Due to a recommendation from the Paul Ehrlich Institute (PEI) on March 15, 2021, the federal government suspended corona vaccinations with AstraZeneca as a precautionary measure. Further investigations were necessary. The European Medicines Agency (EMA) examined whether and how the new findings would affect the approval of the vaccine. After intensive consultations on the serious thrombotic events that have occurred in Germany and Europe, the Paul Ehrlich Institute (PEI) recommended the temporary suspension of vaccinations with the Covid-19 vaccine AstraZeneca. Compared to March 11th, 2021, further cases (as of Monday, March 15th, 2021) have been reported in Germany. When analyzing the new data, the experts from the Paul Ehrlich Institute saw a noticeable increase in a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a lack of blood platelets (thrombocytopenia) and bleeding close to vaccinations with the COVID-19 vaccine AstraZeneca. The data was further analyzed and assessed by the European Medicines Agency (EMA). Vaccinations with the AstraZeneca Covid-19 vaccine have been suspended in Germany until the EMA has completed its assessment. The decision affected both initial and subsequent vaccinations. The Paul Ehrlich Institute pointed out that people who have received the COVID-19 vaccine AstraZeneca and feel increasingly unwell more than four days after vaccination, for example with severe and persistent headaches or pinpoint skin bleeding, should seek medical treatment immediately should go.
Prof. Dr. Hartmut Göbel: “The new onset of headaches, usually over four or more days, in connection with neurological deficits such as dizziness, visual disturbances, tinnitus and eye muscle paralysis and varying disturbances of consciousness is the decisive key symptom constellation for sinus vein thrombosis. These headaches are significantly different from typical headaches after a Covid vaccination. The latter occur in around 50% within 17 hours after vaccination with an average duration of 18 hours. Disturbances of consciousness do not exist as an accompanying symptom.”
The European Medicines Agency (EMA) examined the matter and recommended continued vaccination with the AstraZeneca vaccine on March 18, 2021. On March 18, 2021, the federal and state health ministers decided to resume vaccinations with the AstraZeneca vaccine from March 19, 2021. The justification for the approach was that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side effects. A warning has been included in the product information.
A Rote Hand letter dated March 24, 2021 explains: “Those who have been vaccinated should be instructed to see a doctor immediately if they develop symptoms such as shortness of breath, chest pain, leg swelling or persistent abdominal pain after vaccination. “In addition, anyone who experiences neurological symptoms after vaccination, such as severe or persistent headaches or blurred vision, or who develops skin bruising (petechiae) outside the site of vaccination after a few days, should seek medical attention immediately.”
Download: Red Hand Letter COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders
In this context, the question arises as to why vaccination with the AstraZeneca vaccine in Germany was restricted to people under 65 years of age, contrary to approval by the EMA (European Medicines Agency), citing insufficient efficacy data in older people. Young women in particular in the health system , nurses, doctors, etc., have been given priority treatment with this vaccine. It remains to be seen what benefit an additional warning in the package insert has regarding complications if no alternatives are available. This would be understandable if there had been no other options. However, these were available with Biontech/Pfizer and other active ingredients. According to current findings, young women belong to the special risk group of the complications described. On March 29, 2021 the Euskirchen district decided with immediate effect not to vaccinate women younger than 55 years with the AstraZeneca active ingredient. According to its announcement dated March 26, 2021, following the death of a 49-year-old nurse, the Rostock University Clinic is also suspending AstraZeneca vaccinations for people with high blood pressure, overweight and women who take the pill. The Canadian expert committee for the corona vaccination campaign is also currently recommending the suspension of Astrazeneca's drug for people under the age of 55. According to a report from March 30, 2021, the state-owned Charité and Vivantes clinics in Berlin are also suspending vaccinations with the Astrazeneca preparation for women under 55 years of age. After Berlin, the city of Munich also announced on August 30, 2021 that it would no longer vaccinate people under 60 with AstraZeneca until further notice. On March 30, 2021, the directors of five university clinics in North Rhine-Westphalia also called for a temporary stop to vaccinations of younger women with the AstraZeneca vaccine. And also today on March 30, 2021, the Standing Vaccination Commission (Stiko) announced: “Based on the currently available, although still limited, evidence and taking into account the current pandemic situation, Stiko recommends the Covid-19 Vaccine AstraZeneca for people of old age Use for 60 years. However, their use below this age limit remains possible at the doctor's discretion and with individual risk acceptance after careful information. Stiko will comment on the second vaccine dose for younger people who have already received a first dose of the Covid-19 Vaccine AstraZeneca by the end of April.”
In addition to aspirin and ibuprofen, Novaminsulfone is also an option.
The medication should not be taken preventatively, but only when symptoms appear. The vaccination does not have to be canceled if you already have a headache. Over 50% of those vaccinated experience malaise and headaches. The new onset of headaches, usually over four or more days, in conjunction with neurological deficits such as dizziness, visual disturbances, tinnitus and eye muscle paralysis and varying disorders of consciousness is the decisive key symptom constellation for sinus vein thrombosis. These headaches are significantly different from typical headaches after a Covid vaccination. The latter occur in around 50% within 17 hours of vaccination, with an average duration of 18 hours. Disturbances of consciousness do not exist as an accompanying symptom.
The RKI writes about this ( https://www.rki.de/SharedDocs/FAQ/COVID-Impfen/total.html ): Since April 1st, 2021, the STIKO has only recommended vaccination with the Vaxzevria vaccine from AstraZeneca for older people of ≥60 years.
The reason for this age restriction lies in the rare cases of thrombosis in combination with thrombocytopenia, which occurred in a few vaccinated people after vaccination.
These serious, sometimes fatal, side effects were predominantly observed in women aged ≤55 years.
But men and older people were also affected. (see FAQ “What should people <60 years of age who have already been vaccinated with the AstraZeneca vaccine pay attention to?”) The STIKO therefore limits its recommendation to both genders after a risk-benefit assessment.
In the age group of ≥60 years The risk of severe or fatal COVID-19 disease increases, so that the benefit-risk balance here is clearly in favor of vaccination:
vaccination with AstraZeneca effectively prevents (severe) COVID-19 disease in a population group that - compared to those in the 18 to 60 age group - have a more than 60 times higher risk of dying from COVID-19 (source: RKI reporting data). At the same time, 89% of the reported thromboembolic events occurred in people <60 years old and This means that it does not occur in this age group ≥60 years, which is particularly at risk from COVID-19.
The STIKO therefore continues to recommend vaccination with the COVID-19 Vaccine AstraZeneca to people ≥60 years of age. In the older age group, the vaccine is generally better tolerated and leads to less frequent and less severe vaccination reactions.
In addition, regardless of age, a decision based on medical discretion for the first or second vaccine dose with Vaxzevria from AstraZeneca is possible, which is made after careful information based on individual risk acceptance.
To date, there is no data on the risk of a second vaccination. As of: April 1, 2021
Good afternoon Professor Göbel,
as far as I understand, Astra Zeneca has so far been mainly vaccinated against younger people, because until recently it was not recommended for people over 65 years of age.
Shouldn't we conclude from this that this form of thrombosis only occurred in younger people because the older ones have hardly been vaccinated with it up to now? I myself am 71. Thank you and kind regards
Uta Dohmeyer
Dear Professor Göbel,
on April 1st, i.e. in 3 days, I will be vaccinated with AstraSeneca. I received the vaccination certificate because of the chronic migraines, the very severe fibromyalgia that has been present since July and, above all, the severe depression.
Now my doctor asked me, Dr. Seeck-Hirschner to ask you which painkiller I should take if I have a severe headache. In recent years I have been taking Novaminsulfone 500mg/ml, with increasingly moderate success. Would that be suitable or even allowed in the event of a vaccination? Above you recommend aspirin – would that also be an option for me?
Of course, I'm also worried about a sinus vein thrombosis, especially since I wouldn't be able to differentiate between this and the normal migraine pain, because for me it usually lasts for several days, with dizziness, visual and speech problems.
Do I have to cancel the vaccination if I already have a headache on the day of the vaccination?
I would be very grateful for a prompt reply.
Kind regards from Flensburg,
your
Gyde Kuchcinski
Dear Ms. Schröter
, the vaccination usually does not trigger migraines.
In around 50%, the immune reaction causes a moderate headache lasting around 17 hours. These are independent of migraines. Migraines do not cause an increased risk of sinus vein thrombosis.
Triptans do not work for post-vaccination headaches.
Ibuprofen or aspirin would be suitable. Kind regards
Hartmut Göbel
Hello Professor Göbel,
As a migraine sufferer (f, 45, NR, normal weight) with aura (vision problems, periods of numbness, etc.), am I more at risk for the relevant thrombosis due to an Astra Zeneca vaccination?
Thank you very much for your assessment.
Kind regards from the west bank
I (70 years old) will probably be vaccinated with AstraZeneca on April 18th, 2021. Since I have been suffering from migraines for about 60 years, I suspect a severe migraine as a vaccination reaction.
Question: 1. Is there a risk of sinus vein thrombosis in migraine patients due to the vaccination - especially since I was once diagnosed with an anastomosis in the brain?
and 2. Can I take triptans in the event of a vaccine reaction with a headache?
Kind regards,
Annegret Schröter