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…«
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?
Die Ema hats wiedwr zugelassen. Wer hätte auch was anderes Erwartet
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.youtube.com/watch?v=kQWJZTqflUA
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.
@mentions
"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.
@mentions
"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.
@mentions
“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.
@mentions
“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.
@mentions
"We're also launching additional investigations to understand more about these rare cases, and we're conducting targeted observational studies”, says Cooke.
@mentions
"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.
@mentions
"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."
@mentions
“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).
@mentions
“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."
@mentions
“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.
@mentions
“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…"
@mentions
“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."
• • •
https://threadreaderapp.com/thread/1372579807213596676?refresh=1616085650
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.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots
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:
breathlessness,
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.
"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.
EMA: Skrupellose Mörderbande. Wozu gibts den Laden überhaupt, wenn er seiner Aufgabe nicht nachkommt. Dann kann man den auch gleich einstampfen und alles freigeben.
@Ulla
Ich muss mich leider selbst zitieren:
Alles verimpfen, was bei Plusgraden einen flüssigen Aggegratzustand aufweist!
Alles andere wäre verantwortungslos!
Ja
Lobbyismus ist was tolles 🙁
https://www.welt.de/wissenschaft/article228658633/Corona-Pandemie-EMA-haelt-AstraZeneca-Vakzin-fuer-sicher-und-empfiehlt-Verimpfung.html
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 …
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.
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.
Quelle:
Kekulés Corona-Kompass #160: Warum der Stopp von Astrazeneca richtig ist | MDR https://www.youtube.com/watch?v=FS7poDdQW34
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"
https://youtu.be/jgBtgRhVbPE
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) ?
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.