Categories: Health

AstraZeneca finally abandons plan to get Covid injection approved in US

AstraZeneca is no longer trying to get its Covid vaccine in the US after regulators refused to sign 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) declined to give the green light due to incomplete data and fears about the shot’s link to blood clots.

After a stalemate of more than a year, AstraZeneca has now withdrawn its application.

Pfizer, on the other hand, last week boasted to investors that the Covid pandemic would remain a “multi-billion” franchise for years to come. It is estimated to have made $80 billion from the pandemic.

AstraZeneca said today that it had abandoned the application after it became too complicated and “very large.” Regulators refused to sign the jab due to incomplete data, fearing it could cause a deadly blood clot

The above shows the four Covid shots approved for use in the US. The Pfizer and Moderna shots that rely on mRNA technology were the first to sign off

AstraZeneca said its application for Emergency Use Authorization in the US would be withdrawn after it became “too complicated.”

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

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

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

December 30, 2020: The AstraZeneca shot approved for emergency use in the UK

January 29: French President Emmanuel Macron claims UK-made AstraZeneca vaccine is only ‘quasi-effective’ in the over-65s, just hours before EU drug regulator approves the injection

February 26: 66-year-old German Chancellor Angela Merkel notes she won’t get the AstraZeneca jab because she’s not in the recommended age group of under 65

March 1: French government’s U-turns, approval of AstraZeneca use for over-65s

11 March: Denmark, Norway and Iceland stop using AstraZeneca vaccines over blood clot concerns

March 15France suspends use of AstraZeneca over fear of blood clots

March 19: France approves AstraZeneca again, but limits it to over-55s

April 7: EU drug regulator says it has found a rare side effect of a blood clot from the AstraZeneca shot, but added that the overall risk/benefit remains positive in favor of the vaccine

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

May 12thUK drug regulator says it has noticed 294 cases of clots in Britons given a first dose of AstraZeneca, affecting about one in 80,000

September 9th: AstraZeneca and Pfizer shots are approved for third-dose use in the UK as part of a Covid booster program

the 4th of November: EU drug regulator reportedly in talks to approve AstraZeneca vaccine for use as part of booster program

AstraZeneca’s vaccine was based on traditional adenovirus technology, which used an attenuated cold virus to deliver some of Covid’s spike protein and train cells to recognize it.

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

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

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

AstraZeneca initially expected to file an application for FDA approval in 2020.

But concerns were raised about the lack of elderly people in the shotmaker’s trials of its vaccine.

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Only two people over 65 have contracted Covid during 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 deadly blood clots fueled even more hesitation.

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

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

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

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

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

Yesterday, AstraZeneca said its application for Emergency Use Authorization in the US would be withdrawn after things got too complicated.

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

The Anglo-Swedish giant – whose vaccine was backed by the UK government – delivered the cheapest shot of the Covid pandemic.

It cost about $3.50 per dose and was intended to make jabs accessible to third world countries.

In comparison, the shots sold by Pfizer and Moderna cost about $19 per dose.

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

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

However, most were shipped to third world countries after the US refused to give them the green light for use.

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

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

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

As demand for the jab wanes, the other coronavirus treatment — a preventative antibody therapy called Evusheld — is seeing solid sales.

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

AstraZeneca’s results on Thursday also showed the group increased its earnings outlook thanks to better-than-expected performance so far this year.

It said core earnings per share could grow at a “high rate of 20 to low 30,” contrary to previous expectations of a mid-to-high 20’s rise thanks to strong demand for drugs such as Farxiga for diabetes and Tagrisso for diabetes. cancer.

Pfizer boasts more than billions of franchises

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 in a profit call last week, his company’s vaccine and antivirals are said to be “relevant for many years to come.”

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

So far, Pfizer has generated approximately $80 billion in annual revenue from the sale of Covid vaccines and the antiviral drug Paxlovid.

The company announced last month that it will triple the price of its injection 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 single shot costs just $1.18 to make — meaning the new price represents a 10,000 percent markup.

Analysts speculate that the move has been made so that Pfizer can still meet its $32 billion goal in vaccine revenues this year.


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