WASHINGTON —
White House chief of staff Mark Meadows on Friday pressed Food and Drug Administration chief Stephen Hahn to grant an emergency use authorization for Pfizer’s coronavirus vaccine by the end of the day or face possible firing, two administration officials said.
The vaccine produced by Pfizer Inc. and its German partner BioNTech won a critical endorsement Thursday from an FDA panel of outside advisers, and signoff from the agency – which was expected this weekend – is the next step needed to get the shots to the public.
The FDA is not required to follow the panel’s guidance, but the devastation caused by the virus makes the vaccine’s authorization almost certain.
Meadows spoke to Hahn by telephone Friday, according to a senior administration official who was familiar with the call but was not authorized to discuss private conversations.
The chief of staff also told Hahn his job was in jeopardy if the emergency use authorization was not issued before Saturday, said a second administration official familiar with the conversation.
Hahn signalled that he would tell regulators to grant the decision, the official said.
President Donald Trump has been pressing for quick approval for the vaccine and tweeted directly at Hahn earlier Friday, complaining that FDA “is still a big, old, slow turtle.” Trump has publicly bashed the pace of the FDA’s vaccine review process.
“Get the dam vaccines out NOW, Dr. Hahn,” Trump tweeted Friday. “Stop playing games and start saving lives.”
Hahn disputed characterizations of his conversation with Meadows.
“This is an untrue representation of the phone call with the Chief of Staff,” Hahn said in a statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”
The FDA said earlier Friday that it “will rapidly work” to finalize emergency use of the vaccine.
Dr. Ashish Jha, dean of Brown University’s school of public health, called the pressure an “unforced error” by the White House that could chip away at public confidence in a vaccine.
“It creates a veneer of political meddling,” Jha said. “Every time you see the president get involved, you see vaccine confidence drop by 10%.”
Hahn and other top health officials have been working for months to boost public confidence in the government’s vaccine effort, which will eventually need to reach most Americans to suppress the virus.
Recent polls show only about half of all Americans are ready to roll up their sleeves for a shot. Many have safety concerns and want to wait and see how the initial rollout fares. But concerns that a vaccine was rushed due to political pressure could further undermine the unprecedented vaccination effort.
“The last thing this process needs now is to undermine the public’s faith in the vaccine with political pressure to hurry up an already rushed process with threats of firings,” said Carl Tobias, law professor at the University of Richmond in Virginia.
Jha added that FDA officials don’t need the added pressure. “They already feel the weight of what’s happening in our country,” he said.
Trump’s frustration with the FDA has been mounting, particularly as other countries have beaten the U.S. in issuing emergency approvals for the vaccine. Meadows issued the ultimatum to Hahn at Trump’s direction, a senior administration official said.
The FDA decision – when it comes – will kickstart an unprecedented vaccination campaign needed to eventually defeat the virus, now blamed for nearly 300,000 deaths in the U.S. And the agency’s greenlight of the vaccine was virtually assured after Thursday’s positive vote by agency advisers.
In a separate move Friday, Trump administration officials announced the purchase of 100 million additional doses of a different upcoming vaccine from drugmaker Moderna. That’s on top of a previous purchase of 100 million doses. FDA’s expert advisory panel is scheduled to review that vaccine next Thursday, with a decision soon thereafter.
FDA’s review is critical to assuring the safety and effectiveness of vaccine that will eventually be given to millions of Americans, including highly vulnerable groups like nursing home residents.
The agency’s careful approach is unique around the world in that the FDA actually reanalyzes all company data to verify its accuracy. That’s different from the abbreviated process used by the U.K. and other countries, which rely on summary data produced by manufacturers.
Hahn has stated for months that “science, not politics” would determine when the agency gives the vaccine the go-ahead.
More than 150 FDA staffers have been working in shifts over nights, weekends and the Thanksgiving holiday to review tens of thousands of pages of Pfizer’s application.
Hahn told The Associated Press earlier this week that his agency had already teed up authorization by prefilling all the necessary legal paperwork.
“We’re doing everything we can to cut down on the red tape, which I think is really important,” Hahn told the AP.
Trump has been livid with the FDA for not moving faster to approve the shots, blaming the fact that a vaccine was not available before the Nov. 3 election for his loss. Trump also has levelled unfounded claims that drug companies deliberately delayed vaccine development to hinder his reelection chances, though there is no evidence to suggest that took place.
As he has refused to accept his loss to Democratic President-elect Joe Biden, Trump also has told close confidants that he believes the vaccine is still being slow-walked in a bid to undermine his efforts to challenge the results.
If the vaccine were shipped out sooner, he has argued, it would rally public opinion to his side.
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Lemire reported from Wilmington, Del. Associated Press writer Zeke Miller contributed to this report.
TORONTO – Roots Corp. may have built its brand on all things comfy and cosy, but its CEO says activewear is now “really becoming a core part” of the brand.
The category, which at Roots spans leggings, tracksuits, sports bras and bike shorts, has seen such sustained double-digit growth that Meghan Roach plans to make it a key part of the business’ future.
“It’s an area … you will see us continue to expand upon,” she told analysts on a Friday call.
The Toronto-based retailer’s push into activewear has taken shape over many years and included several turns as the official designer and supplier of Team Canada’s Olympic uniform.
But consumers have had plenty of choice when it comes to workout gear and other apparel suited to their sporting needs. On top of the slew of athletic brands like Nike and Adidas, shoppers have also gravitated toward Lululemon Athletica Inc., Alo and Vuori, ramping up competition in the activewear category.
Roach feels Roots’ toehold in the category stems from the fit, feel and following its merchandise has cultivated.
“Our product really resonates with (shoppers) because you can wear it through multiple different use cases and occasions,” she said.
“We’ve been seeing customers come back again and again for some of these core products in our activewear collection.”
Her remarks came the same day as Roots revealed it lost $5.2 million in its latest quarter compared with a loss of $5.3 million in the same quarter last year.
The company said the second-quarter loss amounted to 13 cents per diluted share for the quarter ended Aug. 3, the same as a year earlier.
In presenting the results, Roach reminded analysts that the first half of the year is usually “seasonally small,” representing just 30 per cent of the company’s annual sales.
Sales for the second quarter totalled $47.7 million, down from $49.4 million in the same quarter last year.
The move lower came as direct-to-consumer sales amounted to $36.4 million, down from $37.1 million a year earlier, as comparable sales edged down 0.2 per cent.
The numbers reflect the fact that Roots continued to grapple with inventory challenges in the company’s Cooper fleece line that first cropped up in its previous quarter.
Roots recently began to use artificial intelligence to assist with daily inventory replenishments and said more tools helping with allocation will go live in the next quarter.
Beyond that time period, the company intends to keep exploring AI and renovate more of its stores.
It will also re-evaluate its design ranks.
Roots announced Friday that chief product officer Karuna Scheinfeld has stepped down.
Rather than fill the role, the company plans to hire senior level design talent with international experience in the outdoor and activewear sectors who will take on tasks previously done by the chief product officer.
This report by The Canadian Press was first published Sept. 13, 2024.
VANCOUVER – Mediated talks between the union representing HandyDART workers in Metro Vancouver and its employer, Transdev, are set to resume today as a strike that has stopped most services drags into a second week.
No timeline has been set for the length of the negotiations, but Joe McCann, president of the Amalgamated Transit Union Local 1724, says they are willing to stay there as long as it takes, even if talks drag on all night.
About 600 employees of the door-to-door transit service for people unable to navigate the conventional transit system have been on strike since last Tuesday, pausing service for all but essential medical trips.
Hundreds of drivers rallied outside TransLink’s head office earlier this week, calling for the transportation provider to intervene in the dispute with Transdev, which was contracted to oversee HandyDART service.
Transdev said earlier this week that it will provide a reply to the union’s latest proposal on Thursday.
A statement from the company said it “strongly believes” that their employees deserve fair wages, and that a fair contract “must balance the needs of their employees, clients and taxpayers.”
This report by The Canadian Press was first published Sept. 12, 2024.
MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.
The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.
The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.
Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.
On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.
Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.
This report by The Canadian Press was first published Sept. 12, 2024.
