Pfizer's COVID vaccine set for emergency approval 'in days'

 

Pfizer and BioNTech's groundbreaking coronavirus vaccine has been found to work even better than previously thought, and the company claimed it was safe.

The vaccine was likely to be sent off for emergency government health approvals in the United States and Europe "within days".

The pharmaceutical giant said that its vaccine was 95 per cent effective against the bug, slightly more than a rival Moderna jab that revealed results this week.

Pfizer and its German partner BioNTech said there were no adverse reactions, with side effects, including fatigue and headache, affecting less than five per cent of participants in a major trial.

"The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic," said Dr Albert Bourla, Pfizer chairman and CEO.

"With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world."

Ugur Sahin, co-founder of BioNTech, said the data showed a high rate of protection against COVID-19 could be achieved "very fast" after the first dose.

The new data released by Pfizer was based on almost double the number of infections that were revealed last week.

In the stage 3 trial of 43,000 volunteers, there were 170 infections, and of those 162 had been given a placebo, while eight had been given the Pfizer vaccine.

That pushed its effectiveness to 95 per cent, just ahead of Moderna's jab, which claimed 94.5 per cent effectiveness.

Russia's Sputnik V jab has claimed 92 per cent effectiveness.

Importantly, the Pfizer jab was found to work in people over 65, who are the most at risk group of dying from coronavirus.

The Pfizer jab, however, will be difficult to roll out, because it needs to be stored at temperatures of -70 degrees, while the Moderna vaccine can be stored in a fridge.

Australia has a deal for 10 million Pfizer vaccines, while it has not secured an order for the Moderna option, instead going for the Oxford University and University of Queensland candidates.

The Oxford University candidate was due to report its results this month.

 

Dolly Parton has been revealed as a major donor to Pfizer rival Moderna’s effort to find a vaccine.
Dolly Parton has been revealed as a major donor to Pfizer rival Moderna’s effort to find a vaccine.

THE STAR WHO HELPED FUND THE FIGHT AGAINST THE VIRUS

Meanwhile, superstar Dolly Parton has been revealed as a major donor to Pfizer rival Moderna's effort to find a vaccine.

Parton is being hailed as a COVID "saviour" after donating $A1.4 million to help fund the Moderna vaccine.

The iconic country singer, 74, donated the cash back in April to Vanderbilt University Medical Centre in Nashville, Tennessee, for coronavirus research.

This week, US company Moderna announced its vaccine may be 94.5 per cent effective against the killer respiratory disease and Parton is namechecked in the preliminary report, The Sun reports.

Published in the New England Journal of Medicine, the report states that the work was supported by the "Dolly Parton COVID-19 Research Fund" among other groups.

The glamorous music star became friends with Dr Naji Abumrad of the Vanderbilt Institute when he treated her in 2014 following a car crash.

Earlier this year, the scientist told Parton that his team was making "some exciting advancements" in the search for a cure of the virus.

She then donated $1m to help fund the research and encouraged other wealthy people on Twitter to do the same.

The singer told the BBC: "I'm sure many, many millions of dollars from many people went into that (research fund) but I felt so proud to have been part of that little seed money that hopefully will grow into something great and help to heal this world.

"Lord knows we need it!"

 

AMERICANS 'MOST EAGER'

In the meantime Moderna, which developed its product in conjunction the National Institutes of Health in the US, has signed agreements to provide the vaccine to Canada, Japan, Israel, Qatar and Britain, he said.

Mr Bancel said there is much red tape involved in getting a vaccine approved, complicated by the EU having 27 member nations.

 

 

 

By contrast, it took just two weeks to cement a deal on providing the vaccine to Canada, from the time the two sides began talks to the signing of a contract.

If EU medical regulatory authorities approve the Moderna vaccine by the end of the year but no contract has been signed, the EU will not be among the first to receive it.

"So we will get started in Switzerland, it will get started a little in Japan, Israel, Canada - in the countries that have placed orders. But I will not be able to send product to countries that have not placed orders." said Mr Bancel.

"The longer they wait, the longer it will take," he told said, adding that the price is not an issue in talks with the Europeans, and declining to comment further on the negotiations.

The European Commission, which has signed deals with Pfizer and other manufacturers, said the negotiations were highly complex.

"Are we simply concluding contracts because all of a sudden, there are some nice press reports about the status of this vaccine? That is clearly not the case," commission spokesman Stefan de Keersmaecker said Tuesday at a briefing.

The Americans on the other hand have been most eager, Mr Bancel noted. As early as March 2, said Mr Bancel, he and other Big Pharma executives were sitting in the White House in a meeting with US President Donald Trump.

 

 

 

HOW COVID WILL FAST-TRACK VACCINES FOR OTHER DISEASES

Scientists are confident they will now be able to fast track vaccines against any new disease after the success of a second COVID-19 vaccine using new age mRNA technology.

Instead of having to go through the lengthy process of deactivating a pathogen to make a vaccine all they need now to make a vaccine is a fragment of the virus' genetic code.

US company Moderna cemented the success of this new method when it reported clinical trials showing its COVID-19 vaccine is 94 per cent effective at preventing COVID-19.

Like the first successful COVID-19 vaccine made by Pfizer, Moderna's uses a radical new technology called mRNA.

To make the vaccine researchers use a piece of the coronavirus' genetic code called messenger RNA (mRNA) to train the body to make the virus' spike protein.

This prompts the immune system to recognise and respond when it comes across the virus.

Conventional vaccines usually contain inactivated disease-causing particles of the virus to stimulate an immune response and can take some time to produce.

The mRNA technology is a new way of making vaccines that is much faster and cheaper and it holds tremendous potential.

No vaccines using this method have ever been used in humans before but now we have two clinical trials suggesting the method actually works very well.

The speed with which these vaccines were produced shows they have the edge over more conventional methods of vaccine production.

 

 

 

Dr Zoltán Kis from the Future Vaccine Manufacturing Hub at Imperial College London, said the beauty of this technology was that "vaccine candidates can be produced against virtually any disease".

"This is a platform technology, meaning that the production process, the purification processes and the formulation processes can remain the same no matter what vaccine or vaccine candidate is produced," he said.

This is a huge advantage in terms of the speed at which vaccine candidates can be developed and produced in the future, he said.

"With conventional vaccine production technologies, each vaccine required the development of a new production process, whereas in the case of the RNA vaccine production platform technology one process can produce vaccines and vaccine candidates against virtually any disease," he said.

Moderna's vaccine can be stored in a normal refrigerator which gives it a huge advantage over the successful Pfizer vaccine which needs to be stored at temperatures below minus 70 -80 degrees.

It has been tested in the elderly and well as people from ethnically diverse backgrounds.

While it prevents people from getting COVID-19 - the illness caused by the virus - it is unclear whether it actually prevents the spread of the virus.

Australia does not have a direct deal to purchase the Moderna vaccine. However, we have signed up to the Covax initiate, an international agreement for vaccine supply which will eventually give us access to this vaccine.

Moderna says it can make 20 million doses of the vaccine by the end of the year. It aims to produce 500 million doses next year, with the possibility of 1 billion doses if it can obtain enough raw materials.

MORE NEWS

 

How the Pfizer and Moderna vaccines compare

COVID-19 vaccines selling for $24,000 on black market

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Originally published as Contract delay could stall vaccine delivery



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