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Federal spending on COVID-19 vaccine candidates tops $9 billion, spread among 7 companies

USA TODAY logo USA TODAY 8/10/2020 Karen Weintraub and Elizabeth Weise, USA TODAY
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The federal government has allocated more than $9 billion to develop and manufacture candidate vaccines. More than $2.5 billion more has been earmarked for vials to store the vaccines, syringes to deliver them, and on efforts to ramp up manufacturing and capacity.

And they're not done yet. 

So far, the largest sums have gone to pharmaceutical giants Pfizer, AstraZeneca, and a collaboration between Sanofi and GSK, as well as biotech firms Moderna and Novavax – all of which have candidate vaccines being tested in people.

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To save time in the development process, the companies have been running trials simultaneously that they usually run in sequence.

Moderna, for instance, hasn't yet published its phase 2 trial results, but is already in larger-scale phase 3 trials, beginning tests last week of its candidate vaccine in 15,000 volunteers. Phase 3 trials started this summer are expected to return results this fall, with the timing depending on how quickly they can find volunteers.

None of the candidate vaccines use the whole virus, so they cannot cause COVID-19. Instead, they train the immune system to respond to the virus' spike protein – which gives the coronavirus its distinctive shape. Once the immune system is trained to recognize the spike protein, it should be able to rapidly clear the virus should the person be exposed again.

The vaccine candidates now receiving government funding are all based on new technologies, most of which have not been the basis of previously approved vaccines. They have been chosen because they were faster to develop than more conventional vaccines, which is important in fighting a virus currently killing about 1,000 Americans a day.

If any of these approaches prove safe and effective, it could transform vaccine development worldwide, allowing faster attack strategies against dangerous viruses that may emerge in the future, as well as those that mutate rapidly, like the flu.

Almost all the candidate vaccines in human trials will require two doses to become fully effective, which means many hundreds of millions of doses will be needed to vaccinate the majority of America's 328 million residents.

It is not known exactly what percentage of a population must be vaccinated to provide enough "herd immunity" to stop or prevent an outbreak, but researchers believe at least 50%-70% of the population will need protection.

To win government approval, all the candidate vaccines have to go through three phases of testing in people, starting small to prove basic safety, and ending in 30,000-person trials, where half the volunteers get a placebo and half get an active vaccine. This stage proves the vaccine will be safe for the vast majority of people who get it, though rare reactions can still occur. 

In each of the phase 3 trials, only about 150-160 people will have to fall ill with COVID-19 for statisticians to be able to calculate the effectiveness of the vaccine.

The FDA has said it will approve any vaccine that is shown to be safe and to prevent infection or severe symptoms in at least half of those who are vaccinated. Several companies have said they are hoping to show their vaccine is effective at least 60% of the time.  

Here's how more than $9 billion taxpayer dollars have been allocated so far for vaccine development: 

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Sanofi and GSK: $2.1 billion

Sanofi Pasteur and GSK received nearly $31 million in April as a base award, and were allocated an additional $2.1 billion on July 31 to complete development and to manufacture 100 million doses by the end of the year. More than half of the money will go to complete development of the candidate vaccine, including a phase 1/phase 2 trial to start in September, and a large-scale phase 3 trial to be started before the end of the year. The government holds an option on 500 million more doses to be made next year. 

The companies' candidate vaccine is an edited version of the spike protein delivered via a harmless virus that normally infects insect cells. This approach was designed by a company Sanofi bought in 2017. The vaccine also includes a booster, called AS03, designed by GSK.

Pfizer and BioNTech: $1.95 billion

The government will pay Pfizer, in collaboration with German company BioNTech, $1.95 billion if it receives FDA approval for its candidate vaccine and produces 100 million doses by the end of the year. The government also has reserved the right to order 500 million more next year.

Pfizer/BioNtech developed their candidate vaccine without government assistance and recently started a phase 2/phase 3 trial, which they also will self-fund. The two have already invested billions of dollars in their work, according to a Pfizer spokesman.

Their candidate vaccine, BNT162, uses mRNA technology, which turns the body's cells into tiny factories producing the spike protein. The messenger RNA is packaged inside tiny balls of fat that should boost the duration of the immune response. This kind of vaccine was quick to design and should allow for rapid scale-up of manufacturing. 

The down side to mRNA vaccines is that they must be kept very cold at all times – around minus 70 Fahrenheit – so they are challenging to distribute to rural areas, and may be more expensive than other vaccines. Pfizer is currently working to address this shortcoming.

Novavax: $1.6 billion

Novavax has signed an agreement worth $1.6 billion to complete development, test and produce 300 million doses of its candidate vaccine as early as the end of this year. The company recently completed a phase 1 trial and expects to begin a phase 3 trial this fall. 

Its candidate vaccine, NVX-CoV2373, includes a spike protein delivered by tiny particles, and an adjuvant that boosts its effectiveness.

Some of this funding is intended to help demonstrate that large-scale vaccine manufacturing is feasible.

Janssen: $1.5 billion

Janssen Research & Development, a subsidiary of Johnson & Johnson, is developing a COVID-19 vaccine delivered by a harmless virus called Adenovirus 26. Janssen has spent years working with this virus, and has begun phase 1 testing in people, with phase 3 slated to begin late this year. 

This human virus is uncommon in nature, so most people have not developed immunity to it.

The company received $456 million in March for research and the phase 1 trial and an additional $1 billion in early August to produce 100 million doses.

AstraZeneca and Oxford: $1.2 billion

AstraZeneca, which collaborates with Oxford University, has been awarded up to $1.2 billion to produce 300 million doses of its candidate vaccine as soon as the end of 2020. 

The AZD1222 candidate vaccine uses a virus that normally infects chimpanzees to deliver the spike protein into human cells, which then learn to recognize it. 

Their vaccine is expected to enter a phase 3 trial within the next month.

AZD1222 delivers its spike protein with the help of the chimpanzee virus. The advantage to this is the human immune system has not yet seen the virus, so hasn't made soldiers to fight it. With some vaccines delivered by human viruses, like one being developed in China, a large percentage of the population has already developed immunity to the virus, which is likely to limit the vaccine's effectiveness and the ability to deliver multiple doses. 

Moderna: $955 million

Moderna has received just under $1 billion to develop its candidate vaccine and recently launched a phase 3 trial. The company, whose mRNA-1273 candidate vaccine was partially developed by government researchers, has received three large federal grants: A base award of more than $430 million in April, an additional $53 million in May, and nearly $472 million in late July. 

The company has not signed a deal to deliver a certain number of doses to the government, though it has said it is collaborating with drug manufacturer Lonza to produce as many as 600 million to 1 billion doses next year. 

Moderna's, like Pfizer's is an mRNA vaccine, so it must be kept very cold and requires two shots. 

Merck and IAVI USA: $38 million

Merck and its collaborator IAVI USA received $38 million in federal funding in April to advance development of their candidate vaccine.

Their vaccine uses a virus called a vesicular stomatitis virus, engineered to be harmless, to express spike proteins. The same virus was used as part of Merck's successful Ebola vaccine, ERVEBO, licensed in December 2019. IAVI has been working for years to develop rVSV vaccines for HIV as well as other emerging infectious diseases such as Lassa fever, Marburg, and Ebola Sudan disease.

Dr. Roger Perlmutter, president of Merck Research Laboratories, said in last week's earnings report Merck's vaccine will provide protection with only a single dose, and it will be delivered orally, like the polio vaccine, rather than via a shot.

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: Federal spending on COVID-19 vaccine candidates tops $9 billion, spread among 7 companies


Gallery: The COVID-19 vaccine race and the billions behind it (Lovemoney)

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