They are investing billions to be the first to get a vaccine

In the race to develop a vaccine to end the covid-19 pandemic, governments, humanitarian organizations and big pharmaceutical companies are investing billions of dollars with very little chance of success.

They speed up testing and regulatory consideration of vaccines without any guarantees that they will be effective. They build and equip vaccine factories with little chance of being approved.

They are placing orders for vaccines that, in the end, probably won't be produced.

It is, as Reuters writes, a new pandemic paradigm, extremely risky with a focus on speed.

"The crisis in the world is so great that each of us is putting ourselves at maximum risk to stop this disease," Paul Stoffels of Johnson & Johnson ( JNJ.N ), which partnered with the U.S. government in a billion-dollar investment, told the British agency. in order to accelerate the development and production of a vaccine that has not yet been proven to work. "If it doesn't work, then it will be very bad," Stoffels told Reuters.

Historically, only six percent of vaccine candidates have ended up on the market, mostly after a multi-year process that doesn't attract large investments until tests show the product is effective.

However, traditional rules for drug and vaccine development have been sidelined by the virus, which has infected over 2,8 million people and killed over 200 as the global economy has been devastated.

When it comes to covid-19, the goal is to have a vaccine identified, tested and made available in the form of hundreds of millions of doses in just 12 to 18 months.

Unprecedented scale of risky investments

The scale of risky investments by pharmaceutical companies, governments and investors is unprecedented.

The general consensus among more than 30 pharmaceutical executives, government officials and pandemic experts interviewed by Reuters is that the risks are necessary to ensure not only that a vaccine for the novel coronavirus is developed quickly, but that it is ready for distribution as soon as it is available. approved.

Investments from governments, global health groups and philanthropists are primarily focused on the 100 most promising vaccine candidates. However, only a handful of them have made it to the stage of human testing, which is actually the real measure of effectiveness - and the stage where most vaccines fail.

Even among the most promising projects, few will succeed. It is possible that more than one vaccine will be effective, and yet it is possible that none will work.

For the companies participating in this race, of course, there are benefits: they prove themselves in the field of vaccine production and thus strengthen their reputation and raise the value of their shares.

Although some major companies, including Johnson & Johnson and GlaxoSmithKline Plc, say they plan to offer the vaccine at an affordable price, at least initially, they are sure to make money in the long run if seasonal vaccination is established and states start stockpiling .

However, finding an effective vaccine is of no use if there is no possibility for its production and distribution. This means that the construction of production factories should be started now.

"We want to invest up front, aware of the risks, even before we know if the vaccine works so we can immediately start producing tens or hundreds of millions of doses," said Richard Hatchett, a physician who guided US policy during the flu pandemic while was in the White House for President George W. Bush and later returned and advised President Barack Obama during the 2009 swine flu pandemic.

Hatchett now heads the Coalition for Epidemiological Preparedness Innovations (CEPI), a vaccine development consortium supported by private donors as well as the UK, Canada, Belgium, Norway, Switzerland, Germany and the Netherlands. The organization has raised more than $915 million of the $XNUMX billion it expects to spend to speed up testing and build specialized manufacturing plants for at least three vaccine candidates against the new coronavirus.

In the United States, the Biomedical Advanced Research and Development Agency (BARDA), the federal agency that funds disease-fighting technologies, has announced an investment of nearly $19 billion to support the development of a vaccine against Covid-XNUMX and ramp up production for promising candidates.

There will not be enough vaccines for everyone

However, the fear expressed by everyone interviewed by Reuters reporters is that even if the vaccine is found to be effective, there will not be enough for everyone.

Making reserves around the world to immediately vaccinate the critical population - healthcare workers, the elderly, the chronically ill - would slow down the pandemic and enable economic recovery, Hachet said. The alternative, according to him, is actually a repeat of past pandemics, including the 1 H1N2009 flu pandemic, when rich countries stockpiled vaccines.

If that happens, experts warn that outbreaks will continue to break out, and each of them will have the potential to create a new wave of disease.

The race to develop a vaccine against the coronavirus is unprecedented in history. There are 115 vaccine development initiatives underway worldwide, and the race is changing the rules for speed and testing in drug and vaccine development.

Some companies conduct safety and efficacy tests in parallel, instead of consecutively as is usually the case, thus shortening traditional testing protocols.

Because of this, it is particularly risky to invest in production factories for individual candidates, since different types of vaccines require different production lines.

The most investments are attracted by candidates based on confirmed approaches of companies that have certain reputations in this field.

BARDA plans to invest in five projects, focusing mainly on those implemented by experienced pharmaceutical companies. This agency, for example, is investing half a billion dollars in J&J's efforts.

Unthinkable shortcuts

Even for vaccines that are already in human trials, it will be months before there is concrete evidence of safety or effectiveness - which the sponsors are well aware of.

Due to the urgency of the situation, scientists decided on previously unimaginable shortcuts.

Usually, vaccines undergo clinical trials involving thousands of people before widespread vaccination is allowed. However, after testing the possible vaccine on a smaller group of people to make sure it is not toxic, the Swiss researchers want to "vaccinate a large part of the Swiss population in the next six months and then produce it for the world market," said Dr. Martin Bahman, head of the department. for immunology at the University Hospital of Bern.

Portpartol of the Swiss regulatory agency said that it is in contact with Bahman's group and that it will not allow this type of testing until the agency is convinced that there are no security risks.

The Swiss vaccine is based on virus-like particles to induce an immune response, an approach that is theoretically considered safer because it does not involve people being directly exposed to the virus through the vaccine. So far, the vaccine has only been tested on mice.

Ugly lessons from the 2009 pandemic.

In the war against covid-19, we should not forget the lessons of the fight against another virus ten years ago.

In the spring of 2009, the H1N1 swine flu virus emerged in the United States and Mexico and spread around the world. Within weeks, the World Health Organization declared the first pandemic since 1968.

Wealthier governments that had conditional contracts with vaccine manufacturers immediately invoked them, thereby "monopolizing the global supply of vaccines," Hatchett said, citing numerous official reports. The US alone ordered 250 million vaccines, and Australia, Brazil, France, Italy, New Zealand, Norway, Switzerland and Britain all had vaccines.

Under pressure from the WHO, those countries eventually agreed to share ten percent of their supplies with poor countries. However, due to failures in production and distribution, only about 77 million doses were sent - less than needed - and only after the disease had peaked in many regions.

If an effective vaccine for the new coronavirus appears, a repeat is possible, experts warn. None of the representatives of global medical authorities interviewed by Reuters believe there will be enough supplies to meet the immediate demand. Governments will be under enormous pressure to vaccinate their citizens and get life back to normal, so stockpiling huge stocks is a serious risk.

Ronald St. John, who has collaborated with the US and Canadian governments in efforts to combat infectious diseases, expects a similar scenario with vaccines.

"During production, one's own interest will be looked at," he said.

Throughout history, only six percent of vaccine candidates have ended up on the market, mostly after a multi-year process

BARDA explicitly gives priority to projects that promise American production capacity.

"We are asking the American taxpayer to allocate a lot of money for the vaccine, so it is important for us that the US has access to a successful vaccine," said Bright, who has recently headed BARDA.

However, he added that BARDA also encourages companies to build production capacity outside the US, so that "we can also have a global supply".

They invest and expect to be the first to get the vaccine

Many governments are pouring money into vaccine development initiatives with the expectation that they will be first in line if a vaccine is produced. San Diego-based biotech company Arcturus Therapeutics Holdings Inc has received $10 million from the Singapore government to develop a vaccine. If the vaccine is approved, Singapore will be the first to receive it, said the company's executive director, Joseph Payne. Everything after that, according to him, goes "to whoever pays".

"Companies are not responsible for the ethics of distribution - governments are responsible for that - and in order for governments to get the vaccine, they have to pay," said Payne. "The country that takes the most risks and makes the most vaccine stocks will win."

In China, a major global vaccine producer, the government is supporting several vaccine development projects, and likely plans to vaccinate its 1,4 billion population first. The government-backed company Sinovac Biotech Ltd has already started human trials and is awaiting the first results.

On Friday, the World Health Organization announced a "historic collaboration" across the international community to raise $XNUMX billion to accelerate development of a coronavirus vaccine and ensure equal access worldwide to any successful vaccine. Countries across Europe, Asia, Africa, and the Middle East have announced their participation, but not the USA and China, the two largest pharmaceutical powers.

"The US will not participate," the spokesman for the US mission in Geneva told Reuters, stressing that the US supports "global cooperation for the development of a vaccine."

China did not respond to questions from Reuters as to why it would not participate in the international initiative.

People involved in the global vaccine race told Reuters that the uncertainty about which vaccine will be effective is actually the biggest incentive for countries to promise to share vaccines.

Since no country can be sure whether the vaccine candidates it supports will be successful, committing to share the vaccine with other countries means that they too will have the first stock to vaccinate health care workers and other critical groups.