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COVID-19 vaccine Vaxzevria no longer authorized in the EU

Kasper Schantz by Kasper Schantz
August 1, 2024
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As of today, AstraZeneca’s COVID-19 vaccine Vaxzevria is no longer authorized in the EU. Social media attributes this to safety concerns, but the reality is more about commercial interests.

COVID-19 vaccine Vaxzevria no longer authorized in the EU
COVID-19 vaccine Vaxzevria

On the platform X (formerly Twitter), headlines claim the British-Swedish manufacturer AstraZeneca’s COVID-19 vaccine has been halted. One user wrote, “First, they couldn’t force the experimental stuff on people fast enough, and now this.” Another user posted, “It’s not like we didn’t see it coming, that we should keep a big distance from #AstraZeneca.” But what are the real reasons?

Authorization for AstraZeneca vaccine withdrawn

In fact, the European Commission revoked the authorization for AstraZeneca’s Vaxzevria on March 27, with the decision made public on April 3. According to the commission’s decision, the revocation took effect on May 7. In the EU, the European Commission is the central body for authorizing or revoking authorizations for medications, including vaccines. Such a commission decision is valid across Europe. The commission receives recommendations from the European Medicines Agency (EMA).

Contrary to social media suggestions, safety concerns were not the reason for this step. A commission spokesperson told ARD-faktenfinder that the step was initiated by AstraZeneca. The commission had no doubts about the vaccine’s safety or efficacy.

The commission clarified that it’s not unusual for companies to request the withdrawal of marketing authorizations for medicines or vaccines for commercial reasons. This might happen, for instance, if the product is no longer in demand in the EU.

AstraZeneca requested marketing authorization withdrawal

AstraZeneca confirmed to ARD-faktenfinder that the company requested the revocation. The reason given was that multiple variants of COVID-19 vaccines have been developed, and many updated vaccines are now available. This led to a decline in demand for Vaxzevria, which is no longer manufactured or distributed.

The Paul-Ehrlich-Institut, Germany’s federal institute for vaccines and biomedical drugs, noted that Vaxzevria has not been used in Germany since December 1, 2021. The institute did not link this decision directly to known vaccine side effects.

Potential negative effects, such as the Thrombosis with Thrombocytopenia Syndrome (TTS), are noted in the product information, the institute said in response to ARD-faktenfinder. The institute has periodically reported on COVID-19 vaccine safety, including TTS, from the pandemic’s start.

According to the Paul-Ehrlich-Institut, as of a few months ago, the reporting rate for “suspected severe side effects” in Germany remained at 0.29 per 1,000 vaccinations. This means there is a suspected case of severe side effects approximately every 3,450 vaccinations.

Side effects known since 2021

When AstraZeneca disclosed the vaccine’s side effects has been debated. Media reports in the UK and Germany recently suggested AstraZeneca admitted in court documents that its vaccine could cause rare side effects. The British newspaper “The Telegraph” first reported this in the case of Jamie Scott.

AstraZeneca disputed this portrayal to ARD-faktenfinder, stating, “The recent media reports about safety are not new and do not reflect the facts.” The company said product information for the AstraZeneca-Oxford vaccine had been updated with approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2021 to include the possibility of TTS. This update was well-documented and publicly available.

AstraZeneca’s communication criticized

The British High Court referred ARD-faktenfinder to the ongoing proceedings and did not comment on the potentially new side effects mentioned by “The Telegraph.” Court documents in the Scott case, reviewed by ARD-faktenfinder, state that “in very rare cases,” the vaccine could trigger TTS, which can also occur without vaccination. Whether these documents are the ones referenced by “The Telegraph” is unclear.

The law firm Leigh Day, representing Jamie Scott, told ARD-faktenfinder that initially, AstraZeneca’s product information in the UK did not clearly indicate the possibility of TTS, only a “possible connection.” At the start of the proceedings, AstraZeneca also denied the causal link, but has since revised its position.

Tags: AstraZenecaCOVID-19 vaccineVaxzevria

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