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Scientists Worry About Political Influence Over Coronavirus Vaccine Project – The New York Times

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In April, with hospitals overwhelmed and much of the United States in lockdown, the Department of Health and Human Services produced a presentation for the White House arguing that rapid development of a coronavirus vaccine was the best hope to control the pandemic.

“DEADLINE: Enable broad access to the public by October 2020,” the first slide read, with the date in bold.

Given that it typically takes years to develop a vaccine, the timetable for the initiative, called Operation Warp Speed, was incredibly ambitious. With tens of thousands dying and tens of millions out of work, the crisis demanded an all-out public-private response, with the government supplying billions of dollars to pharmaceutical and biotechnology companies, providing logistical support and cutting through red tape.

It escaped no one that the proposed deadline also intersected nicely with President Trump’s need to curb the virus before the election in November.

The ensuing race for a vaccine — in the middle of a campaign in which the president’s handling of the pandemic is the key issue after he has spent his time in office undermining science and the expertise of the federal bureaucracy — is now testing the system set up to ensure safe and effective drugs to a degree never before seen.

Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation, according to interviews with administration officials, federal scientists and outside experts.

Even in a less politically charged environment, there would be a fraught debate about how much to accelerate the process of trials and approval. The longer that vaccines are tested before being released, the likelier they are to be safe and effective.

But with 1,000 people dying each day in the United States, schools finding it difficult to reopen and the deep recession inflicting economic pain across the country, the desire to find a way to return to normal life is powerful and transcends partisan politics and borders. On Sunday, Russia announced that it planned to start a nationwide inoculation campaign in October with a vaccine that had yet to complete clinical trials, the latest evidence of the global potential for cutting corners.

Despite concerted efforts by the Trump administration and a bevy of pharmaceutical companies it is working with, the original October target has slipped, with the administration now pushing to have hundreds of millions of doses available by the end of the year or early 2021.

But experts inside and outside the government still say they fear the White House will push the Food and Drug Administration to overlook insufficient data and give at least limited emergency approval to a vaccine, perhaps for use by specific groups like front-line health care workers, before the vote on Nov. 3.

“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, ‘We’ve tested it on a few thousand people, it looks safe, and now we are going to roll it out,’” said Dr. Paul A. Offit of the University of Pennsylvania, who is a member of the Food and Drug Administration’s vaccine advisory committee.

“They are really worried about that,” he added. “And they should be.”

Mr. Trump relentlessly touts progress toward a vaccine, raising hopes of quick approval. Touring a North Carolina biotechnology lab last week, he vowed to “deliver a vaccine in record time.” In a tweet last month, he explicitly tied vaccines to his re-election hopes.

Credit…Hans Pennink/Associated Press

On a campaign call with supporters in Pennsylvania on Sunday evening, Mr. Trump said the “F.D.A. has been great, at my instruction,” and he again raised hopes of rapid progress.

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“We expect to have a vaccine available very, very early before the end of the year, far ahead of schedule,” he said. “We’re very close to having that finalized.”

The president’s son-in-law and senior adviser, Jared Kushner, who is helping to steer the re-election campaign from the White House, is a regular participant in meetings of a board formed to oversee the vaccine effort.

While White House officials do not specifically mention the election during the board’s discussions, people familiar with the conversations say they ask regularly about October, a date that hangs over the effort. Trump campaign advisers privately call a pre-election vaccine “the holy grail.”

The Food and Drug Administration’s approval of a new vaccine is typically an exhaustive process, where agency employees meticulously go through data from clinical trials to review whether the vaccine is both safe and effective. The threshold for approving vaccines is typically higher than it is for therapeutic drugs because they will be used in millions of otherwise healthy people, meaning that even rare side effects could affect many more people than a drug that treats a specific illness.

An independent advisory panel of outside experts also weighs in, and while the agency has the power to make its own decision, it typically follows the advice of its outside panels. The Food and Drug Administration’s senior regulator has the power to approve or deny vaccines for emergency use, but that decision could be overridden by the agency’s top leaders, or by the secretary of health and human services.

White House officials said that Mr. Trump would not distort the vaccine review process to help his campaign. “The rapid research, development, trials and eventual distribution of a Covid-19 vaccine is emblematic of President Trump’s highest priority: the health and safety of the American people,” said Judd Deere, a White House spokesman. “It has nothing to do with politics.”

Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers on Friday that he remained “cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.”

Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, has not ruled out emergency approval of a vaccine.

“We would consider using an emergency use authorization if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine,” he told The Journal of the American Medical Association in an online interview.

He also said regulators would certify that any vaccine would meet the agency’s rigorous standards, adding, “My job as commissioner is to make sure to the fullest extent possible that any pressure that comes to the agency is not reflected downward” onto regulators and scientists studying the vaccines.

At the same time, a senior administration official refused to promise that any emergency approval of a vaccine would be vetted through the Food and Drug Administration’s outside advisory panel of experts, scheduled to meet on Oct. 22.

Operation Warp Speed got its start in April, the brainchild of Dr. Peter Marks, a pencil-thin, bespectacled physician who leads the regulatory unit at the Food and Drug Administration that approves vaccines and therapies.

A “Star Trek” fan, Dr. Marks named the initiative Warp Speed and pitched it in an April 10 phone call to Alex M. Azar II, the secretary of health and human services, who quickly embraced it. In a follow-up phone call a few days later, according to a person familiar with the discussions, several health officials said the October deadline was unrealistic; over the next few months, officials began publicly citing the end of the year or early 2021 as a target.

With his job on the line, Mr. Azar, the target of Mr. Trump’s wrath over the virus, was especially eager to prove his worth to the White House. He teamed up with Defense Secretary Mark T. Esper, whose department has long experience with vaccine development and distribution to protect troops. An expert in complex logistics, Gen. Gustave F. Perna, became the operation’s chief operating officer.

Mr. Kushner, Dr. Deborah L. Birx, the White House coronavirus coordinator, and others interviewed Dr. Moncef Slaoui, a pharmaceutical industry veteran, and orchestrated his appointment as chief scientific adviser despite concerns within the Food and Drug Administration about conflicts of interest because of his financial ties to two companies that are developing a vaccine. Rather than being bothered by the conflict, Mr. Kushner and others reasoned that it took someone with such industry experience to oversee the effort.

Credit…Doug Mills/The New York Times

Dr. Slaoui resigned from the board of Moderna, which has received nearly $1 billion in federal support to develop a vaccine. But as of May he still had nearly $10 million of stock in GlaxoSmithKline, a partner with the French drugmaker Sanofi, which last week signed a $2.1 billion agreement to produce 100 million doses. Dr. Slaoui, who is working on a $1 contract, cleared an ethics review by the Department of Health and Human Services and has said he is determined to avoid any conflict.

Shortly after Dr. Slaoui’s appointment, Dr. Marks resigned from the project he conceived and returned full-time to his post as a senior regulator at the Food and Drug Administration, where he will be the key decision maker on whether a vaccine merits approval.

The administration has conducted the vaccine hunt with a focus lacking in much of the rest of its pandemic response. Contracts have been executed at a brisk pace. Mobile trailers have been speedily delivered for experimental doses to be administered. When a company was short on needles, the Pentagon dispatched planes to deliver supplies within 48 hours.

The pharmaceutical companies are reporting the results of their trials at regular intervals, accelerating the review process. With the government paying much of the cost, the companies are beginning the process of manufacturing millions of doses of vaccine essentially on spec so that they can be distributed quickly if they secure approval.

The process has moved at a remarkable clip. Two vaccine candidates, one developed by Moderna in conjunction with Dr. Fauci’s institute and another by Pfizer, last week began Phase 3 trials, the final stage of clinical experimentation. Others are expected soon.

In Mr. Azar’s conference room at the Department of Health and Human Services headquarters, Mr. Kushner and Dr. Birx join meetings with Mr. Azar, Mr. Esper and others. Mr. Kushner repeatedly pushes the group to move faster and has deputized two close associates, Brad Smith and Adam Boehler, to press the case.

The team has sought to ensure that a variety of different types of potential vaccines are being pursued to increase the chances that at least one will work. Dr. Birx has been interested in what is known as a subunit protein vaccine, and at one point called executives at the biotechnology company Genentech and asked what they could do. (Warp Speed is now working with two companies pursuing that type of vaccine.)

Mark Meadows, the White House chief of staff, also talks with pharmaceutical executives. People briefed on the discussions say the White House has also pushed for progress by the fall on therapeutics — drugs to treat people who fall ill to the disease — including the possibility of an emergency use authorization for one or more of those drugs. Late last month, Mr. Trump called the chief executive of Regeneron Pharmaceuticals to check on the progress of a potential antibody treatment.

Credit…Samuel Corum for The New York Times

Career officials have assured Dr. Hahn that they would stand behind him to head off any vaccine decision not based on science. But Dr. Hahn already lost a measure of credibility with the scientific community for approving the emergency use of hydroxychloroquine and chloroquine, two anti-malaria drugs promoted by the president as treatments for the coronavirus over the objections of his public health advisers. The Food and Drug Administration later revoked the authorization, concluding the risks outweighed the benefits.

Scientists have argued that it would be unwise to cut corners on a vaccine that is to be injected into some 300 million Americans, adding that a failed effort would fuel public distrust of vaccines generally.

But a senior White House official, who discussed the matter on the condition of anonymity, said that it would also be unethical to withhold an effective vaccine for an extra three or four months while more people died just to check the boxes of a more routine trial process.

Michael R. Caputo, a spokesman for Mr. Azar, said October was not the goal.

“Everybody at H.H.S. hopes Operation Warp Speed will achieve 300 million doses of a safe and effective Covid vaccine for Americans by January 2021,” he said. “We know that’s optimistic. I have never heard mention of any other timeline, and certainly not from the secretary.”

“Careless talk about career F.D.A. regulators somehow approving an unsafe and ineffective vaccine just for politics only undermines confidence in the public health system,” he added.

It is not clear that a vaccine approval shortly before the election would be an “October surprise” sufficient to alter the outcome of the vote. An announcement could give Americans hope that the end is in sight. But some Republican strategists said that it might not help Mr. Trump because his opponent, former Vice President Joseph R. Biden Jr., the presumptive Democratic nominee, would surely continue the vaccine process if elected.

“Does it turn everything around for him politically? I don’t know,” said Sarah Longwell, a conservative strategist and prominent Republican opponent of Mr. Trump who regularly conducts focus groups and has found that public attention is more focused on government relief checks and school reopenings.

“If the vaccine is an October surprise, there’s a lot of other things that are cutting against” it as a game-changer, she said.

The drug companies find themselves caught in the middle. While eager to bring products to market as quickly as possible, they face risks in moving too quickly in order to fit an election calendar, analysts said.

“They are acutely aware of the political dynamic here,” said Rob Smith, the director of Capital Alpha Partners, a research firm. A vaccine that flopped would jeopardize their broader business, he said, and it would not make sense “to take a huge reputational risk not just for your vaccine but for all the products across your portfolio to benefit the president politically.”

Dr. Fauci has expressed confidence that the system will hold.

“Historically, the F.D.A. has based their decisions on science,” he told a House committee last week. “They will do so this time also, I am certain.”

Maggie Haberman contributed reporting and Kitty Bennett contributed research.

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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.

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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.

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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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