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Some Worry The Trump Administration Will Play Politics With A COVID-19 Vaccine : Shots – Health News – NPR

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FDA Commissioner Stephen Hahn (left), Vice President Mike Pence, and Dr. Ella Grach, CEO of Wake Research, at the NC Biotechnology Center in July, where Phase 3 trials for a coronavirus vaccine candidate are underway.

Gerry Broome/AP

Gerry Broome/AP

Under normal circumstances, it could take years — if not decades — to bring a new vaccine to market. The COVID-19 pandemic has changed all that. In May, the Trump Administration launched Operation Warp Speed with the goal of delivering initial doses of a safe and effective vaccine by January, 2021 –shortening the development time from years to months.

Some worry that to meet that ambitious schedule, the Administration might cut important scientific corners. They fear that President Trump could announce an “October surprise”– declaring that a vaccine works before it has passed scientific muster in order to enhance his reelection chances.

After all, the President ballyhooed supposed virtues of hydroxychloroquine when most scientists thought the drug was not helpful, and maybe downright dangerous in treating or preventing coronavirus infections. This week, the FDA granted authorization for using convalescent plasma as a treatment for COVID-19, a move some say was done under political pressure from the White House.

FDA officials have maintained that all their decisions are based on science, not politics.

In June, the agency released guidance for what it would require before granting any kind of approval for the COVID-19 vaccine.

The guidance states that at a minimum, the FDA wants to see any vaccine tested in thousands of people so that any relatively rare side effects can be caught, and to see if the vaccine is actually preventing disease. The agency also says the vaccine doesn’t have to prevent 100% of disease to get a green light; just 50% would be sufficient.

How long it would take to show that depends on several factors, including how fast volunteers can be enrolled in trials and how much virus is circulating where the trials are taking place. Certainly it’s a process that would take months.

The Trump Administration has vowed to cut red tape to speed the approval process, and the normal process does require a lot of data and a lot of paperwork.

But the FDA has also said it would consider granting something called an Emergency Use Authorization, or EUA, to the makers of a vaccine candidate that appeared to be safe and effective.

That’s where critics worry political influence could creep in.

“The EUA rules are loose,” says Paul Offit, a vaccine developer at Children’s Hospital of Philadelphia and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee. Usually, the FDA would rely on the independent scientists on that committee to advise it about important decisions concerning new therapies and vaccines. Offit worries the FDA could be pressured into issuing an EUA with little or no scrutiny of that decision.

It’s a concern echoed by the leadership of the Infectious Diseases Society of America and HIV Medicine Association. In a letter to the FDA, they write, “We want to underscore that it is critical that FDA ensures sufficient safety and efficacy data are available and have been reviewed by internal as well as independent experts prior to granting an EUA.”

FDA Commissioner Stephen Hahn has tried to assure skeptics that won’t happen. He wrote an editorial dated Aug. 7, 2020 in the medical journal JAMA.

“The physician leadership of the U.S. Food and Drug Administration (including the authors of this Viewpoint) unequivocally state that candidate COVID-19 vaccines will be reviewed according to the established legal and regulatory standards for medical products,” Hahn wrote.

The editorial continues: “Given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA’s Vaccines and Related Biological Products Advisory Committee will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy.”

Even if the evidence is made public, there could still be a robust scientific debate over whether a vaccine is ready for approval. Opinions will vary about just how convincing the data are, and whether the reported effectiveness is really adequate to rein in the pandemic.

The shorter the time allotted for testing, the less likely there will be ironclad evidence that a vaccine is effective. What’s more, the fewer people in whom the vaccine is tested, the less likely the testing will reveal rare but fatal side effects. Shorter testing periods also mean there’s less certainty about how long any protective effect from a vaccine will last.

So there are bound to be critics of any decision the FDA makes.

Paul Offit says making the right decision is critical.

“We have two ways out of this pandemic. One is hygienic measures — which we don’t seem very good at — and two is the vaccine,” he says.

“Don’t screw this up. The vaccine is our best way out of it at this point. And to shake the American confidence further with either an unsafe or ineffective vaccine would be, I think, a disaster.”

At least two other countries seem to have slighted science in making decisions about vaccines. For example, Russian President Vladimir Putin announced on Aug. 11 that regulators in that country would approve a Russian-made vaccine — long before it had undergone the kind of evaluation scientists say is essential. China also reportedly began giving an unproven vaccine to its citizens in July.

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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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