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US Data, data and more data is what will make a coronavirus vaccine safe, says USA TODAY's vaccine panel

19:01  17 september  2020
19:01  17 september  2020 Source:   usatoday.com

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With three experimental coronavirus vaccines now in large, human clinical trials in the United States and a government expectation at least one could be approved by January, the mantra among experts is “data, data, data” — we need more data.

a close up of a clock: Vaccine Panel 7am Topper © Javier Zarracina Vaccine Panel 7am Topper

They know the country longs for normalcy, which only widespread use of a vaccine that makes the majority of Americans immune to COVID-19 can bring. But they remind us a viable vaccine can only come when there’s solid, verifiable and freely accessible research results showing it works and helps more than harms.

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While efforts to create candidate vaccines have been heroic and followed eagerly by the public, in many ways that's been the easy part, said Prakash Nagarkatti, an immunologist and vice president for research at the University of South Carolina.

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“Vaccine technology is not complicated — any research-intensive university has the technology to develop the vaccine,” he said. The challenge is to get through the clinical trials gauntlet with a product proven to be safe and effective.

To understand when pre-COVID-19 life in America can resume, USA TODAY created a panel of experts in medicine, virology, immunology, logistics and supply chain issues to estimate how close we are to securing a vaccine against SARS-CoV-2, the virus that causes COVID-19.

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Every month, we ask the panelist to estimate where they think the race stands and what time it is on the USA TODAY vaccine clock. Midnight is the starting point of the pandemic in the USA, and noon is the time a vaccine is freely available for anyone who wants it.

This month, for the fourth in a row, they see steady progress with the clock for September reaching 7 a.m. That's an hour closer to noon than last month but still just over halfway to the goal.

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'Planning for the release'

On Wednesday the Centers for Disease Control and Prevention issued a playbook outlining how states and local public health programs should plan and prepare for the release of one or more COVID-19 vaccines.

The CDC planning document says vaccine might be available by early November and that planners should assume that by January 2021 "significantly more COVID-19 vaccine may be available for distribution."

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Testifying before Congress later in the day, CDC Director Robert Redfield said only limited amounts of vaccine initially would be available. The general American public, he anticipated, will not be able to get it and "get back to our regular life" until next summer or fall. Hours later, President Trump said Redfield misspoke, casting more confusion on when a vaccine might be on the market.

In any case, the U.S. Food and Drug Administration must give its blessing for any amount of vaccine to be distributed. Exactly how that will happen is something USA TODAY's panelists are watching.

Dr. Stephen Hahn, head of the FDA, has said there might be an intermediate endpoint — before the completion of a 30,000-person trial — that could meet his standards for a so-called emergency use authorization. Such early approval can only be issued during a federal health emergency.

Hahn has said he could cut a vaccine candidate's final clinical trials short as long as there was sufficient data to prove it was safe and effective.

Our panelists said that basic information is only the start of what is needed.

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At a minimum the data must be openly released to the scientific community and thoroughly vetted by FDA’s external Vaccines and Related Biological Products Advisory Committee, said William Schaffner, a professor and infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee.

In addition, there must be no taint of political pressure on FDA to release it quickly — say in time for the Nov. 3 Presidential election.

That's so important that on Sept. 3 the Biotechnology Innovation Organization issued a public letter reiterating the strict standards its members hold themselves to.

“Trusting science — and the scientific process -- is the best way out of this pandemic,” said BIO's President and CEO, Dr. Michelle McMurry-Heath.

On Sept. 8, nine pharmaceutical companies also issued a joint pledge to “high ethical standards and sound scientific principles” in the development and testing of potential vaccines for COVID-19.

“If we take into account how the U.S. government's response thus far has fostered significant public distrust, the risk-benefit calculus changes, and early release is probably not a good idea,” said Arti Rai, a law professor and expert on health law at Duke University Law School.

Others think the intense focus and reporting on the potential problems make it less likely any vaccine would be approved before being fully vetted.

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Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital in Philadelphia, said he would trust FDA officials if they deem a vaccine ready before clinical trials are over.

“I really don’t think these vaccines are going to be released before there’s solid evidence. I’m choosing to believe that,” Offit said.

Dr. Otto Yang at the University of California, Los Angeles, doesn’t see any approval happening before the new year.

“I really don't think we can have safety data that is good enough until at least winter (three to four months of trial data). Shorter than that is too little time, no matter what the results show,” said Yang, a professor of medicine and associate chief of infectious diseases at UCLA's David Geffen School of Medicine.

The bar for how effective an experimental vaccine is must be very high to make early release a reasonable choice, said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine.

The only circumstances under which he sees justification for early release is if there were major changes in either the rate of death or complications among people who got COVID-19, he said.

For some, though, public concern over the safety of a vaccine perceived as rushed makes any truncated FDA approval process unacceptable. A low rate of adverse effects — which can only happen with a full testing process — must come first, said Dr. Monica Gandhi, a professor of medicine and infectious disease expert at the University of California, San Francisco.

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“I know we are desperate and very eager to get out of this pandemic but the best way to do that is to have an efficacious vaccine that is also safe and that people will accept,” she said.

It’s still chilly early morning

This month our experts’ estimated times to a widely available vaccine ranged from a still dark 5 a.m. to a bright and hopeful 10 a.m.

While the clock leapt forward an hour, the temporary halt last week of AstraZeneca's Phase 3 injected a note of caution into mostly positive timeline progression. News of the British participant developing a neurological condition consistent with a rare but serious spinal inflammation called transverse myelitis, set back some of our experts' clocks.

But some, including structural biologist Pamela Bjorkman, saw it as a good sign.

“The encouraging thing is that AstraZeneca did the right thing and paused the trial until they figured out what is going on," said Bjorkman, who is at the California Institute of Technology. "This shows the importance of completing Phase 3 trials with a large cohort of people in the vaccinated and placebo groups, and also waiting for a long enough time to figure out if there had been any dangerous side effects.”

Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition, added: "Pauses and investigations like this are a normal part of the clinical trial process. They’re an important reminder of why such large studies are essential and not just a hoop to jump through on the way to licensure.”

Vaccine editor Poland agreed. “Finally, some sanity is returning to thinking among all involved that we need to slow down, be careful, and be thoughtful in our enthusiasm,” he said.

Panelists also are optimistic that Pfizer and Moderna, two of the other front-runners, both have vaccine trials almost fully enrolled, although Pfizer announced on Sept.12 it plans to expand its vaccine trial to 44,000 volunteers to include 16-18 year olds, as well as people with medical conditions like HIV and hepatitis.

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On Thursday,  Moderna released a 135-page plan outlining how it is conducting its Phase 3 clinical trials, the first of the major vaccine companies to do so.

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Russian and Chinese coronavirus vaccines already out

While the United States focuses on the progress of clinical trials, the vaccine race may already be over in Russia and China, depending on what clinical standards are applied.

In both countries, coronavirus vaccines are now being given to the military and in some cases the public. On Monday, the United Arab Emirates’ government granted Emergency Use Authorization to a COVID-19 vaccine developed in China for frontline health workers.

These vaccines only have finished what in the United States would be considered Phase 1 or Phase 2 clinical trials. Moving ahead with human use of such vaccines are really “high-stakes gambles,” Moore said.

“Without randomized controlled clinical trials we may never fully understand their real risks or benefits,” she said.

The vaccines being employed in those countries have been in the news in the United States, but will not make it into U.S. arms, the panelists said.

More information has been released about the Chinese vaccines, three of which are currently in Phase 3 clinical trials, said Sam Halabi, a University of Missouri law professor with a focus on public health law. For the Russian vaccine, very little data is available.

“Neither country is known for their candor or transparency, so these vaccines are complete unknowns. Obviously, leaders of both countries have strong political motivations for claiming success,” said UCLA’s Yang.

None of the protocols in those countries have been done in consultation with the FDA, Schaffner pointed out. And without U.S. oversight, a vaccine can’t be approved here.

“The Russian and Chinese vaccines are options for those countries, but not for the United States,” he said.

At the University of South Carolina, Nagarkatti has other concerns as well. Chinese and Russian coronavirus vaccines use a modified form of a common cold virus called Ad5. There’s concern those vaccines might not work in people who already have antibodies to that common cold virus, or it may cause other forms of toxicity.

Not only that, he said. Previous studies using Ad5 “have shown that it may make people become more susceptible to HIV/AIDS.”

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

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

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 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: Data, data and more data is what will make a coronavirus vaccine safe, says USA TODAY's vaccine panel


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