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US We're one-third of the way to a widely available coronavirus vaccine, experts say

23:55  30 june  2020
23:55  30 june  2020 Source:   usatoday.com

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A vaccine to protect against the coronavirus will be many things wrapped up in a small vial: a harbinger of a return to normalcy, a scientific feat for the ages and, depending on when it arrives, a politically potent symbol.

a close up of a clock: clock_promo © Javier Zarracina clock_promo

The timeline for how long it will take to get that vaccine is a moving target and depends on whom you ask – and when.

Anthony Fauci, the top infectious disease expert at the National Institutes of Health, has repeatedly said he hopes a vaccine could be available by the end of 2020 or early 2021.

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President Donald Trump promised a vaccine will be ready by the end of this year or by January. A White House-led partnership, Operation Warp Speed, allocated almost $10 billion to the effort, and as much as $1.2 billion has been promised on a single vaccine candidate.

Pharmaceutical giant AstraZeneca pledged to have at least 300 million doses for the USA delivered as early as October – probably even before a vaccine is approved.

In an effort to cut through some of the hyperbole and get a realistic sense of when a vaccine will be widely available, USA TODAY created a panel of nationally known experts in medicine, virology, immunology, logistics and supply chain issues to estimate how far we are from a coronavirus vaccine. Every month, these experts will track progress and highlight inevitable setbacks.

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If you think of it as a clock ticking from midnight (when the pandemic began) to noon (when vaccines will be widely available in the USA and life returns to something approaching normal), then as of June, the panel said it’s about 4 a.m.

“The sun has not yet peeked over the horizon, but the horizon glows in the East. We are no longer in darkness,” said Dr. Kelly Moore, associate director of immunization education with the Immunization Action Coalition.

The USA TODAY vaccine panel is designed to offer readers an objective, nonpartisan understanding of how close we are to getting an effective vaccine distributed to the nation’s residents. We’re about a third of the way there, they said.

“I think we’ll have a vaccine by the middle of next year,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia.

Pamela Bjorkman, a structural biologist at Caltech University, said she agrees, though one of the hardest parts – scaling up to make enough doses of the vaccine – will be a major challenge.

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“I subtracted an hour from the one-third of the way there estimate to account for manufacturability and distribution issues,” she said via email.

The challenge isn't just to create a safe and effective vaccine – more than 11 possible candidates will be in human testing this summer. But for a vaccine to end up in a pharmacy or doctor's office near you, companies will have to produce hundreds of millions of doses, then deliver them across the country and eventually the world.

It’s 4 a.m.: Vaccines are on their way

For June, 11 panelists answered our timeline question. Their answers fell between 2 a.m. and 6 a.m., with a median of 4 a.m. – the point where half of the answers were earlier and half were later.

The majority said progress on coronavirus vaccines is remarkably far along as scientists work 24/7 on ways to end the pandemic.

‘The brightest minds in the world are in this fight, and they are moving with an incredible sense of urgency,” said Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization, a trade group.

In a historic and global effort, the basic science behind dozens of vaccine development efforts has mostly been finished in the six months since the virus first appeared.

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“The vaccine candidates are largely in hand,” said Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University.

The global effort has been stellar, said Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York City.

“I have never seen science move so fast,” he said.

Safety first in coronavirus vaccines

Though the science to come up with candidate vaccines was hard, it wasn’t insurmountable, given advances in genetics, virology and immunology.

“Science has provided cutting-edge technologies that were not possible a decade ago,” said Prakash Nagarkatti, an immunologist and vice president for research for the University of South Carolina.

Many of the vaccines in the pipeline rely on new technologies whose underlying science is understood, although the actual techniques are being worked out.

Having a vaccine for just the USA won't protect us, said Erica Ollmann Saphire, a structural biologist and professor at the La Jolla Institute for Immunology.

The important date isn’t when the first person in the USA can go to the doctor’s office and get the first shot. The important date is when we have enough coverage to prevent resurgence and recirculation among the human population, she said.

"We have seen very clearly this year that virus anywhere can become virus everywhere," she said.

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The larger issues looming for these experts is always the messy and impossible-to-project outcomes: how safe and effective the vaccines will be when tested in people. Chemistry is a science of formulas. Biology is the very stuff of life, and as such is almost impossible to predict.

The hardest questions to answer are still to come, they said. Will a vaccine provide lasting protection? Is it safe enough to provide to billions of people? Can it be produced quickly and reliably in huge quantities?

Though the world clamors for a vaccine as quickly as possible, there can be no shortchanging safety for economic or political interests, said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine.

Especially, he said, when it comes time to license vaccines for use.

“The Food and Drug Administration needs to demonstrate that it will not kowtow to political pressures and will do all the due diligence, safety testing and review necessary,” Poland said.

The way this work is presented to the public is crucial and the urgency has gotten in the way of emphasizing the care that goes into the process, Schaffner said.

“When we say that we are ‘hurrying, moving fast, etc.,’ what the public thinks is that we are cutting corners,” he said. “The messaging has been unfortunate.”

The goal must be to build public confidence in whatever vaccines become available by “showing our work openly and honestly,” Moore said. For the world to line up for shots when they become available, researchers must “bring the public along as partners in the process as we have not done perhaps since the early days of the polio vaccine.”

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No estimate can totally predict the unimaginable complexities of the body’s immune response to a brand new vaccine, so they remain just that, estimates. Presuming we can know the outcome is impossible.

“You have an unusual virus, a bat coronavirus that has unusual features, and we’re going to meet that with vaccine strategies that have never been tested before in large populations. What,” Offit asked, “could possibly go wrong?”

How we did it

USA TODAY received responses from 11 scientists and researchers, asking how far they think the vaccine development effort has progressed since Jan. 1, when the virus was first internationally recognized. Those responses were aggregated, and the median was calculated.

This month's panelists

Pamela Bjorkman, structural biologist at the California Institute of Technology

Dr. Florian Krammer, virologist at the Icahn School of Medicine at Mount Sinai in New York City

Dr. Michelle McMurry-Heath, president and CEO of Biotechnology Innovation Organization (BIO)

Dr. Kelly Moore, associate director of immunization education, Immunization Action Coalition; former member of the CDC Advisory Committee on Vaccine Practices; chair, World Health Organization Immunization Practices Advisory Committee

Prakash Nagarkatti, immunologist, vice president for research, University of South Carolina

Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia

Dr. Greg Poland, director, Mayo Clinic's Vaccine Research Group, editor-in-chief, Vaccine

Dan Salmon, Johns Hopkins Bloomberg School of Public Health Institute for Vaccine Safety

Erica Ollmann Saphire, structural biologist, professor at the La Jolla Institute for Immunology

Dr. William Schaffner, professor of preventive medicine, Department of Health Policy, and professor of medicine, Division of Infectious Diseases, Vanderbilt University

Prashant Yadav, senior fellow, Center for Global Development, medical supply chain expert

This article originally appeared on USA TODAY: We're one-third of the way to a widely available coronavirus vaccine, experts say

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