AstraZeneca may have used “outdated information” in the results of a large-scale COVID-19 vaccine trial, a U.S. health agency said on Tuesday, casting fresh doubt on the shot, its potential U.S. rollout and plunging its developers, once again, into controversy.
The highly unusual rebuke from federal health officials comes just one day after interim data from the drugmaker showed better-than-expected results from the U.S. trial which had been seen as a scientific counter to concerns that have dogged the shot since late last year.
The vaccine developed with partner Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalization, and posed no increased risk of blood clots.
The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement https://bit.ly/3scE3ji released after midnight in the United States.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” it said, adding that the DSMB had informed AstraZeneca of its concerns.
AstraZeneca did not immediately respond to a Reuters request for comment.
Its shares were down 1% in early morning trade.
NIAID is headed by U.S. infectious diseases expert Anthony Fauci and is part of the National Institutes of Health. The DSMB is organized by NIAID, according to a document outlining the trial design. The board’s role is to provide study oversight and evaluate clinical data to ensure safe and ethical conduct of the study.
Authorization and guidelines for use of the vaccine in the United States will be determined after thorough review of the data by independent advisory committees, the statement added.
Although hailed as a milestone in the fight against the COVID-19 pandemic when it emerged as a vaccine contender last year, the AstraZeneca shot has seen a steady stream of questions raised about its efficacy, dosing regimen and possible side effects.
More than a dozen European countries halted use of the vaccine earlier this month after reports linked it to a rare blood clotting disorder in a very small number of people.
Germany and France resumed inoculations after the EU’s drug regulator said last week it was safe but an opinion poll on Monday showed Europeans remained skeptical about its safety.
Fauci, who also serves as chief medical advisor to U.S. President Joe Biden, said on Monday the U.S. trial found no indication at all of the rare blood clots.
Before the blood clot concerns, there were also earlier separate late-stage studies, run by partner Oxford University, that had raised questions about its dosing regimen and the lack of data about its efficacy for elderly people.
The latest data, which has yet to be reviewed by independent researchers, was based on 141 infections among 32,449 participants.
Analysts had also noted AstraZeneca’s achievement of producing strong trial data against a backdrop of more infectious variants spreading in the United States and other countries.
The AstraZeneca vaccine, which is already widely used outside the United States, is seen as crucial in tackling the spread of COVID-19 across the globe because it is easier and cheaper to transport than rival shots.
It has been granted conditional marketing or emergency use authorisation in more than 70 countries. Many countries are relying heavily on it to end the pandemic, and several state leaders have taken the shot to boost confidence in the vaccine including South Korea’s President Moon Jae-in who received it on Tuesday.
The shot has also been at the center of a growing conflict between Brussels and London over so-called vaccine nationalism after a string of supply setbacks in Europe.
Almost half of Shopify’s top execs to depart company: CEO
By Moira Warburton
(Reuters) – Three of e-commerce platform Shopify’s seven top executives will be leaving the company in the coming months, chief executive officer and founder of Canada‘s most valuable company Tobi Lutke said in a blog post on Wednesday.
The company’s chief talent officer, chief legal officer and chief technology officer will all transition out of their roles, Lutke said, adding that they have been “spectacular and deserve to take a bow.”
“Each one of them has their individual reasons but what was unanimous with all three was that this was the best for them and the best for Shopify,” he said.
The trio follow the departure of Craig Miller, chief product officer, in September. Lutke took on the role in addition to CEO.
Shopify, which provides infrastructure for online stores, has seen its valuation soar in the last year as many businesses went virtual during COVID-19 lockdowns. It has a market cap valuation of C$182.7 billion ($146 billion), above Canada‘s top lender Royal Bank of Canada.
It is Canada‘s biggest homegrown tech success story, founded in 2006 and supporting over 1 million businesses globally, according to the company.
“We have a phenomenally strong bench of leaders who will now step up into larger roles,” Lutke said, but did not name replacements.
Shopify said in February revenue growth would slow this year as vaccine rollouts encourage people to return to stores and warned it does not expect 2020’s near doubling of gross merchandise volume, an industry metric to measure transaction volumes, to repeat this year.
Chief talent officer, Brittany Forsyth, was the 22nd employee hired at Shopify and has been with the company for 11 years. She said on Twitter that post-Shopify she would be focusing on Backbone Angels, an all-female collective of angel investors she co-founded in March.
Shopify shares fell 5.1% while the benchmark Canadian share index ended marginally down.
($1 = 1.2515 Canadian dollars)
(Reporting by Moira Warburton in Toronto; Editing by Aurora Ellis)
CANADA STOCKS – TSX falls 0.14% to 19,201.28
* The Toronto Stock Exchange’s TSX falls 0.14 percent to 19,201.28
* Leading the index were Stantec Inc <STN.TO>, up 3.4%, Imperial Oil Ltd, up 3.3%, and Corus Entertainment Inc, higher by 2.9%.
* Lagging shares were Aphria Inc, down 14.2%, Village Farms International Inc, down 9.9%, and Aurora Cannabis Inc, lower by 9.4%.
* On the TSX 91 issues rose and 134 fell as a 0.7-to-1 ratio favored decliners. There were 24 new highs and no new lows, with total volume of 228.0 million shares.
* The most heavily traded shares by volume were Toronto-dominion Bank, Royal Bank Of Canada and Suncor Energy Inc.
* The TSX’s energy group fell 0.32 points, or 0.3%, while the financials sector climbed 2.46 points, or 0.7%.
* West Texas Intermediate crude futures rose 0.52%, or $0.31, to $59.63 a barrel. Brent crude rose 0.4%, or $0.25, to $63.2 [O/R]
* The TSX is up 10.1% for the year.
Air Canada signs C$5.9 billion government aid package, agrees to buy Airbus, Boeing jets
By David Ljunggren and Allison Lampert
OTTAWA/MONTREAL (Reuters) -Air Canada, struggling with a collapse in traffic due to the COVID-19 pandemic, reached a deal on Monday on a long-awaited aid package with the federal government that would allow it to access up to C$5.9 billion ($4.69 billion) in funds.
The agreement – the largest individual coronavirus-related loan that Ottawa has arranged with a company – was announced after the airline industry criticized Prime Minister Justin Trudeau’s Liberal government for dawdling. The United States and France acted much more quickly to help major carriers.
Canada‘s largest carrier, which last year cut over half its workforce, or 20,000 jobs, and other airlines have been negotiating with the government for months on a coronavirus aid package.
In February, Air Canada reported a net loss for 2020 of C$4.65 billion, compared with a 2019 profit of C$1.48 billion.
As part of the deal, Air Canada agreed to ban share buybacks and dividends, cap annual compensation for senior executives at C$1 million a year and preserve jobs at the current level, which is 14,859.
It will also proceed with planned purchases of 33 Airbus SE 220 airliners and 40 Boeing Co 737 MAX airliners.
Chris Murray, managing director, equity research at ATB Capital Markets, said the deal took into account the “specific needs of Air Canada in the short and medium term without being overly onerous.”
He added: “It gives them some flexibility in drawing down additional liquidity as needed.”
Transport Minister Omar Alghabra said the government was still in negotiations with other airlines about possible aid.
Canada, the world’s second-largest nation by area, depends heavily on civil aviation to keep remote communities connected.
Opposition politicians fretted that further delays in announcing aid could result in permanent damage to the country.
Air Canada said it would resume services on nearly all of the routes it had suspended because of COVID-19.
‘SIGNIFICANT LAYER OF INSURANCE’
The deal removes a potential political challenge for the Liberals, who insiders say are set to trigger an election later this year.
The government has agreed to buy C$500 million worth of shares in the airline, at C$23.1793 each, or a 14.2% discount to Monday’s close, a roughly 6% stake.
“Maintaining a competitive airline sector and good jobs is crucially important,” Finance Minister Chrystia Freeland told reporters, adding the equity stake would allow taxpayers to benefit when the airline’s fortunes recovered.
The Canadian government previously approved similar loans for four other companies worth up to C$1.billion, including up to C$375 million to low-cost airline Sunwing Vacations Inc. The government has paid out C$73.47 billion under its wage subsidy program and C$46.11 billion in loans to hard-hit small businesses.
Michael Rousseau, Air Canada‘s president and chief executive officer, said the liquidity “provides a significant layer of insurance for Air Canada.”
Jerry Dias, head of the Unifor private-sector union, described the announcement as “a good deal for everybody.”
Unifor represents more than 16,000 members working in the air transportation sector.
But the Canadian Union of Public Employees, which represents roughly 10,000 Air Canada flight attendants, said the package protected the jobs of current workers rather than the 7,500 members of its union who had been let go by the carrier.
($1=1.2567 Canadian dollars)
(Reporting by David Ljunggren in Ottawa and Allison Lampert in Montreal; Additional reporting by Julie Gordon in Ottawa and Munsif Vengattil in Bengaluru; Editing by Dan Grebler and Peter Cooney)
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