AstraZeneca Withdraws COVID-19 Vaccine Application in the US


After losing the approval for emergency use of COVID-19 vaccines, AstraZeneca has finally stopped efforts to sell its COVID-19 vaccine shots in the United States. AstraZeneca has now decided to withdraw its application for the COVID-19 vaccine Vaxzevria with the US FDA, said CEO Pascal Soriot during a press briefing.

Because the US FDA has already approved mRNA vaccines from Moderna and Pfizer-BioNTech, the emergency use authorization pathway of the US FDA for other vaccines is closed. In the third quarter of 2022, Vaxzevria vaccine booked no US sales, and the global revenue of the vaccine decreased sharply by 83 percent.

AstraZeneca has cut its full-year sales guidance from 21 million dollars to a range of 18 billion dollars. After withdrawing of the vaccine applicationin the US, the anti-COVID efforts of the company are shifting to its anti-body combination drug Evusheld. EvuSheld is authorized to prevent COVID-19 in immunocompromised people in the United States, and is cleared in Europe to treat the disease.

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According to Pascol Soriot, AstraZeneca is closely working to update Evusheld, and based on a productive and good relationship with the US FDA, the company hopes to launch Evusheld 2.0 by the second half of 2023.

Last month, the US FDA warned the public of an increased risk of developing the disease in those exposed to different variants of the virus that are not neutralized by Evusheld, and the variants include the emerging omicron subvariant BA.4.6.