AstraZeneca drops plans for Covid jab approval in US

Drugs giant says application with the FDA had become overly complicated and ‘very large’

Chief Pharmacist Richard Harrison with the Oxford/AstraZeneca coronavirus vaccine at Askham Bar park-and-ride in York, as ten further mass vaccination centres opened in England with more than a million over-80s invited to receive their coronavirus jab. Picture date: Monday January 18, 2021. PA Photo. See PA story HEALTH Coronavirus. Photo credit should read: Danny Lawson/PA Wire

Drugs giant AstraZeneca has abandoned plans to seek approval for its Covid-19 jab in the United States as it revealed falling sales of the vaccine worldwide.

The Anglo-Swedish group, which developed the Vaxzevria vaccine with Oxford University, revealed in its third-quarter results that it would drop an application with the Food and Drug Administration (FDA) in the US and instead focus its efforts elsewhere globally, including for its use as a booster.

The group’s figures showed demand was waning for the Covid jab – which was one of the first to be developed worldwide – with sales of Vaxzevria dropping to $173 million (€170 million) in its third quarter from $1.05 billion a year earlier.

The vaccine was quickly approved for use in the UK, Europe and elsewhere worldwide, but not in the US, where regulators wanted more data.


AstraZeneca had planned to go for full approval from the FDA, but the firm’s boss said the application had become overly complicated and “very large”.

The group said: “As the primary vaccination needs of the US are being met already, AstraZeneca has decided that it will not submit a biologics licence application for Vaxzevria in the US.”

The firm has mostly distributed its Covid vaccine on a not-for-profit basis and it has been widely used in developing countries, with three billion doses sold worldwide so far.

While demand for the jab is tailing off, its other coronavirus treatment – a preventive antibody therapy called Evusheld – is seeing solid sales.

It notched up $537 million sales of Evusheld, which is targeted at people with weakened immune systems, in the third quarter after gaining approval for emergency use in the US in December last year.

AstraZeneca’s results on Thursday also showed the group increasing its earnings outlook, thanks to a better-than-expected performance so far this year. It said core earnings per share could grow by a “high 20s to low 30s percentage”, against its previous guidance of a mid-to-high 20s increase, thanks to strong demand for drugs such as Farxiga for diabetes and Tagrisso for cancer.

The company saw third-quarter pretax profits jump to $922 million from losses of $2 billion a year ago on better-than-expected revenues of $11 billion, up 19 per cent year on year. – PA