Add latest EMA safety update about AstraZeneca

ljl-covid · Jul 30, 2021 · cd1f3f6 · cd1f3f6
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 * After 10 March 2021, several European countries suspended administration of the AstraZeneca COVID-19 vaccine, following some unusual blood clotting events. Statements in English are available from the [Norwegian Medicines Agency](https://legemiddelverket.no/nyheter/norwegian-medicines-agency-notified-of-blood-clots-and-bleeding-in-younger-people-after-vaccination-with-astrazeneca-vaccine) and the German [Paul Ehrlich Institute](https://www.pei.de/EN/newsroom/hp-news/2021/210315-pei-informs-temporary-suspension-vaccination-astra-zeneca.html). Later on 15 March, [Germany suspends use of AstraZeneca vaccine, along with Italy, France, Spain](https://www.dw.com/en/germany-suspends-use-of-astrazeneca-vaccine-along-with-italy-france-spain/a-56878920) despite the Italian Medicines Agency having stated the previous day [Unjustified alarm on safety of AstraZeneca vaccine](https://www.aifa.gov.it/en/web/guest/-/aifa-ingiustificato-allarme-sulla-sicurezza-del-vaccino-astrazeneca). In April 2021, the EMA announces [AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets](https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood) and calls for this issue to be listed as a very rare side effects, but still recommends the vaccine for all adults; however, [the UK regulator recommends against using the vaccine in people below 30, and further European countries (Italy, Spain, Belgium) limit it to older ages](https://www.politico.eu/article/comms-crisis-regulators-fail-to-assuage-concerns-over-oxford-astrazeneca-vaccine/)
 * [AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis](https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html) in an AstraZeneca press release announcing the US trial found overall 79% efficacy including in 65+ people (who constituted 20% of the trial subjects, and 60% of them had comorbidities), and 100% efficacy in preventing severe disease and hospitalization; AstraZeneca also points out that the specifically monitored for thrombosis in general and [cerebral venous sinus thrombosis](https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombosis) (due to the events in Europe) and found no signs of it; however, this press release was [criticized the following night, in an unusual move](https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine), by the [DSMB](https://en.wikipedia.org/wiki/Data_monitoring_committee), which was quickly picked up by the NIIAD and NIH as well as [Anthony Fauci commenting on it](https://www.statnews.com/2021/03/23/astrazeneca-may-have-used-outdated-information-in-announcing-covid19-vaccine-results/); the Washington Post, which has obtained a letter from the DSMB to AstraZeneca, states that [AstraZeneca used ‘outdated and potentially misleading data’ that overstated the effectiveness of its vaccine, independent panel says](https://www.washingtonpost.com/world/astrazeneca-oxford-vaccine-concerns/2021/03/23/2f931d34-8bc3-11eb-a33e-da28941cb9ac_story.html), the criticism mainly being around the fact that the data appeared cherry-picked to claim a higher efficacy than the 69% to 75% inferred when all data are included, and the DSMB having discussed this with AstraZeneca prior to their press release
 * [Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination](https://www.nejm.org/doi/full/10.1056/NEJMoa2104840) is a study published on the NEJM on 28 patients in Germany and Austria, after the German Society for Thrombosis and Hemostasis Research (GTH) issued a [statement on vaccination with the AstraZeneca COVID-19 vaccine](https://gth-online.org/wp-content/uploads/2021/03/GTH-Statement-AstraZeneca_englisch_3-29-2021.pdf) which describes their findings that a [HIT](https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopenia)-like reaction has occurred in examined patients who suffered or died from sinus or cerebral vein thrombosis after being administered the AstraZeneca AZD11222 vaccine in Germany; [Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination](https://www.nejm.org/doi/full/10.1056/NEJMoa2104882) reports analogous findings in 5 patients in Norway, and [Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination](https://www.nejm.org/doi/full/10.1056/NEJMoa2105385) reports on 23 patients in the United Kingdom, with 30% older than 50 and 61% female, of which 7 died
+* [14 July 2021 COVID-19 vaccine safety update VAXZEVRIA](https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-update-vaxzevria-previously-covid-19-vaccine-astrazeneca-14-july-2021_en.pdf) informs that the EMA is currently investigating adverse reactions related to [Guillain-Barré syndrome](https://en.wikipedia.org/wiki/Guillain%E2%80%93Barr%C3%A9_syndrome), Acute Macular [Retinopathy](https://en.wikipedia.org/wiki/Retinopathy), [Myocarditis](https://en.wikipedia.org/wiki/Myocarditis) and [Pericarditis](https://en.wikipedia.org/wiki/Pericarditis) (also observed with Pfizer/BNT), and two conditions involving [Thrombocytopenia](https://en.wikipedia.org/wiki/Thrombocytopenia), for which the vaccine had already been suspended, in whole or for certain age groups, in various parts of the EU
 
 #### Johnson&Johnson-Janssen (aka Ad26.COV2.S, JNJ-78436735, Ad26COVS1, VAC31518)