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Canada among targets in Russian hack on U.S., private companies, Microsoft says – The Globe and Mail

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The Communications Security Establishment Canada (CSEC) complex in Ottawa, on Oct. 15, 2013.

Sean Kilpatrick/The Canadian Press

Tech giant Microsoft Corp. says Canada was among the targets of a major hack that is believed to have been carried out by Russian intelligence against U.S. government computer systems, private companies and others around the world.

Ottawa has said little about the sophisticated cybersecurity breach. However, the U.S. Cybersecurity and Infrastructure Security Agency (CISA) said Texas-based SolarWinds Inc.’s’ widely used network-management software was targeted in order to breach government and corporate networks.

Microsoft president Brad Smith said in a blog late Thursday that his company was hacked in connection with the attack on SolarWinds and that Canada was also hit.

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“While roughly 80 per cent of these customers are located in the United States, this work so far has also identified victims in seven additional countries,” Mr. Smith said. “This includes Canada and Mexico in North America; Belgium, Spain and the United Kingdom in Europe; and Israel and the UAE in the Middle East. It’s certain that the number and location of victims will keep growing.”

Mr. Smith said more than 40 organizations were hacked including U.S. government agencies, companies with contracts with the U.S. government, tech companies and think tanks. He suggested Russia was behind the hack, pointing to the cybertechniques the country used in the 2016 U.S. election and French presidential election of 2017.

But he said this sophisticated cyberintrusion is far more worrying.

“This is not ‘espionage as usual,’ even in the digital age. Instead, it represents an act of recklessness that created a serious technological vulnerability for the United States and the world,” he wrote. “The recent attackers used a technique that has put at risk the technology supply chain for the broader economy.”

Canada’s Communications Security Establishment, which is responsible for electronic surveillance and cybersecurity, said Friday that it is assessing the situation and working to ensure federal information technology (IT) systems and networks remain secure.

“While this situation remains ongoing, the Canadian Centre for Cyber Security is actively engaged with our government and non-government partners sharing cybersecurity advice and guidance, mitigation, and operational updates,” CSE spokesperson Evan Koronewski said in an e-mail.

Mr. Koronewski said the Canadian Centre for Cyber Security, a unit of CSE, has issued a Cyber Alert with recommended actions and mitigation advice including isolating SolarWinds servers and blocking internet egress from servers or other endpoints with SolarWinds software.

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“The Cyber Centre does not comment on reporting by Canadian organizations regarding cyber incidents. As a result, we do not have any further information to add on potential targets and/or victims,” he added.

The Department of National Defence (DND) said it had used SolarWinds products in the past.

“The contracts for SolarWinds software identified, used at CFB Shilo, expired about ten years ago and did not involve the specific vulnerable version reported by U.S. agencies,” said Daniel Le Bouthillier, head of media relations at National Defence.

However, he said DND is assessing and monitoring “our systems to ensure our personnel, operations and capabilities are protected.” He provided no further comment.

Shared Services Canada, which manages the majority of Ottawa’s IT infrastructure, said that at this point, none of the SolarWinds platforms and products used by the government have been affected by the incident.

“As this is an ongoing issue, Shared Services Canada continues to assess the situation and is working with its government partners to ensure networks remain secure,” the department said Friday.

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The U.S. government’s CISA said the hacking operation, which is believed to have started in March, breached U.S. federal agencies and “critical infrastructure” in an attack that was hard to detect and will be difficult to undo.

“This threat actor has demonstrated sophistication and complex tradecraft in these intrusions,” CISA said. “Removing the threat actor from compromised environments will be highly complex and challenging.”

CISA has not said who it thinks is the “advanced persistent threat actor” behind the “significant and ongoing” campaign, but many experts are pointing to Russia.

“The magnitude of this ongoing attack is hard to overstate,” former U.S. Homeland Security adviser Thomas Bossert said in an article in The New York Times. “The Russians have had access to a considerable number of important and sensitive networks for six to nine months.”

Russian presidential spokesman Dmitry Peskov said Moscow had nothing to do with this hack.

“Even if it is true [that] there have been some attacks over many months and the Americans managed to do nothing about them, possibly it is wrong to groundlessly blame Russians right away,” Mr. Peskov told the Russian news agency Tass.

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President-elect Joe Biden vowed to make the breach a top priority when he takes office in early January.

“We need to disrupt and deter our adversaries from undertaking significant cyberattacks in the first place,” he said in a statement. “We will do that by, among other things, imposing substantial costs on those responsible for such malicious attacks, including in co-ordination with our allies and partners.”

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Canada seeking reassurance as Europe mulls export controls on COVID-19 vaccines – CTV News

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OTTAWA —
Prime Minister Justin Trudeau says he remains confident in Canada’s vaccine supplies despite threats from Europe that it might impose export controls on vaccines produced on that continent.

Speaking to reporters outside his Ottawa residence Tuesday morning, Trudeau said the situation in Europe is worrisome but he is “very confident” Canada is going to get all the COVID-19 vaccine doses promised by the end of March. And despite the sharp decline in deliveries of a vaccine from Pfizer and BioNTech this month, he said Canada will still vaccinate all Canadians who want shots by the end of September.

“We will continue to work closely with Europe to ensure that we are sourcing, that we are receiving the vaccines that we have signed for, that we are due,” Trudeau said.

European Commission President Ursula von der Leyen said in a video statement posted to Twitter Tuesday that Europe will set up a “vaccine export transparency mechanism” so Europe knows exactly how many doses are being produced in the world’s largest trading bloc and where they are being shipped.

“Europe invested billions to help develop the world`s first COVID-19 vaccines to create a truly global common good,” she said. “And now the companies must deliver.”

Europe is also getting smaller shipments from Pfizer than promised, because the company temporarily slowed production at its plant in Belgium so it can be expanded.

AstraZeneca has also warned Europe its first shipments of vaccine will be smaller than expected because of production problems.

But Europe, which invested more than C$4 billion in vaccine development, is demanding the companies fulfil their contracts on time.

“Europe is determined to contribute to this global common good but it also means business,” said von der Leyen.

International Trade Minister Mary Ng said she had spoken to her European counterpart, Valdis Dombrovskis, about the situation and will keep working with Europe to keep the supply chain open.

“There is not a restriction on the export of vaccines to Canada,” Ng said in question period.

Conservative health critic Michelle Rempel Garner accused Ng of playing games with her response, noting the issue isn’t that there is an export ban now, but that Europe is threatening to impose one.

With all of Canada’s current vaccine doses coming from Europe, “that’s a concern,” Rempel Garner said.

“If the Europeans ban exports of vaccines, what’s Plan B for Canada?” she asked.

Both Pfizer and Moderna are making doses of their vaccine in the U.S. and in Europe, but all U.S.-made doses are currently only shipped within the U.S.

Former U.S. president Donald Trump invoked the Defence Production Act last year to prevent export of personal protection equipment. He then signed an executive order in December demanding U.S.-produced vaccines be prioritized for Americans only and threatened to use the act to halt vaccine exports as well.

President Joe Biden has already invoked the act to push for faster production of PPE and vaccines. Though he has not specifically mentioned exports, Biden has promised 100 million Americans will be vaccinated within his first 100 days of office, making the prospects the U.S. shares any of its vaccine supply unlikely.

Canada has contracts with five other vaccine makers, but only two are on the verge of approval here. AstraZeneca, which has guaranteed Canada 20 million doses, needs to finish a big U.S. trial before Health Canada decides whether to authorize it.

Johnson and Johnson is to report results from its Phase 3 trial next week, one of the final things needed before Health Canada can make a decision about it. Canada is to get 10 million doses from Johnson and Johnson, but it is the one vaccine that so far is administered as only a single dose.

Trudeau said AstraZeneca isn’t supplying Canada from its European production lines. A spokeswoman for Procurement Minister Anita Anand said Canada will not say where the other vaccines are coming from because of the concerns about security of supplies.

AstraZeneca and Johnson and Johnson have set up multiple production lines in the United States, the United Kingdom, Europe, India, Australia and Africa. Canada has no current ability to produce either those vaccines or the ones from Pfizer-BioNTech and Moderna. It is entirely reliant on foreign production at the moment.

More than 113,000 people in Canada have received two full doses of either the Moderna or BioNTech vaccine. Another 752,000 have received a single dose.

But the reduction in Pfizer shipments to Canada forced most provinces to slow the pace of injections. Europe, Mexico, Bahrain and Saudi Arabia also have slowed their vaccination campaigns because of the supply limits.

Trudeau said Pfizer CEO Albert Bourla assured him the full shipments will resume in mid-February, and that Canada will get its contracted four million doses by the end of March. He said he spoke to Moderna CEO Stephane Bancel Tuesday morning and was promised Moderna’s shipments of two million doses by March 31 are also on track.

MPs were scheduled to have an emergency debate on Canada’s vaccine program Tuesday night.

This report by The Canadian Press was first published Jan. 26, 2021

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European Union aims to tighten its control of vaccine shipments – The Globe and Mail

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Priority patients wait to receive the AstraZeneca/Oxford University COVID-19 vaccine as they attend the NHS Nightingale North East hospital on Jan. 26, 2021 in Sunderland, England.

Ian Forsyth/Getty Images

The European Union plans to exert more control over the export of COVID-19 vaccines as part of a growing row with drug makers that threatens to disrupt vaccination programs in several countries including Canada.

The EU said Tuesday that it’s finalizing a proposal that will require pharmaceutical companies to register their vaccine exports from the bloc. The plan is expected to come into force later this week and it could lead to restrictions on exports.

The move is the latest twist in a dispute between EU officials and AstraZeneca over delays in shipments of the company’s vaccine, which has been developed in conjunction with the University of Oxford. However, any export-control measure would affect vaccine production by Pfizer-BioNTech and Moderna, which also have manufacturing facilities in Europe. Moderna’s vaccine is manufactured outside of the EU but final processing and distribution takes place within the bloc.

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All of Canada’s supply of Pfizer-BioNTech and Moderna vaccines comes from the companies’ European sites. Canada has yet to approve the AstraZeneca vaccine, which is made in several locations including Belgium. The federal government has purchased 20 million doses, if it’s authorized by Health Canada, and shipments are expected to start in the second quarter of 2021.

During a press conference on Tuesday, Prime Minister Justin Trudeau batted away any suggestion that the EU threats would affect vaccine shipments to Canada.

Mr. Trudeau said he spoke with executives at Pfizer and Moderna who assured him “that we are very much continuing to be on track for receiving our full doses of vaccines in the timelines provided.”

“It was very, very clear that the Canadian contracts that have been signed and the delivery schedule laid out will be respected,” he added.

Canada has purchased 40 million doses of Moderna’s vaccine, which is made at a facility in Switzerland, according to Paul Monlezun, a spokesperson for Moderna. After initial production in Switzerland, which is not an EU member, the vaccine is bottled and packaged in Spain and shipped to Canada through Belgium.

The 40 million doses that Canada has bought from Pfizer are expected to come from the company’s Belgian plant.

A statement from Pfizer Canada said it’s critical that governments don’t impose export restrictions or other trade barriers on the vaccines. “We look forward to receiving further details on the EU proposal and assessing its impact on patients,” Pfizer spokesperson Christina Antoniou said Tuesday.

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The EU’s action highlights the mounting tension over lagging vaccine production. AstraZeneca and Pfizer have both announced production slowdowns in recent weeks, leaving many countries scrambling to meet vaccination targets.

Pfizer said recently that it was remodelling its plant in Belgium in order to nearly double its production to two billion doses this year. The company said the refurbishment would affect some shipments until mid-February, but it added that the allocation of doses to Canada and other countries “will balance out” by the end of March. Canada was hit particularly hard by the slowdown and received no Pfizer doses this week, and is only expecting 79,000 doses next week. Updated numbers for the rest of February have not yet been released.

AstraZeneca’s vaccine is expected to be approved by EU regulators this week and health officials were counting on 80 million doses this quarter. However, last Friday, AstraZeneca said that because of production issues in Europe it would only be able to supply 31 million doses.

That enraged EU officials who have accused AstraZeneca of failing to properly explain the delay. “This new schedule is not acceptable to the European Union,” said Stella Kyriakides, the European Commissioner for Health and Food Safety. The EU “wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered.”

The EU and AstraZeneca will hold further talks on Wednesday to try to resolve the issue, but EU officials have made it clear they will be taking a tough line. The new regulations don’t amount to an export ban, but they will force drug makers to provide details about how many doses they manufacture in the EU and where they are shipped.

German Health Minister Jens Spahn wants the EU to go further and restrict exports altogether. “This is not about EU first; this is about Europe’s fair share,” he said.

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European Commission President Ursula von der Leyen has also indicated that the EU expects a return for its investment in vaccines. “Europe invested billions to help develop the world’s first COVID-19 vaccines,” Ms. von der Leyen said in a speech at the World Economic Forum on Tuesday. “And now, the companies must deliver. They must honour their obligations.”

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Made-in-Canada coronavirus vaccine starts human clinical trials – CBC.ca

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A made-in-Canada vaccine to protect against COVID-19 began human clinical trials Tuesday in Toronto, says the biotechnology company that developed the vaccine.

Toronto-based Providence Therapeutics said three shots will be given to 60 adult volunteers at a clinical trial site in Toronto in the first phase of the trial on Tuesday. 

Fifteen of those volunteers will receive a placebo, and 45 will get the vaccine, called PTX-COVID19-B.

Brad Sorenson, the company’s CEO, said it’s the first time a vaccine designed and manufactured in Canada has begun clinical trials. The company has purchased a site in Calgary to mass produce the vaccine. 

Vaccines are designed to trigger an immune response in the body. Providence’s product is an mRNA vaccine and is similar to the Moderna coronavirus shot being given to people across Canada.

Quebec-based pharmaceutical Medicago began clinical trials last July of its coronavirus vaccine that is based on another technology. Unlike Providence, a large portion of Medicago’s vaccine doses will be manufactured outside the country, in North Carolina.

A vial is shown in this handout image provided by Providence Therapeutics. The company says it is the first fully made-in-Canada coronavirus vaccine to reach clinical trials in this country. (Providence Therapeutics/The Canadian Press)

Medicago’s vaccine is currently in Phase 3 clinical trials — the last stage before it can apply for approval from Health Canada and other regulators to market the product. 

Sorenson said Providence designed and built its vaccine last March.

“We reached out to the Canadian government in April and said, ‘Hey, you’ve heard of Moderna. We’re doing the exact same thing,’ ” Sorenson said in an interview.

“We went from concept into the clinic in under a year without the same level of support as our peers had.”

Purchased Calgary site

The federal government provided financial sponsorship and support for the early phase clinical trial through the National Research Council of Canada’s Industrial Research Assistance Program. 

Currently, Canada lacks the capacity to manufacture the millions of doses of coronavirus vaccines needed to immunize people outside of a clinical trial setting. It’s why the federal government struck deals with Pfizer-BioNTech and Moderna — both manufactured abroad — to obtain the vaccines being rolled out across Canada.

While the company was developing the vaccine in pre-clinical studies, Sorenson said it also started to build the infrastructure to manufacture the vaccine in Canada as well.

A typical vaccination station is seen at the COVID-19 vaccination clinic at the Health Sciences Centre in Winnipeg on Dec. 14. Currently, Canada lacks the capacity to manufacture the millions of doses of coronavirus vaccines needed to immunize people outside of a clinical trial setting. (John Woods/The Canadian Press)

The company purchased a 20,000-square-foot facility in Calgary that includes 12,000 square feet of lab space to mass produce the vaccine. The facility will be up and running in two months, Sorensen said. 

Pending regulatory approval, a larger Phase 2 trial with adults over 65, youths under 18 and pregnant people could start in May, Sorenson said.

Initial focus was cancer research

If the vaccine proves safe and effective in clinical trials and Health Canada approves it, the goal is to have it ready for the global market by January 2022.

Several other Canadian vaccine candidates are poised to start clinical trials in Canada, including one from Saskatoon-based VIDO-Intervac that’s currently recruiting volunteers for a Phase 1 clinical trial in Halifax.

Virologist Alyson Kelvin, an assistant professor at Dalhousie University and a scientist at the Canadian Centre for Vaccinology at VIDO-Intervac, is one of the many Canadian researchers involved in vaccine development and anticipating the results of clinical trials, including from Providence. 

“The mRNA vaccines produced by Pfizer and Moderna have shown to have very robust immune responses, so perhaps this is a good strategy to be backing,” Kelvin said. “Phase one clinical trials will help us determine if this mRNA vaccine is going into that same progression.”

Michael Gardam, an infectious disease physician and chief operating officer at Health PEI, said the idea of having a domestic pandemic vaccine supplier makes sense. But Canada’s plan was based on making more familiar influenza vaccines. 

 “If we’re in Phase one, Phase two trials, by the time this Canadian vaccine may be approved, the pandemic may be largely over,” said Gardam, who is not involved in vaccine development. “But the concept is a good one.”

Sorenson founded Providence Therapeutics in 2013 to focus on cancer vaccines.

Several scientists contributed to the pre-clinical research on Providence’s vaccine, including those at the lab of Dr. Mario Ostrowski, a scientist at the Keenan Research Centre for Biomedical Science and an infectious disease clinician at St. Michael’s Hospital, Dr. Anne-Claude Gingras at Mt. Sinai Hospital, Dr. Samira Mubareka and Dr. Rob Kozak at Sunnybrook Research Institute, as well as Dr. Michael Pollanen, Ontario’s chief forensic pathologist.

In August, Ostrowski, whose laboratory performed the animal trials, said results were on par with tests of vaccines from Moderna and Pfizer-BioNTech at that stage.

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