LONDON (AP) — AstraZeneca, the pharmaceutical giant, has formally requested the European Medicines Agency (EMA) to withdraw the authorization for its COVID-19 vaccine, Vaxzevria, in Europe.
The EMA confirmed this development in an update on its website on Wednesday.
The approval for AstraZeneca's vaccine was initially granted by the EMA in January 2021. However, concerns arose shortly thereafter regarding its safety. Several countries suspended the use of the vaccine when rare but unusual cases of blood clots were reported in a small number of vaccinated individuals. Despite the EMA's conclusion that the overall risk of blood clots was not increased by the vaccine, doubts about its safety persisted.
One of the issues that clouded the perception of AstraZeneca's vaccine was a manufacturing error in the initial trial data, which was used by the UK to authorize the vaccine. Additionally, there was insufficient data initially regarding the vaccine's effectiveness in older populations, leading some countries to limit its use to younger age groups before eventually expanding access.
Although billions of doses of the AstraZeneca vaccine were distributed to low-income countries through a U.N.-led program due to its affordability and ease of distribution, studies later indicated that the mRNA vaccines from Pfizer-BioNTech and Moderna provided better protection against COVID-19 and its variants. Consequently, most countries transitioned to these vaccines.
In the UK, AstraZeneca's vaccine was a cornerstone of the national immunization program in 2021, largely developed by Oxford University scientists with substantial government funding. However, even the UK has since opted for mRNA vaccines for booster shots, and the use of AstraZeneca's vaccine has dwindled globally.
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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP bears sole responsibility for the content.