Pfizer Inc. (NYSE: PFE) will manage distribution of its COVID-19 vaccine on its own rather than through the U.S. government’s designated coordinator, but officials question whether the U.S. has an adequate supply of medical-grade freezers at the point of use for vaccines requiring storage at ultra-cold temperatures.
The Centers for Disease Control and Prevention in August tasked McKesson Corp. to be the central distributor for COVID vaccines and related supplies needed to administer vaccinations. Most pharmaceutical companies will deliver approved vaccines to McKesson distribution centers, which will arrange delivery to hospitals, nursing homes and other administration points.
Pfizer has a different, just-in-time distribution plan. It will ship COVID medicine directly from U.S. manufacturing facilities and warehouses to end users with the help of trusted transportation providers, said Tanya Alcorn, the company’s vice president for biopharma global supply chain, during a Thursday webinar organized by the U.S. Chamber of Commerce.
“We’ve been working from the beginning with the U.S. government to ensure that model is successful,” she said.
The U.S. government has contracted with the New York-based pharmaceutical company to deliver 100 million initial doses once its vaccine is approved, with an option for an additional 500 million doses. Pfizer’s product must be maintained at minus 75 degrees Celsius (-109.3 degrees Fahrenheit) to maintain its effectiveness. Officials this week said they expect to provide safety data from final-stage clinical trials to the Food and Drug Administration by the third week of November and then apply for an emergency use authorization if everything checks out.
Moderna also is also developing a vaccine for the government with similar technology and temperature requirements. It said Thursday it too is on pace to deliver data from a Phase 3 trial of its experimental COVID-19 vaccine in November. The company expects to be able to produce 20 million doses by the end of the year, and between 500 million and 1 billion in 2021.
Pharmaceutical and logistics industry representatives on the Chamber webinar said the U.S. is well positioned to handle ultra-cold vaccines, but federal health regulators last month expressed doubts about whether there is adequate infrastructure nationwide.
The responsibility for determining how many deep-freeze machines exist at health care facilities has fallen on states because there is no central inventory.
“Not all of those [vaccination sites] will have the ultra-cold deep freezers to be able to store vaccines, particularly the Pfizer product,” said Jay Butler, CDC deputy director for infectious diseases, during a mid-October media briefing. “So that is an important part of the state planning effort to determine where that capacity is.”
That means the nation’s 64 vaccinations jurisdictions are on their own to secure cryogenic freezers, which could lead to shortages as every region competes for a limited resource, much like states fought each other for ventilators early in the pandemic, Roll Call recently reported.
“There’s no historical precedent for us maintaining vaccines on dry ice in the United States. That’s never happened,” testified Paul Offit, an adviser to the FDA on vaccines and director of vaccine education at the Children’s Hospital of Philadelphia, before a House panel Sept. 30. “We’ve always shipped in the United States at most at freezer temperatures. … I do worry about that. I think it’s going to be an enormous challenge.”
Experts say vaccines will likely be administered at hospitals and other large sites because typical spots such as pharmacies and doctor’s offices don’t have ultra-cold freezers. Large sites could share some of their shipments with local facilities if they have excess doses, but the vaccines could lose a day or two of freshness for transport, experts told Roll Call.
Nancy Messonnier, the CDC’s director of immunization and respiratory diseases, recommended during an industry conference call in late September against states investing in their own deep freezers, which cost as much as $15,000, because they won’t be needed for very long as less sensitive vaccines that take longer to develop are produced, according to the Roll Call report.
If sites quickly use up the doses ultra-cold storage may be less of a concern.
Medicines at standard frozen and refrigerated temperatures are much easier to distribute, according to industry representatives. Johnson & Johnson’s vaccine can remain stable at minus 20 Celsius.
“Our vaccine candidate is better suited to the world,” especially areas that don’t have the latest cold storage technology, said Remo Colarusso, vice president of supply chain at Johnson & Johnson, during the U.S. Chamber event.
(Source: Johnson & Johnson, U.S. Department of Defense.)
Pfizer packaging innovation
Direct shipping enables Pfizer to have greater control and real-time insights into the status of the frozen vials.
Uncertainty about the cold-chain capabilities of transportation providers and vaccine administration facilities led the drugmaker to co-create a special thermal cooler with real-time GPS and thermal monitoring that can keep its vaccine in a deep freeze for 10 days if left unopened. The shipping container, about the size of a small suitcase, uses dry ice to maintain recommended storage conditions. Once opened, vials can be stored at normal refrigerated temperatures for five days. Replenishing dry ice can extend the storage time after opening to 15 days.
Alcorn said Pfizer also developed a control tower that will get real-time alerts if the temperature deviates from the required range or a shipment doesn’t reach its destination within a prescribed time frame.
Control towers are centralized hubs with logistics specialists that capture data from all stages of the supply chain to improve processes and manage events.
Data loggers have provided GPS information for pharmaceutical shipments for several years, but Alcorn said having location data integrated with temperature readings from a refrigerated container is new for the industry.
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.
