Posted on 07/11/2021 3:10:13 PM PDT by ransomnote
(h/t Cathi)
EMA’s safety committee (PRAC) has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen. The Committee also recommended that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.
The Committee reviewed 3 cases of capillary leak syndrome in people who had received COVID-19 Vaccine Janssen, which occurred within 2 days of vaccination. One of those affected had a history of capillary leak syndrome and two of them subsequently died. As of 21 June 2021, more than 18 million doses of COVID-19 Vaccine Janssen had been administered worldwide.
Capillary leak syndrome is a very rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low blood levels of albumin (an important blood protein).
Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition.
People who have been vaccinated with COVID-19 Vaccine Janssen should seek immediate medical assistance if they experience rapid swelling of the arms and legs or sudden weight gain in the days following vaccination. These symptoms are often associated with feeling faint (due to low blood pressure).
PRAC will continue to monitor for cases of the condition and will take any further actions necessary. The Committee has also asked Janssen, the company marketing the vaccine, for further information about a possible mechanism for the development of capillary leak syndrome following vaccination.
As for all vaccines, EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.
A similar review was recently finalised for another COVID-19 vaccine, Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
A direct healthcare professional communication (DHPC) will be sent in due course to healthcare professionals prescribing, dispensing or administering the vaccine. The DHPC will also be published on a dedicated page.
COVID-19 Vaccine Janssen is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. The vaccine is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making the S protein from SARS-CoV-2. COVID-19 Vaccine Janssen does not contain the virus itself and cannot cause COVID-19.
The most common side effects are usually mild or moderate and improve within a few days after vaccination.
The review was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, in the context of a procedure known as a 'type II variation'. The PRAC’s recommendations will be submitted to EMA’s human medicine committee, CHMP, for endorsement.
PING
Isn’t this vaccine also contraindicated for women on the pill?
My friend took this vaccine—forced to if she wanted to work (nurse)—and besides other side effects (rash on lower body and horrendous headaches), she had massive swelling of her lower legs that lasted a couple weeks. I’ll have to tell her about this capillary leak syndrome. Thanks for posting.
Bttt.
Where did that come from? I've never heard of it before. It took some wading through a lot of the EU pages to find this company:
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Then a bit more digging reveal the on the CDC website: "Manufacturer: Janssen Pharmaceuticals Companies of Johnson & Johnson" and "Johnson & Johnson’s Janssen (J&J/Janssen)." I guess "Janssen" is "Johnson" in Dutch.
Aren’t these “vaccines” just the greatest thing ever? /s/
This is only the J&J. The Pfizer jab causes low platelets and hemorrhagic strokes. Only problem, no one will report that the Pfizer vaccine is the root cause.
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