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.
TOKYO (AP) — Japanese technology group SoftBank swung back to profitability in the July-September quarter, boosted by positive results in its Vision Fund investments.
Tokyo-based SoftBank Group Corp. reported Tuesday a fiscal second quarter profit of nearly 1.18 trillion yen ($7.7 billion), compared with a 931 billion yen loss in the year-earlier period.
Quarterly sales edged up about 6% to nearly 1.77 trillion yen ($11.5 billion).
SoftBank credited income from royalties and licensing related to its holdings in Arm, a computer chip-designing company, whose business spans smartphones, data centers, networking equipment, automotive, consumer electronic devices, and AI applications.
The results were also helped by the absence of losses related to SoftBank’s investment in office-space sharing venture WeWork, which hit the previous fiscal year.
WeWork, which filed for Chapter 11 bankruptcy protection in 2023, emerged from Chapter 11 in June.
SoftBank has benefitted in recent months from rising share prices in some investment, such as U.S.-based e-commerce company Coupang, Chinese mobility provider DiDi Global and Bytedance, the Chinese developer of TikTok.
SoftBank’s financial results tend to swing wildly, partly because of its sprawling investment portfolio that includes search engine Yahoo, Chinese retailer Alibaba, and artificial intelligence company Nvidia.
SoftBank makes investments in a variety of companies that it groups together in a series of Vision Funds.
The company’s founder, Masayoshi Son, is a pioneer in technology investment in Japan. SoftBank Group does not give earnings forecasts.
Shopify Inc. executives brushed off concerns that incoming U.S. President Donald Trump will be a major detriment to many of the company’s merchants.
“There’s nothing in what we’ve heard from Trump, nor would there have been anything from (Democratic candidate) Kamala (Harris), which we think impacts the overall state of new business formation and entrepreneurship,” Shopify’s chief financial officer Jeff Hoffmeister told analysts on a call Tuesday.
“We still feel really good about all the merchants out there, all the entrepreneurs that want to start new businesses and that’s obviously not going to change with the administration.”
Hoffmeister’s comments come a week after Trump, a Republican businessman, trounced Harris in an election that will soon return him to the Oval Office.
On the campaign trail, he threatened to impose tariffs of 60 per cent on imports from China and roughly 10 per cent to 20 per cent on goods from all other countries.
If the president-elect makes good on the promise, many worry the cost of operating will soar for companies, including customers of Shopify, which sells e-commerce software to small businesses but also brands as big as Kylie Cosmetics and Victoria’s Secret.
These merchants may feel they have no choice but to pass on the increases to customers, perhaps sparking more inflation.
If Trump’s tariffs do come to fruition, Shopify’s president Harley Finkelstein pointed out China is “not a huge area” for Shopify.
However, “we can’t anticipate what every presidential administration is going to do,” he cautioned.
He likened the uncertainty facing the business community to the COVID-19 pandemic where Shopify had to help companies migrate online.
“Our job is no matter what comes the way of our merchants, we provide them with tools and service and support for them to navigate it really well,” he said.
Finkelstein was questioned about the forthcoming U.S. leadership change on a call meant to delve into Shopify’s latest earnings, which sent shares soaring 27 per cent to $158.63 shortly after Tuesday’s market open.
The Ottawa-based company, which keeps its books in U.S. dollars, reported US$828 million in net income for its third quarter, up from US$718 million in the same quarter last year, as its revenue rose 26 per cent.
Revenue for the period ended Sept. 30 totalled US$2.16 billion, up from US$1.71 billion a year earlier.
Subscription solutions revenue reached US$610 million, up from US$486 million in the same quarter last year.
Merchant solutions revenue amounted to US$1.55 billion, up from US$1.23 billion.
Shopify’s net income excluding the impact of equity investments totalled US$344 million for the quarter, up from US$173 million in the same quarter last year.
Daniel Chan, a TD Cowen analyst, said the results show Shopify has a leadership position in the e-commerce world and “a continued ability to gain market share.”
In its outlook for its fourth quarter of 2024, the company said it expects revenue to grow at a mid-to-high-twenties percentage rate on a year-over-year basis.
“Q4 guidance suggests Shopify will finish the year strong, with better-than-expected revenue growth and operating margin,” Chan pointed out in a note to investors.
This report by The Canadian Press was first published Nov. 12, 2024.
TORONTO – RioCan Real Estate Investment Trust says it has cut almost 10 per cent of its staff as it deals with a slowdown in the condo market and overall pushes for greater efficiency.
The company says the cuts, which amount to around 60 employees based on its last annual filing, will mean about $9 million in restructuring charges and should translate to about $8 million in annualized cash savings.
The job cuts come as RioCan and others scale back condo development plans as the market softens, but chief executive Jonathan Gitlin says the reductions were from a companywide efficiency effort.
RioCan says it doesn’t plan to start any new construction of mixed-use properties this year and well into 2025 as it adjusts to the shifting market demand.
The company reported a net income of $96.9 million in the third quarter, up from a loss of $73.5 million last year, as it saw a $159 million boost from a favourable change in the fair value of investment properties.
RioCan reported what it says is a record-breaking 97.8 per cent occupancy rate in the quarter including retail committed occupancy of 98.6 per cent.
This report by The Canadian Press was first published Nov. 12, 2024.
