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Novavax submits coronavirus vaccine to Health Canada for approval – Global News

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Canada’s hopes of speeding up COVID-19 vaccinations brightened slightly over the weekend as regulators began work to approve a new inoculation, even as the federal government sought to head off any restrictions on vaccine shipments from Europe.

Pharmaceutical company Novavax quietly submitted its COVID-19 vaccine to Health Canada for regulatory approval on Friday, less than two weeks after Ottawa finalized a deal with the Maryland-based company for 52 million doses of the shot.

Because of the emergency nature of the pandemic Health Canada is accepting applications for vaccines before the final trial data is ready, allowing the review team to start pouring over the documents on an ongoing basis, rather than waiting until everything is finished.

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The rolling review allows for much faster approval once the final results from clinical trials are complete.

“Health Canada is expediting the review of all COVID-19 vaccines,” Health Canada spokesman Andre Gagnon said in an email. “This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer.”

Novavax is the fifth vaccine maker to submit an application for rolling review. AstraZeneca, Pfizer-BioNTech and Moderna all submitted in early October, and Johnson and Johnson followed suit at the end of November.

Health Canada approved the Pfizer-BioNTech vaccine on Dec. 9 and gave Moderna the green light on Dec. 23, both about three weeks after the companies completed their Phase 3 trials. A decision on AstraZeneca is expected in the next couple of weeks.

Johnson and Johnson reported results from its Phase 3 trial just last week.

Novavax also reported results Thursday from a trial in the United Kingdom, but a large trial in the U.S. is still at least a month or two away from yielding final results.






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The company has said its vaccine was 89 per cent effective in the U.K. trial. It also touts its product as very effective against the new British and South African strains of COVID-19, and says it could start delivering doses in the spring once it has received regulatory approval.

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“The doses that will ultimately be sent to Canada are being made outside the U.S.,” Novavax spokeswoman Amy Speak said in an email.

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Novavax’s application comes as the federal Liberal government faces withering criticism for the pace of vaccinations across the country, with opposition parties and some provincial governments complaining about a lack of shots.

Those critiques have come as Pfizer slows delivery of its vaccines to Canada so it can expand a production plant in Belgium. The European pharmaceutical giant is also pressing Canada to allow six shots per vial of vaccine instead of the current five.

Moderna has also said that it will deliver fewer doses than originally promised, though the Liberal government insists the slowdowns are temporary and that both companies will make good on their promised deliveries over the coming months.

Read more:
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There are also concerns that Canada’s troubled vaccine supplies will be further affected by new controls on vaccine exports that have been imposed by the European Union, which is also struggling with delivery shortfalls from manufacturers.

The measures allow the European Union to deny vaccine exports if the manufacturer has not fulfilled its promised deliveries to the 27-country bloc, which is where most of Canada’s shots are being made.

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Ottawa has been working to head off any impact on Canada’s supply, with International Trade Minister Mary Ng speaking by phone to her EU counterpart on Saturday for the second time in three days.

That follows Prime Minister Justin Trudeau’s own phone call with European Commission President Ursula von der Leyen late last week, after which Trudeau asserted that the new export controls would not affect vaccines destined for Canada.

Ng was told the same thing during her phone call with Valdis Dombrovskis, the European Commission’s commissioner for trade, according to a summary of their conversation provided by Global Affairs Canada.






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The federal department said Ng’s call was “part of a broader ongoing engagement across government … to minimize any impact of the EU’s Transparency and Authorization Mechanism on vaccines manufactured in Europe destined for Canada,” the summary read.

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Former Canadian diplomat Colin Robertson, who is now vice-president of the Canadian Global Affairs Institute, said the number of calls between the government and European officials _ and the fact they have been revealed publicly _ is unusual and “is the kind of thing you would do if you’re concerned.”

Robertson nonetheless expressed his hopes that Ottawa’s close relationship with the EU, formalized in various trade and political agreements, along with the contracts between Ottawa and the drug companies would prevent the Europeans from curtailing shipments to Canada.

Von der Leyen said Friday the commission is following through on a threat to force COVID-19 vaccine makers to show them what vaccines they are producing in Europe and where those are going.

She said the export transparency rule is temporary but has to be done as the continent is in an ongoing battle with vaccine-makers about slow deliveries.

Both Pfizer-BioNTech and AstraZeneca are behind on their scheduled deliveries to European nations, but it is the latter with which Europe is having the loudest fight.

The EU is demanding the company ship doses made in the United Kingdom to make up for shortfalls due to production issues in its European plants.

© 2021 The Canadian Press

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Canada’s Denis Shapovalov wins Belgrade Open for his second ATP Tour title

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BELGRADE, Serbia – Canada’s Denis Shapovalov is back in the winner’s circle.

The 25-year-old Shapovalov beat Serbia’s Hamad Medjedovic 6-4, 6-4 in the Belgrade Open final on Saturday.

It’s Shapovalov’s second ATP Tour title after winning the Stockholm Open in 2019. He is the first Canadian to win an ATP Tour-level title this season.

His last appearance in a tournament final was in Vienna in 2022.

Shapovalov missed the second half of last season due to injury and spent most of this year regaining his best level of play.

He came through qualifying in Belgrade and dropped just one set on his way to winning the trophy.

Shapovalov’s best results this season were at ATP 500 events in Washington and Basel, where he reached the quarterfinals.

Medjedovic was playing in his first-ever ATP Tour final.

The 21-year-old, who won the Next Gen ATP Finals presented by PIF title last year, ends 2024 holding a 9-8 tour-level record on the season.

This report by The Canadian Press was first published Nov. 9, 2024.

The Canadian Press. All rights reserved.



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Talks to resume in B.C. port dispute in bid to end multi-day lockout

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VANCOUVER – Contract negotiations resume today in Vancouver in a labour dispute that has paralyzed container cargo shipping at British Columbia’s ports since Monday.

The BC Maritime Employers Association and International Longshore and Warehouse Union Local 514 are scheduled to meet for the next three days in mediated talks to try to break a deadlock in negotiations.

The union, which represents more than 700 longshore supervisors at ports, including Vancouver, Prince Rupert and Nanaimo, has been without a contract since March last year.

The latest talks come after employers locked out workers in response to what it said was “strike activity” by union members.

The start of the lockout was then followed by several days of no engagement between the two parties, prompting federal Labour Minister Steven MacKinnon to speak with leaders on both sides, asking them to restart talks.

MacKinnon had said that the talks were “progressing at an insufficient pace, indicating a concerning absence of urgency from the parties involved” — a sentiment echoed by several business groups across Canada.

In a joint letter, more than 100 organizations, including the Canadian Chamber of Commerce, Business Council of Canada and associations representing industries from automotive and fertilizer to retail and mining, urged the government to do whatever it takes to end the work stoppage.

“While we acknowledge efforts to continue with mediation, parties have not been able to come to a negotiated agreement,” the letter says. “So, the federal government must take decisive action, using every tool at its disposal to resolve this dispute and limit the damage caused by this disruption.

“We simply cannot afford to once again put Canadian businesses at risk, which in turn puts Canadian livelihoods at risk.”

In the meantime, the union says it has filed a complaint to the Canada Industrial Relations Board against the employers, alleging the association threatened to pull existing conditions out of the last contract in direct contact with its members.

“The BCMEA is trying to undermine the union by attempting to turn members against its democratically elected leadership and bargaining committee — despite the fact that the BCMEA knows full well we received a 96 per cent mandate to take job action if needed,” union president Frank Morena said in a statement.

The employers have responded by calling the complaint “another meritless claim,” adding the final offer to the union that includes a 19.2 per cent wage increase over a four-year term remains on the table.

“The final offer has been on the table for over a week and represents a fair and balanced proposal for employees, and if accepted would end this dispute,” the employers’ statement says. “The offer does not require any concessions from the union.”

The union says the offer does not address the key issue of staffing requirement at the terminals as the port introduces more automation to cargo loading and unloading, which could potentially require fewer workers to operate than older systems.

The Port of Vancouver is the largest in Canada and has seen a number of labour disruptions, including two instances involving the rail and grain storage sectors earlier this year.

A 13-day strike by another group of workers at the port last year resulted in the disruption of a significant amount of shipping and trade.

This report by The Canadian Press was first published Nov. 9, 2024.

The Canadian Press. All rights reserved.



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The Royal Canadian Legion turns to Amazon for annual poppy campaign boost

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The Royal Canadian Legion says a new partnership with e-commerce giant Amazon is helping boost its veterans’ fund, and will hopefully expand its donor base in the digital world.

Since the Oct. 25 launch of its Amazon.ca storefront, the legion says it has received nearly 10,000 orders for poppies.

Online shoppers can order lapel poppies on Amazon in exchange for donations or buy items such as “We Remember” lawn signs, Remembrance Day pins and other accessories, with all proceeds going to the legion’s Poppy Trust Fund for Canadian veterans and their families.

Nujma Bond, the legion’s national spokesperson, said the organization sees this move as keeping up with modern purchasing habits.

“As the world around us evolves we have been looking at different ways to distribute poppies and to make it easier for people to access them,” she said in an interview.

“This is definitely a way to reach a wider number of Canadians of all ages. And certainly younger Canadians are much more active on the web, on social media in general, so we’re also engaging in that way.”

Al Plume, a member of a legion branch in Trenton, Ont., said the online store can also help with outreach to veterans who are far from home.

“For veterans that are overseas and are away, (or) can’t get to a store they can order them online, it’s Amazon.” Plume said.

Plume spent 35 years in the military with the Royal Engineers, and retired eight years ago. He said making sure veterans are looked after is his passion.

“I’ve seen the struggles that our veterans have had with Veterans Affairs … and that’s why I got involved, with making sure that the people get to them and help the veterans with their paperwork.”

But the message about the Amazon storefront didn’t appear to reach all of the legion’s locations, with volunteers at Branch 179 on Vancouver’s Commercial Drive saying they hadn’t heard about the online push.

Holly Paddon, the branch’s poppy campaign co-ordinator and bartender, said the Amazon partnership never came up in meetings with other legion volunteers and officials.

“I work at the legion, I work with the Vancouver poppy office and I go to the meetings for the Vancouver poppy campaign — which includes all the legions in Vancouver — and not once has this been mentioned,” she said.

Paddon said the initiative is a great idea, but she would like to have known more about it.

The legion also sells a larger collection of items at poppystore.ca.

This report by The Canadian Press was first published Nov. 9, 2024.

The Canadian Press. All rights reserved.



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