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I’m part of a coronavirus vaccine trial. Keep politics out of it. – The Washington Post

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In April, I signed up for the world’s first coronavirus vaccine trial. I was twice injected with the highest dose of mRNA-1273, an experimental vaccine made by the National Institutes of Health and the private biotechnology company Moderna. That vaccine candidate, along with a handful of others, has progressed to the final stage of clinical testing. If proved safe and effective, it may put a stop to the pandemic.

President Trump has promised a coronavirus vaccine will be approved next month and the public will have access to it “immediately.” Talk about an October surprise. At a White House news briefing on Sept. 18, he said “hundreds of millions of doses will be available every month, and we expect to have enough vaccines for every American by April.”

Overconfidence aside, a recent survey by the Pew Research Center found about half of Americans say they would not take such a vaccine. Across all age groups, ethnicities and education levels, confidence in future coronavirus vaccinations is plummeting. Concerns over side effects and effectiveness loom large. The White House launched Operation Warp Speed in the spring to accelerate a vaccine, but Pew finds nearly 9 in 10 Democrats are more worried that the process is moving too fast, not too slow. Nearly 7 in 10 Republicans agree.

To ward off this growing anxiety, the Food and Drug Administration may soon issue tougher standards for vaccine approval. But Trump has said he may reject such a plan, saying it “sounds like a political move.”

What’s the point of developing a vaccine at “warp speed” if most Americans refuse to take it? This crisis of confidence could undermine the entire vaccine development effort, at least in this country. It will get much worse if partisan actors — up to and including Trump — tie vaccine approval to a political deadline.

Science does not happen on a fixed schedule. It takes time to get things right. Interfering with that process for political purposes would not only be dangerous, but it would also be an insult to the tens of thousands of vaccine volunteers like me who have already taken on personal risk on behalf of others.

How should the vaccine timetable be set? By science, of course.

Phase 1 trials, like the one I am in, are designed to discover whether a vaccine is safe in a small number of healthy people. When I received the highest experimental dose of the Moderna vaccine, I suffered a fever of more than 103, nausea and other unpleasant side effects that lasted one day. But my reaction helped scientists discover the dose I had been given was probably too high. That high dose is no longer being tested.

Phase 3 trials, like the one my mother is enrolled in, establish whether a vaccine actually works in a much larger and more diverse population. At their core, such trials are surprisingly simple: Thousands of volunteers like my mom get injected with either a vaccine or a placebo, then they’re monitored to see whether they catch the virus as they go about their daily lives. If people who received the placebo get infections at a higher rate than those who got the real vaccine, we know the vaccine is protective. Phase 3 trials can also reveal whether a vaccine causes rare side effects that earlier trials didn’t turn up in smaller populations.

How do scientists decide when a Phase 3 trial is over? When a predetermined number of participants are infected. How many is agreed on ahead of time — the larger the number, the more confident we can all be in the protective power of the vaccine.

In a commendable act of transparency, the companies behind four of the leading vaccine candidates — Moderna, Astra-Zeneca, Pfizer and Johnson & Johnson — have publicly released their full Phase 3 trial plans, including the predetermined number of infections they are looking for. In clinical-trial speak, these infections are euphemistically called “events.” Each trial is recruiting tens of thousands of volunteers and is designed for between 150 and 170 events.

Few people know how many infections have occurred within these Phase 3 trials — that critical data is seen only by an independent monitoring board that is not beholden to the companies or the government.

But soon, regulators will receive updates about how the Phase 3 trials are going. It is at those crucial moments when partisan pressure could be applied.

There is a chance initial results will point unambiguously toward approval or rejection, but things could also be murky. The number of infections in the trials might not be high enough to know for certain whether the vaccine is working. But the president has already promised approval.

The FDA, led by Stephen Hahn, has the power to grant emergency approval based on incomplete clinical trial data. We must rely on the agency to do the right thing, even if it means missing Trump’s mid-October deadline. But if the FDA commissioner declines to approve a vaccine in October because of limited data, the secretary of health and human services, Alex Azar, may be able to override that decision. Such interference from the top down is what led to emergency use authorization for the unproven drug hydroxychloroquine earlier this year. Eventually, the FDA reversed that decision, explaining the malaria medication was “unlikely to be effective” against covid-19, the disease the novel coronavirus causes, and any potential benefit of taking it would not outweigh “known and potential risks.”

In a bid to boost public trust — and partly for fear politics might undermine it — nine leading companies in the vaccine race recently pledged not to seek approval or emergency use authorization for their vaccines until “demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as F.D.A.” It’s a noble pledge, but only if they stick to it.

I hope we develop a safe and effective vaccine as soon as possible. I put my body on the line to help make that happen. But people will have confidence in a coronavirus vaccine only if science — not partisan politics — leads the way.

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As Trump weakens rules insulating civil servants from politics, an official resigns in protest. – The New York Times

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The head of a federal panel that advises the White House on compensation issues resigned on Monday to protest President Trump’s new executive order that could wipe out employment protections for tens of thousands of federal workers.

Ronald P. Sanders, the chairman of the Federal Salary Council, who was appointed by Mr. Trump in 2017, said that the new executive order would replace “political expertise with political obeisance.”

The order, signed last week, gives Mr. Trump and his political appointees the power to hire and fire certain federal civil servants who now hold jobs that are supposed to be exempt from political influence.

“The Executive Order is nothing more than a smokescreen for what is clearly an attempt to require the political loyalty of those who advise the President, or failing that, to enable their removal with little if any due process,” Mr. Sanders, who called himself a lifelong Republican, wrote in his resignation letter, dated today and sent to the White House. “I have concluded that as a matter of conscience, I can no longer serve him or his administration.”

The president’s executive order has already provoked protests by federal labor unions and some Democrats in Congress. If Mr. Trump is not re-elected, the next administration could repeal the measure.

Mr. Sanders wrote of civil servants, “The only ‘boss’ that they serve is the public,” adding, “No president should be able to remove career civil servants whose only sin is that they may speak such a truth to him.” The board Mr. Sanders resigned from is made up of experts in labor relations and representatives of federal labor unions.

A White House official did not immediately respond to a request for comment.

The White House, in a statement that accompanied the executive order, said the new employee classification was justified because under current rules “removing poor performers, even from these critical positions, is time-consuming and difficult.”

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Commons showdown highlights tension between politics and science – Trail Times

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Monday’s vote on a Conservative motion to launch an in-depth review of the Liberal government’s COVID-19 response highlights a key challenge of pandemic politics: how to hold a government accountable for decisions based on science, when the science itself is changing nearly every day.

The opposition wants a committee probe into everything from why regulators are taking so long to approve rapid testing to an early decision not to close the border to international travel, and what concerns the Liberals is how that probe is being framed.

“One of the narratives that I find most distressing coming from the opposition, is that somehow because advice changed at some point that the government was hiding information or that the government was giving misinformation,” Health Minister Patty Hajdu said late last week.

“And nothing could be further from the truth.”

It’s not the science itself that’s up for debate, said Conservative Leader Erin O’Toole.

“In a pandemic, borders, since the Middle Ages, have been part of a stop of spreading of the virus and that was a failure of elected officials to put the health of Canadians first,” O’Toole told reporters last week.

“There has been conflicting information on masks and other things. My concern is that the Trudeau government relies more on open source data from China than our own science and intelligence experts.”

The relationship between a nation’s scientists and their senior politicians is a challenging one, said Ian Culbert, executive director of the Canadian Public Health Association.

Chief Public Health Officer Dr. Theresa Tam provides the scientific evidence there is, but at the end of the day, it is the politicians who make the call, he said.

A decision on whether or not to close the borders is a good example, he said.

In the early days of the pandemic, the World Health Organization cautioned against widespread border closures. Scientific research has suggested there’s little medical benefit to them and the economic impacts can be severe and wide-ranging.

READ MORE: Companies warn Tory motion could deter domestic production of PPE

But the optics of border closures, the idea that if countries can keep out a virus out they will be immune, creates political pressure to act, Culbert said .

“The tension between what is in the public’s good, as opposed to all of the varying political considerations the politicians have to take into consideration — there’s always a tension there,” Culbert said.

While heated, the interplay between Liberal government and Opposition Conservatives is a far cry from the hyper-partisanship around pandemic response in the U.S., where even the president has circulated misinformation and challenged that country’s top scientists.

Canadian researchers studying the response of political elites here in the early days of the pandemic found no evidence of MPs casting doubt on the seriousness of the pandemic, or spreading conspiracy theories about it. In fact, there was a cross partisan consensus around how seriously it needed to be taken.

“As far as we can tell, that story hasn’t changed,” said Eric Merkley, a University of Toronto political scientist who led the study.

Both he and Culbert said a review of the Liberals’ pandemic response is warranted, but a balancing act is required.

“Everyone has 20/20 hindsight and thinks that they can go, look back, and and point to points at which bad decisions were made,” Culbert said.

“But that’s with the knowledge that we have today. We didn’t have that knowledge back in March.”

The Liberals have sometimes hit back at criticism by pointing to how the previous Conservative government handled the science and health files, including budget cuts and efforts to muzzle scientists.

But critics can’t be painted as anti-science for asking questions, Merkley said.

“There’s plenty of scope for democratic debate about proper responses to the pandemic, there’s plenty of scope for disagreement,” Merkley said.

“And just because there’s that disagreement and an Opposition party holding government accountable, that’s not necessarily a bad thing. In fact, that’s a sign of a healthy democracy.”

Stephanie Levitz, The Canadian Press


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Commons showdown highlights tension between politics and science – Alberni Valley News

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Monday’s vote on a Conservative motion to launch an in-depth review of the Liberal government’s COVID-19 response highlights a key challenge of pandemic politics: how to hold a government accountable for decisions based on science, when the science itself is changing nearly every day.

The opposition wants a committee probe into everything from why regulators are taking so long to approve rapid testing to an early decision not to close the border to international travel, and what concerns the Liberals is how that probe is being framed.

“One of the narratives that I find most distressing coming from the opposition, is that somehow because advice changed at some point that the government was hiding information or that the government was giving misinformation,” Health Minister Patty Hajdu said late last week.

“And nothing could be further from the truth.”

It’s not the science itself that’s up for debate, said Conservative Leader Erin O’Toole.

“In a pandemic, borders, since the Middle Ages, have been part of a stop of spreading of the virus and that was a failure of elected officials to put the health of Canadians first,” O’Toole told reporters last week.

“There has been conflicting information on masks and other things. My concern is that the Trudeau government relies more on open source data from China than our own science and intelligence experts.”

The relationship between a nation’s scientists and their senior politicians is a challenging one, said Ian Culbert, executive director of the Canadian Public Health Association.

Chief Public Health Officer Dr. Theresa Tam provides the scientific evidence there is, but at the end of the day, it is the politicians who make the call, he said.

A decision on whether or not to close the borders is a good example, he said.

In the early days of the pandemic, the World Health Organization cautioned against widespread border closures. Scientific research has suggested there’s little medical benefit to them and the economic impacts can be severe and wide-ranging.

READ MORE: Companies warn Tory motion could deter domestic production of PPE

But the optics of border closures, the idea that if countries can keep out a virus out they will be immune, creates political pressure to act, Culbert said .

“The tension between what is in the public’s good, as opposed to all of the varying political considerations the politicians have to take into consideration — there’s always a tension there,” Culbert said.

While heated, the interplay between Liberal government and Opposition Conservatives is a far cry from the hyper-partisanship around pandemic response in the U.S., where even the president has circulated misinformation and challenged that country’s top scientists.

Canadian researchers studying the response of political elites here in the early days of the pandemic found no evidence of MPs casting doubt on the seriousness of the pandemic, or spreading conspiracy theories about it. In fact, there was a cross partisan consensus around how seriously it needed to be taken.

“As far as we can tell, that story hasn’t changed,” said Eric Merkley, a University of Toronto political scientist who led the study.

Both he and Culbert said a review of the Liberals’ pandemic response is warranted, but a balancing act is required.

“Everyone has 20/20 hindsight and thinks that they can go, look back, and and point to points at which bad decisions were made,” Culbert said.

“But that’s with the knowledge that we have today. We didn’t have that knowledge back in March.”

The Liberals have sometimes hit back at criticism by pointing to how the previous Conservative government handled the science and health files, including budget cuts and efforts to muzzle scientists.

But critics can’t be painted as anti-science for asking questions, Merkley said.

“There’s plenty of scope for democratic debate about proper responses to the pandemic, there’s plenty of scope for disagreement,” Merkley said.

“And just because there’s that disagreement and an Opposition party holding government accountable, that’s not necessarily a bad thing. In fact, that’s a sign of a healthy democracy.”

Stephanie Levitz, The Canadian Press


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