean for those taking it?

Blood clots: The pill vs the AstraZeneca vaccine

The rate of blood clots in the AstraZeneca vaccine is roughly one in every 250,000.

The risk of getting a blood clot per year from being on the pill is one in 2,500.

Australia is having people under 50 take Pfizer.  I found plenty of articles on blood clots in the news this morning with mentions of oral contraception so plenty of people also made the same association between being estogen loaded and this particular side effect.

 

While blood clots are more prevalent among those taking the pill, they are generally more severe when associated with the vaccine.

[NRSKarenRN, BSN, RN]

Thanks Subee.  With the vaccine its the combo of blood clots AND thrombocytopenia occuring together that's the issue as Heparin anticoagulation --usual TX for  blood clot,  not indicated with both conditions.

From VIPIT to VITT: Thrombosis and COVID Vaccines
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..Shortly after these problems started to surface, researchers in Germany and Norway quickly identified an autoantibody called platelet factor 4 antibody that appeared to be linked to the syndrome. Platelet factor 4 antibody causes heparin-induced thrombocytopenia (HIT), a rare clotting disorder that affects 1%-2% of people after exposure to heparin. In rare cases, platelet factor 4 antibody has been associated with CVST...

...Greinacher and colleagues wrote that the disorder "resembles" severe HIT, but "unlike the usual situation" none of these patients received heparin in the past. They noted that autoimmune or spontaneous HIT can occur without exposure to heparin, and is characterized by "unusually severe thrombocytopenia, increased rates of DIC and atypical clots." They concluded that the AstraZeneca vaccine can result in a rare syndrome that "clinically mimics autoimmune heparin-induced thrombocytopenia," and propose using the term "vaccine induced immune thrombotic thrombocytopenia" (VITT) to avoid confusion.

In a past publication, Greinacher and colleagues had referred to this syndrome as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). ...

...Meanwhile, the U.K.'s Expert Haematology Panel has offered guidance for diagnosis and management of these very rare events, as did Greinacher and colleagues in their NEJM publication. In probable cases, they recommend urgent use of IV immunoglobulin, use of non-heparin anticoagulants, and avoidance of platelet transfusions. They added that vitamin K antagonists (e.g., warfarin) are contraindicated in acute thrombocytopenia and DIC.

 

Some countries now restricting AstraZeneca to older adults.

[NRSKarenRN, BSN, RN]

 

[JVBT, ASN]

From what I understand, the one person we know of who died after the J&J vaccine was also given heparin, now known to be a contraindication in this particular case. There is at least one other person (for a total of 6 known affected) in critical condition.

I so appreciate the measured tone of this conversation so far.

[MunoRN, RN]

An interesting back-and-forth on the subject (between statistician Nate Silver and a prominent Epidemiologist). 

Nate Silver & CNN's Cecille Gounder Feud on Twitter about J&J Vaccine Pause (mediaite.com)

[subee, MSN, CRNA]

Actually, I think Silver is right but for the wrong reason.  IMHO, they should have released an "In an abundance of caution....we will limit the J and J to males and women over 55 (let's just go right up to menopause) and a brief non-medicalized mention that that requires a warning against Heparin if this syndrome is diagnosed...would do no harm.  So many people wanted the J and J and not might not agree to taking  an mRNA brand.

[LovingLife123]

Just an interesting fact, right before all of this came out, I had a patient with this exact condition.  The exact thrombosis and a low platelet count.  I had found it very odd that my patient had such a low platelet count.  
 

It seemed so odd that the platelet count was low but had a huge thrombosis.  Also the CRP was elevated.  I was questioning the use of heparin and we eventually switched to argatroban.  One of the pharmacists told me he was seeing this low platelet count in post covid patients.

I asked the patient had she had the vaccine yet or had she had ever been diagnosed with covid.  Response was no.  I did a rapid swab also negative.  The condition was being attributed to the birth control patch that had a higher estrogen level.  We also determined the patient had an autoimmune disorder.  
 

This news about the JJ vaccine came out a week later and it really made me think about my previous case and wonder what all these women had in common and did they have the same condition my pt did?  I’ve seen people die from these thrombosis and it’s usually birth control related.  
 

This whole thing just made me think.