Inzwischen 13 Fälle von Thrombosen in Hirnvenen nach AstraZeneca-Impfung

Geht es um Aufklärung oder dar­um, die ande­ren Stoffe in bes­se­rem Licht erschei­nen zu las­sen? welt​.de berich­tet am 18.3.:

»Nach der vor­sorg­li­chen Aussetzung der Corona-Impfungen mit dem Mittel des Herstellers AstraZeneca sind wei­te­re Vorfälle in Deutschland bekannt gewor­den. Inzwischen gebe es 13 gemel­de­te Fälle von Blutgerinnseln (Thrombosen) in Hirnvenen in zeit­li­chem Zusammenhang zu Impfungen, wie das Bundesgesundheitsministerium am Donnerstag mit­teil­te. Drei Patienten sei­en gestor­ben. Es han­de­le sich um zwölf Frauen und einen Mann zwi­schen 20 und 63 Jahren…«

17 Antworten auf „Inzwischen 13 Fälle von Thrombosen in Hirnvenen nach AstraZeneca-Impfung“

  1. Dieser Beitrag passt bes­ser hierher:

    Der Vorteil des EMA-Entschlusses für den AZ-Geimpften ist, dass er über die mög­li­che Nbw Sinusvenenthrombose auf­ge­klärt wird!
    Und damit (noch?) sehen­den Auges die Konsequenzen sei­ner Entscheidung in Kauf neh­men kann.

    My body, my choice.
    Why not?

  2. Kai Kupferschmidts bis­he­ri­ge Tweets zur EMA-Eingangserklärung, wie sie auf fol­gen­der Veranstaltung vor­ge­tra­gen wurde:
    LIVE: European Medicines Agency reve­als AstraZeneca vac­ci­ne is 'safe and effec­ti­ve' https://​www​.you​tube​.com/​w​a​t​c​h​?​v​=​k​Q​W​J​Z​T​q​f​lUA

    13 tweets, 6 min read
    "The com­mit­tee has come to a clear sci­en­ti­fic con­clu­si­on: This is a safe and effec­ti­ve vac­ci­ne. Its bene­fits in pro­tec­ting peo­p­le from #COVID19 with the asso­cia­ted risks of death and hos­pi­ta­lizati­on out­weigh the pos­si­ble risks”, says Emer Cooke at @EMA_News press conference.
    "The com­mit­tee also con­clu­ded that the vac­ci­ne is not asso­cia­ted with an increa­se in the over­all risk of throm­bo embo­lic events or blood clots”, says Cooke.
    "During the inve­sti­ga­ti­on and review we began to see a small num­ber of cases of rare and unusu­al but very serious clot­ting dis­or­ders, and this then trig­ge­red a more focu­sed review based on the evi­dence available”, says Cooke.
    “After days of in-depth ana­ly­sis of lab results, cli­ni­cal reports, auto­psy reports and other infor­ma­ti­on from the cli­ni­cal tri­als, we still can­not rule out defi­ni­tively a link bet­ween the­se cases and the vac­ci­ne”, says Cooke.
    “What the com­mit­tee has the­r­e­fo­re recom­men­ded is to rai­se awa­re­ness of the­se pos­si­ble risks making sure that they're inclu­ded in the pro­duct infor­ma­ti­on, dra­wing atten­ti­on to the­se pos­si­ble rare con­di­ti­ons”, says Cooke.
    "We're also laun­ching addi­tio­nal inve­sti­ga­ti­ons to under­stand more about the­se rare cases, and we're con­duc­ting tar­ge­ted obser­va­tio­nal stu­dies”, says Cooke.
    "I want to rei­te­ra­te that our sci­en­ti­fic posi­ti­on is that this vac­ci­ne is a safe, an effec­ti­ve opti­on to pro­tect citi­zens against #COVID19”, says Cooke.
    "We're very much awa­re that some mem­ber sta­tes have pau­sed vac­ci­na­ti­ons, wai­ting for EMA's out­co­me of a review”, says Cooke. “But given that 1000s of peo­p­le in the EU die every day. … it real­ly was cru­cial for EMA to review rapid­ly and tho­rough­ly all the available evidence."
    “This vac­ci­ne is safe and effec­ti­ve in pre­ven­ting #COVID19 and its bene­fits con­ti­n­ue to be far grea­ter than its risks. PRAC has found no evi­dence of a qua­li­ty or a batch issue”, says Sabine Straus, chair of EMA's safe­ty com­mit­tee (PRAC).
    “PRAC has con­clu­ded that the­re was no increa­se in the over­all risk of blood clots”, says Straus. “Moreover, becau­se the vac­ci­ne is effec­ti­ve in pre­ven­ting #COVID19 dise­a­se, which in its­elf, of cour­se, is a cau­se of blood clots, it likely redu­ces the risk of throm­bo­tic events."
    “However, the­re are also still some uncer­tain­ties”, says Straus. "We have seen some very rare case reports, describ­ing spe­ci­fic unusu­al events of a com­bi­na­ti­on of throm­bo­sis and throm­bo­cy­to­pe­nia and blee­ding.” Mentions dis­se­mi­na­ted intra­vas­cu­lar coagu­la­ti­on (DIC) and CVTs.
    “The evi­dence we have is, at the moment, not suf­fi­ci­ent to con­clude with cer­tain­ty whe­ther the­se adver­se events are inde­ed cau­sed by the vac­ci­ne or not”, says Straus . "So PRAC will con­ti­n­ue to gather more infor­ma­ti­on on the­se con­di­ti­ons, inclu­ding addi­tio­nal studies…"
    “PRAC also con­clu­ded that it's very important that the­se events are rare”, says Straus. "As of last night, seven cases of this dis­se­mi­na­ted intra­vas­cu­lar coagu­la­ti­on and 18 cases of cere­bral venous sinus throm­bo­sis were repor­ted out of almost 20 mil­li­on vac­ci­na­ted people."
    • • •

    1. COVID-19 Vaccine AstraZeneca: bene­fits still out­weigh the risks despi­te pos­si­ble link to rare blood clots with low blood plate­lets Share
      News 18/03/2021 https://​www​.ema​.euro​pa​.eu/​e​n​/​n​e​w​s​/​c​o​v​i​d​-​1​9​-​v​a​c​c​i​n​e​-​a​s​t​r​a​z​e​n​e​c​a​-​b​e​n​e​f​i​t​s​-​s​t​i​l​l​-​o​u​t​w​e​i​g​h​-​r​i​s​k​s​-​d​e​s​p​i​t​e​-​p​o​s​s​i​b​l​e​-​l​i​n​k​-​r​a​r​e​-​b​l​o​o​d​-​c​l​ots

      EMA’s safe­ty com­mit­tee, PRAC, con­clu­ded its preli­mi­na­ry review of a signal of blood clots in peo­p­le vac­ci­na­ted with COVID-19 Vaccine AstraZeneca at its extra­or­di­na­ry mee­ting of 18 March 2021. The Committee con­firm­ed that:

      the bene­fits of the vac­ci­ne in com­ba­ting the still wide­spread thre­at of COVID-19 (which its­elf results in clot­ting pro­blems and may be fatal) con­ti­n­ue to out­weigh the risk of side effects;
      the vac­ci­ne is not asso­cia­ted with an increa­se in the over­all risk of blood clots (throm­bo­em­bo­lic events) in tho­se who recei­ve it;
      the­re is no evi­dence of a pro­blem rela­ted to spe­ci­fic bat­ches of the vac­ci­ne or to par­ti­cu­lar manu­fac­tu­ring sites;
      howe­ver, the vac­ci­ne may be asso­cia­ted with very rare cases of blood clots asso­cia­ted with throm­bo­cy­to­pe­nia, i.e. low levels of blood plate­lets (ele­ments in the blood that help it to clot) with or wit­hout blee­ding, inclu­ding rare cases of clots in the ves­sels drai­ning blood from the brain (CVST).

      These are rare cases – around 20 mil­li­on peo­p­le in the UK and EEA had recei­ved the vac­ci­ne as of March 16 and EMA had review­ed only 7 cases of blood clots in mul­ti­ple blood ves­sels (dis­se­mi­na­ted intra­vas­cu­lar coagu­la­ti­on, DIC) and 18 cases of CVST. A cau­sal link with the vac­ci­ne is not pro­ven, but is pos­si­ble and deser­ves fur­ther analysis.

      The PRAC invol­ved experts in blood dis­or­ders in its review, and work­ed clo­se­ly with other health aut­ho­ri­ties inclu­ding the UK’s MHRA which has expe­ri­ence with admi­ni­stra­ti­on of this vac­ci­ne to around 11 mil­li­on peo­p­le. Overall the num­ber of throm­bo­em­bo­lic events repor­ted after vac­ci­na­ti­on, both in stu­dies befo­re licen­sing and in reports after roll­out of vac­ci­na­ti­on cam­paigns (469 reports, 191 of them from the EEA), was lower than that expec­ted in the gene­ral popu­la­ti­on. This allo­ws the PRAC to con­firm that the­re is no increa­se in over­all risk of blood clots. However, in youn­ger pati­ents the­re remain some con­cerns, rela­ted in par­ti­cu­lar to the­se rare cases.

      The Committee’s experts loo­ked in extre­me detail at records of DIC and CVST repor­ted from Member States, 9 of which resul­ted in death. Most of the­se occur­red in peo­p­le under 55 and the majo­ri­ty were women. Because the­se events are rare, and COVID-19 its­elf often cau­ses blood clot­ting dis­or­ders in pati­ents, it is dif­fi­cult to esti­ma­te a back­ground rate for the­se events in peo­p­le who have not had the vac­ci­ne. However, based on pre-COVID figu­res it was cal­cu­la­ted that less than 1 repor­ted case of DIC might have been expec­ted by 16 March among peo­p­le under 50 within 14 days of recei­ving the vac­ci­ne, whe­re­as 5 cases had been repor­ted. Similarly, on avera­ge 1.35 cases of CVST might have been expec­ted among this age group whe­re­as by the same cut-off date the­re had been 12. A simi­lar imba­lan­ce was not visi­ble in the older popu­la­ti­on given the vaccine.

      The Committee was of the opi­ni­on that the vaccine’s pro­ven effi­ca­cy in pre­ven­ting hos­pi­ta­li­sa­ti­on and death from COVID-19 out­weighs the extre­me­ly small likeli­hood of deve­lo­ping DIC or CVST. However, in the light of its fin­dings, pati­ents should be awa­re of the remo­te pos­si­bi­li­ty of such syn­dro­mes, and if sym­ptoms sug­ge­sti­ve of clot­ting pro­blems occur pati­ents should seek imme­dia­te medi­cal atten­ti­on and inform heal­th­ca­re pro­fes­sio­nals of their recent vac­ci­na­ti­on. Steps are alre­a­dy being taken to update the pro­duct infor­ma­ti­on for the vac­ci­ne to include more infor­ma­ti­on on the­se risks.

      The PRAC will under­ta­ke addi­tio­nal review of the­se risks, inclu­ding loo­king at the risks with other types of COVID-19 vac­ci­nes (alt­hough no signal has been iden­ti­fi­ed from moni­to­ring so far). Close safe­ty moni­to­ring of reports of blood clot­ting dis­or­ders will con­ti­n­ue, and fur­ther stu­dies are being insti­tu­ted to pro­vi­de more labo­ra­to­ry data as well as real-world evi­dence. EMA will com­mu­ni­ca­te fur­ther as appropriate.
      Information for patients

      COVID-19 Vaccine AstraZeneca is not asso­cia­ted with an increa­sed over­all risk of blood clot­ting disorders.
      There have been very rare cases of unusu­al blood clots accom­pa­nied by low levels of blood plate­lets (com­pon­ents that help blood to clot) after vac­ci­na­ti­on. The repor­ted cases were almost all in women under 55.
      Because COVID-19 can be so serious and is so wide­spread, the bene­fits of the vac­ci­ne in pre­ven­ting it out­weigh the risks of side effects.
      However, if you get any of the fol­lo­wing after recei­ving the COVID-19 Vaccine AstraZeneca:
      pain in the chest or stomach,
      swel­ling or cold­ness in an arm or leg,
      seve­re or wor­sening hea­da­che or blur­red visi­on after vaccination,
      per­si­stent bleeding,
      mul­ti­ple small brui­ses, red­dish or purp­lish spots, or blood bli­sters under the skin,

      plea­se seek prompt medi­cal assi­stance and men­ti­on your recent vaccination.
      Information for heal­th­ca­re professionals

      Cases of throm­bo­sis and throm­bo­cy­to­pe­nia, some pre­sen­ting as mesen­te­ric vein or cere­bral vein/cerebral venous sinus throm­bo­sis, have been repor­ted in per­sons who had recent­ly recei­ved COVID-19 Vaccine AstraZeneca, most­ly occur­ring within 14 days after vac­ci­na­ti­on. The majo­ri­ty of reports invol­ved women under 55, alt­hough some of this may reflect grea­ter expo­sure of such indi­vi­du­als due to tar­ge­ting of par­ti­cu­lar popu­la­ti­ons for vac­ci­ne cam­paigns in dif­fe­rent Member States.
      The num­ber of repor­ted events exce­eds tho­se expec­ted, and cau­sa­li­ty alt­hough not con­firm­ed, can­not the­r­e­fo­re be exclu­ded. However, given the rari­ty of the events, and the dif­fi­cul­ty of estab­li­shing base­line inci­dence sin­ce COVID-19 its­elf is resul­ting in hos­pi­ta­li­sa­ti­ons with throm­bo­em­bo­lic com­pli­ca­ti­ons, the strength of any asso­cia­ti­on is uncertain.
      EMA con­siders that the bene­fit-risk balan­ce of the medi­ci­ne remains posi­ti­ve, and the­re is no asso­cia­ti­on with throm­bo­em­bo­lic dis­or­ders over­all. However, steps will be taken to update the SmPC and packa­ge leaf­let with infor­ma­ti­on on cases of DIC and CVST that have occurred.
      Healthcare pro­fes­sio­nals are urged to be alert for pos­si­ble cases of throm­bo­em­bo­lism, DIC or CVST occur­ring in vac­ci­na­ted individuals.
      Recipients should be war­ned to seek imme­dia­te medi­cal atten­ti­on for sym­ptoms of throm­bo­em­bo­lism, and espe­ci­al­ly signs of throm­bo­cy­to­pe­nia and cere­bral blood clots such as easy brui­sing or blee­ding, and per­si­stent or seve­re hea­da­che, par­ti­cu­lar­ly bey­ond 3 days after vaccination.

      A direct heal­th­ca­re pro­fes­sio­nal com­mu­ni­ca­ti­on (DHPC) will be sent to heal­th­ca­re pro­fes­sio­nals pre­scrib­ing, dis­pen­sing or admi­ni­ste­ring the medi­ci­ne. The DHPC will also be published on a dedi­ca­ted page on the EMA website.
      More about the medicine

      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. COVID-19 Vaccine AstraZeneca does not con­tain the virus its­elf and can­not cau­se COVID-19.

      The most com­mon side effects with COVID-19 Vaccine AstraZeneca are usual­ly mild or mode­ra­te and impro­ve within a few days after vaccination.
      More about the procedure

      The review of throm­bo­em­bo­lic events with COVID-19 Vaccine AstraZeneca was car­ri­ed out in the con­text of a safe­ty signal, under an acce­le­ra­ted time­ta­ble. A safe­ty signal is infor­ma­ti­on on a new or incom­ple­te­ly docu­men­ted adver­se event that is poten­ti­al­ly cau­sed by a medi­ci­ne such as a vac­ci­ne and that war­rants fur­ther investigation.

      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. EMA’s human medi­ci­ne com­mit­tee, CHMP, will now rapid­ly assess any neces­sa­ry chan­ges to the pro­duct information.

    2. "We're also laun­ching addi­tio­nal inve­sti­ga­ti­ons to under­stand more about the­se rare cases, and we're con­duc­ting tar­ge­ted obser­va­tio­nal studies” 

      Das passt gut zusam­men mit Staatsanwälten die genaue Untersuchungen verbieten.

  3. EMA: Skrupellose Mörderbande. Wozu gibts den Laden über­haupt, wenn er sei­ner Aufgabe nicht nach­kommt. Dann kann man den auch gleich ein­stamp­fen und alles freigeben.

    1. @Ulla

      Ich muss mich lei­der selbst zitieren:
      Alles ver­imp­fen, was bei Plusgraden einen flüs­si­gen Aggegratzustand aufweist! 

      Alles ande­re wäre verantwortungslos!

  4. Jetzt bin ich ja mal gespannt, was das Paul-Ehrlich-Institut nach dem heu­ti­gen EMA-„Sicherheitsnachweis“ zu sagen hat …

    Am Montag, d. 15.03.2021 gibt es bei 7 Fällen fol­gen­de Information ab:

    „ Bei der Analyse des neu­en Datenstands sehen die Expertinnen und Experten des Paul-Ehrlich-Instituts jetzt eine auf­fäl­li­ge Häufung einer spe­zi­el­len Form von sehr sel­te­nen Hirnvenenthrombosen (Sinusvenenthrombosen) in Verbindung mit einem Mangel an Blutplättchen (Thrombozytopenie) und Blutungen in zeit­li­cher Nähe zu Impfungen mit dem COVID-19-Impfstoff AstraZeneca.“

    Was sagen die­sel­ben Experten nun bei 13 Fällen, also fast einer Verdopplung inner­halb von drei Tagen, wobei noch zu berück­sich­ti­gen ist, dass ab Montag nicht mehr geimpft wur­de mit AstraZeneca?

    Auffällig oft wur­de eben in der Pressekonferenz der EMA dar­auf hin­ge­wie­sen, dass sich deren Einschätzung auf die gemel­de­ten Fälle von gestern bezieht …
    Die ken­nen also ganz genau den Stand von heu­te, und sie konn­ten sich auch dar­auf ver­las­sen, dass kein Journalist kri­tisch nach­fra­gen würde …

  5. Ärger allein hilft nicht wei­ter. Da die­ser Effekt von erfah­re­nen Ärzten öffent­lich vor­her gesagt wur­de bedeu­tet ver­ant­wor­tungs­vol­les Handeln jetzt:
    – vor allen gen­tech­ni­schen Mitteln wird ein Blutbild bei jedem zu Impfenden gemacht und die Thrombocytenzahl bestimmt
    – das glei­che wird … Tage nach der Verabreichung des Mittels wie­der­holt, wenn sich die erwünsch­te Antikörperbildung vollzieht.
    Es soll ja geprüft wer­den ob die sich auch gegen Thrombocyten rich­ten. Das hat nicht nur mit Astra-Zeneca zu tun, ist auch bei BionTech zu machen.
    Ich hof­fe die tat­säch­li­chen Vorfälle soll­ten Anlass genug sein jetzt das zu machen was man eigent­lich vor jeder Zulassung (egal wie man die jetzt nen­nen will) hät­te tun müs­sen. Jetz ist doch sicher klar dass hier nicht ein­fach ein paar Drops ein­ge­wor­fen wer­den. Man muss das schon ernst nehmen.

  6. Prof Kekule weist auf fol­gen­de grund­sätz­li­che Diagnoseproblematik hin – ab Min 56:00

    – Übersehene bzw. wegen des erfor­der­li­chen gro­ßen tech­ni­schen Aufwands noch gar nicht gesuch­te, auf jeden Fall aber nicht detek­tier­te – aber immer­hin schon denkbare/vorstellbare – Sinusvenenthrombosen,
    – nicht iden­ti­fi­zier­te [ich ergän­ze: sowie das Dunkelfeld begriff­lich noch nicht iden­ti­fi­zier­ba­rer] Folgewirkungen / Kausalzusammenhänge usw.
    => Da läp­pert sich erst im Laufe der Zeit eine grö­ße­re Fallzahl zusammen.
    Kekulés Corona-Kompass #160​: Warum der Stopp von Astrazeneca rich­tig ist | MDR https://​www​.you​tube​.com/​w​a​t​c​h​?​v​=​F​S​7​p​o​D​d​Q​W34

  7. Dieses Interview mit Prof. Exner auf Phoenix zur heu­ti­gen Ema Entscheidung ist auch ein wun­der­schö­nes Beispiel an Desinformation und Propaganda.
    "Enorme Vorteile in der Durchimpfung der Bevölkerung"

    Eine Ansammlung von Vermutungen und Wahrscheinlichkeiten, Pudding an die Wand, und Hauptsache alle müssen/können geimpft werden. 

    Was ist noch­mal der Sinn von Impfungen für halb­wegs gesun­de Menschen (90% der Bevölkerung) ?

  8. 60% Wirksamkeit, Chapeau, da kann man sich eine Thrombose lei­sten. 20Mio Menschen kön­nen nicht irren.…woran erin­nert mich die­ser Spruch gera­de?? Ach ja ,die sieb­zi­ger, aber da waren es Fliegen.

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