AstraZeneca admits defeat in America: The vaccine maker finally abandons the plan to have the Covid injection approved in the US

AstraZeneca admits defeat in America: The vaccine maker finally abandons the plan to have the Covid injection 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 record.

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

However, the Food and Drug Administration (FDA) refused to give the green light due to incomplete data and fears that the sting could be linked to blood clots.

After a stalemate of more than a year, AstraZeneca has now abandoned its bid.

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

AstraZeneca was the only vaccine maker to sell its injections at cost, at about $3 a dose. In comparison, Pfizer and Moderna sold them for about $19 each.

AstraZeneca said today it had abandoned the application after it became too complicated and “really big”. Regulators refused to sign off on the sting due to incomplete data, fearing it could result in a fatal blood clot

The above shows the four Covid vaccinations approved for use in the US.  Pfizer and Moderna Jabs, which are based on mRNA technology, were the first to withdraw

The above shows the four Covid vaccinations approved for use in the US. Pfizer and Moderna Jabs, which are based on mRNA technology, were the first to withdraw

AstraZeneca said its US emergency permit application was being abandoned after it became “too complicated”.

CEO Pascal Soriot said: ‘With primary vaccine needs already met in the US, AstraZeneca has decided not to submit Vaxzevria for US biologics approval.

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

From the world’s only non-profit Covid vaccine to an EU outcast: the tumultuous launch of AstraZeneca

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

January 29: French President Emmanuel Macron claims the UK-made AstraZeneca vaccine is only “quasi-effective” in people over 65 just hours before the EU Medicines Agency approves the injection

February 26: 66-year-old German Chancellor Angela Merkel notes that she will not get the AstraZeneca vaccine because she is not in the recommended age group under 65

March 1st: The French government turns around and authorizes the use of AstraZeneca for the over 65s

11 March: Denmark, Norway and Iceland suspend use of AstraZeneca vaccines over blood clot concerns

March, 15: France suspends use of AstraZeneca over blood clot fears

March 19: France approves AstraZeneca again, but restricts it to those over 55

April 7: The EU medicines regulator says it found a rare side effect of blood clots with vaccination with AstraZeneca, but the overall additional risk/benefit ratio remains positive in favor of the vaccine

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

May 12: The UK Medicines Agency says it has noticed 294 cases of blood clots in Britons who received a first dose of AstraZeneca, affecting around one in 80,000

September 9: AstraZeneca and Pfizer vaccines approved for third dose in UK under Covid booster scheme

November 4th: The EU Medicines Agency is reportedly in talks to approve the AstraZeneca vaccine for use as part of a booster program

AstraZeneca’s vaccine was based on traditional adenovirus technology, which uses a weakened common cold virus to deliver a piece of Covid’s spike protein and train cells to recognize it.

It was less effective than Pfizer and Moderna’s new mRNA triggers, which work similarly but slightly differently.

They use RNA, a messenger molecule that sends instructions to cells on how to defend themselves against a virus.

Although similar, studies and field data have shown that the mRNA vaccines provide stronger and longer lasting protection.

AstraZeneca originally expected to apply for FDA approval in 2020.

However, there were concerns about the lack of older people in the shot maker’s trials of its vaccine.

Only two people over 65 contracted Covid during the studies, out of 660 participants in that age group.

When the vaccine was launched in Europe, a small but growing number of reports of fatal blood clots caused further hesitation.

A number 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 stopped using AstraZeneca altogether.

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

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

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

Yesterday, AstraZeneca said its US emergency permit application was being abandoned after it became too complicated.

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

The Anglo-Swedish giant – whose vaccine was backed by the British government – provided the cheapest shot at the Covid pandemic.

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

By comparison, Pfizer and Moderna’s jabs cost about $19 per dose.

AstraZeneca’s Jab was approved in the UK in late 2020 and in Europe early next year.

America acquired up to 300 million vaccine doses pending FDA approval early in the pandemic.

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

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

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

The vaccine is widely available in developing countries, with three billion doses sold worldwide to date.

While demand for the vaccine is waning, the other coronavirus treatment – a preventive antibody therapy called Evusheld – is enjoying strong sales.

The company posted $537 million in third-quarter sales of Evusheld, which targets people with compromised immune systems, after it received US emergency use approval last December.

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

Core earnings per share could grow at a “high 20s to low 30s rate,” against previous expectations for a mid-to-high 20s increase thanks to strong demand for drugs like Farxiga for diabetes and Tagrisso for cancer .

Pfizer has more than billions in franchises

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

David Denton told investors in a conference call last week that his company’s vaccine and antiviral drugs will be relevant for many years to come.

The CFO said he expected the Covid virus to be “something like the flu … but more deadly” – meaning therapies will continue to play a big role in fighting the virus.

Pfizer has so far made about $80 billion in annual sales from sales of Covid vaccines and the antiviral drug Paxlovid.

The company announced last month that it would triple the price of its injection next year to $130 a dose — a far cry from the roughly $19 to $30 a dose the government was paying for.

Some experts estimate that each individual shot costs just $1.18 to produce — meaning the new price represents a 10,000 percent premium.

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

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