The U.S. on Wednesday authorized its first update to COVID-19 vaccines; booster doses that target today’s most common Omicron strain. Shots could begin within days.
The move by the Food and Drug Administration tweaks the recipe of shots made by Pfizer and rival Moderna that already have saved millions of lives. The hope is that the modified boosters will blunt yet another winter surge.
“You’ll see me at the front of the line,” FDA vaccine chief Dr. Peter Marks told The Associated Press shortly before his agency cleared the new doses.
For Canada, Moderna announced last week that it will supply 12 million doses of its COVID-19 shot adapted to target the Omicron variant of the coronavirus.
A Health Canada spokesperson said Aug. 22 that a decision on Moderna’s bivalent vaccine is expected within the next two weeks.
‘Broadest opportunity for protection’
Until now, COVID-19 vaccines have targeted the original coronavirus strain, even as wildly different mutants emerged.
The new U.S. boosters are combination, or “bivalent” shots. They contain half that original vaccine recipe and half protection against the newest Omicron versions, called BA.4 and BA.5, that are considered the most contagious yet.
The combination aims to increase cross-protection against multiple variants.
“It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told AP.
There’s one more step before a fall booster campaign in the U.S. begins: The Centers for Disease Control and Prevention must recommend who should get the additional shot. (Luke Dray/Getty Images)
The updated boosters are only for people who have already had their primary vaccinations using the original vaccines.
Doses made by Pfizer and its partner BioNTech are for anyone 12 and older while Moderna’s updated shots are for adults, if it has been at least two months since their last primary vaccination or their latest booster. They’re not to be used for initial vaccinations.
There’s one more step before a fall booster campaign begins: The Centers for Disease Control and Prevention must recommend who should get the additional shot. An influential CDC advisory panel will debate the evidence Thursday, including whether people at high risk from COVID-19 should go first.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” FDA Commissioner Dr. Robert Califf said in a statement.
The U.S. has purchased more than 170 million doses from the two companies. Pfizer said it could ship up to 15 million of those doses by the end of next week.
The big question is whether people weary of vaccinations will roll up their sleeves again. Just half of vaccinated Americans got the first recommended booster dose, and only a third of those 50 and older who were urged to get a second booster did so.
British health authorities have authorized an updated version of Moderna’s coronavirus vaccine that aims to protect against the original virus and the Omicron variant. (Rogelio V. Solis/The Associated Press)
It’s time for U.S. authorities to better explain that the public should expect an updated COVID-19 vaccination every so often, just like getting a fall flu shot or a tetanus booster after stepping on a rusty nail, said University of Pennsylvania immunologist E. John Wherry.
“We need to rebrand it in a societally normal-looking way,” rather than a panicked response to new mutants, Wherry said. “Give a clear, forward-looking set of expectations.”
Here’s the rub: The original vaccines still offer strong protection against severe disease and death from COVID-19 for most generally healthy people, especially if they got that important first booster dose. It’s not clear just how much more benefit an updated booster will bring beyond a temporary jump in antibodies capable of fending off an Omicron infection.
One reason: The FDA cleared the modifications ahead of studies in people, a step toward eventually handling COVID-19 vaccine updates more like yearly flu shots.
WATCH | Health Canada poised to approve new Omicron-targeting vaccine
Health Canada poised to approve new Omicron-targeting vaccine
9 days ago
Duration 2:01
Health Canada says it could make a decision on approving Moderna’s new Omicron-targeting vaccine within two weeks. If approved, it will leave Canadians with a decision: wait for the new shot, or get boosted with an existing vaccine.
First, FDA checked human studies of earlier Pfizer and Moderna attempts to update their vaccines — shots matching the omicron strain that struck last winter. That recipe change was safe, and substantially boosted antibodies targeting the earlier variant — better than another dose of the original vaccine — while adding a little protection against today’s genetically distinct BA.4 and BA.5 omicron versions.
But FDA ordered the companies to brew even more up-to-date doses that target those newest omicron mutants instead, sparking a race to roll out shots in less than three months. Rather than waiting a few more months for additional human studies of that recipe tweak, Marks said animal tests showed the latest update spurs “a very good immune response.”
The hope, he said, is that a vaccine matched to currently spreading variants might do a better job fighting infection, not just serious illness, at least for a while.
What’s next? Even as modified shots roll out, Moderna and Pfizer are conducting human studies to help assess their value, including how they hold up if a new mutant comes along.
And for children, Pfizer plans to ask FDA to allow updated boosters for five to 11 year-olds in early October.
It’s the first U.S. update to the COVID-19 vaccine recipe, an important but expected next step — like how flu vaccines get updated every year.
And the U.S. isn’t alone. Britain recently decided to offer adults over 50 a different booster option from Moderna, a combo shot targeting that initial BA.1 omicron strain.
European regulators are considering whether to authorize one or both of the updated formulas.
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.
TORONTO – Canada Goose Holdings Inc. trimmed its financial guidance as it reported its second-quarter revenue fell compared with a year ago.
The luxury clothing company says revenue for the quarter ended Sept. 29 totalled $267.8 million, down from $281.1 million in the same quarter last year.
Net income attributable to shareholders amounted to $5.4 million or six cents per diluted share, up from $3.9 million or four cents per diluted share a year earlier.
On an adjusted basis, Canada Goose says it earned five cents per diluted share in its latest quarter compared with an adjusted profit of 16 cents per diluted share a year earlier.
In its outlook, Canada Goose says it now expects total revenue for its full financial year to show a low-single-digit percentage decrease to low-single-digit percentage increase compared with earlier guidance for a low-single-digit increase.
It also says it now expects its adjusted net income per diluted share to show a mid-single-digit percentage increase compared with earlier guidance for a percentage increase in the mid-teens.
This report by The Canadian Press was first published Nov. 7, 2024.
