Health Corona vaccine “Vaxzevria”
This is behind the end of approval for the AstraZeneca vaccine
Status: 08.05.2024 | Reading time: 4 minutes
Source: dpa/Robert Michael
The “Vaxzevria” vaccine against Covid-19 is no longer used in this country; the manufacturer AstraZeneca has now ended its approval in the EU. Questions and answers about the decision and the reasons.
At the request of the Swedish-British pharmaceutical company AstraZeneca, the corona vaccine “Vaxzevria” is no longer approved in the EU. The group cites “commercial reasons”. But since then there has been speculation on social networks about possible other causes – even though the EU Commission has long since said that “the decision is not based on doubts about the safety or effectiveness of the vaccine“. Many people may not realize that such a move is far from mysterious, as one trade association explains.
Is a revocation of approval unusual?
No. The figures for Germany alone show this: “Every year the approval of 5 to 10 original drugs is typically withdrawn, almost always for commercial reasons,” said Rolf Hömke, research spokesman for the Association of Research-Based Drug Manufacturers (vfa), in Berlin. “For comparison: On average, almost 36 medications with new active ingredients are introduced in Germany every year.”
The background is often that there are now even better medications to treat the disease in question and the old ones are therefore hardly used anymore and are dispensable.
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Regarding “Vaxzevria”, AstraZeneca explained that there was now a surplus of available updated vaccines, i.e. those adapted to new variants. “This has resulted in a decline in demand for ‘Vaxzervria,’ which is no longer manufactured or supplied.”
Have there been such cases with corona vaccines so far?
Yes. It was only in March that the European Medicines Agency (EMA) terminated the approval for the corona vaccine “VidPrevtyn Beta” at the request of the manufacturer Sanofi Pasteur, and in October that for the corona vaccine “Valneva” from the company Valneva Austria. In both cases, commercial reasons were also given. mRNA vaccines adapted to newly emerged corona variants are now mainly used for booster vaccinations to protect against severe Covid-19 courses.
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There are also examples of approval being withdrawn for vaccines against other diseases, said Hömke. For example, the approval for the “Fluenz” vaccine against seasonal flu (2011-2014) was withdrawn when the successor product “Fluenz4” was introduced, which could protect against more flu virus strains.
Why don’t companies just stop production?
“We cannot say how companies weigh up in individual cases between an application for the withdrawal of approval or an ‘out of sales’ position,” explained Hömke. However, one consideration is certainly that companies have to pay an annual fee to maintain approval from the medicines authority EMA. “Another is that a manufacturer must continually create and submit periodic safety update reports to the EMA for all of its approved products – even if it does not market a product at all.” This ties up time and resources.
What kind of vaccine is “Vaxzevria”?
“Vaxzevria” is a so-called vector vaccine based on a virus into which the gene that creates the spike protein of the novel coronavirus has been introduced. This caused vaccinated people to produce spike proteins that triggered an immune response. The vaccine received its first emergency approval in Great Britain at the end of December 2020. At the end of January 2021, approval – initially conditional – was granted in the European Union.
What side effects are known?
The approval studies showed normal reactions for vaccinations such as pain at the injection site, fatigue and general malaise as well as headaches and, in rare cases, other possible complications. Thrombosis with thrombocytopenia syndrome (TTS) was observed as a very rare serious side effect during mass vaccinations, usually two to three weeks after vaccination. Blood clots occur in combination with thrombocytopenia – a lack of blood platelets. In some cases, cerebral vein thrombosis occurred.
How was the connection between vaccination and increased risk of thrombosis reacted?
In spring 2021, “Vaxzevria” vaccinations were temporarily suspended in some European countries, including Germany, following reports of cerebral vein thrombosis. According to the Paul Ehrlich Institute (PEI), out of around 8.5 million vaccine doses administered by May 25, 2021, a total of 94 cases of TTS were reported in Germany and 17 people died. Two thirds of those affected were younger than 60.
The Medicines Agency EMA, among others, took a close look at the cases. Result: The benefits of the vaccination clearly outweigh the risk of extremely rare potential side effects. There was an unqualified recommendation from the EMA until the approval was revoked by decision of March 27, 2024.
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In Germany, the Standing Vaccination Commission (Stiko) recommended vaccination only for people over 60 years of age from the end of March 2021. Unlike mRNA vaccines adapted to variants, the vaccine has not been used in this country for a long time.
Have there been any lawsuits against AstraZeneca in Germany?
Yes. In April, for example, a woman from Upper Franconia achieved partial success against the manufacturer in a trial over suspected corona vaccination damage. AstraZeneca was ordered to provide comprehensive information about the side effects of “Vaxzevria”. This information has not yet been received, said the plaintiff’s lawyer, Volker Loeschner. The plaintiff’s compensation and pain and suffering proceedings are continuing. Similar lawsuits have been filed elsewhere.