AstraZeneca finally abandons plan to get Covid-shot approved in 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 over the jab’s links to blood clots.

After a stalemate lasting more than a year, AstraZeneca has now abandoned its application.

Pfizer, on the other hand, boasted to investors last week that the Covid pandemic would continue to be a “multi-billion” franchise for years to come. It has made $80 billion from the pandemic, according to estimates.

AstraZeneca was the only vaccine manufacturer selling its syringes at a cost of about $3 per dose. By comparison, Pfizer and Moderna sold them for about $19 each.

AstraZeneca said its application for emergency approval in the US would be withdrawn after it became “overcomplicated”.

CEO Pascal Soriot said: “As US primary vaccination needs are already met, AstraZeneca has decided that it will not submit a biologics license application for Vaxzevria in the US.

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

AstraZeneca’s vaccine relied on traditional adenovirus technology, where a weakened cold virus was used to deliver a piece of Covid’s spike protein and train cells to recognize it.

This was less effective than the new mRNA jabs distributed by Pfizer and Moderna, which work in a similar but slightly different way.

They use RNA, a messenger molecule that carries instructions to cells, telling them how to defend themselves against a virus.

Although similar, studies and real-world data showed that the mRNA vaccines provided stronger and longer-lasting protection.

AstraZeneca initially expected to apply to the FDA for approval in 2020.

But concerns were raised about the lack of older people in the shot maker’s trials of its vaccine.

Only two people over 65 caught Covid in trials, out of 660 participants in that age group.

When the vaccine was rolled out in Europe, a small but growing number of reports of fatal blood clots created even more skepticism.

A number of EU countries including France, Germany, Spain and Italy restricted the vaccine to certain age groups or temporarily suspended it.

Some countries, such as Denmark, Norway and Sweden, completely stopped using AstraZeneca.

The vaccine can trigger a chain reaction that causes the body to mistake its own platelets for virus fragments.

For reasons that scientists are still investigating, the body then mistakes these platelets as a threat and produces antibodies to fight them.

The combination of the platelets and the antibodies clumping together leads to the formation of dangerous blood clots.

Yesterday, AstraZeneca said its application for emergency approval in the US would be withdrawn after it became too complicated.

About 68 percent of Americans — or 227 million people — have already received two shots against Covid.

The Anglo-Swedish giant – which had its vaccine backed by the British government – delivered the cheapest shot of the Covid pandemic.

It cost about $3.50 per dose and aimed to make the jabs available to third world nations.

By comparison, jabs sold by Pfizer and Moderna cost about $19 a dose.

AstraZeneca jab was approved for use in the UK in late 2020 and in Europe early the following year.

America secured up to 300 million doses of the jab early in the pandemic, pending FDA approval.

However, most ended up being sent to third world countries after the US refused to give them the green light for use.

AstraZeneca is also behind the antibody cocktail Evusheld, which is approved in the US for the treatment of patients at high risk of Covid.

Demand for AstraZeneca’s Covid jab is waning globally, with sales of the jab falling 80 percent from $1.05 billion a year ago to $173 million in the third quarter of this year.

Jab has been widely used in developing countries with three billion doses sold worldwide to date.

While demand for the jab is slowing, its other coronavirus treatment — a preventive antibody therapy called Evusheld — is seeing steady sales.

It added $537 million in sales of Evusheld, which targets people with weakened immune systems, in the third quarter after receiving approval for emergency use in the US last December.

AstraZeneca’s results on Thursday also showed the group raised its earnings outlook thanks to better-than-expected results 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.