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Health Canada has final data needed from Moderna to make a decision on vaccine – The Globe and Mail



Health Canada says it will “soon” be ready to announce if it can authorize a second COVID-19 vaccine after receiving final documents from U.S. biotech firm Moderna over the weekend.

Moderna’s new Canadian general manager – hired just three weeks ago to establish a Canadian office for the company – said Moderna’s team and Health Canada are in constant communication.

“Everybody worked really diligently all weekend,” Patricia Gauthier told The Canadian Press in an interview Monday.

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She said the process is following the required course and “we’re hoping for a decision when Health Canada is ready.”

Eric Morrissette, a spokesman for Health Canada, said the documents are being reviewed as fast as possible.

The U.S. Food and Drug Administration issued an emergency authorization for the Moderna vaccine late last week, becoming the first country to approve it. The COVID-19 vaccine is also the first Moderna product ever authorized for use.

The company was established about a decade ago specifically to work on messenger RNA technology, or mRNA.

The final documents Health Canada needed included data on manufacturing. The Canadian doses of Moderna’s vaccine are being made in Switzerland and sent to Spain for the “fill and finish” process, where six doses will be filled into each vial and the vials packed into freezers for shipping.

As many as 110,000 doses can be transported on a single pallet. Moderna intends to start shipping its vaccine to Canada within 48 hours of approval, with as many as 168,000 doses anticipated before the end of December and two million by the end of March.

Health Canada initially contracted to buy 20 million doses from Moderna, but exercised an option to buy 20 million more earlier this month, for a total of 40 million.

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Gauthier said that is enough to vaccinate two-thirds of the Canadian adult population, and that there are still 16 million doses remaining for Canada to potentially buy as part of the contract. Sources not authorized to speak on the matter tell The Canadian Press a decision on whether to buy those extra doses will likely be announced this week.

The Moderna vaccine is only recommended for use on adults over the age of 18. Gauthier said clinical trials on adolescents began earlier this month and the vaccine will be tested on younger children in 2021.

Health Canada approved a vaccine from Pfizer-BioNTech on Dec. 9 and vaccinations with that product began last week. It was about five days from the time the final documents were received until Pfizer got a green light, but Health Canada’s chief medical adviser Dr. Supriya Sharma has said Moderna’s production facilities are new to Health Canada and may take longer to review.

The vaccines from Pfizer and Moderna both use messenger RNA technology, which sends a genetic code to human cells to train them to create an immune response to COVID-19. Both drugmakers say the vaccines were more than 94 per cent effective at preventing infection.

But Pfizer’s technology requires the vaccine to be kept frozen between -60 C and -80 C until just before use, requiring complex shipping processes, dry ice and ultra-low-temperature freezers.

Moderna’s product can be kept stable at only -20 C and can be at room temperature for almost a month. The company said last week that where it is necessary, the vaccine can be shipped at temperatures between 2 C and 8 C.

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It means Moderna’s vaccine can be more easily deployed wherever it is needed, including to the North, remote Indigenous communities and long-term care homes.

Moderna will be picked up by FedEx in Europe and shipped in freezers to Toronto, where logistics company Innomar Strategies will take possession of it.

Innomar president Guy Payette said the company will be the importer of record, run a quality assurance check on the vaccines, and then repackage the shipments into smaller amounts to be forwarded to provincial and territorial governments.

“We’re working on the assumption that it is imminent, and that we need to be ready when the vaccines get approved,” Payette told The Canadian Press.

Gauthier is now helping set up the Canadian division of Moderna, intending to hire a team of people whose first focus will be helping governments in Canada get the vaccine administered.

She says that includes efforts to communicate to Canadians the safety and effectiveness of the vaccine.

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Gold price maintains daily gains as Yellen says 'U.S. does not seek weaker dollar' – Kitco NEWS



Editor’s Note: With so much market volatility, stay on top of daily news! Get caught up in minutes with our speedy summary of today’s must-read news and expert opinions. Sign up here!

(Kitco News) Treasury Secretary nominee Janet Yellen confirmed U.S. commitment to market-set currency rate during her testimony in front of the Senate Finance Committee on Tuesday.

When asked about the U.S. dollar and market-determined exchange rate if confirmed by the Senate, Yellen said that the “U.S. does not seek a weaker currency to gain competitive advantage, and we should oppose attempts by other countries to do so.”

These comments do not come as a surprise as markets were widely expecting Yellen to highlight this topic during her testimony.

“I believe in the market-determined exchange rates. The value of currencies should be determined by markets,” Yellen clarified.

The Treasury Secretary nominee also noted that she would work with President-elect Joe Biden will oppose other countries who try to gain an advantage in trade by using currency manipulation.

She added that targeting exchange rates for commercial advantage is unacceptable.

“I believe in a strong U.S. economy that delivers goods jobs for Americans. Stability in U.S. financial system is good for America,” Yellen said.

If confirmed, Yellen will replace Treasury Secretary Steven Mnuchin and will be the first female treasury secretary in U.S. history.

Gold maintained its daily gains following the comments, with most of the statements already priced in. The February Comex gold futures were last trading near daily highs at $1,841.30, up 0.62% on the day.

Live 24 hours gold chart [Kitco Inc.]

Yellen also warned that there is a risk to the economy if the government does nothing, noting that it is better to “act big” now.

“Without further action, we risk a longer, more painful recession now — and long-term scarring of the economy later,” she said. “Neither the president-elect, nor I, propose this relief package without an appreciation for the country’s debt burden. But right now, with interest rates at historic lows, the smartest thing we can do is act big.”

Getting people back to work is our first task, Yellen said. The second task is rebuilding the economy to create more prosperity.

The pandemic caused widespread devastation, she added. “Eighteen million unemployment insurance claims are being paid every week. Food bank shelves are going empty. The damage has been sweeping, and as the president-elect said last Thursday, our response must be too,” she said.

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Norway policy on Pfizer vaccine unchanged after alarm over deaths – Al Jazeera English



Norway will not change its policy on the use of Pfizer-BioNTech’s COVID-19 vaccine following deaths among highly frail recipients, but officials have said that health workers should properly assess patients before deciding whether to give them the jab.

As of January 14, 23 reports of deaths suspected to be associated with COVID-19 vaccines had been submitted to the Norwegian health registry.

Of the 13 cases analysed in detail so far, the concerned individuals were elderly, frail and had serious diseases, Camilla Stoltenberg, director of the Norwegian Institute of Public Health (FHI), told reporters on Monday.

“It is important to remember that about 45 people die every day in nursing homes in Norway, so it is not a given that this represents any excess mortality or that there is a causal connection,” she said.

Stoltenberg reiterated that the FHI’s guidelines on administering the vaccine remained the same, stating doctors should consider the overall health of their patients before giving them the jab.

“One should have an assessment of each and every one before offering the vaccine,” she said.

But, she added: “It’s not impossible that some of those who have gotten the vaccine are so frail that maybe you should have reconsidered and not given them the vaccine, because they are so sick that they might have become worse from the normal side effects as the body reacts and builds up immunity.”

News of the deaths had raised alarm over the safety of the vaccine.

BioNTech had earlier said that Norwegian health authorities changed their recommendation in relation to vaccination of the terminally ill.

But the company later retracted the statement following clarification from Norway. Pfizer did not have any immediate comment.

Norway’s death toll from the pandemic currently stands at 521 people, according to data compiled by Johns Hopkins University.

‘Very rare occurrences’

Norway is currently vaccinating residents of care homes, including those with serious underlying conditions.

An average of 400 people die each week in nursing homes and long-term care facilities in the Nordic country.

Common adverse reactions to messenger RNA vaccines – such as the Pfizer-BioNTech shot – include fever, nausea, and diarrhoea.

A number of countries, including Norway’s neighbours Denmark, Finland, Iceland and Sweden, have also reported post-vaccination deaths, but no direct links to the vaccine have been established.

More than 48,000 people have been vaccinated in Norway so far.

PM eases restrictions

Norway has had one of the lowest infection rates in Europe during the pandemic, imposing tighter restrictions earlier than many other countries.

The 14-day cumulative number of COVID-19 cases per 100,000 inhabitants was at 157.95 in the week ending January 10, the fifth-lowest in Europe behind Iceland, Greece, Bulgaria and Finland, according to the European Centre for Disease Prevention and Control.

Prime Minister Erna Solberg on Monday announced the easing of some coronavirus restrictions after extra measures put in place for two weeks appeared to have achieved the desired effect in slowing transmission.

But Solberg stressed that infection rates remained too high for comfort.

“Although the measures seem to be working, and the infection rates are somewhat lower, the situation is still uncertain,” she told parliament. “Infection rates are still too high but with common efforts, we can reduce the spread.”

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Stocks Rise, Bonds Drop With Earnings Picking Up: Markets Wrap – Yahoo Canada Finance



The Canadian Press

The Latest: Haines pledges support role to FBI on US threats

WASHINGTON — The Latest on Senate confirmation hearings for President-elect Joe Biden’s nominees for his administration (all times local): 11:05 a.m. President-elect Joe Biden’s pick for national intelligence director says that the intelligence community under her watch would have a support role in assessing the threat coming from domestic extremists like the ones who stormed the U.S. Capitol this month. Avril Haines said at her Senate confirmation hearing on Tuesday that the primary responsibility for U.S.-based threats belongs to the FBI and the Department Homeland Security. But she says she expects that intelligence agencies would be involved in those discussions, particularly if there are connections between Americans and foreign-based extremist groups. Haines called the events of Jan. 6 “truly disturbing” and said it was “eerie” coming to the Senate and seeing the National Guard deployed around Washington. ___ HERE’S WHAT YOU NEED TO KNOW ABOUT PRESIDENT-ELECT JOE BIDEN’S CABINET PICKS: President-elect Joe Biden’s national security Cabinet may be bare on Day One of his presidency, but an inauguration eve spurt of Senate confirmation hearings suggests that won’t be the case for long. Read more: — Yellen urges Congress to do more to fight pandemic recession ___ HERE’S WHAT ELSE IS GOING ON: 10:45 a.m. President-elect Joe Biden’s pick for national intelligence director says that perhaps no greater priority on the job right now is “building the trust and confidence necessary to protect the American people.” Avril Haines is vowing at her Senate intelligence committee confirmation hearing Tuesday to speak “truth to power” even when that truth is inconvenient or difficult. The comments signalled a course correction to the four years of the Trump administration, when President Donald Trump repeatedly attacked intelligence community assessments that he disagreed with — particularly about Russia. Haines also says the American people deserve a “government worthy of their trust” and that she will work to promote transparency in the intelligence community. 10:40 a.m. The Democratic vice chairman of the Senate intelligence committee is telling President-elect Joe Biden’s pick for national intelligence director that the intelligence community will have to “recover” from the experience of Donald Trump’s leadership. Sen. Mark Warner says that during the four years of the Trump administration, intelligence community officials willing to speak the truth were “vilified, reassigned, fired or retaliated against.” Warner told Avril Haines at her confirmation hearing on Tuesday that she will be expected to keep politics out of national security decision making. He says he expects to hear a strong statement of support for the professionalism of the intelligence community. ___ 10:30 a.m. One of President Donald Trump’s national intelligence directors is introducing President-elect Joe Biden’s nominee for the job at her confirmation hearing. Dan Coats, a former Republican senator who held the post under Trump, is speaking Tuesday at Avril Haines’ confirmation hearing before the Senate intelligence community. His appearance is designed to show that Haines, who served in the Obama administration, has bipartisan support. He says Haines is committed to bringing “nonpoliticized truth to power” and restoring trust in confidence in the intelligence community. He calls Haines an “exceptional choice.” ___ 10 a.m. President-elect Joe Biden’s nominee to lead the Department of Homeland Security will address the Jan. 6 attack on the U.S. Capitol at the start of his Senate confirmation hearing. Alejandro Mayorkas says in prepared remarks released ahead of the Tuesday hearing that the Jan. 6 pro-Trump riot was “horrifying” and authorities still have much to learn about what happened that day and what led to the insurrection. Mayorkas says that as secretary of Homeland Security he would do everything he can to ensure that “the tragic loss of life, the assault on law enforcement, the desecration of the building that stands as one of the three pillars of our democracy and the terror felt by you, your colleagues, staff, and everyone present, will not happen again.” If confirmed, the former federal prosecutor and senior Homeland Security official under President Barack Obama would be the first Latino and first immigrant to lead the department. He would lead one of the largest agencies in government to enforce the nation’s immigration laws and run the immigration services agency as well as the components such as the Federal Emergency Management Agency and the civilian cybersecurity agency. ___ 6:30 a.m. President-elect Joe Biden’s nominee to be America’s top diplomat says he’s ready to confront challenges posed by China, Iran, North Korea and Russia. Secretary of State-designate Antony Blinken also says he’s committed to rebuilding the State Department after four years of atrophy under the Trump administration. Blinken is set to appear Tuesday before the Senate Foreign Relations Committee. In testimony prepared for his appearance, Blinken says he sees a world of rising nationalism and receding democracy. He also says that mounting threats from authoritarian states are reshaping all aspects of human life, particularly in cyberspace. Blinken says American global leadership still matters and without it rivals will either step in to fill the vacuum or there will be chaos. He says neither choice is palatable. Blinken also promises to bring Congress in as a full foreign-policy partner, a subtle jab at President Donald Trump’s administration and its secretary of state, Mike Pompeo, who routinely ignored or bypassed lawmakers in policy-making. ___ 6 a.m. President-elect Joe Biden’s pick for national intelligence director is planning to tell Senate lawmakers that intelligence and national security issues will not be politicized under her watch. Avril Haines faces a confirmation hearing Tuesday before the Senate intelligence committee. Haines will also tell lawmakers that the Office of the Director of National Intelligence must not shy away from “speaking truth to power” even if inconvenient or difficult. That’s according to excerpts of her prepared remarks released ahead of the hearing. Haines served in the Obama administration as deputy director of the CIA and deputy national security adviser. If confirmed, Haines would be tasked with restoring stability to an intelligence community that has been repeatedly denigrated by President Donald Trump. She would also be the first woman to hold the position. The Associated Press

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