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US FDA panel okays COVID-19 booster jabs for people over 65 – Al Jazeera English

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Recommendation comes after science advisory panel rejects Pfizer proposal to provide booster jabs to most people.

A United States Food and Drug Administration (FDA) advisory panel has given approval to a booster jab of the Pfizer COVID-19 vaccine for people over the age of 65 and others at high risk of the disease.

But the influential FDA panel of scientists on Friday rejected widespread delivery of boosters to most Americans, delivering a surprise blow to the Biden administration’s plan to combat the highly contagious Delta variant by rolling out third jabs of the vaccine next week.

Members of the FDA’s panel of outside experts voted unanimously to support boosters for older Americans and at-risk people after rejecting Pfizer’s proposal to provide boosters of the vaccine to the general public.

The FDA’s move to clear the way for booster jabs only for older and at-risk people came as President Joe Biden planned to host a COVID-19 summit on the sidelines of the United Nations General Assembly in New York next week.

The US has been pushing partner nations to increase the availability of vaccines worldwide. The World Health Organization has urged the US to hold off providing boosters to its citizens until more of the worldwide population has received an initial inoculation.

“We will be asking participants to commit to a higher level of ambition” on a “common vision for defeating COVID-19 together”, White press secretary Jen Psaki said in a statement.

During several hours of discussion, the FDA panel of scientific advisers voiced frustration that Pfizer had provided little data on the safety of extra doses. And they complained information provided by Israeli researchers about their booster campaign was not useful for predicting the US experience.

Pfizer Inc and its German partner BioNTech, as well as rival vaccine maker Moderna Inc, have presented analyses of clinical trials showing that the effectiveness of the vaccines wanes over time.

As a result, people who were vaccinated earlier on in the pandemic are now more vulnerable to infections, particularly in the face of the fast-spreading Delta variant of coronavirus.

Booster doses help restore the waning levels of antibodies produced by the original inoculation, the drugmakers have said.

Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them but some of the agency’s top scientists arguing they are not needed yet.

Members of the advisory panel said the Pfizer and the FDA request for approval for people as young as 16 years old is too broad. Most of them said they would support boosters for older Americans, but did not think they were needed yet for younger adults.

Many vaccine experts said the data so far only suggested a need for boosters in older adults and people with compromised immune systems. The critics include two FDA scientists who resigned as the Biden administration announced its booster shot plans.

A separate panel advising the US Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House said it was ready to roll out boosters next week if health officials approve the plan. That programme now is likely to be narrowed in light of the advisory panel’s views and the FDA’s partial approval of the use of boosters.

A report published in The Lancet medical journal on September 13 concluded that even with the threat of the more contagious Delta variant, “booster doses for the general population are not appropriate at this stage in the pandemic.”

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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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