AstraZeneca finally abandons plan to get Covid shot approved in the US

AstraZeneca is no longer trying to get its Covid vaccine into the US after regulators refused to sign off on the shot.

The British pharmaceutical giant’s vaccine was approved in the UK and Europe early in the pandemic.

But the Food and Drug Administration (FDA) refused to give it the green light over incomplete data and fears the jab could trigger a fatal blood clot.

After more than a year of negotiations AstraZeneca has now abandoned its application after it became overcomplicated and ‘very large’.

Pfizer on the other hand which boasted to investors last week that it had a ‘multi-billion’ franchise for years to come. It has made $80billion from the pandemic.

AstraZeneca’s vaccine relied on old technology, with a Covid spike protein — which it uses to invade cells — attached to a weakened cold virus to trigger an immune response.

This was less effective than the new mRNA jabs deployed by others, which tricked human cells into manufacturing Covid spikes to spark immunity.

America approved four Covid vaccines in the pandemic, but ended up relying on Pfizer and Moderna’s mRNA shots.

The US is now rolling out an updated bivalent booster targeting Omicron variants, also made by Pfizer and Moderna.

AstraZeneca had planned to apply for full approval of its vaccine to the FDA in late 2020.

But concerns over its data — after the company inadvertently gave some participants half doses — saw this delayed until the following year.

Revealing its plans to drop the Emergency Use Authorization application yesterday, AstraZeneca said it had become overcomplicated and ‘very large’.

They also said almost every American that wanted an initial course of the Covid vaccine had now received their shots. 

‘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,’ they said.

‘The company will continue to focus its efforts on ensuring availability of Vaxzevria elsewhere around the world, including submissions for its use as a booster.’

The British giant — which had its vaccine backed by the UK Government — delivered the cheapest shot of the Covid pandemic.

It was priced at about $3.50 a dose, compared to about $19 per shot for either Pfizer or Moderna’s vaccine.

The jab was rolled out in Europe in 2020, but quickly ran into trouble after it was linked to fatal blood clots. 

Several countries later abandoned plans to inoculate their populations with it, instead shipping the doses to third world countries.

America secured up to 300million doses of the jab early in the pandemic, but ended up sending most of these to other countries.

AstraZeneca did, however, get Evusheld approved in the US which is an antibody cocktail that battles Covid in those at high risk from the virus.

AstraZeneca’s figures show demand for Covid jabs is waning globally, with sales of the jab dropping 80 per cent from $1.05billion a year ago to $173million in the third quarter of this year.

The jab 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 US dollars in 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.