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U.S. planning massive coronavirus vaccine testing effort to meet year-end deadline – The Globe and Mail

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In this March 20, 2020, file photo, Dr. Rhonda Flores looks at protein samples at one of the labs developing a COVID-19 vaccine, in Rockville, Md.

ANDREW CABALLERO-REYNOLDS/AFP/Getty Images

The United States plans a massive testing effort involving more than 100,000 volunteers and a half dozen or so of the most promising vaccine candidates in an effort to deliver a safe and effective one by the end of 2020, scientists leading the program told Reuters.

The project will compress what is typically 10 years of vaccine development and testing into a matter of months, testimony to the urgency to halt a pandemic that has infected more than 5 million people, killed over 335,000 and battered economies worldwide.

To get there, leading vaccine makers have agreed to share data and lend the use of their clinical trial networks to competitors should their own candidate fail, the scientists said.

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Candidates that demonstrate safety in small early studies will be tested in huge trials of 20,000 to 30,000 subjects for each vaccine, slated to start in July.

Between 100,000 and 150,000 people may be enrolled in the studies, said Dr. Larry Corey, a vaccine expert at Fred Hutchinson Cancer Center in Seattle, who is helping design the trials.

“If you don’t see a safety problem, you just keep going,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told Reuters. The vaccine effort is part of a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) announced last month.

The effort fits into the research and development arm of “Operation Warp Speed,” the White House program announced last week to accelerate coronavirus vaccine development.

Vaccines, which are intended for use in healthy people, are typically tested in successive steps, starting with trials in animals.

Human testing begins with a small safety trial in healthy volunteers, followed by a larger study to find the right dose and get an early read on efficacy. The final stage consists of large-scale testing in thousands of people. Only then would a vaccine developer commit to manufacturing millions of doses.

In the era of coronavirus, many of those steps will overlap, particularly the midstage and late-stage trials, Collins and Corey said.

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The approach has its risks, as certain safety issues may only appear in large-scale trials. Americans are concerned about the speed of the vaccine effort, a Reuters/Ipsos poll showed.

A highly effective vaccine could be tested in as little as six months if there is a big difference in benefit between the vaccine and placebo groups, Corey said. For a modestly effective vaccine, trials could take nine to 12 months.

The U.S. government has committed billions of dollars to help manufacturers produce doses of vaccines that may never prove successful.

THE SHORTLIST

To get the quickest answer, vaccines will be tested in health care workers and communities where the virus is still spreading to show whether they reduced new cases of COVID-19.

Washington, D.C, which has not reached the peak of its outbreak, is one likely test site. Trials may be conducted abroad, including in Africa, where the virus has just started to spread, Collins said.

The government plans to tap its own trial networks, including the Department of Veterans Affairs’ 100 health care facilities, for potential study volunteers, while drugmakers will recruit from their clinical research networks.

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A Moderna Inc vaccine, developed in partnership with the NIH, will be the first to the enter large-scale testing in July, and may be joined by a vaccine from Britain’s Oxford University and AstraZeneca Plc, Collins said.

The U.S. government said on Thursday it would spend $1.2-billion to secure 300 million doses of the Oxford vaccine.

“What we might try to do is run those two side by side, but with a control arm” that would also include 10,000 healthy individuals who got a dummy vaccine, Collins said.

Moderna’s candidate is already proceeding to midstage human trials. Vaccines by Johnson & Johnson, Sanofi and Merck & Co are a month or two behind the front-runners and “may get added over the course of the summer” following early-stage human trials, Collins said.

Merck has not made any specific announcements on its vaccine program and declined to comment.

Collins would not name other candidates on the U.S. shortlist of 14, but said they will need to finish early safety testing by this summer to make it into the bigger trials.

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Trials will need to assess if the vaccines cause disease enhancement – a potentially dangerous side effect in which the vaccine makes the disease worse in some individuals instead of preventing it. Disease enhancement has been seen in animal studies of vaccines developed to fight a close cousin of the virus that causes COVID-19.

“If there is enhancement, that’s a big stop sign for everything,” said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases at NIH.

“If all the cards fall into the right place and all the stars are aligned, you definitely could get a vaccine by December or January,” Fauci said.

The United States called on the World Health Organisation on Friday to begin working immediately on investigating the source of the novel coronavirus, as well as its handling of the response to the pandemic. Reuters

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Shortages of some baby formula in Quebec due to panic buying, U.S. supply issues

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MONTREAL — When Catherine Labrecque-Baker went to purchase hypoallergenic baby formula in mid-April for her six-month-old baby, her Quebec City pharmacist told her there was none left.

In response, Labrecque-Baker travelled to another pharmacy in the city and bought five times the amount she normally does. Then she started to stress as she fed her baby and watched her stockpile slowly shrink.

Her son has an intolerance to cow’s milk protein and relies on Alimentum, a product by American formula maker Abbott, which voluntarily recalled its products in February after four illnesses were reported in babies who had consumed powdered formula from its Michigan plant.

“What am I supposed to do?” Labrecque-Baker asked Monday in an interview. “I cried an entire night, wondering what will I do when I won’t have any more formula.”

The disruptions at Abbott, the United States’ largest formula maker, are causing supply issues for specific hypoallergenic formulas across Canada, according to Retail Council of Canada spokeswoman Michelle Wasylyshen.

But in Quebec, parents are noticing shortages of other formulas on the province’s pharmacy shelves — a result of panic buying, Wasylyshen said.

“There’s a ripple effect,” she said in an interview Monday, referring to parents like Labrecque-Baker who are scooping up more formula than normal because they fear it will go out of stock.

“We don’t want to see a return to panic buying — that approach doesn’t help anyone,” Wasylyshen said. “Some of our retailers have put limitations in place in terms of what customers can purchase, just to make sure there’s enough for everyone.”

Abbott’s decision to shut its Michigan plant exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves across much of the United States. The company is one of only a handful that produce the vast majority of the U.S. formula supply, so Abbott’s product recall — involving brands Similac, Alimentum and EleCare — wiped out a large segment of the market intended for babies with allergies or intolerance to cow’s milk protein.

On Monday, Abbott said it has reached an agreement with U.S. health officials to restart production at its Michigan factory, a key step toward easing a nationwide shortage.

Quebec is not facing the same kind of shortages as in the United States, but Wasylyshen said images of empty pharmacy shelves in the province started circulating online, causing anxiety.

The province’s Health Department on Monday said it’s working with Quebec’s association of pharmacy owners, the Association québécoise des pharmaciens propriétaires, to minimize the shortage’s impact.

“We are looking as far away as Europe to counter this lack of supply,” department spokesperson Marjorie Larouche said, adding that shortages are being noticed across Canada.

Marilie Beaulieu-Gravel of the pharmacy owners association said that after Abbott’s Alimentum formula disappeared from shelves, parents rushed to purchase Nutragimen, another hypoallergenic formula, made by Mead Johnson & Company.

“There isn’t a production issue with this product, but rather a domino effect,” Beaulieu-Gravel said Monday in an interview. “The demands for the products increase sharply and unexpectedly on the market.”

While Nutragimen products are expected to be back on shelves by mid-June, Beaulieu-Gravel said her association isn’t expecting the supply of Alimentum to return before the end of summer.

Meanwhile, some parents, including Labrecque-Baker, are left searching for formula everywhere, even online.

“I looked on Facebook Marketplace, on Kijiji … friends have been looking for me or giving me what they can,” Labrecque-Baker said. “This week, I spent $200 because I can’t wait and risk it. The more I can stock, the more days I can feed my child.”

This report by The Canadian Press was first published on May 17, 2022.

— With files from The Associated Press.

This story was produced with the financial assistance of the Meta and Canadian Press News Fellowship.

 

Virginie Ann, The Canadian Press

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If you thought gas prices were high, have you checked out diesel? – CBC News

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There is little relief from pain at the pumps these days, especially as the price of diesel has nearly doubled in the last year.

Diesel is now averaging $2.29 per litre across Canada, and is even more expensive than premium gasoline. In the last month alone, a litre of diesel has climbed by 35 cents.

Some are stuck having to grin and bear it, like Peter Ruiter, a dairy farmer from Ottawa, who relies on diesel to power his farm equipment.

“The reality is I can’t go till these fields by hand — there’s just too many acres to do,” he said.

Rising fuel prices are another blow to consumers struggling with the escalating cost of living, as inflation hit a level in March that hasn’t been seen in decades.

And the sky-high cost of diesel means the transportation of goods has become more costly, as diesel — which is typically more efficient and economical — powers the trucks, the trains and some of the ships our supply chains rely on.


The Russian invasion of Ukraine has sparked a sharp rise in commodity prices, including crude oil. Many countries have introduced sanctions on Russia, which is a major exporter of oil and natural gas. At the same time, demand for fuel is climbing as economic activity picks up around the world.

“There’s been a diesel shortage globally, meaning that inventories are [at an] all-time low. I’ve never seen such low inventories,” Vijay Muralidharan, a senior consultant at Kalibrate, an analytics firm that tracks fuel prices.


Another part of the reason diesel prices have soared across North America is because of record exports from the U.S. Gulf Coast. The majority of the fuel is destined for South America, where countries are burning diesel for electricity as the hydropower supply falls during the Southern Hemisphere’s winter season.

There is an increased reliance on diesel in some of those countries this year, said Muralidharan, because of reduced supplies of natural gas.

Diesel prices are at currently at record highs in many parts of the world, including Canada. (CBC)

It also comes at a time when more and more families are needing assistance, said Emily-anne King, co-executive director of Backpack Buddies, an organization that supplies food to more than 4,000 children in British Columbia.

“It’s really alarming for us to see these price increases,” said King. “Not delivering is simply not an option.… We’ve made these commitments and we will continue to find ways to get there and be there for the families and kids that we support.”

The organization itself is feeling the pinch of sky-high diesel prices, as costs are rising to deliver food throughout the province to families that are struggling to make ends meet.

“These last couple of weeks, we have felt more pressure and received more calls from communities and individuals that are needing support,” she said. “And it just isn’t slowing down.”

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Gas prices: Average in Canada tops $2 for first time – CTV News

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Gasoline prices are showing no signs of letting up as the average price in Canada tops $2 a litre for the first time.

Natural Resources Canada says the average price across the country for regular gasoline hit $2.06 per litre on Monday for an all-time high.

The average was a nine-cent jump from the $1.97 per litre record set last week, and is up about 30 cents a litre since mid-April.

Prices averaged about $2.34 a litre in Vancouver on Monday, while in Toronto the average was almost $2.09 per litre. Edmonton, in contrast, averaged just under $1.69 per litre.

Gasoline prices have been elevated since late February when oil spiked to around US$100 a barrel after Russia invaded Ukraine, while the price jumped to over US$110 per barrel last week.

Prices have also been spiking more recently as the reopening of the economy, and the start of the busy travel season, have led to high demand for gasoline that refiners have limited capacity to meet.

This report by The Canadian Press was first published May 17, 2022. 

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