Based on a recommendation from the Paul Ehrlich Institute (PEI) on March 15, 2021, the German Federal Government suspended COVID-19 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 vaccine's approval. Following intensive consultations regarding the serious thrombotic events that had occurred in Germany and Europe, the Paul Ehrlich Institute (PEI) recommended the temporary suspension of vaccinations with the AstraZeneca COVID-19 vaccine. As of Monday, March 15, 2021, further cases had been reported in Germany since March 11, 2021. Analyzing the new data, experts at the Paul Ehrlich Institute observed a striking cluster of a specific form of very rare cerebral venous thrombosis (sinus vein thrombosis) in conjunction with a deficiency of blood platelets (thrombocytopenia) and bleeding in close temporal proximity to vaccinations with the AstraZeneca COVID-19 vaccine. The data were further analyzed and evaluated by the European Medicines Agency (EMA). Until the EMA's assessment is complete, vaccinations with the AstraZeneca COVID-19 vaccine have been suspended in Germany. This decision applies to both primary and booster vaccinations. The Paul Ehrlich Institute advised that individuals who have received the AstraZeneca COVID-19 vaccine and experience increasing discomfort more than four days after vaccination, for example, with severe and persistent headaches or pinpoint skin hemorrhages, should seek immediate medical attention.
Prof. Dr. Hartmut Göbel: “The onset of headaches, usually lasting four days or more, in conjunction with neurological symptoms such as dizziness, visual disturbances, tinnitus, and eye muscle paralysis, as well as varying degrees of altered consciousness, is the key symptom constellation for cerebral venous thrombosis. These headaches differ significantly from typical headaches following a COVID-19 vaccination. The latter occur in approximately 50% of cases within 17 hours of vaccination and last an average of 18 hours. Altered consciousness is not a common accompanying symptom.”
The European Medicines Agency (EMA) reviewed the situation and recommended on March 18, 2021, that vaccinations with the AstraZeneca vaccine continue. The federal and state health ministers decided on March 18, 2021, to resume vaccinations with the AstraZeneca vaccine starting March 19, 2021. This decision was based on the fact 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 was added to the product information.
A Dear Healthcare Professional Letter dated March 24, 2021, explains: “Vaccinated individuals should be advised to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, or persistent abdominal pain after vaccination. Furthermore, anyone experiencing neurological symptoms after vaccination, such as severe or persistent headaches or blurred vision, or who develops bruising (petechiae) on the skin outside the injection site a few days later, should seek immediate medical attention.”
Download: Dear Doctor Letter COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders
In this context, the question arises as to why, in Germany, vaccination with the AstraZeneca vaccine was restricted to people under 65, contrary to its approval by the EMA (European Medicines Agency), citing insufficient efficacy data in older people. that young women in the healthcare system , such as nurses and doctors, have been given priority for treatment with this vaccine. The benefit of an additional warning about complications in the package insert, when no alternatives are offered, remains unclear. This would be understandable if no other options existed. However, such options were available, including vaccines from BioNTech/Pfizer. According to current findings, young women belong to the high-risk group for the described complications. Consequently, on March 29, 2021, the Euskirchen district decided with immediate effect to no longer vaccinate women under 55 with the AstraZeneca vaccine. Following the death of a 49-year-old nurse, Rostock University Hospital announced on March 26, 2021, that it is suspending AstraZeneca vaccinations for people with high blood pressure, obesity, and women taking birth control pills. Similarly, the Canadian expert panel for the COVID-19 vaccination campaign currently recommends suspending the AstraZeneca vaccine for people under 55. According to a report from March 30, 2021, the state-owned Charité and Vivantes hospitals in Berlin are also suspending AstraZeneca vaccinations for women under 55. Following Berlin's announcement, the city of Munich also announced on August 30, 2021, that it will no longer administer AstraZeneca to anyone under 60 until further notice. On March 30, 2021, the directors of five university hospitals in North Rhine-Westphalia also advocated for a temporary halt to vaccinations of younger women with the AstraZeneca vaccine. And also on March 30, 2021, the Standing Committee on Vaccination (STIKO) announced: “Based on the currently available, albeit still limited, evidence and taking into account the current pandemic situation, STIKO recommends using the AstraZeneca COVID-19 vaccine for people over 60 years of age. Its use below this age remains possible at the discretion of a physician and with individual risk acceptance after careful consultation. STIKO will issue a statement regarding the second vaccine dose for younger people who have already received a first dose of the AstraZeneca COVID-19 vaccine by the end of April.”
In addition to aspirin and ibuprofen, metamizole (novaminsulfone) is also an option. These medications should not be taken preventively, but only if symptoms occur. The vaccination does not need to be canceled if headaches are already present.
Over 50% of vaccinated individuals experience malaise and headaches. The new onset of headaches, usually lasting four days or more, in conjunction with neurological deficits such as dizziness, visual disturbances, tinnitus, and eye muscle paralysis, as well as varying degrees of altered consciousness, is the key symptom constellation for cerebral venous thrombosis. These headaches differ significantly from typical headaches following a COVID-19 vaccination. The latter occur in approximately 50% of cases within 17 hours of vaccination, with an average duration of 18 hours. Altered consciousness is not a common accompanying symptom in this case.
The Robert Koch Institute (RKI) writes ( https://www.rki.de/SharedDocs/FAQ/COVID-Impfen/gesamt.html ): Since April 1, 2021, the Standing Committee on Vaccination (STIKO) has recommended vaccination with the AstraZeneca vaccine Vaxzevria only for individuals aged 60 and older.
This age restriction is due to rare cases of thrombosis combined with thrombocytopenia that have occurred in a small number of vaccinated individuals after vaccination.
These severe, sometimes fatal, side effects were predominantly observed in women aged 55 and younger. However, men and older individuals were also affected. (See FAQ “What should people under 60 who have already been vaccinated with the AstraZeneca vaccine be aware of?”)
STIKO is therefore restricting its recommendation for both sexes after a risk-benefit assessment.
In the 60+ age group, the risk of severe or fatal COVID-19 increases, so the benefit-risk assessment clearly favors vaccination:
Vaccination with AstraZeneca effectively prevents (severe) COVID-19 in a population group that – compared to those aged 18 to 60 – has a more than 60 times higher risk of dying from COVID-19 (source: RKI reporting data). At the same time, 89% of reported thromboembolic events occurred in people under 60, and thus not in this age group 60+ that is particularly vulnerable to COVID-19.
The STIKO (Standing Committee on Vaccination) therefore continues to recommend vaccination with the AstraZeneca COVID-19 vaccine for people 60+. In older age groups, the vaccine is generally better tolerated and leads to fewer and less severe adverse reactions.
Furthermore, regardless of age, a decision regarding the first or second dose of the AstraZeneca Vaxzevria vaccine can be made at the physician's discretion, based on individual risk acceptance and after careful explanation. Currently, no data are available on the risks associated with a second dose. (
Status: April 1, 2021)
Good day Professor Göbel,
as far as I understand, AstraZeneca has so far been administered primarily to younger people because, until recently, it was not recommended for those over 65. Doesn't this suggest that this form of thrombosis has only occurred in younger individuals because older people have hardly been vaccinated with it until now? I myself am 71.
Thank you very much and best regards
, Uta Dohmeyer
Dear Professor Göbel,
On April 1st, in three days, I will be vaccinated with AstraSeneca. I received the vaccination authorization certificate because of my chronic migraines, the very severe fibromyalgia that has plagued me since July, and, most importantly, my severe depression.
My doctor, Dr. Seeck-Hirschner, asked me to inquire with you about which painkiller I should take in case of severe headaches. For the past few years, I've been taking Novaminsulfon 500mg/ml, with increasingly limited success. Would that be suitable, or even permitted, if I'm getting vaccinated? You also recommended Aspirin earlier – would that be an option for me?
Of course, I too am worried about sinus vein thrombosis, especially since I cannot distinguish between such a condition and normal migraine pain, which usually lasts for several days, accompanied by dizziness, visual disturbances and speech problems.
Do I need 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
,
Gyde Kuchcinski
Dear Ms. Schröter,
the vaccination does not usually trigger migraines. In about 50% of cases, moderate headaches occur for approximately 17 hours due to the immune response. These are unrelated to migraines.
Migraines do not increase the risk of sinus vein thrombosis.
Triptans are ineffective for headaches after vaccination. Ibuprofen or aspirin would be suitable.
Kind regards
, Hartmut Göbel
Good day, Professor Göbel,
As a migraine sufferer (female, 45, non-smoker, normal weight) with aura (visual disturbances, numbness phases, etc.), am I at greater risk for the relevant thromboses due to an AstraZeneca vaccination?
Thank you very much for your assessment.
Kind regards from the west bank
I (70 years old) am scheduled to receive the AstraZeneca vaccine on April 18, 2021. Since I have suffered from migraines for approximately 60 years, I suspect a severe migraine as a reaction to the vaccine.
Questions: 1. Is there a risk of cerebral venous thrombosis for migraine patients who receive the vaccine – especially since I was previously diagnosed with a cerebral anastomosis? and
2. In the event of a headache as a reaction to the vaccine, am I allowed to take triptans?
Sincerely,
Annegret Schröter