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?

24 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​.lak​e​me​dels​ver​ket​.se/​s​v​/​n​y​h​e​t​e​r​/​a​s​t​r​a​-​z​e​n​e​c​a​s​-​v​a​c​c​i​n​-​b​y​t​e​r​-​n​a​m​n​-​t​i​l​l​-​v​a​x​z​e​v​ria

    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​.aerz​te​blatt​.de/​n​a​c​h​r​i​c​h​t​e​n​/​1​2​2​5​6​0​/​S​T​I​K​O​-​e​m​p​f​i​e​h​l​t​-​A​s​t​r​a​z​e​n​e​c​a​-​I​m​p​f​s​t​o​f​f​-​n​u​r​-​n​o​c​h​-​f​u​e​r​-​P​e​r​s​o​n​e​n​-​i​m​-​A​l​t​e​r​-​a​b​-​6​0​-​J​a​h​ren

    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​.aerz​te​blatt​.de/​a​r​c​h​i​v​/​1​9​8​9​3​5​/​A​r​z​t​-​u​n​d​-​E​t​h​o​s​-​A​u​f​k​l​a​e​r​u​n​g​-​u​n​d​-​i​n​f​o​r​m​e​d​-​c​o​n​s​ent

  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​.euro​pa​.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​.euro​pa​.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​.euro​pa​.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​.euro​pa​.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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