The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration (FDA) on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts are anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.
The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85 per cent protective against the most severe COVID-19 illness, in a massive study that spanned three continents — protection that remained strong even in countries such as South Africa, where the variants of most concern are spreading.
“This is really good news,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told The Associated Press Saturday. “The most important thing we can do right now is to get as many shots in as many arms as we can.”
Shipments of a few million doses to be divided among states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.
A person is administered the Johnson & Johnson vaccine at a hospital in Cape Town, South Africa, on Feb. 17. (Nardus Engelbrecht/The Associated Press)
J&J also is seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization. Worldwide, the company aims to produce about 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain became the first to clear its use.
Health Canada is still reviewing the vaccine. Canada has ordered 10 million doses from Johnson & Johnson with options for up to 28 million more, if necessary. Most of those shots are expected to arrive by the end of September.
‘We’re champing at the bit to get more supply’
On Sunday, a U.S. advisory committee will meet to recommend how to prioritize use of the single-dose vaccine. And one big challenge is what the public wants to know: Which kind of vaccine is better?
“In this environment, whatever you can get — get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the vaccine’s benefits outweigh its risks.
Data is mixed on how well all the vaccines being used around the world work, prompting reports in some countries of people refusing one kind to wait for another.
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In the U.S., the two-dose Pfizer and Moderna shots were 95 per cent protective against symptomatic COVID-19. J&J’s one-dose effectiveness of 85 per cent against severe COVID-19 dropped to 66 per cent when moderate cases were rolled in. But there’s no apples-to-apples comparison because of differences in when and where each company conducted its studies, with the Pfizer and Moderna research finished before concerning variants began spreading.
Collins said the evidence of effectiveness shows no reason to favour one vaccine over another.
“What people I think are mostly interested in is, is it going to keep me from getting really sick?” Collins said. “Will it keep me from dying from this terrible disease? The good news is all of these say yes to that.”
Also, J&J is testing two doses of its vaccine in a separate large study. Collins said if a second dose eventually is deemed better, people who got one earlier would be offered another.
The FDA cautioned that it’s too early to tell if someone who gets a mild or asymptomatic infection despite vaccination still could spread the virus.
There are clear advantages aside from the convenience of one shot. Local health officials are looking to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors who are spending months on fishing vessels — communities where it’s hard to be sure someone will come back in three to four weeks for a second vaccination.
WATCH | Canada’s procurement minister on Johnson & Johnson vaccine:
The CBC’s Tom Parry asks Procurement Minister Anita Anand how many doses of Johnson & Johnson’s COVID-19 vaccine Canada will receive after it’s approved by Health Canada. 4:56
The J&J vaccine also is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
“We’re champing at the bit to get more supply. That’s the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staffers were readying electronic health records, staffing and vaccine storage in anticipation of offering J&J shots soon.
The FDA said studies detected no serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache.
The FDA said there is “a remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with the Pfizer and Moderna vaccines.
The vaccine has been authorized for emergency use in adults 18 and older for now. But like other vaccine makers, J&J is about to begin a study of its vaccine in teens before moving to younger children later in the year, and also plans a study in pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spike protein that coats it. But they’re made in very different ways.
WATCH | Provinces offer different timelines for COVID-19 vaccine rollout:
When Canadians will be able to get a COVID-19 vaccine may depend on where they live. The provinces have started revealing their rollout plans, but the timing of who can get a shot varies across the country. 1:58
J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along. It’s the same technology the company used in making an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca and China’s CanSino Biologics.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make those harmless spike copies.
The AstraZeneca vaccine — which was approved for use in Canada on Friday and is already in use in numerous other countries — is finishing a large U.S. study needed for FDA clearance. Also in the pipeline, Novavax uses a still different technology, made with lab-grown copies of the spike protein, and has reported preliminary findings from a British study suggesting strong protection.
Still other countries are using “inactivated vaccines,” made with killed coronavirus by Chinese companies Sinovac and Sinopharm.
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.
