AstraZeneca-Stoff heißt jetzt Vaxzevria

Das teil­te die EMA am 26.3. mit. Der Vorgang, einem Impfstoff einen eige­nen Namen zu geben, ist nicht unüb­lich. Hier drängt sich jedoch der Verdacht auf, einen Imageverlust zu hei­len. Hat man schon von Nebenwirkungen von Vaxzevria gehört?

21 Antworten auf „AstraZeneca-Stoff heißt jetzt Vaxzevria“

  1. Der Name ist pri­ma, den kann sich nie­mand mer­ken. Es drän­gen sich Namens-Mutanten auf. Beispiel? Vaxkrepira. Ich glau­be, da muss die Marketing-Abteilung noch­mal ran. Lokal anpassen.

    1. @ ewi­ger Morgenstern

      Im Gegensatz zu den "Corona-Toten", die immer wei­ter fröh­lich auf­sum­miert wer­den. Genauso wie man das eben bei den Grippe-Toten macht.

  2. Ob der Name des Impfstoffs wirk­lich was ändert? Es ist immer noch Vaxzevria von AstraZeneca.
    Dann müß­te sich schon AstraZeneca selbst umbe­nen­nen viel­leicht in "Regenbogeneinhornwunderland", das wür­de viel­leicht ein bes­se­res Image erzeu­gen (mei­ne Tochter wür­de es mögen 😉 ). Und wenn schon, dann rich­tig: Oxford soll­te sich auch gleich noch umbenennen.

  3. Wenn man ein fau­les Ei neu eti­ket­tiert, hört es des­we­gen auch nicht mit stin­ken auf…

    oder ein­fach nur: Alter Wein in neu­en Schläuchen.

  4. Astra Zenecas vac­cin byter namn till Vaxzevria

    Publicerad: 29 mars 2021
    Senast upp­date­rad: 29 mars 2021
    Kategori: Nyhet https://www.lakemedelsverket.se/sv/nyheter/astra-zenecas-vaccin-byter-namn-till-vaxzevria

    Coronavaccinet ”Covid-19 Vaccine AstraZeneca” från AstraZeneca byter nu namn till ”Vaxzevria”. Namnbytet inne­bär inga förändrin­gar i övrigt, men det är vik­tigt att vac­ci­na­tö­rer ute i regio­ner­na har kän­ne­dom om ändrin­gen då pro­dukt­in­for­ma­ti­on, mär­k­ning och för­pack­nin­gar kan se oli­ka ut.

    Namnändring av ett läke­me­del är en så kal­lad typ IIa-änd­ring som bland annat reg­le­ras av Läkemedelsverkets föres­krif­ter (LVFS 2005:11) om mär­k­ning och bipack­sed­lar för läke­me­del. Namnändringen godkän­des av EMA den 25 mars efter ansö­kan från företaget.

    Alla läke­me­del ska ha god­tag­ba­ra och särs­kil­jan­de ben­äm­nin­gar. Både fan­ta­si­na­mn och gene­ris­ka namn (Covid-19 Vaccine AstraZeneca) kan använ­das vid namngiv­ning av läkemedel.

    En särs­kild väg­led­ning finns som ett stöd till de före­tag som ska namnge läke­me­del och den byg­ger på den väg­led­ning som EMA til­läm­par beträf­fan­de namn för human­lä­ke­me­del som god­känns i den cen­tra­la godkännandeproceduren.
    Mer information

    Vaxzevria – produktinformation
    Namngivning av läkemedel

  5. Diejenigen Bürger, die glau­ben, wir ste­cken in der bedroh­lichs­ten Pandemie seit dem Mittelater und dass der Tod zur­zeit an jeder Straßenecke lau­ert, wer­den sicher­lich bes­ser schla­fen kön­nen, wenn das Zeug Vaxzevria heißt. Man könn­te es auch Rohrkrepierer nen­nen, wäre die­sen Leuten auch egal.

    Die mei­nungs­of­fe­nen Bürger, meis­tens haben die­se auch ein bes­se­res Gedächtnis, wer­den der EMA zurecht ein hin­ter­lis­ti­ges Täuschungsmanöver vor­wer­fen, wel­ches ohne Rücksicht auf mensch­li­che Verluste nur den Impfwahn der für die der­zei­ti­ge Misere zustän­di­gen Verantwortlichen befriedigt.

  6. "Der Pandemiebeauftragte des Klinikums rechts der Isar der Technischen Universität München, Christoph Spinner, sieht das vor­läu­fi­ge Aussetzen der Astrazeneca-Impfungen für unter 60-Jährige als nach­voll­zieh­ba­ren Schritt. „Wenn man auf ganz sicher gehen will – und das wol­len wir in Deutschland – dann ist das jetzt die rich­ti­ge Entscheidung“, sag­te Spinner. Allerdings plä­dier­te der Oberarzt am Universitätsklinikum dafür, jün­ge­ren Menschen die Entscheidungshoheit zu geben, ob sie den Impfstoff wol­len oder nicht."

    https://www.aerzteblatt.de/nachrichten/122560/STIKO-empfiehlt-Astrazeneca-Impfstoff-nur-noch-fuer-Personen-im-Alter-ab-60-Jahren

    Also"jüngeren Menschen die Entscheidungshoheit zu geben, ob sie den Impfstoff wol­len oder nicht."

    Hmmm,
    Konzept infor­med Konzept in der TU München noch unbekannt?

    Konzept „infor­med consent“

    "Mehr als 200 Jahre nach Kant haben wir eine reich­hal­ti­ge Literatur zu die­ser Thematik, die mit dem Begriff „Aufklärung“ aber nur eine Seite der Medaille in den Blick nimmt. Zu ver­wei­sen wäre zudem auf das bereits in der früh­neu­zeit­li­chen Diskussion um die Grundrechte auf­schei­nen­de Autonomieprinzip. Dieses garan­tiert jeder Person die Entscheidungsfreiheit, auch und gera­de im Hinblick auf (zum Teil erheb­lich in die kör­per­li­che Integrität ein­grei­fen­de) medi­zi­ni­sche Therapien. Um auto­nom ent­schei­den zu kön­nen, muss – so steht es heu­te in jedem Lehrbuch der Medizinethik – der Patient in die Lage ver­setzt wer­den, für sich eine ver­nünf­ti­ge Entscheidung zu tref­fen. Wie das geschieht, beschreibt das Konzept der auto­no­men bezie­hungs­wei­se infor­mier­ten Zustimmung (infor­med con­sent), das in den letz­ten Jahrzehnten durch ethi­sche Grundsatzdiskussionen und Gerichtsentscheide geprägt und wei­ter­ent­wi­ckelt wurde." 

    https://www.aerzteblatt.de/archiv/198935/Arzt-und-Ethos-Aufklaerung-und-informed-consent

  7. 29 March 2021
    COVID-19 vaccine
    safe­ty update
    VAXZEVRIA
    AstraZeneca AB http://webcache.googleusercontent.com/search?q=cache:gnXabhZYGY8J:www.quotidianosanita.it/allegati/create_pdf.php%3Fall%3D4841212.pdf+&cd=14&hl=de&ct=clnk&gl=de&lr=lang_da%7Clang_de%7Clang_en%7Clang_es%7Clang_fr%7Clang_it%7Clang_tr%7Clang_el&client=firefox-b‑d

    Embolic and throm­bo­tic events
    Cases of embo­lic and throm­bo­tic events (for­ma­ti­on of blood clots in the
    blood ves­sels) have been repor­ted for Vaxzevria from its use in
    vac­ci­na­ti­on campaigns.
    Following dis­cus­sions during and after its mee­ting held 8 to 11 March
    2021, on 18 March 2021 PRAC con­duc­ted a preli­mi­na­ry assessment -
    invol­ving experts in blood dis­or­ders – of the avail­ab­le evi­dence from case
    reports in EudraVigilance (see sec­tion 3), qua­li­ty, cli­ni­cal, pre-cli­ni­cal and
    sci­en­ti­fic lite­ra­tu­re data, and data from the mar­ke­ting authorisation
    hol­der. PRAC con­clu­ded the following:
    There was no evi­dence of a pro­blem with manu­fac­tu­ring or pro­duct quality
    rela­ted to the vac­ci­ne bat­ches spe­ci­fied in the case reports. This was
    based on a qua­li­ty assess­ment car­ri­ed out wit­hin the EU regulatory
    net­work. This inclu­ded the infor­ma­ti­on from the offi­cial medi­ci­nes control
    labo­ra­to­ry release cer­ti­fi­ca­tes. These com­pri­se inde­pen­dent tes­ting and
    che­cking of the manufacturer’s key test results befo­re release of any
    batch of COVID-19 vac­ci­nes to the EU/EEA market.
    Overall, the num­ber of cases of embo­lic and throm­bo­tic events after
    vac­ci­na­ti­on repor­ted to EudraVigilance (see sec­tion 3) in rela­ti­on to the
    num­ber of peop­le vac­ci­na­ted was lower than the rate of such events in the
    gene­ral population.
    However, Vaxzevria could pos­si­b­ly be asso­cia­ted with very rare cases of
    spe­ci­fic embo­lic and throm­bo­tic events in com­bi­na­ti­on with low levels of
    blood plate­lets (throm­bocy­to­pe­nia) and rela­ted blee­ding. These events
    inclu­de dis­se­mi­na­ted intra­vascu­lar coagu­la­ti­on (DIC) (whe­re blood clots
    occur in mul­ti­ple blood ves­sels) and cere­bral venous sinus
    throm­bo­sis (CVST) (whe­re blood clots in the brain's venous sinuses
    pre­vent blood from drai­ning out of the brain).
    In the repor­ted cases, inclu­ding some that resul­ted in death, the­se events
    occur­red wit­hin 14 days after vac­ci­na­ti­on. They occur­red most­ly in people
    under 55 years of age, the majo­ri­ty of whom were women. However,
    the­se pati­ent cha­rac­te­ris­tics could reflect the hig­her pro­por­ti­on of such
    indi­vi­du­als offe­red Vaxzevria in vac­ci­na­ti­on cam­pai­gns. As part of the
    preli­mi­na­ry assess­ment, the num­ber of cases repor­ted were com­pa­red to
    rates for the­se events app­li­ca­ble to the gene­ral EU popu­la­ti­on befo­re the
    SARS-Cov‑2 pan­de­mic. This com­pa­ri­son show­ed incre­a­sed num­bers in
    vac­ci­na­ted peop­le. Such imba­lan­ces in num­bers of cases bet­ween the
    gene­ral and vac­ci­na­ted popu­la­ti­ons were not visi­ble for the older age
    groups.
    A cau­sal link of DIC and CVST with the vac­ci­ne is not pro­ven but cannot
    be exclu­ded and requi­res fur­ther investigation.
    People vac­ci­na­ted with Vaxzevria should seek immedia­te medi­cal attention
    if sym­ptoms of blood clot­ting occur and inform health­ca­re pro­fes­sio­nals of
    their recent vac­ci­na­ti­on. Such sym­ptoms inclu­de short­ness of breath,
    chest or per­sis­tent abdo­mi­nal pain, leg swel­ling, seve­re or persistent

    hea­da­che, blur­red visi­on, per­sis­tent blee­ding, and skin brui­sing or round,
    pin­point spots bey­ond the site of vac­ci­na­ti­on appearing after a few days.
    The pro­duct infor­ma­ti­on for Vaxzevria has been updated with this
    warning, and a direct health­ca­re pro­fes­sio­nal com­mu­ni­ca­ti­on (DHPC) has
    been sent out to rai­se awa­reness among health­ca­re professionals4.
    Based on all avail­ab­le data on embo­lic and throm­bo­tic events, PRAC
    con­si­de­red that the bene­fits of Vaxzevria in pre­ven­ting COVID-19 and
    rela­ted death con­ti­nue to out­weigh the risks, and that this vac­ci­ne can be
    used while fur­ther data collec­tion and assess­ment are ongoing5.

    Page 1
    http://www.ema.europa.eu
    29 March 2021
    COVID-19 vaccine
    safe­ty update
    VAXZEVRIA
    AstraZeneca AB
    Severe all­er­gic reac­tion will be inclu­ded in the
    pro­duct infor­ma­ti­on as a known side effect.
    A warning on very rare spe­ci­fic blood clot
    events has been inclu­ded in the product
    infor­ma­ti­on, while fur­ther inves­ti­ga­ti­ons into a
    pos­si­ble cau­sal rela­ti­ons­hip with the vac­ci­ne are
    ongoing.
    Vaccinated per­sons should seek immediate
    medi­cal atten­ti­on if sym­ptoms of blood clotting
    and/or blee­ding occur.
    The bene­fits of Vaxzevria in pre­ven­ting COVID-
    19 con­ti­nue to out­weigh the risks; and there
    are no recom­men­ded chan­ges regar­ding the
    use of this vaccine.
    Safety updates pro­vi­de the out­co­mes of the assess­ment of emer­ging data
    sin­ce mar­ke­ting aut­ho­ri­sa­ti­on for COVID-19 vac­ci­nes. The assessments
    are car­ri­ed out by EMA’s safe­ty com­mit­tee (Pharmacovigilance Risk
    Assessment Committee [PRAC]). The safe­ty updates are published
    regu­lar­ly at COVID-19 vac­ci­nes: authorised.
    All publis­hed safe­ty updates for Vaxzevria (pre­vious­ly known as COVID-19
    Vaccine AstraZeneca) are avail­ab­le at Vaxzevria: safe­ty updates.
    Page 2
    COVID-19 vac­ci­ne safe­ty update
    VAXZEVRIA
    http://www.ema.europa.eu
    Page 2/6
    This safe­ty update is the first update after the mar­ke­ting aut­ho­ri­sa­ti­on in
    the European Union (EU).
    Since its mar­ke­ting aut­ho­ri­sa­ti­on in the EU on 29 January 2021 until 25
    March 2021, more than 10 mil­li­on doses of Vaxzevria have been
    admi­nis­te­red in the EU/EEA1.
    1. Updates on safe­ty of Vaxzevria
    At its mee­tings held 8 to 11 March, on 18 March and on 25 March 2021,
    PRAC asses­sed all new safe­ty data emer­ging world­wi­de, inclu­ding the
    latest Summary Monthly Safety Report2 from the mar­ke­ting authorisation
    hol­der, and con­clu­ded that the bene­fit-risk balan­ce of Vaxzevria remains
    positive.
    Specifically, the fol­lowing was con­clu­ded by PRAC in rela­ti­on to:
    Anaphylaxis and other all­er­gic reactions
    Cases of suspec­ted ana­phy­la­xis (seve­re all­er­gic reac­tion) have been
    repor­ted for Vaxzevria from its use in vac­ci­na­ti­on cam­pai­gns. In
    par­ti­cu­lar, 41 cases repor­ted to EudraVigilance (see sec­tion 3) from
    around 5 mil­li­on vac­ci­na­ti­ons in the United Kingdom (UK) (data lock point:
    16-February-2021) were asses­sed at the PRAC mee­ting held 8 to 11
    March 20213.
    Following PRAC assess­ment, ana­phy­la­xis and other allergic
    (hyper­sen­si­ti­vi­ty) reac­tions will now be inclu­ded in the EU product
    infor­ma­ti­on as known side effects. The fre­quen­cy of the­se side effects, for
    inclu­si­on in the EU pro­duct infor­ma­ti­on, could not yet be estimated.
    Anaphylaxis con­ti­nues to be clo­se­ly monitored.
    Information on the cli­ni­cal manage­ment of ana­phy­la­xis is alrea­dy available
    in the pro­duct infor­ma­ti­on and does not requi­re updating.
    1 The European Centre for Disease Prevention and Control (ECDC) collects the­se data
    from EU Member States as well as from the addi­tio­nal coun­tries of the European
    Economic Area (EEA) Norway, Iceland and Liechtenstein.
    2 Summary Monthly Safety Reports will be com­pi­led by the mar­ke­ting authorisation
    hol­ders for COVID-19 vac­ci­nes to sup­port time­ly and con­ti­nuous bene­fit-risk evaluations.
    These reports com­ple­ment the sub­mis­si­on of Periodic Safety Update Reports (PSURs).
    3 See Meeting Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
    8–11 March 2021.
    Page 3
    COVID-19 vac­ci­ne safe­ty update
    VAXZEVRIA
    http://www.ema.europa.eu
    Page 3/6
    Embolic and throm­bo­tic events
    Cases of embo­lic and throm­bo­tic events (for­ma­ti­on of blood clots in the
    blood ves­sels) have been repor­ted for Vaxzevria from its use in
    vac­ci­na­ti­on campaigns.
    Following dis­cus­sions during and after its mee­ting held 8 to 11 March
    2021, on 18 March 2021 PRAC con­duc­ted a preli­mi­na­ry assessment -
    invol­ving experts in blood dis­or­ders – of the avail­ab­le evi­dence from case
    reports in EudraVigilance (see sec­tion 3), qua­li­ty, cli­ni­cal, pre-cli­ni­cal and
    sci­en­ti­fic lite­ra­tu­re data, and data from the mar­ke­ting authorisation
    hol­der. PRAC con­clu­ded the following:
    There was no evi­dence of a pro­blem with manu­fac­tu­ring or pro­duct quality
    rela­ted to the vac­ci­ne bat­ches spe­ci­fied in the case reports. This was
    based on a qua­li­ty assess­ment car­ri­ed out wit­hin the EU regulatory
    net­work. This inclu­ded the infor­ma­ti­on from the offi­cial medi­ci­nes control
    labo­ra­to­ry release cer­ti­fi­ca­tes. These com­pri­se inde­pen­dent tes­ting and
    che­cking of the manufacturer’s key test results befo­re release of any
    batch of COVID-19 vac­ci­nes to the EU/EEA market.
    Overall, the num­ber of cases of embo­lic and throm­bo­tic events after
    vac­ci­na­ti­on repor­ted to EudraVigilance (see sec­tion 3) in rela­ti­on to the
    num­ber of peop­le vac­ci­na­ted was lower than the rate of such events in the
    gene­ral population.
    However, Vaxzevria could pos­si­b­ly be asso­cia­ted with very rare cases of
    spe­ci­fic embo­lic and throm­bo­tic events in com­bi­na­ti­on with low levels of
    blood plate­lets (throm­bocy­to­pe­nia) and rela­ted blee­ding. These events
    inclu­de dis­se­mi­na­ted intra­vascu­lar coagu­la­ti­on (DIC) (whe­re blood clots
    occur in mul­ti­ple blood ves­sels) and cere­bral venous sinus
    throm­bo­sis (CVST) (whe­re blood clots in the brain's venous sinuses
    pre­vent blood from drai­ning out of the brain).
    In the repor­ted cases, inclu­ding some that resul­ted in death, the­se events
    occur­red wit­hin 14 days after vac­ci­na­ti­on. They occur­red most­ly in people
    under 55 years of age, the majo­ri­ty of whom were women. However,
    the­se pati­ent cha­rac­te­ris­tics could reflect the hig­her pro­por­ti­on of such
    indi­vi­du­als offe­red Vaxzevria in vac­ci­na­ti­on cam­pai­gns. As part of the
    preli­mi­na­ry assess­ment, the num­ber of cases repor­ted were com­pa­red to
    rates for the­se events app­li­ca­ble to the gene­ral EU popu­la­ti­on befo­re the
    SARS-Cov‑2 pan­de­mic. This com­pa­ri­son show­ed incre­a­sed num­bers in
    vac­ci­na­ted peop­le. Such imba­lan­ces in num­bers of cases bet­ween the
    gene­ral and vac­ci­na­ted popu­la­ti­ons were not visi­ble for the older age
    groups.
    A cau­sal link of DIC and CVST with the vac­ci­ne is not pro­ven but cannot
    be exclu­ded and requi­res fur­ther investigation.
    People vac­ci­na­ted with Vaxzevria should seek immedia­te medi­cal attention
    if sym­ptoms of blood clot­ting occur and inform health­ca­re pro­fes­sio­nals of
    their recent vac­ci­na­ti­on. Such sym­ptoms inclu­de short­ness of breath,
    chest or per­sis­tent abdo­mi­nal pain, leg swel­ling, seve­re or persistent
    Page 4
    COVID-19 vac­ci­ne safe­ty update
    VAXZEVRIA
    http://www.ema.europa.eu
    Page 4/6
    hea­da­che, blur­red visi­on, per­sis­tent blee­ding, and skin brui­sing or round,
    pin­point spots bey­ond the site of vac­ci­na­ti­on appearing after a few days.
    The pro­duct infor­ma­ti­on for Vaxzevria has been updated with this
    warning, and a direct health­ca­re pro­fes­sio­nal com­mu­ni­ca­ti­on (DHPC) has
    been sent out to rai­se awa­reness among health­ca­re professionals4.
    Based on all avail­ab­le data on embo­lic and throm­bo­tic events, PRAC
    con­si­de­red that the bene­fits of Vaxzevria in pre­ven­ting COVID-19 and
    rela­ted death con­ti­nue to out­weigh the risks, and that this vac­ci­ne can be
    used while fur­ther data collec­tion and assess­ment are ongoing5.
    Immune throm­bocy­to­pe­nia (ITP)
    For all COVID-19 vac­ci­nes used in the EU, a spe­ci­fic PRAC assess­ment of
    immu­ne throm­bocy­to­pe­nia (ITP, low blood plate­let levels that can lead to
    brui­sing and blee­ding) as a suspec­ted side effect has been initia­ted. At
    this sta­ge of the assess­ment, a cau­sal asso­cia­ti­on of ITP with any COVID-
    19 vac­ci­ne has not been established6.

  8. An der Namensänderung kann man unschwer erken­nen, für wie blöd "die" uns hal­ten. So, ich gehe jetzt hin­aus zu mei­nem VW und kle­be eine Porsche-Plakette drü­ber. Meine Nachbarn wer­den staunen.

  9. Aus AstraZeneca wird nun Vaxzevria! Ist das jetzt der Höhepunkt der Leute-Verarschung, nein, nein; EU hat ein­ge­kauft und will nun mit EMA-Beschönigung die­sen Ramsch los wer­den. Ganz sicher wird die­se Verarschung wei­ter gehen. Solange man die freie Wahl des Vakzins dem Probanden ver­wei­gert, soll­te man sich nicht imp­fen las­sen. Es ist ZU VIEL VERTRAUEN zer­stört worden.

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