‘Our moon shot’: Vaccine makers go ahead with unproven candidates to meet 2021 goal experts say may be unrealistic

In series of breathtaking multibillion-dollar series of bets by vaccine makers, possible candidates to fight the coronavirus already are being prepared for production across the globe, before it’s even known whether any of them will work.

It's one of the most dramatic examples of short cuts and streamlining to try to meet what many experts consider unrealistic U.S. target dates for a vaccine.

Director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci, front and center at White House news conferences, has repeatedly told a pandemic-weary nation a vaccine against the new coronavirus may be ready in 12 to 18 months.

That timeline would shatter all precedents for developing a new, vaccine which typically takes many years. The fastest it has ever been done was for mumps, which took four years.

“I think the goal of 18 months is one that will be very, very difficult to achieve," said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “But it just may be our moon shot.”

Manufacturing tens of millions of unproven vaccine doses on spec is unheard of in vaccine production. It underscores the urgent need to have solutions ready as quickly as possible to stop a scourge that has killed almost 200,000 people worldwide and laid waste to the global economy.

There is no certainty any of the experimental vaccines will work. If one does prove effective, getting it into the arms of people around the world will require another bold move: the Food and Drug Association would have to cut short its normal approval process and give vaccinations on an emergency use basis..

As testing data becomes available, work on vaccines that fail or have unacceptable side effects will be stopped, and stockpiles of that vaccine will be destroyed.

“This is indeed a brave new world. ” said L.J. Tan chief strategy officer at the Immunization Action Coalition.

'Absolutely unprecedented'

Pharmaceutical giant Johnson & Johnson is one of several major vaccine developers taking the leap.

The company already has begun work to meet its promise of producing one billion doses of its vaccine, even with human trials months away, says Macaya Douoguih, the company’s head of clinical development of vaccines.

The move is risky financially, but could shave a year or more off of the process.

U.S.-based Pfizer has four coronavirus vaccine candidates it expects to enter clinical trials, possibly within the next week.

The company has already begun ramping its production capacity to produce millions of vaccine doses by the end of the year – long before it knows which, if any, of them will pan out, the company told USA TODAY.

“It’s absolutely unprecedented, and it shows the strong commitment by our industry to eradicate COVID-19 and get any future vaccine to patients as quickly as possible —despite the incredible risks involved,” said Phyllis Arthur, vice president of Infectious Diseases & Diagnostics Policy at the biotechnology industry group BIO.

An international public-private partnership is making the biggest bet. The Coalition of Epidemic Preparedness Innovation (CEPI) is an international organization based in Oslo, Norway whose vaccine effort is funded by 14 governments as well as the Bill and Melinda Gates Foundation and the U.K.'s Wellcome Trust.

With $2 billion in financial support, it is helping 10 leading candidates manufacture vaccines “at risk,” said James Robinson, a consultant managing the manufacturing strategy for CEPI.

“At risk” means the companies are taking on all the financial costs, all the legal liability and the clinical trial costs, with no guarantee of a market.

“Production has started for many programs at limited scale; full-scale production should be underway by summer,” Robinson said.

The goal is that as testing progresses, scientists will be able to identify the most promising candidates and have massive quantities of doses read to be deployed.

“The risk of it failing is still reasonably high but at least you have some data to support the investment,” Robinson said.

The financial risk to the companies is also unprecedented.

“You’ve potentially just spent a million dollars to learn something interesting” but have nothing to show for it, said Gregory Poland, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, and editor-in-chief of the journal "Vaccine.

Vaccine manufacturing and production even in normal times is a financial risk, the rates of return are low and outbreaks can wane, pulling public attention and money away. That makes the decision to begin to produce multiple vaccines before they’re tested all the more remarkable.

“Companies don’t want to risk making all those doses until they know a vaccine is going to be licensed and can be sold,” said Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine.

But in today’s environment, the choices are stark.

“Maybe you say, ‘This is a pandemic. It’s important enough that we’ll try,’” Neuzil said. “It’s absolutely a gamble. There’s no doubt about it.”

Screen grab taken from video issued by Britain's Oxford University, showing microbiologist Elisa Granato, being injected as part of the first human trials in the UK for a potential coronavirus vaccine.

A COVID-19 vaccine may be impossible

It's possible there will be no vaccine. Vaccines for respiratory ailments have a history of setbacks. In 1966, two toddlers died from a vaccine for Respiratory Syncytial Virus, or RSV. It wasn't until late last year that any vaccine for that respiratory virus was approved.

Vaccine developers also have to contend with antibody-dependent enhancement, where a possible vaccine ends up making it easier for the virus to infect a cell.

Then there’s the history of problems in making a vaccine against coronaviruses, of which SARS-CoV-2 that causes the disease COVID-19 is one.

No one has ever developed a vaccine for the common cold, which is often caused by different strains of the coronavirus. Attempts at a vaccine for Severe Acute Respiratory syndrome led to animals getting sick. The SARS virus is closely related to the Covid-19 virus.

The urgency to stop the pandemic has brought together unprecedented resources and expertise to find a solution, yet it remains extremely difficult to develop a vaccine. It's one reason there is still nothing for HIV or the common cold, said Esther Krofah, executive director of FasterCures, a Washington, D.C.–based think tank that focuses on accelerating medical research.

“It’s not an absolute guarantee, even though we have all these efforts underway,” she said.

Osterholm, who wrote the bestseller, "Deadliest Enemy" about public health crises, believes we must presume one won't be found. That puts the burden on treatments and social distancing until the disease has run its course. He recently estimated that 800,000 Americans will die of COVID-19.

“I think our planning for responding to the pandemic has to be as if there is no vaccine,” said Osterholm, who has been involved as a public health expert in numerous past epidemics.

“With a disease of this infectiousness, you probably are talking 60% to 70% of the population would have to be infected and develop immunity for us to see substantial reduction in transmission,” he said.

Currently there are more than 70 vaccine candidates for SARS-CoV-2, according to the World Health​ Organization. The hope is that many will succeed.

To protect the world’s 7.8 billion people will require multiple vaccines produced at dozens of facilities. No single vaccine maker could possibly make enough doses for the entire population.

A vaccine might be possible in late 2021 or early 2022 but it’s hard to say, said Jon Andrus, a professor of global vaccinology and vaccine policy at the Milken Institute of Public Health at George Washington University.

“We’re building this plane as we fly it,” he said. “With science, you expect the unexpected. You can’t wave a magic wand and say this is going to happen.”

Source: https://www.usatoday.com/story/news/2020/04/23/coronavirus-vaccine-makers-covid-19-crisis/2983177001/

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