Science is making incredible progress toward a COVID-19 vaccine, but as approval nears – potentially as early as December – worry has shifted to the complexity of distribution.
Overall, hopefulness was the theme of USA TODAY’s vaccine panel this month. After five months, the panel’s countdown clock to a widely available vaccine skipped forward another hour, to 8 a.m.
Companies and observers generally expect at least one COVID-19 candidate vaccine soon will receive a regulatory thumbs up. Dr. Francis Collins, director of the National Institutes of Health, joined the chorus Tuesday when he told NPR he was “guardedly optimistic” one or more of the candidates will be judged safe and effective by the end of the year.
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But reality is setting in about how hard it will be to get an approved vaccine into the arms of everyone who wants it – twice.
“The initial vaccine supply and the distribution and vaccination programs will not live up to the public’s desire for immediate, widespread access to a safe and effective vaccine,” said Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition.
Health care workers and first responders are likely to be prioritized for an approved vaccine, followed by high-risk elderly.
Even those limited groups account for as many as 150 million Americans, said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. Unless three vaccines win approval simultaneously, it’s unlikely enough doses will be available right away.
The two leading vaccine candidates have to be delivered in different ways, adding to the difficulty of getting the right vaccine into the right person. Both require two doses, but the Pfizer-BioNTech vaccine shots are given 21 days apart, while Moderna’s second shot is delivered at 28 days.
Moderna’s vaccine must be kept frozen. Pfizer’s has to be kept even colder – at minus-78 degrees Fahrenheit, the temperature of dry ice – meaning it needs different shipping and storing protocols.
Another variable is whether the vaccines will be equally effective in groups such as the elderly. Studies underway may show one vaccine is more effective than another among high-risk populations, adding even more complexity.
“It’s going to be hard,” Offit said, to get the right vaccine into the right person’s arm at the right time. And then to do it again with a second dose.
For the past five months, USA TODAY has asked a dozen or more experts in all aspects of vaccine development to gauge the progress on a COVID-19 vaccine.
We asked panel members to place vaccine development on a 12-hour clock, on which midnight, the starting point, is the moment in early January when the world became aware of the virus known as SARS-CoV-2, and noon is the time a vaccine will become widely available.
In late June, panelists put the time at 4 a.m., one-third of the way – a stunning amount of progress considering the short time frame.
By July, the panel’s estimate crept forward to 5 a.m. as the launch of large clinical trials fueled optimism, tempered by concern that “a lot had to go right.”
August and September each saw the clock advance an hour. There were no major setbacks, and plans began to fall into place for distributing an eventual vaccine.
This month, panelists moved the clock yet another hour closer to a broadly available vaccine, though there was a wider spread than usual among the 15. Some said we’re still in the very early morning hours. Others said we’re closing in on the goal.
For October, the midway point among our experts’ times was 8 a.m., nearing three-quarters of the way there.
First generation versus next-gen
All six candidate vaccines backed by U.S. taxpayers were developed quickly this spring. They received government financing for development, manufacturing or both, so they could be made faster than conventional vaccines, which have taken a minimum of four years and often far longer to develop.
All the companies are contractually obligated to produce at least 100 million doses of vaccine in return for funding. All those doses won’t be available the first day a vaccine gets a thumbs up from the U.S. Food and Drug Administration.
“For the two or three lead candidates, we may have a few million stockpiled doses and a clear production plan for the first couple of hundred million doses,” said Prashant Yadav, a medical supply chain expert and senior fellow at the Center for Global Development.
If none of the front-runners pans out, things get less clear, he said.
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Two of the leaders, Pfizer and Moderna, use messenger RNA platforms never before used for an approved vaccine, noted Duke University Law School professor and health law expert Arti Rai.
Even if one or more works, there might be better vaccines to come – for instance, requiring just one dose or proving more effective in older or more vulnerable people. Once a vaccine is secured, it may be difficult to convince tens of thousands of people to volunteer to test a 2.0 or 3.0 version.
As infections hopefully drop once a vaccine becomes available, it will be harder to find volunteers in the USA likely to contract COVID-19. The trials include 30,000 people, and at least 150 of them need to get sick to statistically prove whether a vaccine is effective. Fewer infections means it will take longer to reach that number.
Virtually all the USA TODAY panelists said they expect it will be difficult to improve on first-generation vaccines.
Waning public interest after a first COVID-19 vaccine is approved could mean that “some of these vaccine trials trailing behind will have to close,” said Dr. Monica Gandhi, a professor of medicine and infectious disease expert at the University of California-San Francisco.
Bringing multiple COVID-19 vaccines across the finish line will be crucial for ensuring everyone, regardless of age, ethnicity, health status and other variables, has a safe and effective vaccine available, said Dr. Michelle McMurry-Heath, president and CEO of Biotechnology Innovation Organization.
“It’s why having diversity among the volunteers in clinical trials is so important, so researchers can follow the data to know precisely how vaccines work in different populations,” she said. “The more solutions we have, the better prepared we will be to end this global pandemic.”
Distribution and other concerns
Like Offit, Sandra Crouse Quinn, senior associate director of the Maryland Center for Health Equity, said she’s worried about how state and local health departments will deal with the complexity of vaccinating so many people.
“From my interactions with some county and state public health agencies, they are trying to get their plans organized,” she said. “But without knowing which or how many vaccines will make it successfully though, it is a challenge to plan.”
There are tremendous logistical challenges ahead, said Dr. Gregory Poland, director of the Mayo Clinic’s Vaccine Research Group and editor-in-chief of the journal Vaccine.
“It will be confusing and likely chaotic,” he said.
Pamela Bjorkman, a structural biologist at the California Institute of Technology, said her “optimism was diminished” by holds put on two of the leading vaccine candidates.
AstraZeneca’s trial was paused in September after a British volunteer had a rare neurological complication. Although the trial in the U.K. was allowed to resume, the FDA continued the hold on the U.S. trial.
This month, Johnson & Johnson’s trial was paused after a participant came down with an “unexplained illness.”
Trial pauses are relatively routine, “so nothing necessarily to worry about in terms of vaccine safety,” Bjorkman said. “It shows, however, that testing vaccines should be done carefully and without skipping any safety standards.”
How we did it
USA TODAY received responses from 15 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 we calculated the median, the midway point among them.
This month’s panelists
Pamela Bjorkman, structural biologist at the California Institute of Technology
Dr. Monica Gandhi, an infectious disease expert at the University of California-San Francisco
Sam Halabi, professor of law, University of Missouri; scholar at the O’Neill Institute for National and Global Health Law at Georgetown University
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
Dr. Kelly Moore, associate director of immunization education, Immunization Action Coalition; former member of the CDC Advisory Committee on Immunization Practices; chair, World Health Organization Immunization Practices Advisory Committee
Prakash Nagarkatti, immunologist and 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.
Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, and a former FDA Associate Commissioner for External Relations.
Dr. Gregory Poland, director, Mayo Clinic’s Vaccine Research Group, editor-in-chief, Vaccine
Sandra Crouse Quinn, senior associate director of the Maryland Center for Health Equity, and chair of the department of family science at the University of Maryland School of Public Health
Arti Rai, law professor and health law expert at Duke University Law School
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
Dr. Otto Yang, a professor of medicine and associate chief of infectious disease at the David Geffen School of Medicine at UCLA
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: USA TODAY’s experts say securing a COVID-19 vaccine in record time could be easy, but distributing it won’t be