אייראפעישער מעדיסינעס אַגענסי: ווייַטער אַסעסמאַנט געפינט זייער זעלטן ינסאַדאַנס פון בלאָט קלאַץ לינגקט צו אַסטראַזענעקאַ וואַקצין

EMA’s safety committee (PRAC) has concluded today (7 April) that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.

EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.

People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets (see below).

די PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

The Committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (עודראַוויגילאַנסע) as of 22 March 2021, 18 of which were fatal.¹ The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine.

COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State.

אַדווערטייזמאַנט

One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and will take any further actions necessary.

די PRAC stresses the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications.

Patients should seek medical assistance immediately if they have the following symptomsshortness of breathchest painswelling in your legpersistent abdominal (belly) painneurological symptoms, including severe and persistent headaches or blurred visiontiny blood spots under the skin beyond the site of injection

Vaxzevria is one of four vaccines authorised in the EU for protecting against COVID-19. Studies show that it is effective at preventing the disease. It also reduces the risk of hospitalisation and deaths from COVID-19.

ווי פֿאַר אַלע וואַקסינז, EMA וועט פאָרזעצן צו מאָניטאָר די זיכערקייַט און יפעקטיוונאַס פון די וואַקסאַניישאַן און צושטעלן די לעצטע אינפֿאָרמאַציע.

Information for the general public

• Cases of unusual blood clots with low platelets have occurred in people who received Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
• The chance of having this occur is very low, but you should still be aware of symptoms so you can get prompt medical treatment to help recovery and avoid complications.
• You must seek urgent medical attention immediately if you have any of the following symptoms in the weeks after your injection:
  • שאָרטנאַס פון אָטעם
  • קאַסטן ווייטיק
  • געשווילעכץ אין די פוס
  • persistent abdominal (belly) pain
  • neurological symptoms, such as severe and persistent headaches or blurred vision
  • קליינטשיק בלוט ספּאַץ אונטער די הויט ווייַטער פון די אָרט פון ינדזשעקשאַן.
• Speak to your healthcare professional or contact your relevant national health authorities if you have any questions about the roll out of the vaccine in your country.

אינפֿאָרמאַציע פֿאַר כעלטקער פּראָפעססיאָנאַלס

• EMA has reviewed cases of thrombosis in combination with thrombocytopenia, and in some cases bleeding, in people who received Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

• These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis as well as arterial thrombosis. Most of the cases reported so far have occurred in women under the age of 60 years. Most cases occurred within 2 weeks of the person receiving their first dose. There is limited experience with the second dose.
• As for the mechanism, it is thought that the vaccine may trigger an immune response leading to an atypical heparin-induced-thrombocytopenia like disorder. At this time, it is not possible to identify specific risk factors.
• פּראָפעססיאָנאַלס פֿאַר כעלטקער זאָל זיין פלינק פֿאַר די וואונדער און סימפּטאָמס פון טהראָמבאָעמבאָליסם און טהראָמבאָסיטאָפּעניאַ, אַזוי אַז זיי קענען פּונקט מייַכל די אַפעקטיד מענטשן אין לויט מיט די פאַראַנען גיידליינז.
• פּראָפעססיאָנאַלס פֿאַר כעלטקער זאָל זאָגן מענטשן וואָס באַקומען די וואַקסאַניישאַן אַז זיי מוזן זוכן מעדיציניש ופמערקזאַמקייט אויב זיי אַנטוויקלען:
  • סימפּטאָמס פון בלוט קלאַץ אַזאַ ווי שאָרטנאַס פון אָטעם, ווייטיק אין קאַסטן, געשווילעכץ אין די פוס, פּערסיסטענט אַבדאָמינאַל ווייטיק
  • נוראַלאַדזשיקאַל סימפּטאָמס אַזאַ ווי שטרענג און פּערסיסטענט כעדייקס און בלערד זעאונג
  • פּעטעטשיאַע נאָך עטלעכע טעג נאָך די וואַקסאַניישאַן פּלאַץ.
• די בענעפיץ פון די וואַקצין פאָרזעצן צו העכערונג די ריסקס פֿאַר מענטשן וואָס באַקומען עס. די וואַקסין איז עפעקטיוו אין פּרעווענטינג COVID-19 און רעדוצירן כאַספּיטאַלאַזיישאַנז און דעטס.
• National authorities may provide additional guidance on the roll out of the vaccine based on the situation in your country.

Healthcare professionals involved in giving the vaccine in the EU will receive a direct healthcare professional communication (DHPC). The DHPC will also be פאַראַנען.

More about the medicine

Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) 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. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. The vaccine 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.

מער וועגן דעם פּראָצעדור

This review was carried out in the context of a זיכערקייַט סיגנאַל, אונטער אַ אַקסעלערייטיד פאָרפּלאַן. א זיכערקייַט סיגנאַל איז אינפֿאָרמאַציע אויף אַ נייַע אָדער ינקאַמפּליטידלי דאַקיאַמענטאַד אַדווערס געשעעניש that is potentially caused by a medicine such as a vaccine and that warrants further investigation.

The review was carried out by EMA's פאַרמאַקאָוויגילאַנסע ריזיקירן אַסעסמאַנט קאַמיטי (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. EMA’s human medicine committee, טשמפּ, will now rapidly assess any necessary changes to the פּראָדוקט אינפֿאָרמאַציע.

EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. EMA’s recommendations are the foundation upon which individual EU Member States will design and implement their own national vaccination campaigns. These may differ from country to country depending on their national needs and circumstances, such as infection rates, priority populations, vaccine availability and hospitalzsation rates.

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¹ As of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis were reported to עודראַוויגילאַנסע. Around 34 million people had been vaccinated in the EEA and UK by this date. The more recent data do not change the PRAC'ס רעקאַמאַנדיישאַנז.

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