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-BioNTech’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 guidance of its advisory committees, 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.
U.S. President Donald Trump listens as FDA chief Stephen Hahn speaks during a media briefing at the White House on Aug. 23. (Alex Brandon/The Associated Press)
Hahn signaled that he would tell regulators to allow the vaccine to be issued on an emergency basis, 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.”
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 per cent.”
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.
WATCH | Health officials hope to reassure those reluctant to get COVID-19 vaccine:
While doses of a COVID-19 vaccine are still months away for most Canadians, health officials are already working on ways to allay concerns some people have about how quickly vaccines were developed. The Public Health Agency of Canada acknowledges there’s a ‘sizeable minority’ with reservations, but says it’s committed to making sure Canadians know they will be safe. 2:05
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.
‘Science, not politics’
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.
Typically, the FDA does not publicly comment on the progress or timing of its reviews, which are considered confidential government information.
The FDA’s review is critical to assuring the safety and effectiveness of a vaccine that will eventually be given to millions of Americans, including highly vulnerable groups like nursing home residents.
A nurse administers the Pfizer-BioNTech COVID-19 vaccine in London on Tuesday. (Frank Augstein/AP)
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.
He surprised many critics in October by defying the White House and publishing strict FDA safety guidelines for upcoming COVID-19 vaccines. The standards effectively closed the door on Trump’s long-stated goal of delivering a vaccine by Election Day and undercut White House staffers who had blocked the guidelines for weeks.
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.
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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 re-election 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.
TOKYO (AP) — Japanese technology group SoftBank swung back to profitability in the July-September quarter, boosted by positive results in its Vision Fund investments.
Tokyo-based SoftBank Group Corp. reported Tuesday a fiscal second quarter profit of nearly 1.18 trillion yen ($7.7 billion), compared with a 931 billion yen loss in the year-earlier period.
Quarterly sales edged up about 6% to nearly 1.77 trillion yen ($11.5 billion).
SoftBank credited income from royalties and licensing related to its holdings in Arm, a computer chip-designing company, whose business spans smartphones, data centers, networking equipment, automotive, consumer electronic devices, and AI applications.
The results were also helped by the absence of losses related to SoftBank’s investment in office-space sharing venture WeWork, which hit the previous fiscal year.
WeWork, which filed for Chapter 11 bankruptcy protection in 2023, emerged from Chapter 11 in June.
SoftBank has benefitted in recent months from rising share prices in some investment, such as U.S.-based e-commerce company Coupang, Chinese mobility provider DiDi Global and Bytedance, the Chinese developer of TikTok.
SoftBank’s financial results tend to swing wildly, partly because of its sprawling investment portfolio that includes search engine Yahoo, Chinese retailer Alibaba, and artificial intelligence company Nvidia.
SoftBank makes investments in a variety of companies that it groups together in a series of Vision Funds.
The company’s founder, Masayoshi Son, is a pioneer in technology investment in Japan. SoftBank Group does not give earnings forecasts.
Shopify Inc. executives brushed off concerns that incoming U.S. President Donald Trump will be a major detriment to many of the company’s merchants.
“There’s nothing in what we’ve heard from Trump, nor would there have been anything from (Democratic candidate) Kamala (Harris), which we think impacts the overall state of new business formation and entrepreneurship,” Shopify’s chief financial officer Jeff Hoffmeister told analysts on a call Tuesday.
“We still feel really good about all the merchants out there, all the entrepreneurs that want to start new businesses and that’s obviously not going to change with the administration.”
Hoffmeister’s comments come a week after Trump, a Republican businessman, trounced Harris in an election that will soon return him to the Oval Office.
On the campaign trail, he threatened to impose tariffs of 60 per cent on imports from China and roughly 10 per cent to 20 per cent on goods from all other countries.
If the president-elect makes good on the promise, many worry the cost of operating will soar for companies, including customers of Shopify, which sells e-commerce software to small businesses but also brands as big as Kylie Cosmetics and Victoria’s Secret.
These merchants may feel they have no choice but to pass on the increases to customers, perhaps sparking more inflation.
If Trump’s tariffs do come to fruition, Shopify’s president Harley Finkelstein pointed out China is “not a huge area” for Shopify.
However, “we can’t anticipate what every presidential administration is going to do,” he cautioned.
He likened the uncertainty facing the business community to the COVID-19 pandemic where Shopify had to help companies migrate online.
“Our job is no matter what comes the way of our merchants, we provide them with tools and service and support for them to navigate it really well,” he said.
Finkelstein was questioned about the forthcoming U.S. leadership change on a call meant to delve into Shopify’s latest earnings, which sent shares soaring 27 per cent to $158.63 shortly after Tuesday’s market open.
The Ottawa-based company, which keeps its books in U.S. dollars, reported US$828 million in net income for its third quarter, up from US$718 million in the same quarter last year, as its revenue rose 26 per cent.
Revenue for the period ended Sept. 30 totalled US$2.16 billion, up from US$1.71 billion a year earlier.
Subscription solutions revenue reached US$610 million, up from US$486 million in the same quarter last year.
Merchant solutions revenue amounted to US$1.55 billion, up from US$1.23 billion.
Shopify’s net income excluding the impact of equity investments totalled US$344 million for the quarter, up from US$173 million in the same quarter last year.
Daniel Chan, a TD Cowen analyst, said the results show Shopify has a leadership position in the e-commerce world and “a continued ability to gain market share.”
In its outlook for its fourth quarter of 2024, the company said it expects revenue to grow at a mid-to-high-twenties percentage rate on a year-over-year basis.
“Q4 guidance suggests Shopify will finish the year strong, with better-than-expected revenue growth and operating margin,” Chan pointed out in a note to investors.
This report by The Canadian Press was first published Nov. 12, 2024.
TORONTO – RioCan Real Estate Investment Trust says it has cut almost 10 per cent of its staff as it deals with a slowdown in the condo market and overall pushes for greater efficiency.
The company says the cuts, which amount to around 60 employees based on its last annual filing, will mean about $9 million in restructuring charges and should translate to about $8 million in annualized cash savings.
The job cuts come as RioCan and others scale back condo development plans as the market softens, but chief executive Jonathan Gitlin says the reductions were from a companywide efficiency effort.
RioCan says it doesn’t plan to start any new construction of mixed-use properties this year and well into 2025 as it adjusts to the shifting market demand.
The company reported a net income of $96.9 million in the third quarter, up from a loss of $73.5 million last year, as it saw a $159 million boost from a favourable change in the fair value of investment properties.
RioCan reported what it says is a record-breaking 97.8 per cent occupancy rate in the quarter including retail committed occupancy of 98.6 per cent.
This report by The Canadian Press was first published Nov. 12, 2024.
