The Denver Post

Global race for vaccine intensifie­s

Nations, companies move at unheard of speeds to be first, raising concerns

- By David E. Sanger, David D. Kirkpatric­k, Carl Zimmer, Katie Thomas and Sui-lee Wee

WASHINGTON» Four months after a mysterious new virus began its deadly march around the globe, the search for a vaccine has taken on an intensity never before seen in medical research, with huge implicatio­ns for public health, the world economy and politics.

Seven of the approximat­ely 90 projects being pursued by government­s, pharmaceut­ical makers, biotech innovators and academic laboratori­es have reached the stage of clinical trials. With political leaders increasing­ly pressing for progress, and with big potential profits at stake for the industry, drugmakers and researcher­s have signaled they are moving ahead at unheard-of speeds.

But the whole enterprise remains dogged by uncertaint­y about whether any coronaviru­s vaccine will prove effective, how fast it could be made available to millions or billions of people and whether the rush — compressin­g a process that can take 10 years into 10 months — will sacrifice safety.

Some experts say the more immediatel­y promising field might be the developmen­t of treatments

to speed recovery from COVID-19, an approach that has generated some optimism in the past week through initially encouragin­g research results on remdesivir, an antiviral drug previously tried in fighting Ebola.

In an era of intense nationalis­m, the geopolitic­s of the vaccine race are growing as complex as the medicine. The months of mutual vilificati­on between the United States and China over the origins of the virus have poisoned most efforts at cooperatio­n between them.

The U.S. government is warning that American innovation­s must be protected from theft — chiefly from Beijing.

“Biomedical research has long been a focus of theft, especially by the Chinese government, and vaccines and treatments for the coronaviru­s are today’s Holy Grail,” John Demers, the assistant attorney general for national security, said on Friday. “Putting aside the commercial value, there would be great geopolitic­al significan­ce to being the first to develop a treatment or vaccine. We will use all the tools we have to safeguard American research.”

Race for vaccine

Two of the leading entrants in the United States, Johnson & Johnson and Moderna, have announced partnershi­ps with manufactur­ing firms, with Johnson & Johnson promising 1 billion doses of an as-yetundevel­oped vaccine by the end of next year.

Not to be left behind, the Britain-based pharmaceut­ical giant Astrazenec­a said this week that it was working with a vaccine developmen­t project at the University of Oxford to manufactur­e tens of millions of doses by the end of this year.

With the demand for a vaccine so intense, there are escalating calls for “human-challenge trials” to speed the process: tests in which volunteers are injected with a potential vaccine and then exposed to the coronaviru­s.

Even when promising solutions are found, there are big challenges to scaling up production and distributi­on.

Bill Gates, the Microsoft founder, whose foundation is spending $250 million to help spur vaccine developmen­t, has warned about a critical shortage of a mundane but vital component: medical glass.

Without sufficient supplies of the glass, there will be too few vials to transport the billions of doses that ultimately will be needed.

Given the stakes, it is no surprise that while scientists and doctors talk about finding a “global vaccine,” national leaders emphasize immunizing their own population­s first.

Trump said he was personally in charge of “Operation Warp Speed” to get 300 million doses into American arms by January.

Given the proliferat­ion of vaccine projects, the best outcome may be none of them emerging as a clear winner.

“Let’s say we get one vaccine quickly but we can only get 2 million doses of it at the end of next year,” said Anita Zaidi, who directs the Bill and Melinda Gates Foundation’s vaccine developmen­t program. “And another vaccine, just as effective, comes three months later but we can make a billion doses. Who won that race?”

The answer, she said, “is we will need many different vaccines to cross the finish line.”

Speed vs. safety

At 1 a.m. March 21, 1963, a 5-year-old girl named Jeryl Lynn Hilleman woke up her father.

She had come down with the mumps, which had made her miserable with a swollen jaw.

It just so happened that her father, Maurice, was a vaccine designer. So he told Jeryl Lynn to go back to bed, drove to his lab at Merck to pick up some equipment, and returned to swab her throat.

Hilleman refrigerat­ed her sample back at his lab and soon got to work weakening her viruses until they could serve as a mumps vaccine.

In 1967, it was approved by the FDA.

To vaccine makers, this story is the stuff of legend. Hilleman still holds the record for the quickest delivery of a vaccine from the lab to the clinic.

Vaccines typically take 10 to 15 years of research and testing.

And only 6% of the projects that scientists launch reach the finish line.

For a world in the grips of COVID-19, on the other hand, this story is the stuff of nightmares. No one wants to wait four years for a vaccine, while millions die and economies remain paralyzed.

Designing vs. manufactur­ing

It is one thing to design a vaccine in record time. It is an entirely different challenge to manufactur­e and distribute one on a scale never before attempted — billions of doses, specially packaged and transporte­d at below-zero temperatur­es to nearly every corner of the world.

“If you want to give a vaccine to a billion people, it better be very safe and very effective,” said Stoffels of Johnson & Johnson. “But you also need to know how to make it in amounts we’ve never really seen before.”

So the race is on to get ahead of the enormous logistical issues, from basic manufactur­ing capacity to the shortages of medical glass and stoppers that Gates and others have warned of.

Treatments vs. vaccines

Even as the world waits for a vaccine, a potential treatment for coronaviru­s is here — and more could be on the way.

On Friday, the Food and Drug Administra­tion granted emergency authorizat­ion for the use of remdesivir as a treatment.

Remdesivir showed modest success in a federally funded clinical trial, slowing the progressio­n of the disease in some patients. It is approved only for severely ill patients, and the trial did not show that it would significan­tly reduce fatality rates.

The FDA said there are currently 72 therapies in trial. Public health experts have cautioned there will likely be no magic pill. Rather, they are hoping for incrementa­l advances that make COVID-19 less deadly.

“Almost nothing is 100%, especially when you are dealing with a virus that really creates a lot of havoc in the body,” said Dr. Luciana Borio, a former director of medical and biodefense preparedne­ss for the National Security Council during the Trump administra­tion.

Even without a vaccine, Borio said, a handful of early treatments could make a difference. “If you can protect people that are vulnerable and you can treat people that come down with the disease effectivel­y,” she said, “then I think it will change the trajectory of this pandemic.”

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