Let me give you a brief background story: It was around Easter 2021, a good year after the outbreak of the pandemic, when I was able to secure a dose of vaccine with an out-of-order mouse click. At that time, a few thousand doses of the AstraZeneca vaccine surprisingly became available in Hamburg, and the city gave everyone over 60 the chance to get their first shot. I will not forget the relieved mood in the vaccination center that was set up in one of the exhibition halls. We were finally able to do something against the virus that had brought not only Hamburg to a standstill, but almost the entire world. Not to mention the terrible images that came from the intensive care units everywhere. So put it in the upper arm!
According to plan, a second dose was to follow weeks later to stabilize the immune response. But that didn’t happen for me: at the beginning of July, the way was clear for the new mRNA vaccines, which had outstanding results in studies, even for everyone who had previously been vaccinated with Vaxzevria. Because – and this insight has not changed to this day – if you mix the corona vaccines, it seems to strengthen rather than weaken protection against severe Covid-19 disease. And now we Astra-vaccinated people are reading that the approval of our vaccine for the EU has been withdrawn. Do we have to be afraid? Are we still in danger?
“Medicinal product no longer authorized” is now written diagonally above the summary description of Vaxzevria and all other documents on this corona vaccine, which were put online by the European Medicine Agency (EMA) under the reference number EMA/609262/2021. In the German version Version still lacks a reference to the withdrawal of approval, but that is of no importance as the vaccine has not been used in our country since the end of 2021.
With 14.4 million of a total of 224 million doses delivered by the official end of the pandemic last spring, the AstraZeneca vaccine played only a minor role here anyway. Although there were indications of rare side effects, such as cerebral vein thrombosis, shortly after the emergency approval, the EMA concluded after examining it that the benefits far outweighed such risks (around two to eight cases per million doses of Vaxzevria vaccine).
After emergency approval in Great Britain in December 2020, exactly one year after the first Covid-19 cases became known in Wuhan, China, the vaccine was authorized in over 170 countries around the world. However, on March 27th of this year, approval for the European Union was withdrawn and came into force on May 7th by decision of the EU Commission.
Please note: This is a withdrawal of a marketing authorization – not a new safety or effectiveness classification. The authorization, which was valid until the end of October 2027 and could then have been renewed for another five years, would have simply continued if AstraZeneca itself had not backed out now.
There is speculation that this is related to an upcoming court case pending in the UK. A then 44-year-old Englishman was given the AstraZeneca vaccine in April 2021. Ten days later he suffered, among other things, cerebral hemorrhages and a blood clot. What followed was a month-long coma and a severe impairment of his entire life to this day with many rehabilitation measures. He and his wife apparently do not want to be satisfied with the state compensation of the equivalent of almost 140,000 euros.
But was it really the vaccine that caused the severe disability? And should there have been more warnings about possible side effects? This will soon have to be decided in court, and the verdict could cost the company millions. On closer inspection, however, it is unlikely that this process and possibly subsequent ones would have led to an application for an end to market approval.
Possible side effects such as the rare cerebral vein thrombosis mentioned have been known since 2021, and neither the EU nor the manufacturer has changed the assessment of the safety of Vaxzevria since then. What has changed dramatically, however, is the importance of Vaxzevria: The vaccine is no longer even produced and loses potential effectiveness with each new variant of the corona virus.
In India, where Vaxzevria was manufactured under license by the Serum Institute of India under the name “Covishield” and was initially very important, protection against Covid-19 dropped significantly with the emergence of the omicron variants. At around 70 percent, it was still considerable, but was around 20 percent below the products of competitors such as Biontech/Pfizer or Moderna. Since their vaccines are based on a different principle than that of AstraZeneca, they can be more easily adapted to new developments in the corona virus.
For example, the EMA emergency task force has just recommended new booster vaccines for next fall, this time targeting the JN.1 virus variant. It also belongs to the now unmanageably large family of omicron subvariants. AstraZeneca, like all market authorization holders, would have been required to adapt its vaccine to JN.1. But why bother if it’s no longer being produced anyway?
No matter, you might think. The approval will expire at some point. But of course the EMA requires payment for approvals and even any contact with this authority relating to one of the medical products. As of March 14, these fees have just increased. In 1995, for example, the “placing on the market with complete documentation” for a human medicine was calculated at 286,900 euros, but this has now increased to 357,600. All other amounts have also been revised upwards.
And that’s not all. The fees only relate to a specific dosage and dosage form. If anything is changed, additional payments will be made to the EMA. And of course there are annual fees, inspection fees, renewal or transfer fees. In other words: Which reasonably cost-conscious management should be prepared to make such payments for a product that is no longer being produced and whose production will no longer be started?
So it is almost certainly business considerations like these that motivated AstraZeneca to take this step. Further withdrawals of market approvals have already been announced, including in Great Britain and ultimately worldwide. Vaccinated people don’t have to worry if they have been injected with Vaxzevria. Our organism has “forgotten” this vaccine for a long time – but hopefully not also the immune protection against Covid-19, to which Vaxzevria once contributed.
