The European Medicines Agency recommended conditional approval for a coronavirus vaccine developed by BioNTech and Pfizer to be used across the European Union.
Following a closed-doors expert meeting Monday, the EU drug regulator said it was recommending the shot be licensed for use in people over 16 years of age, with some exceptions. The pharmaceutical companies will need to submit followup data on their vaccine for the next year.
“This is really a historic scientific achievement,” said Emer Cooke, the head of the agency. “It is a significant step forward in our fight against the pandemic.”
The approval needs to be rubber-stamped by the EU’s executive branch on Monday evening.
European Commission President Ursula von der Leyen tweeted that the EMA’s approval was decisive moment.
It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!<br><br>The <a href=”https://twitter.com/EMA_News?ref_src=twsrc%5Etfw”>@EMA_News</a> just issued a positive scientific opinion on the <a href=”https://twitter.com/hashtag/BioNTech?src=hash&ref_src=twsrc%5Etfw”>#BioNTech</a> / <a href=”https://twitter.com/pfizer?ref_src=twsrc%5Etfw”>@pfizer</a> vaccine.<br><br>Now we will act fast. I expect a <a href=”https://twitter.com/EU_Commission?ref_src=twsrc%5Etfw”>@EU_Commission</a> decision by this evening.
Authorities in Germany and several other European countries have said they hope to begin vaccinating people on Dec. 27.
“Today is a particularly personal and emotional day for us at BioNTech,” said Ugur Sahin, the company’s chief executive and co-founder. “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.”
“We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light,” Sahin said.
The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible. EMA originally set Dec. 29 as the date for its evaluation of the vaccine made by Germany-based BioNTech, but moved up the meeting to Monday after calls from the German government and other countries for the agency to move more quickly.
The vaccine has already been given some form of regulatory authorization in at least 15 countries, including Canada.
A worker is seen at a COVID-19 vaccination center in Berlin on Monday. (Hannibal Hanschke/Reuters)
Britain and the U.S. authorized the vaccine to be used according to emergency provisions, meaning the shot is an unlicensed product whose temporary use is justified by the pandemic that has killed almost 1.7 million people worldwide to date, according to a tally by Johns Hopkins University.
Health Canada said its approval was made under an interim order that allowed it to “assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada’s high standards.”
“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” the health agency said in a Dec. 9 statement announcing the authorization of the Pfizer-BioTech vaccine.
In a statement last week that appeared to address concerns by some in Europe about the speed of the process, the EMA stressed that the vaccine would only be approved after a scientific assessment showed its overall benefits outweighed the risks.
“A vaccine’s benefits in protecting people against COVID-19 must be far greater than any side-effect or potential risks,” it said.
Scientists are still waiting for more long-term followup data to see how long immunity from the vaccines lasts and if there are any rare or serious side-effects. Final testing of the vaccine is still ongoing. More information on whether the shot works in children is needed, in addition to its effects in pregnant women.
The vaccine is not made with the coronavirus itself, meaning there’s no chance anyone could catch it from the shots. Instead, the vaccine contains a piece of genetic code that trains the immune system to recognize the spiked protein on the surface of the virus.
On the day Britain began its vaccination campaign, authorities warned people with severe allergies not to get the shot after two people suffered serious allergic reactions; it’s unclear if the reactions were caused by the immunization.
The U.S. Centers for Disease Control and Prevention said that as of Friday they had seen six cases of severe allergic reaction out of more than 250,000 shots of the BioNTech-Pfizer vaccine given, including in one person with a history of vaccination reactions.
BioNTech and Pfizer offered the EU 400 million doses of the vaccine, but the bloc’s executive Commission chose to buy only 200 million doses, with an option for 100 million more.
The EMA plans to hold a meeting on Jan. 12 to decide if the coronavirus vaccine made by Moderna should be licensed. It has reviews ongoing for a shot developed by Oxford University and AstraZeneca and another from Janssen, but neither of those have made a formal request for the EMA to approve their vaccine.
The European Centre for Disease Prevention and Control, meanwhile, said “timely efforts” to prevent and control the spread of cases of COVID-19 involving the new coronavirus variant observed in Britain are needed, but infections have already been reported in at least three other countries in Europe.
The Stockholm-based agency said in a “threat assessment” Monday that while preliminary analysis in the U.K. suggests the new variant is “significantly more transmissible” there is no indication that infections are more severe.
ECDC said a few cases with the new variant have been reported already by Iceland, Denmark and the Netherlands. It also cited media reports of cases in Belgium and Italy.
What’s happening across Canada
As of 7:30 a.m. ET on Monday, Canada’s COVID-19 case count stood at 507,795 with 76,859 of those cases considered active. A CBC News tally of deaths based on provincial reports, regional health information and CBC’s reporting stood at 14,228.
Ontario Premier Doug Ford is set to address the public Monday afternoon after sources said the entire province will be sent into lockdown on Dec. 24. The province — which as of Sunday had 875 COVID-19 patients in hospital, including 261 in intensive care units — has seen six days straight with more than 2,000 daily cases of COVID-19.
What’s happening in the U.S.
U.S. congressional leaders reached agreement on Sunday on a $900 billion US package to provide the first new aid in months to an economy and individuals battered by the surging coronavirus pandemic, with votes likely on Monday.
The package would be the second-largest economic stimulus in U.S. history, following a $2.3 trillion aid bill passed in March. It comes as the pandemic accelerates, infecting more than 214,000 people in the country each day. More than 317,000 Americans have already died.
The package would give $600 direct payments to individuals and boost unemployment payments by $300 a week. It also includes billions for small businesses, food assistance, vaccine distribution, transit and health care. It extends a moratorium on foreclosures and provides $25 billion in rental aid.
WATCH | Millions in U.S. at risk of homelessness without support, eviction ban:
Millions of renters in the U.S. are in limbo as they wait for a new COVID-19 financial package from Congress. Without an extended evictions ban and other financial support, many of those renters could become homeless. 1:59
The United States is monitoring the new strain of COVID-19 emerging in Britain, multiple U.S. officials said, adding that it was unclear whether the mutated variant had made its way to the U.S.
What’s happening around the world
As of early Monday morning, more than 76.9 million cases of COVID-19 had been reported around the world with more than 43.3 million of those cases considered recovered or resolved, according to a coronavirus tracking tool maintained by Johns Hopkins University. The global death toll was approaching 1.7 million.
In Africa, South Africa announced that a new variant of the COVID-19 virus is driving the country’s current resurgence of the disease, which is seeing higher numbers of confirmed cases, hospitalizations and deaths.
The new variant, known as 501.V2, is dominant among new confirmed infections in South Africa, according to health officials and scientists leading the country’s virus strategy.
“It is still very early but at this stage, the preliminary data suggests the virus that is now dominating in the second wave is spreading faster than the first wave,” Prof. Salim Abdool Karim, chair of the government’s ministerial advisory committee, said in a briefing to journalists.
South Africa may see “many more cases” in the new wave than it experienced in the first surge of the disease, said Abdool Karim.
South Africa currently has more than 8,500 people hospitalized with COVID-19, surpassing the previous high of 8,300 recorded in August.
A nurse from Lancet Netcare hospital, right, performs a COVID-19 coronavirus test in Johannesburg, South Africa, late last week. (Luca Sola/AFP/Getty Images)
“We are seeing a much earlier and much sharper rise in the second wave or resurgence than we anticipated,” Prof. Ian Sanne, a member of the advisory committee, told South Africa’s News24.
The new strain, different from the one in Britain, appears to be more infectious than the original virus. South African scientists are studying if the vaccines against COVID-19 will also offer protection against the new strain.
Some of the vaccines, including the one developed by Oxford University and AstraZeneca, are undergoing clinical tests in South Africa. The scientists studying the new variant emphasized that preventive measures like wearing masks and social distancing are vital.
In response to the resurgence of COVID-19, the South African government has introduced tougher lockdown restrictions which include limited days and hours for the trade of alcohol and the closure of beaches in areas identified as hotspots.
The country has recorded a total of 912,477 cases, including 24,539 deaths.
In the Asia-Pacific region, Hong Kong will ban flights from Britain after a more infectious variant of the coronavirus was found in the country, according to the city’s top health official.
Tokyo Gov. Yuriko Koike on Monday asked all residents to celebrate Christmas and New Year at home just with their families and asked organizers to have events close early in the night.
Japan’s daily coronavirus cases have been steadily on the rise and Tokyo hit its new high at 822 last Friday. On Monday, the Japanese capital city found 392 new cases for a prefectural total of 51,838.
Thailand’s total number of confirmed coronavirus cases surged past 5,000 on Monday as hundreds of migrant workers tested positive for the disease.
Thailand has been one of several Southeast Asian countries that had been relatively unscathed by the pandemic. But on Saturday, health officials reported a daily record of 548 new cases, almost all of them among migrant workers in the seafood industry in Samut Sakhon province, about 35 kilometres southwest of Bangkok, the capital.
Thai Prime Minister Prayuth Chan-ocha said his government would wait to see how the situation looked in a week’s time before deciding on any special restrictions for New Year’s celebrations.
In the Middle East, Saudi Arabia shut its land and sea borders late on Sunday and suspended international commercial flights temporarily over fears of a new coronavirus strain, but foreign flights already in the country can leave, the Interior Ministry said.
Fellow Gulf Arab state Oman will close its land, air and sea borders for one week starting Tuesday, state television reported on Monday.
In Kuwait, the civil aviation authority added the United Kingdom to its high-risk list of countries on Sunday, meaning all flights from it are banned.
The U.S. remained the hardest-hit country in the Americas, trailed by Brazil, which has seen more than 7.2 million reported cases of COVID-19 and more than 186,700 deaths.
Telus Corp. says it is avoiding offering “unprofitable” discounts as fierce competition in the Canadian telecommunications sector shows no sign of slowing down.
The company said Friday it had fewer net new customers during its third quarter compared with the same time last year, as it copes with increasingly “aggressive marketing and promotional pricing” that is prompting more customers to switch providers.
Telus said it added 347,000 net new customers, down around 14.5 per cent compared with last year. The figure includes 130,000 mobile phone subscribers and 34,000 internet customers, down 30,000 and 3,000, respectively, year-over-year.
The company reported its mobile phone churn rate — a metric measuring subscribers who cancelled their services — was 1.09 per cent in the third quarter, up from 1.03 per cent in the third quarter of 2023. That included a postpaid mobile phone churn rate of 0.90 per cent in its latest quarter.
Telus said its focus is on customer retention through its “industry-leading service and network quality, along with successful promotions and bundled offerings.”
“The customers we have are the most important customers we can get,” said chief financial officer Doug French in an interview.
“We’ve, again, just continued to focus on what matters most to our customers, from a product and customer service perspective, while not loading unprofitable customers.”
Meanwhile, Telus reported its net income attributable to common shares more than doubled during its third quarter.
The telecommunications company said it earned $280 million, up 105.9 per cent from the same three-month period in 2023. Earnings per diluted share for the quarter ended Sept. 30 was 19 cents compared with nine cents a year earlier.
It reported adjusted net income was $413 million, up 10.7 per cent year-over-year from $373 million in the same quarter last year. Operating revenue and other income for the quarter was $5.1 billion, up 1.8 per cent from the previous year.
Mobile phone average revenue per user was $58.85 in the third quarter, a decrease of $2.09 or 3.4 per cent from a year ago. Telus said the drop was attributable to customers signing up for base rate plans with lower prices, along with a decline in overage and roaming revenues.
It said customers are increasingly adopting unlimited data and Canada-U.S. plans which provide higher and more stable ARPU on a monthly basis.
“In a tough operating environment and relative to peers, we view Q3 results that were in line to slightly better than forecast as the best of the bunch,” said RBC analyst Drew McReynolds in a note.
Scotiabank analyst Maher Yaghi added that “the telecom industry in Canada remains very challenging for all players, however, Telus has been able to face these pressures” and still deliver growth.
The Big 3 telecom providers — which also include Rogers Communications Inc. and BCE Inc. — have frequently stressed that the market has grown more competitive in recent years, especially after the closing of Quebecor Inc.’s purchase of Freedom Mobile in April 2023.
Hailed as a fourth national carrier, Quebecor has invested in enhancements to Freedom’s network while offering more affordable plans as part of a set of commitments it was mandated by Ottawa to agree to.
The cost of telephone services in September was down eight per cent compared with a year earlier, according to Statistics Canada’s most recent inflation report last month.
“I think competition has been and continues to be, I’d say, quite intense in Canada, and we’ve obviously had to just manage our business the way we see fit,” said French.
Asked how long that environment could last, he said that’s out of Telus’ hands.
“What I can control, though, is how we go to market and how we lead with our products,” he said.
“I think the conditions within the market will have to adjust accordingly over time. We’ve continued to focus on digitization, continued to bring our cost structure down to compete, irrespective of the price and the current market conditions.”
Still, Canada’s telecom regulator continues to warn providers about customers facing more charges on their cellphone and internet bills.
On Tuesday, CRTC vice-president of consumer, analytics and strategy Scott Hutton called on providers to ensure they clearly inform their customers of charges such as early cancellation fees.
That followed statements from the regulator in recent weeks cautioning against rising international roaming fees and “surprise” price increases being found on their bills.
Hutton said the CRTC plans to launch public consultations in the coming weeks that will focus “on ensuring that information is clear and consistent, making it easier to compare offers and switch services or providers.”
“The CRTC is concerned with recent trends, which suggest that Canadians may not be benefiting from the full protections of our codes,” he said.
“We will continue to monitor developments and will take further action if our codes are not being followed.”
French said any initiative to boost transparency is a step in the right direction.
“I can’t say we are perfect across the board, but what I can say is we are absolutely taking it under consideration and trying to be the best at communicating with our customers,” he said.
“I think everyone looking in the mirror would say there’s room for improvement.”
This report by The Canadian Press was first published Nov. 8, 2024.
CALGARY – TC Energy Corp. has lowered the estimated cost of its Southeast Gateway pipeline project in Mexico.
It says it now expects the project to cost between US$3.9 billion and US$4.1 billion compared with its original estimate of US$4.5 billion.
The change came as the company reported a third-quarter profit attributable to common shareholders of C$1.46 billion or $1.40 per share compared with a loss of C$197 million or 19 cents per share in the same quarter last year.
Revenue for the quarter ended Sept. 30 totalled C$4.08 billion, up from C$3.94 billion in the third quarter of 2023.
TC Energy says its comparable earnings for its latest quarter amounted to C$1.03 per share compared with C$1.00 per share a year earlier.
The average analyst estimate had been for a profit of 95 cents per share, according to LSEG Data & Analytics.
This report by The Canadian Press was first published Nov. 7, 2024.
BCE Inc. reported a loss in its latest quarter as it recorded $2.11 billion in asset impairment charges, mainly related to Bell Media’s TV and radio properties.
The company says its net loss attributable to common shareholders amounted to $1.24 billion or $1.36 per share for the quarter ended Sept. 30 compared with a profit of $640 million or 70 cents per share a year earlier.
On an adjusted basis, BCE says it earned 75 cents per share in its latest quarter compared with an adjusted profit of 81 cents per share in the same quarter last year.
“Bell’s results for the third quarter demonstrate that we are disciplined in our pursuit of profitable growth in an intensely competitive environment,” BCE chief executive Mirko Bibic said in a statement.
“Our focus this quarter, and throughout 2024, has been to attract higher-margin subscribers and reduce costs to help offset short-term revenue impacts from sustained competitive pricing pressures, slow economic growth and a media advertising market that is in transition.”
Operating revenue for the quarter totalled $5.97 billion, down from $6.08 billion in its third quarter of 2023.
BCE also said it now expects its revenue for 2024 to fall about 1.5 per cent compared with earlier guidance for an increase of zero to four per cent.
The company says the change comes as it faces lower-than-anticipated wireless product revenue and sustained pressure on wireless prices.
BCE added 33,111 net postpaid mobile phone subscribers, down 76.8 per cent from the same period last year, which was the company’s second-best performance on the metric since 2010.
It says the drop was driven by higher customer churn — a measure of subscribers who cancelled their service — amid greater competitive activity and promotional offer intensity. BCE’s monthly churn rate for the category was 1.28 per cent, up from 1.1 per cent during its previous third quarter.
The company also saw 11.6 per cent fewer gross subscriber activations “due to more targeted promotional offers and mobile device discounting compared to last year.”
Bell’s wireless mobile phone average revenue per user was $58.26, down 3.4 per cent from $60.28 in the third quarter of the prior year.
This report by The Canadian Press was first published Nov. 7, 2024.
