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

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 today it had abandoned the application after it became overcomplicated and “very large”. Regulators refused to sign off on the jab because of incomplete data and feared it could cause a fatal blood clot

The above shows the four Covid jabs approved for use in the US.  Pfizer and Moderna's jabs relying on mRNA technology were the first to be printed

The above shows the four Covid jabs approved for use in the US. Pfizer and Moderna’s jabs relying on mRNA technology were the first to be printed

AstraZeneca said its application for emergency approval in the US would be withdrawn after it became “overcomplicated”.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

From the world’s only non-profit Covid jab to EU outcasts: AstraZeneca’s turbulent rollout

December 30, 2020: AstraZeneca jab approved for emergency use in UK

January 29: French President Emmanuel Macron claims UK AstraZeneca vaccine is only ‘quasi-effective’ in 65-year-old just hours before EU medicines agency approves jab

February 26: 66-year-old German Chancellor Angela Merkel comments that she will not have the AstraZeneca bump because she is not in the recommended age group of under 65

March 1: French government U-turns, approves use of AstraZeneca for people over 65

11th of March: Denmark, Norway and Iceland stop use of AstraZeneca vaccines after concerns about blood clots

March 15th: France suspends use of AstraZeneca due to blood clot fears

March 19: France re-authorizes AstraZeneca but limits it to over 55s

April 7: The EU’s medicines watchdog says it has found a rare blood clotting side effect of the AstraZeneca jab but added that the overall risk/benefit remains positive in favor of the vaccine

May 7: UK restricts use of AstraZeneca vaccine to people over 40 over small but statistically significant risk of blood clots in younger people.

May 12: The UK Medicines Agency says it has detected 294 cases of blood clots in Britons given a first dose of AstraZeneca, affecting about one in 80,000

September 9th: AstraZeneca and Pfizer jabs approved in UK to be used for third doses as part of Covid booster program

November 4: The EU’s medicines regulator is reported to be in talks to approve the AstraZeneca vaccine for use as part of a booster program

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.

Pfizer has over multi-billion dollar franchise

Pfizer’s chief financial officer has described the Covid pandemic as a “multi-billion dollar franchise” – and expects profits to continue.

David Denton told investors on an earnings call last week that his company’s vaccines and antivirals would remain “relevant for many years to come.”

The CFO said he expects the Covid virus to be “something like a flu … but more deadly” – meaning therapeutics will still have a huge role in controlling the virus.

So far, Pfizer has reaped about $80 billion in annual revenue from sales of Covid vaccines and the antiviral drug Paxlovid.

The company announced last month that it will triple the price of its syringe to up to $130 per dose next year — a far cry from the roughly $19 to $30 per dose the government paid.

Some experts estimate that each individual take costs just $1.18 to make — meaning the new price represents a 10,000 percent markup.

Analysts speculate that the move was made so that Pfizer could still meet its target of $32 billion in expected vaccine revenue this year.

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