The chief executive of AstraZeneca says it is not uncommon for vaccine trials to be paused because of an adverse event and he believes the company can still deliver a safe COVID-19 vaccine by the end of the year.
“If you have an event that you didn’t expect, then you stop to look at it and explore it and study it,” Pascal Soriot said Thursday during a conference sponsored by British news outlet Tortois Media. “And that’s what happened in our case, but it’s really common.”
AstraZeneca announced this week that it had halted the Phase 3 trial of a COVID-19 vaccine the company is developing with researchers at Oxford University. It is considered one of the best candidates for a viable vaccine, but the trial was stopped after a female volunteer in Britain fell ill. She developed symptoms consistent with a rare disorder called transverse myelitis, which causes inflammation of the spinal cord. The woman’s condition has been improving, and she was expected to leave hospital this week.
Mr. Soriot said an independent safety committee was reviewing the case and it had yet to determine if the volunteer had actually developed transverse myelitis. He added that the trial won’t restart until the review is completed. The committee can either allow the trial to continue or stop the project altogether.
This was the second time the trial for the vaccine, known as AZD1222, has been halted. Mr. Soriot confirmed that another pause happened in July when a participant experienced neurological symptoms. Further examination found the participant had multiple sclerosis, which was deemed unrelated to the vaccine.
Mr. Soriot said that although transverse myelitis is rare, it had surfaced in other vaccine projects. “What is true is that you will see transverse myelitis mentioned in the product information of several other vaccines,” he said. “And the issue with vaccines is you actually vaccinate thousands and thousands of people, so you will see all sorts of issues come up that are often not related to the vaccine.”
He added that many other vaccine trials have had to stop but such developments rarely get much public attention. “The difference with other vaccine trials is the whole world is not watching them, of course, so they stop, they study and they restart. What happened here is not uncommon,” he said. “What we have here is a very special set of circumstances where the entire world becomes involved in the conduct of the clinical trial and wants to know every step of the way.”
The Phase 3 trial of AZD1222 involves 30,000 participants in Britain, the United States, Brazil and South Africa. Such trials often last several years, but AstraZeneca has been able to speed up the process by working in parallel with regulators. Usually drug companies complete their trials and then submit the data to regulators, who spend months analyzing the information. AstraZeneca has been handing over data as the trials proceed.
“We could not do this for every single vaccine or drug because the system would not be supporting it – the regulator would not have the resources,” Mr. Soriot said. He added that the vaccine will ultimately be tested on as many as 60,000 people before it is approved.
Despite the setback, Mr. Soriot said that if the trial can restart soon the company is on track to deliver the vaccine in a few months. “We could still have a vaccine by the end of this year, maybe early next year, but by the end of this year is still possible.”
Two other vaccines in development – by Pfizer Inc. and Moderna Therapeutics – are also in Phase 3 testing and could be ready by early 2021, he said.
AstraZeneca is producing the vaccine on a non-profit basis and has lined up manufacturing partners around the world to ensure it can be delivered in all regions at roughly the same time. The company and Oxford are also working with non-profit organizations to co-ordinate distribution among developing countries and to people in refugee camps.
Medical experts said it was not uncommon for trials to stop because a participant fell ill. “A suspension such as this is not unusual for Phase 3 trials, which have tens of thousands of participants,” said Ohid Yaqub, a senior lecturer at the science policy research unit at the University of Sussex.
“Suspending the trial gives time to investigate whether the incident is related to the vaccine or is happening by coincidence. If the data and safety monitoring board decides it’s the latter, the trial will resume. Other trials will also investigate their data, too.”
U.S. top infectious disease expert, Dr. Anthony Fauci, in an online forum moderated by PBS NewsHour’s Judy Woodruff on Tuesday, said while he thinks it’s “unlikely” there will be a coronavirus vaccine by Election Day, it’s not “impossible.”Reuters
HALIFAX – Ottawa is negotiating a $500-million bailout for Nova Scotia’s privately owned electric utility, saying the money will be used to prevent a big spike in electricity rates.
Federal Natural Resources Minister Jonathan Wilkinson made the announcement today in Halifax, saying Nova Scotia Power Inc. needs the money to cover higher costs resulting from the delayed delivery of electricity from the Muskrat Falls hydroelectric plant in Labrador.
Wilkinson says that without the money, the subsidiary of Emera Inc. would have had to increase rates by 19 per cent over “the short term.”
Nova Scotia Power CEO Peter Gregg says the deal, once approved by the province’s energy regulator, will keep rate increases limited “to be around the rate of inflation,” as costs are spread over a number of years.
The utility helped pay for construction of an underwater transmission link between Newfoundland and Nova Scotia, but the Muskrat Falls project has not been consistent in delivering electricity over the past five years.
Those delays forced Nova Scotia Power to spend more on generating its own electricity.
This report by The Canadian Press was first published Sept. 16, 2024.
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.
