fact finder
As of today, AstraZeneca’s corona vaccine is no longer approved in the EU. Concerns about safety are cited as a reason on social media. In fact, it’s about commercial interests.
The headline currently circulating on Platform X (formerly Twitter) is the corona vaccine from the British-Swedish manufacturer AstraZeneca had been stopped. One user writes: “First you couldn’t force the experimental stuff on millions of people fast enough and now this.” Another user posted: “It’s not as if you didn’t suspect that you should stay far away from #AstraZeneca.” But what are the backgrounds?
Approval for AstraZeneca vaccine withdrawn
In fact, the EU Commission revoked the approval for AstraZeneca’s Vaxzevria vaccine on March 27th. This has been known since April 3rd. According to the commission decision The withdrawal of approval will come into force on May 7th. In the European Union, the EU Commission is the central authority for approvals or the revocation of approvals for medicines – and therefore also for vaccines. Such a Commission decision will then apply across Europe. The EU Commission in turn receives recommendations from the European Medicines Agency (EMA).
Contrary to what is suggested on social media, safety concerns about the vaccine are not a reason for the step. As a spokeswoman for the commission responded to a request from ARD fact finder announced that the step was taken at the initiative of the AstraZeneca company. The EU Commission therefore had no doubts about the safety or effectiveness of the vaccine.
To put this into perspective, the EU Commission said that it was not unusual for “companies to request the withdrawal of marketing authorization for drugs or vaccines for commercial reasons”. This could – the Commission continues – be the case, for example, if the product is no longer in demand in the EU.
AstraZeneca applied for withdrawal of marketing authorization
AstraZeneca itself confirmed at the request of the ARD fact finderthat the company has applied for the authorization to be revoked. AstraZeneca cited the fact that “several variants of COVID-19 vaccines have now been developed” and that there are “a number of updated vaccines available.” This led to a decline in demand for the vaccine, which was then no longer produced or distributed.
When asked, the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Drugs, said that the Vaxzevria vaccine has no longer been used in Germany since December 1, 2021. In its response, the institute did not establish a direct connection with the known vaccination side effects of Vaxzevria.
Possible negative effects such as the so-called thrombosis with thrombocytopenia syndrome – also known as TTS in the product information of the preparation is noted, the institute writes in an answer to the request ARD fact finder. From the beginning of the pandemic, there have been “periodic safety reports on the safety of COVID-19 vaccines and It also repeatedly reports on the TTS, for example“.
Like the Paul Ehrlich Institute dem WDR announced a few months ago, the reporting rate of “suspected cases of serious side effects” in Germany remains 0.29 per 1,000 vaccinations. That means: after about every 3,450. Such a suspected case occurs after vaccination.
Side effects have been known since 2021
When exactly AstraZeneca announced which side effects of the vaccine was recently debated. Media reports in Great Britain and Germany over the weekend headlined that AstraZeneca had admitted for the first time in court documents relating to a case in Great Britain “that its Covid vaccine is said to have caused rare side effects.” The British newspaper “The Telegraph” first reported on the Jamie Scott case.
At the request of ARD fact finder AstraZeneca contradicted this representation. The company said: “Recent media reports regarding safety are not new and do not reflect the facts.” The product information on the AstraZeneca-Oxford vaccine had already been updated in April 2021 with the approval of the British regulatory authority MHRA and also took into account the possibility that the vaccine could trigger TTS in very rare cases, the company wrote in a response. The update was therefore well documented and publicly available.
AstraZeneca’s communication criticized
The British High Court referred at the request of ARD fact finder on the ongoing procedure and has not yet provided any information about which suspected new side effects the British newspaper’s report refers to. In court documents related to the Scott case, the ARD fact finder available, it is said – as in the aforementioned statement from AstraZeneca – that in “very rare cases” the vaccine can trigger TTS. TTS can also occur without a vaccination. It is unclear whether the documents are the ones referred to by The Telegraph.
Law firm Leigh Day, which is representing British plaintiff Jamie Scott in court, said in a response to ARD fact finder, in the manufacturer’s product information in Great Britain there was initially “no clear indication” of the possibility that the vaccine could cause TTS – only a “possible connection” was referred to. At the beginning of the proceedings, AstraZeneca also denied the causal connection. However, AstraZeneca has now revised this.