I’m part of a coronavirus vaccine trial. Keep politics out of it. - The Washington Post | Canada News Media
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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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‘Disgraceful:’ N.S. Tory leader slams school’s request that military remove uniform

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HALIFAX – Nova Scotia Premier Tim Houston says it’s “disgraceful and demeaning” that a Halifax-area school would request that service members not wear military uniforms to its Remembrance Day ceremony.

Houston’s comments were part of a chorus of criticism levelled at the school — Sackville Heights Elementary — whose administration decided to back away from the plan after the outcry.

A November newsletter from the school in Middle Sackville, N.S., invited Armed Forces members to attend its ceremony but asked that all attendees arrive in civilian attire to “maintain a welcoming environment for all.”

Houston, who is currently running for re-election, accused the school’s leaders of “disgracing themselves while demeaning the people who protect our country” in a post on the social media platform X Thursday night.

“If the people behind this decision had a shred of the courage that our veterans have, this cowardly and insulting idea would have been rejected immediately,” Houston’s post read. There were also several calls for resignations within the school’s administration attached to Houston’s post.

In an email to families Thursday night, the school’s principal, Rachael Webster, apologized and welcomed military family members to attend “in the attire that makes them most comfortable.”

“I recognize this request has caused harm and I am deeply sorry,” Webster’s email read, adding later that the school has the “utmost respect for what the uniform represents.”

Webster said the initial request was out of concern for some students who come from countries experiencing conflict and who she said expressed discomfort with images of war, including military uniforms.

Her email said any students who have concerns about seeing Armed Forces members in uniform can be accommodated in a way that makes them feel safe, but she provided no further details in the message.

Webster did not immediately respond to a request for comment.

At a news conference Friday, Houston said he’s glad the initial request was reversed but said he is still concerned.

“I can’t actually fathom how a decision like that was made,” Houston told reporters Friday, adding that he grew up moving between military bases around the country while his father was in the Armed Forces.

“My story of growing up in a military family is not unique in our province. The tradition of service is something so many of us share,” he said.

“Saying ‘lest we forget’ is a solemn promise to the fallen. It’s our commitment to those that continue to serve and our commitment that we will pass on our respects to the next generation.”

Liberal Leader Zach Churchill also said he’s happy with the school’s decision to allow uniformed Armed Forces members to attend the ceremony, but he said he didn’t think it was fair to question the intentions of those behind the original decision.

“We need to have them (uniforms) on display at Remembrance Day,” he said. “Not only are we celebrating (veterans) … we’re also commemorating our dead who gave the greatest sacrifice for our country and for the freedoms we have.”

NDP Leader Claudia Chender said that while Remembrance Day is an important occasion to honour veterans and current service members’ sacrifices, she said she hopes Houston wasn’t taking advantage of the decision to “play politics with this solemn occasion for his own political gain.”

“I hope Tim Houston reached out to the principal of the school before making a public statement,” she said in a statement.

This report by The Canadian Press was first published Nov. 8, 2024.

The Canadian Press. All rights reserved.

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Saskatchewan NDP’s Beck holds first caucus meeting after election, outlines plans

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REGINA – Saskatchewan Opposition NDP Leader Carla Beck says she wants to prove to residents her party is the government in waiting as she heads into the incoming legislative session.

Beck held her first caucus meeting with 27 members, nearly double than what she had before the Oct. 28 election but short of the 31 required to form a majority in the 61-seat legislature.

She says her priorities will be health care and cost-of-living issues.

Beck says people need affordability help right now and will press Premier Scott Moe’s Saskatchewan Party government to cut the gas tax and the provincial sales tax on children’s clothing and some grocery items.

Beck’s NDP is Saskatchewan’s largest Opposition in nearly two decades after sweeping Regina and winning all but one seat in Saskatoon.

The Saskatchewan Party won 34 seats, retaining its hold on all of the rural ridings and smaller cities.

This report by The Canadian Press was first published Nov. 8, 2024.

The Canadian Press. All rights reserved.

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Nova Scotia election: Liberals say province’s immigration levels are too high

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HALIFAX – Nova Scotia‘s growing population was the subject of debate on Day 12 of the provincial election campaign, with Liberal Leader Zach Churchill arguing immigration levels must be reduced until the province can provide enough housing and health-care services.

Churchill said Thursday a plan by the incumbent Progressive Conservatives to double the province’s population to two million people by the year 2060 is unrealistic and unsustainable.

“That’s a big leap and it’s making life harder for people who live here, (including ) young people looking for a place to live and seniors looking to downsize,” he told a news conference at his campaign headquarters in Halifax.

Anticipating that his call for less immigration might provoke protests from the immigrant community, Churchill was careful to note that he is among the third generation of a family that moved to Nova Scotia from Lebanon.

“I know the value of immigration, the importance of it to our province. We have been built on the backs of an immigrant population. But we just need to do it in a responsible way.”

The Liberal leader said Tim Houston’s Tories, who are seeking a second term in office, have made a mistake by exceeding immigration targets set by the province’s Department of Labour and Immigration. Churchill said a Liberal government would abide by the department’s targets.

In the most recent fiscal year, the government welcomed almost 12,000 immigrants through its nominee program, exceeding the department’s limit by more than 4,000, he said. The numbers aren’t huge, but the increase won’t help ease the province’s shortages in housing and doctors, and the increased strain on its infrastructure, including roads, schools and cellphone networks, Churchill said.

“(The Immigration Department) has done the hard work on this,” he said. “They know where the labour gaps are, and they know what growth is sustainable.”

In response, Houston said his commitment to double the population was a “stretch goal.” And he said the province had long struggled with a declining population before that trend was recently reversed.

“The only immigration that can come into this province at this time is if they are a skilled trade worker or a health-care worker,” Houston said. “The population has grown by two per cent a year, actually quite similar growth to what we experienced under the Liberal government before us.”

Still, Houston said he’s heard Nova Scotians’ concerns about population growth, and he then pivoted to criticize Prime Minister Justin Trudeau for trying to send 6,000 asylum seekers to Nova Scotia, an assertion the federal government has denied.

Churchill said Houston’s claim about asylum seekers was shameful.

“It’s smoke and mirrors,” the Liberal leader said. “He is overshooting his own department’s numbers for sustainable population growth and yet he is trying to blame this on asylum seekers … who aren’t even here.”

In September, federal Immigration Minister Marc Miller said there is no plan to send any asylum seekers to the province without compensation or the consent of the premier. He said the 6,000 number was an “aspirational” figure based on models that reflect each province’s population.

In Halifax, NDP Leader Claudia Chender said it’s clear Nova Scotia needs more doctors, nurses and skilled trades people.

“Immigration has been and always will be a part of the Nova Scotia story, but we need to build as we grow,” Chender said. “This is why we have been pushing the Houston government to build more affordable housing.”

Chender was in a Halifax cafe on Thursday when she promised her party would remove the province’s portion of the harmonized sales tax from all grocery, cellphone and internet bills if elected to govern on Nov. 26. The tax would also be removed from the sale and installation of heat pumps.

“Our focus is on helping people to afford their lives,” Chender told reporters. “We know there are certain things that you can’t live without: food, internet and a phone …. So we know this will have the single biggest impact.”

The party estimates the measure would save the average Nova Scotia family about $1,300 a year.

“That’s a lot more than a one or two per cent HST cut,” Chender said, referring to the Progressive Conservative pledge to reduce the tax by one percentage point and the Liberal promise to trim it by two percentage points.

Elsewhere on the campaign trail, Houston announced that a Progressive Conservative government would make parking free at all Nova Scotia hospitals and health-care centres. The promise was also made by the Liberals in their election platform released Monday.

“Free parking may not seem like a big deal to some, but … the parking, especially for people working at the facilities, can add up to hundreds of dollars,” the premier told a news conference at his campaign headquarters in Halifax.

This report by The Canadian Press was first published Nov. 7, 2024.

— With files from Keith Doucette in Halifax

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