At request of AstraZeneca, Europe withdraws marketing authorization of COVID vaccine Vaxzevria

Once hailed as a landmark accomplishment for the speed with which it was developed and a shining example of British innovation, the AstraZeneca coronavirus vaccine has been grounded by the European Medicines Agency (EMA).

On Tuesday, the EMA said it had accepted a request from AZ and withdrawn (PDF) the company’s marketing authorization for its COVID-19 shot Vaxzevria.

The vaccine, which was co-developed by Oxford University, was the world’s third most-used COVID shot, with more than 3 billion doses supplied. The company reported sales of $4 billion from the shot in 2021 and $1.8 billion in 2022.

“As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company said in an emailed statement. “This has led to a decline in demand for Vaxzervria, which is no longer being manufactured or supplied.” 

AZ submitted its withdrawal request to the EMA after admitting in court documents that its vaccine “can, in very rare cases, cause TTS (thrombosis with thrombocytopenia syndrome),” according to The Telegraph.

The dangerous side effect can cause blood clots which can be fatal. According to the U.K.’s healthcare watchdog the Medicines and Healthcare products Regulatory Agency (MHRA), there have been 445 confirmed cases of vaccine-induced immune thrombocytopenia and thrombosis (VISS), with 81 deaths.

In its court admission, AZ was careful not to refer to cases as “vaccine-inducted,” said The Telegraph, which added that more than 50 legal cases have been filed against the company and compiled in a class action lawsuit.

While saying that it does not comment on ongoing litigation, the company added that more than 30 civil proceedings have been “withdrawn, abandoned or have resulted in favorable judgments” for the company.

In December of 2020, just nine months after the World Health Organization declared the coronavirus pandemic, the U.K. authorized use of AZ’s COVID shot on an emergency basis. But soon afterward, as scattered cases of blood clots emerged, many countries restricted use of the shot to younger people or suspended it altogether.  

Because of manufacturing and data submission issues, the FDA never approved Vaxzevria and in November 2022, the company abandoned its efforts to gain approval of the shot in the U.S.

The vaccine was the preferred shot in many of the world’s poorer nations because it was cheaper to manufacture and to distribute as it didn’t have the cold-storage requirements of mRNA shots produced by Pfizer and Moderna.

“We are incredibly proud of the role Vaxzevria played in ending the global pandemic," AZ said on Wednesday. "According to independent estimates, over 6.5 million lives were saved in the first year of use alone. We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the COVID-19 pandemic.”