AstraZeneca withdraws Covid vaccine, after admitting rare side effect

The Oxford-AstraZeneca Covid vaccine is being withdrawn worldwide, months after the pharmaceutical giant first admitted in court papers that it could cause a rare and dangerous side effect.

The vaccine can no longer be used in the European Union after the company voluntarily withdrew its marketing authorization. The request to withdraw the vaccine was filed on March 5 and came into effect on Tuesday.

Similar applications will be filed in the coming months in the United Kingdom and other countries that have approved the vaccine, known as Vaxzevria.

The decision to withdraw it ends the use of the vaccine, which was described by Boris Johnson as a triumph of British science and credited with saving more than six million lives.

AstraZeneca said the vaccine was being withdrawn from the market for commercial reasons. He said the vaccine was no longer being manufactured or supplied, having been replaced by updated vaccines that combat new variants.

Vaxzevria has come under scrutiny in recent months because of a very rare side effect, which causes blood clots and low platelet counts. AstraZeneca admitted in court papers filed with the High Court in February that the vaccine could, in very rare cases, cause TTS.

TTS, which stands for Thrombosis with Thrombocytopenia Syndrome, has been linked to at least 81 deaths in the UK as well as hundreds of serious injuries. AstraZeneca is being sued by more than 50 alleged victims and grieving relatives in the High Court.

But AstraZeneca insisted the decision to withdraw the vaccine is not linked to the trial or the admission that it can cause TTS. He said the timing was pure coincidence.

In a statement, the company said: “We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates, more than 6.5 million lives were saved in the first year of use alone and more than three billion doses were supplied worldwide.

Our efforts have been recognized by governments around the world and are widely seen as a critical part of ending the global pandemic.

While multiple variants of Covid-19 vaccines have since been developed, there is a surplus of updated vaccines available. This led to a drop in demand for Vaxzevria, which is no longer manufactured or supplied. AstraZeneca has therefore taken the decision to initiate the withdrawal of the marketing authorizations for Vaxzevria in Europe.

We will now work with regulators and our partners to align on a clear path to conclude this chapter and contribute meaningfully to the Covid-19 pandemic.

The Telegraph has learned that the company will withdraw marketing authorizations in other countries, including the UK, where it has regulatory approval. AstraZeneca never obtained authorization to use the vaccine in the United States.

The company said: We will work with regulatory authorities around the world to initiate marketing authorization withdrawals of Vaxzevria, for which no future commercial application for the vaccine is expected.

The government largely stopped using the Oxford-AstraZeneca vaccine in autumn 2021, by which time it had supplied around 50 million doses to the UK. It was replaced in the UK by the Pfizer and Moderna vaccines in time for the winter booster campaign at the end of 2021.

Marco Cavaleri, head of vaccines at the European Medicines Agency, the body responsible for medicine safety in the EU, told Italian media: The authorization of the anti-Covid vaccine Vaxzevria by AstraZeneca will be withdrawn and the process has already been officially started with the European Commission. This is consistent with expectations that vaccines that are no longer in use and are updated will be withdrawn, as we indicate.

Mr Cavaleri said he expected all monovalent vaccines that dealt only with the original Wuhan strain to be withdrawn in time.

AstraZeneca accepted that the vaccine could cause TTS in a legal document in February this year. The causal mechanism is not known.

Lawyers for the claimants in the High Court case argue that the drug caused vaccine-induced immune thrombocytopenia and thrombosis (VITT), a subset of TTS, and was not as safe as what individuals had the right to expect. AstraZeneca has always emphasized that patient safety is our top priority.

The company said: Based on the totality of evidence from clinical trials and real-world data, the AstraZeneca-Oxford vaccine has been continually shown to have an acceptable safety profile and regulators around the world consistently state that The benefits of vaccination outweigh the risks of extremely rare potential side effects.