Scientists don’t know whether the vaccine causes the syndrome, and if so, what the mechanism is. “Everyone’s scratching their heads: Is this a real signal?” says Robert Brodsky, a hematologist at Johns Hopkins University. But vaccine safety officials say they did not take the decision lightly, and that symptoms seen in at least 13 patients, all between ages 20 and 50 and previously healthy, in at least five countries are more frequent than would be expected by chance. The patients, at least seven of whom have died, suffer from widespread blood clots, low platelet counts, and internal bleeding—not typical strokes or blood clots. “It’s a very special picture” of symptoms, says Steinar Madsen, medical director of the Norwegian Medicines Agency. “Our leading hematologist said he had never seen anything quite like it.”
In Europe, a 49-year-old intensive care nurse in Austria was one of the first cases. She died last week from what officials called “clotting disorders” that culminated in internal bleeding. (A colleague at the same hospital who received the vaccine developed lung embolisms, but was expected to recover.) A similar constellation of symptoms has been identified in four patients in Norway, two of whom have died, Madsen says.
German officials said Monday they had received seven reports of cerebral venous thrombosis (CVT), three of them fatal, in patients who had recently been vaccinated with the AstraZeneca vaccine. In this rare type of stroke, the vein that drains blood from the brain is blocked, which can result in massive, deadly bleeding in the brain. All of the patients also had low levels of platelets, which aid in clotting, a possible sign of more widespread clotting. One affected patient had blood clots “from head to toe,” says Clemens Wendtner, a hematology and infectious disease specialist at the Munich Clinic, Schwabing. The symptoms remind Wendtner of a syndrome called disseminated intravascular coagulation (DIC), in which blood clots form throughout the body, depleting its platelet supply. When the clots cause blood vessels to burst, the body is less able stop the internal bleeding, which can damage the brain or other organs.
Arnold Ganser, a hematologist at Hannover Medical School, says he is treating another patient who developed CVT within days of vaccination. He says that patient appears to be suffering from another condition called atypical hemolytic uremic syndrome (HUS). (The patient, a woman older than 60, is not yet counted in the seven cases announced in Germany on Monday.) Although it can look similar to DIC, HUS develops from damage to the vascular walls. It is usually caused by a bacterial toxin, but can also arise from unknown factors. The condition can be treated with an antibody targeting the complement system, a cascade of molecular interactions that aids immune clearance of pathogens or diseased cells, and Ganser says the patient appeared to be responding to that treatment.
Germany paused vaccinations on Monday on the recommendation of the Paul Ehrlich Institute (PEI), the country’s agency in charge of vaccine safety. PEI head Klaus Cichutek says all seven cases of CVT had occurred between 4 and 16 days after vaccination, and that an analysis suggested only a single case would normally be expected among the 1.6 million people who received the vaccine in that time window. A group of experts convened on Monday “agreed unanimously that there seemed to be a pattern here and that a link to the vaccine was not implausible and that this should be investigated,” Cichutek says.
Other factors played a role in the recommendation, including the fact that the syndrome is so severe and difficult to treat, and that it affects relatively young people who are at low risk of dying from COVID-19. It was also an opportunity to urge people to seek medical attention immediately if they develop persistent headaches or unusual bruising in the week following vaccination, Cichutek says.
Madsen believes the unusual symptoms may be the result of “a very strong immunological reaction.” Acute infections can trigger clotting and bleeding, sometimes culminating in DIC, Wendtner notes. But abnormal clotting is also a feature of COVID-19. It’s possible, Wendtner says, that the unusual cases had a COVID-19 infection before they got vaccinated; many were health care workers and teachers who may have been exposed at work. Coming on top of the infection, the vaccine might somehow have triggered an overreaction by the immune system, sparking the clotting syndrome. Ganser thinks patients suffering from CVT may be the tip of the iceberg and that more people may suffer similar, but milder, symptoms.
www.bbc.co.uk
[Feb 8, 2021]
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