AstraZeneca Withdraws US Vaxzevria Launch Plan
With vaccine demand already saturated, CEO Pascal Soriot said the company will ask the FDA to cancel its 2020 application for approval.
The Anglo-Swedish company was one of the first to develop a vaccine against the rapidly spreading coronavirus but a series of missteps led the launch to be delayed several times. Later, highly publicized incidents involving side effects such as sometimes-fatal blood clots, along with production glitches that led to supply backups, were added to the mix.
While the European Medicines Agency (EMA) approved Vaxzevria in March 2021, the FDA never approved it, as its scientists were not satisfied with the quality of information the company provided about its clinical trials.
The AstraZeneca decision will oblige the US government to destroy its remaining supplies of the shot and write down unfilled orders, although it wasn’t clear how much money would have ever changed hands, anyway.
Vaxevria, based on an adenovirus, was developed jointly with Oxford University, which had discouraged manufacturing for profit. For further development of the vaccine and the market, the drugmaker received $1.2 billion in financial aid from the US national preparedness agency Biomedical Advanced Research and Development Authority (BARDA).
All vaccine makers have faced hefty declines in sales of Covid vaccines this year. Worldwide, the AZ vaccine’s global revenue plummeted 83% to $173 million, the company recently reported. Weary of quarrels with AZ management, Europe earlier refocused on other manufacturers’ products, predominantly Pfizer/BioNTech.
Unlike other vaccine makers whose original products faced roadblocks, AstraZeneca declined to enter the field of Covid-19 boosters. Earlier this year, Soriot publicly played down their importance.
The UK pharma is refocusing on its monoclonal antibody cocktail Evusheld (tixagevimab/cilgavimab) as a treatment for Covid. This product, developed in part by US researchers, was approved by the FDA in in December 2021 for emergency use in immunocompromised patients.
AstraZenenca’s home market said it would not order the antibody cocktail, citing “insufficient data” on the duration of protection it provides against omicron and its sub-variants. The company has said it will launch an updated version of Evusheld by the second half of next year.
Author: Dede Williams, Freelance Journalist