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Pfizer says COVID-19 vaccine can be stored at higher temperatures – Global News

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Pfizer Inc and BioNTech SE have asked the U.S. health regulator to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures, potentially allowing it to be kept in pharmacy freezers.

Approval by the Food and Drug Administration (FDA) could send a strong signal to other regulators around the world that may ease distribution of the shot in lower-income countries.

The companies have submitted new temperature data to the FDA to support an update to the current label that would allow vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.

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The current label requires the vaccine to be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.

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The shot’s cold-storage requirements set off a scramble among U.S. states at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialized freezers available, for instance in rural areas.






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Pfizer-BioNTech say their COVID-19 vaccine can be stored in ‘normal’ freezer temperatures


Pfizer-BioNTech say their COVID-19 vaccine can be stored in ‘normal’ freezer temperatures

Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, said the higher temepratures should “greatly expand the ability to use this vaccine in many parts of the world (or even the U.S.) that do not have the capacity for deep freeze storage.”

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Pfizer/BioNTech‘s vaccine, along with Moderna Inc’s two-dose shot, has already won U.S. emergency-use authorization and is being widely distributed as part of the country’s mass vaccination efforts.






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New data on effectiveness of single COVID-19 vaccine dose


New data on effectiveness of single COVID-19 vaccine dose

The FDA confirmed that it had received Pfizer’s request and said changes to the vaccine’s authorization must be requested by a company and include data supporting the change. It said authorization would come either through a granting letter or a reissued letter of authorization, either of which would be posted on the regulator’s web site.

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The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was backed by two of the South African government’s top advisers.

The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said.

A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.

“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” BioNTech Chief Executive Ugur Sahin said.

Deutsche Post, which has shipped COVID-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among other states, said -25 degrees would provide some relief but transportation would still not be easy.






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Health Canada approves extraction of six vaccine shots per Pfizer vial – Feb 9, 2021

A spokeswoman said air freight would likely no longer require dry ice on board, increasing storage capacity per plane.

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BioNTech has said it imposed long-term storage and transportation requirements of -70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.

Even though it launched its COVID-19 vaccine development program as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.

If approved, the less onerous storage requirements would provide significant logistical relief.

The World Health Organization’s COVAX global vaccine-sharing program has so far limited distribution of Pfizer-BioNTech vaccines to just a few countries, partly out of concern over a lack of infrastructure in developing nations.

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The WHO said it was hopeful that eased requirements could broaden its reach.

“We are aware of reports of this and look forward to seeing the data. If proven correct, this could make rollout of the vaccine easier in all countries, and particularly in low-income ones,” it said.

Moderna’s product, which like Pfizer’s is based on so-called messenger RNA molecules, is already cleared for storage at -25 to -15 degrees Celsius.

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(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Ludwig Burger in Frankfurt, John Miller in Zurich, Matthias Inverardi in Duesseldorf, Michael Erman in Maplewood, N.J. and Lisa Baertlein in Los Angeles; Editing by Shounak Dasgupta, Anil D’Silva, Jan Harvey and Nick Macfie)

© 2021 Reuters

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Roots sees room for expansion in activewear, reports $5.2M Q2 loss and sales drop

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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.

Companies in this story: (TSX:ROOT)

The Canadian Press. All rights reserved.

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Talks on today over HandyDART strike affecting vulnerable people in Metro Vancouver

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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.

The Canadian Press. All rights reserved.

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Transat AT reports $39.9M Q3 loss compared with $57.3M profit a year earlier

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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.

Companies in this story: (TSX:TRZ)

The Canadian Press. All rights reserved.

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