COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria

[Mary Wilson]

European Medicines Agency
10/03/2021

The Austrian national competent authority has suspended the use of a batch of COVID-19 Vaccine AstraZeneca (batch number ABV5300) after a person was diagnosed with multiple thrombosis (formation of blood clots within blood vessels) and died 10 days after vaccination, and another was hospitalised with pulmonary embolism (blockage in arteries in the lungs) after being vaccinated. The latter is now recovering. As of 9 March 2021, two other reports of thromboembolic event cases had been received for this batch.

There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.

Batch ABV5300 was delivered to 17 EU countries[SUP]1[/SUP] and comprises 1 million doses of the vaccine. Some EU countries[SUP]2[/SUP] have also subsequently suspended this batch as a precautionary measure, while a full investigation is ongoing.

https://www.ema.europa.eu/en/news/c...suggests-no-specific-issue-batch-used-austria

 

[Gert van der Hoek]

Danish health agency to contact recipients of AstraZeneca vaccine

The Danish Medicines Agency is to contact people who have received the AstraZeneca Covid-19 vaccine to provide precautionary advice.

Every fourth person vaccinated in Denmark has received the AstraZeneca vaccine. They will now receive a letter from the Danish Medicines Agency, Danish Health Authority director Soren Brostr?m told broadcaster TV2.

The letter will draw attention to the symptoms of blood clots that those vaccinated should be aware of. People will receive the letter via e-boks, the electronic mail platform accessible to Danish residents via the secure NemID system.

Health authorities will directly contact members of the public after the Danish Medicines Agency decided on Thursday to pause vaccinating with AstraZeneca after finding cases of blood clots shortly after vaccination.

Authorities in Austria previously stopped vaccinations with a batch of AstraZeneca?s Covid-19 inoculation after a nurse died and another became seriously ill after receiving their jabs. The nurse died as a result of severe coagulation disorders, an illness related to the blood?s ability to clot.

There has also been a death in Denmark, according to the Danish Medicines Agency. It is still unknown whether the vaccine is the direct cause of the blood clots.

?What we are doing now is sending a letter to everyone who has received the vaccine from AstraZeneca, stating what they should be aware of regarding symptoms of blood clots,? Brostr?m said to TV2. He also pointed out that if you experience symptoms, you should see a doctor immediately.

https://www.thelocal.dk/20210311/danish-health-agency-to-contact-recipients-of-astrazeneca-vaccine/

 

[Vibrant62]

I suspect that this paper may shed some light on the problems being seen. I also suspect that if there are problems here that are directly related to the spike protein, these will be seen with all vaccines -if its central premise is correct. However, I suspect that people who are sensitive to the spike protein would have had a harder time of a natural infection. Its all food for thought and discussion.

https://www.mdpi.com/2076-393X/9/1/36/htm

 

[Mary Wilson]

ISTH STATEMENT ON ASTRAZENECA COVID-19 VACCINE AND THROMBOSIS

Friday, March 12, 2021
Posted by: Andy Masten

CHAPEL HILL, NC, USA, (March 12, 2021) - The International Society on Thrombosis and Haemostasis (ISTH) recommends that all eligible adults continue to receive their COVID-19 vaccinations, despite the recent decisions by Austria, Denmark, Norway and Iceland to at least temporarily suspend the use of the AstraZeneca vaccine due to reports of thrombosis.

At this time, the small number of reported thrombotic events relative to the millions of administered COVID-19 vaccinations does not suggest a direct link. Thrombotic events are common in the general population and have not previously been associated with vaccination. At present, we do not know whether the timing of the blood clots with vaccination is coincidental or whether vaccination may in rare cases increase the risk of thrombosis. Importantly, well-conducted clinical trials of COVID-19 vaccinations did not identify an increased risk of thrombosis.

Based on all available data, the ISTH believes that the benefits of COVID-19 vaccination strongly outweigh any potential complications even for patients with a history of blood clots or for those taking blood thinning medications. It also recommends that everyone review the signs and symptoms of blood clots, including: leg pain, swelling, tenderness or redness of the skin associated with deep vein thrombosis (DVT); as well as difficulty breathing, chest pain or discomfort, faster than normal or irregular heartbeat, coughing up blood and low blood pressure, light-headedness or fainting associated with pulmonary embolism (PE). Individuals with co-existing medical conditions may wish to consult their physician. ...

https://www.isth.org/news/556057

 

[Emily]

Maybe an intolerance for the vector virus in people who have cirrhosis?

https://www.sciencedirect.com/science/article/pii/S1525001604001066

Severe pulmonary pathology after intravenous administration of vectors in cirrhotic rats


Jeffrey SSmith[SUP]1[/SUP]JieTian[SUP]1[/SUP]Jay NLozier[SUP]2[/SUP]Andrew PByrnes[SUP]1[/SUP]

https://doi.org/10.1016/j.ymthe.2004.03.010Get rights and content

Under a Creative Commons license
open archive

Abstract

After an intravascular injection, adenoviral vectors are normally taken up by the reticuloendothelial system in the liver, where they rapidly trigger an innate response. However, we have previously found that the biodistribution of adenoviral vectors is altered in cirrhotic rats due to the presence of pulmonary intravascular macrophages, which cause a shift in vector uptake from the liver to the lungs. We now report that this is correlated with fatal pulmonary hemorrhagic edema in cirrhotic rats. In addition, cirrhotic rats reacted to vector with enormous increases in TNF-? and IL-6 and markedly prolonged coagulation times. Although we also saw fatal reactions to high doses of adenoviral vectors in normal rats, the time course and symptoms were very different, and pulmonary hemorrhagic edema was seen only in cirrhotic rats. Because abnormal pulmonary reticuloendothelial uptake is known to occur in humans during cirrhosis and other diseases, there is the potential that intravascular administration of adenoviral vectors might cause lung pathology in such patients.
Keywords

adenovirus
cirrhosis
lung
pulmonary intravascular macrophage
gene therapy
edema
hemorrhage
coagulopathy

 

[Emily]

https://www.sciencemag.org/news/202...-covid-19-vaccine-hoping-pause-has-not-dented
European countries resume use of AstraZeneca?s COVID-19 vaccine, hoping pause has not dented confidence


By Kai Kupferschmidt, Gretchen Vogel Mar. 18, 2021 , 7:20 PM
...
Most of the cases of rare blood disorders were among young women, the group where vaccine hesitancy already runs highest, Betsch says. She thinks one way to address concerns among this group could be to give them preferential access to other vaccines.

 

[sharon sanders]

bump this

 

[sharon sanders]

bump this

 

[Emily]

https://www.foxnews.com/world/ukrai...o-side-effects-urged-caution-over-conclusions
Ukraine health ministry says woman who died after COVID vaccine had no side effects
The woman's cause of death is under investigation
By Brie Stimson | Fox News

The Ukrainian government urged the public not to jump to conclusions on Wednesday over the death of a servicewoman who had gotten the AstraZeneca coronavirus vaccine days before, according to a report.

The woman didn't complain of any side effects after receiving the shot before she suddenly lost consciousness and died two days later, the health ministry?s website said, according to Reuters...