In the last four years, Health Canada has approved more than 1,500 new or updated pharmaceuticals.
Ten of them are vaccines.
Five of those are for COVID-19.
Dr. Supriya Sharma, the chief medical adviser at Health Canada helping oversee the review process, has never seen anything like the speed with which the COVID-19 vaccines got approved.
“I mean, unprecedented is the one word that we’ve been overusing, but there’s nothing even close to comparable to this,” she said in an interview.
The five non-COVID vaccines approved, four for influenza and one for shingles, took an average of 397 days from the day the company applied for approval in Canada, until that approval was granted.
The average time for COVID-19 vaccines? 82 days.
That includes 61 days for Pfizer-BioNTech, 72 days for Moderna, 95 days for Johnson & Johnson, 148 days for Oxford-AstraZeneca and 34 days for Covishield, the AstraZeneca vaccine produced by the Serum Institute of India.
Covishield is a slight outlier because Health Canada mostly just needed to review the manufacturing process, as the vaccine is the same formula as the AstraZeneca doses made elsewhere. Sharma likens it to the same recipe made in a different kitchen, but the kitchen still needs to be up to snuff.
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A sixth vaccine from Novavax is still under review, with the results from its big clinical trial not expected until next month. It has been under review by Health Canada for 58 days at this point.
The speed has raised fears among Canadians that everything moved too quickly. Many medical experts worry it is contributing to hesitancy to get the vaccines.
But Sharma says speed did not come at the expense of safety.
“That’s the only priority, the only thought, is what’s best for Canadians,” she said. “There’s no other motivation anywhere.”
Lack of research funds can slow down new drug development, but in this case, as lockdowns shuttered economies worldwide and death tolls mounted, countries poured billions of dollars into getting a vaccine to get us out of the pandemic.
Most of the successful vaccines for COVID-19 so far use existing vaccine technology that was adjusted for the SARS-CoV-2 virus that causes COVID-19.
They start with lab studies to check for safety on animals and see how the vaccine works in a lab setting on blood samples and on samples of the virus.
Then it is tested on a very small number of humans to look for any glaring safety concerns. Then they test it on a slightly larger number of people — usually fewer than 100 — to look for safety and the development of antibodies.
If that goes well, the trial is expanded to thousands of volunteers, some of whom get the vaccine and some of whom don’t. Then they wait to see how many in each group get infected.
Phase 3 trials usually take between one and four years. For the vaccines approved in Canada so far, phase three trials took about three months.
Sharma said the time a trial takes depends on finding enough patients to participate, and then having enough of their trial participants get sick to know how well the vaccine is or isn’t working.
Fortunately and unfortunately, COVID-19 was spreading so rampantly in so many places, getting enough people exposed did not take very long.
Canada has seen very few vaccines tested here so far, mainly because our infection rates weren’t high enough.
While the drug makers were busy getting the trials going, Health Canada was getting ready for their submissions. Sharma said discussions about COVID-19 vaccines began in earnest with international bodies in mid-January 2020, before Canada had even had a single confirmed case.
“I think we knew that … we had a virus that was going to be transmissible, that could be causing significant respiratory disease, and that there would be an interest in therapies and vaccines definitely, very early on,” said Sharma.
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It was determined quickly that this virus was so new there was no existing vaccine that could be adjusted quickly, as had happened with the H1N1 pandemic in 2009.
By March, Health Canada had started putting teams in place to review new therapies and vaccines for COVID-19 as soon as they were ready.
Each team was made up of 12 to 15 people, with varying specialties. There was some overlap between the teams but not a lot because many vaccines were being reviewed at the same time.
The experts on the file included infectious disease specialists, pharmacologists, biostatisticians, and epidemiologists.
Separate from that were teams of people looking at manufacturing facilities. Approving a vaccine isn’t just about making sure the clinical data shows it to be safe and effective, but also about making sure the place it is to be made follows the required safety standards.
They needed an emergency order from Health Minister Patty Hajdu to do a rolling review. Normally drug makers can’t apply until they have every piece of data ready but with a rolling review Health Canada scientists can start reviewing the data as it becomes available.
Hajdu granted that on Sept. 16.
Then the vaccine submissions began pouring in — AstraZeneca applied Oct. 1, Pfizer Oct. 9, Moderna on Oct. 12, and J&J on Nov. 30. The Covishield application came Jan. 23 and Novavax submitted on Jan. 29.
Sharma says the teams were working 15 to 18 hours a day, seven days a week, reviewing data, asking the companies questions, requesting more information or new analyses.
Sometimes they were doing it in the middle of the night. Collaborations with international partners in very different time zones, meant 2 a.m. or 4 a.m. video conference calls were not unusual.
When Pfizer and Moderna were reviewed, it was entirely based on clinical trail and pre-market data because the vaccines hadn’t been approved anywhere else. Canada was the third in the world to authorize Pfizer on Dec. 14th, and second to approve Moderna Dec. 23.
By the time Health Canada authorized AstraZeneca — a review process complicated by some mistakes during the clinical trial in dosing and the number of seniors among its volunteer patients — it was also able to pull data from real-world use of the vaccine in the United Kingdom.
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The regulatory work doesn’t end when the authorization is announced. The post-market surveillance data is still non-stop. The recent blood clot concern with the AstraZeneca vaccine took a lot of time, but just monitoring the data submitted by the vaccine makers on adverse events overall is still critical.
To date, the adverse event reports in Canada have not been different than what was seen in clinical trials.
Companies also adjust their submissions requiring further review. Pfizer has so far asked for two changes, one to the number of doses per vial and another for the temperature at which the vaccine has to be kept.
If anything changes on safety, or if the efficacy seen in a clinical trial doesn’t play out in the real world, Sharma says Canada will not hesitate to make adjustments. But those decisions will be made by Canadian experts, said Sharma, the same ones who have been on the files all along.
“It’s important that if anything comes up, we have people that have reviewed it, have gone through every piece of paper, the 2,000 hours, the hundreds of thousands of pages, and that if anything comes up, it’s like they’ve got a really strong science base, and they can put that stuff in context and we can make decisions really quickly.”
© 2021 The Canadian Press
World Bank sees ‘significant’ inflation risk from high energy prices
Energy Prices are expected to inch up in 2022 after surging more than 80% in 2021, fueling significant near-term risks to global inflation in many developing countries, the World Bank said in its latest Commodity Markets Outlook on Thursday.
The multilateral development bank said energy prices should start to decline in the second half of 2022 as supply constraints ease, with non-energy prices such as agriculture and metals also expected to ease after strong gains in 2021.
“The surge in energy prices poses significant near-term risks to global inflation and, if sustained, could also weigh on growth in energy-importing countries,” said Ayhan Kose, chief economist and director of the World Bank’s Prospects Group, which produces the Outlook report.
“The sharp rebound in commodity prices is turning out to be more pronounced than previously projected. Recent volatility in prices may complicate policy choices as countries recover from last year’s global recession.”
The International Monetary Fund, in a separate blog https://blogs.imf.org/2021/10/21/surging-energy-prices-may-not-ease-until-next-year, said it expected energy prices to revert to “more normal levels” early next year when heating demand ebbs and supplies adjust. But it warned that uncertainty remained high and small demand shocks could trigger fresh price spikes.
The World Bank noted that some commodity prices rose to or exceeded levels in 2021 not seen since a spike a decade earlier.
Natural gas and coal prices, for instance, reached record highs amid supply constraints and rebounding demand for electricity, although they are expected to decline in 2022 as demand eases and supply improves, the bank said.
It warned that further price spikes could occur in the near-term given current low inventories and persistent supply bottlenecks. Other risk factors included extreme weather events, the uneven COVID-19 recovery and the threat of more outbreaks, along with supply-chain disruptions and environmental policies.
Higher food prices were also driving up food-price inflation and raising questions about food security in several developing countries, it said.
The bank projected crude oil prices would reach $74/bbl in 2022, buoyed by strengthening demand from a projected $70/bbl in 2021, before easing to $65/bbl in 2023.
The use of crude oil as a substitute for natural gas presented a major upside risk to the demand outlook, although higher energy prices may start to weigh on global growth.
The bank forecast a 5% drop in metals prices in 2022 after a 48% increase in 2021. It said agricultural prices were expected to decline modestly next year after jumping 22% this year.
It warned that changing weather patterns due to climate change also posed a growing risk to energy markets, potentially affecting both demand and supply.
It said countries could benefit by accelerating installation of renewable energy sources and by cutting their dependency on fossil fuels.
(Reporting by Andrea Shalal; editing by Diane Craft)
U.S. FAA seeks new minimum rest periods for flight attendants between shifts
The Federal Aviation Administration (FAA) is proposing to require flight attendants receive at least 10 hours of rest time between shifts after Congress had directed the action in 2018, according to a document released on Thursday.
Airlines for America, a trade group representing major carriers including American Airlines, Delta Air Lines, United Airlines and others, had previously estimated the rule would cost its members $786 million over 10 years for the 66% of U.S. flight attendants its members employ, resulting from things like unpaid idle time away from home and schedule disruptions.
Aviation unions told the FAA the majority of U.S. flight attendants typically do receive 10 hours of rest from airlines but urged the rule’s quick adoption for safety and security reasons.
Under existing rules, flight attendants get at least 9 hours of rest time but it can be as little as 8 hours in certain circumstances.
“Flight attendants serve hundreds of millions of passengers on close to 10 million flights annually in the United States,” the FAA said, adding that they “perform safety and security functions while on duty in addition to serving customers.”
It cited reports about the “potential for fatigue to be associated with poor performance of safety and security related tasks,” including in 2017, when a flight attendant reported almost causing the gate agent to deploy an emergency exit slide, which was attributed to fatigue and other issues.
The FAA estimated the regulation could prompt the industry to hire another 1,042 flight attendants and cost $118 million annually. If hiring assumptions were cut in half, it said, that would cut estimated costs by over 30%.
After the FAA published an advance notice of the planned rules in 2019, Delta announce it would mandate the 10-hour rest requirement by February 2020.
FAA Administrator Steve Dickson is testifying at a U.S. House Transportation subcommittee hearing on Thursday.
House Transportation Committee chairman Peter DeFazio said on Wednesday that it was “unacceptable” to delay the FAA adopting the flight attendant rest rule and mandating secondary flight deck barriers to better protect the cockpits on all newly manufactured airliners.
Attorneys at the FAA “need a little poke” to move faster on rules when ordered by Congress, DeFazio said on Thursday at the hearing. “Do not screw around with it for three years… you just do it.”
Sara Nelson, president of the Association of Flight Attendants representing 50,000 workers at 17 airlines, said the rule was critical.
“Flight attendant fatigue is real. COVID has only exacerbated the safety gap with long duty days, short night, and combative conditions on planes,” she said. “Congress mandated 10 hours irreducible rest in October 2018, but the prior administration put the rule on a process to kill it.”
During the pandemic, flight attendants have dealt with records numbers of disruptive, occasionally violent passenger incidents, with the FAA citing 4,837 unruly passenger reports, including 3,511 for refusing to wear a mask since Jan. 1.
The FAA proposes to make the new flight attendant rest rules final 30 days after it publishes its final rules.
(Reporting by David Shepardson; editing by Jason Neely and Bill Berkrot)
Bitcoin price hits all-time high, one day after U.S. ETF debut – Global News
The world’s leading cryptocurrency was up 3.30 per cent, trading at US$66,364.72, after reaching a record of US$67,016.50, topping the US$64,895.22 hit on April 14 this year.
Tuesday was the first day of trading for the ProShares Bitcoin Strategy ETF — a development market participants say is likely to drive investment into the digital asset.
The ETF closed up 2.59 per cent at US$41.94 from its opening price of US$40.88 on Tuesday and continued its ascent on Wednesday, last up 3.76 per cent at US$43.52.
The Valkyrie Bitcoin Strategy ETF, expected to debut on the Nasdaq Wednesday, appeared to be delayed after its prospectus was amended in a filing with the Securities and Exchange Commission. A person familiar with the matter said the Nasdaq expects the ETF to launch on Thursday, but that has not been confirmed yet.
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Trading appeared to be dominated by smaller investors and high-frequency trading firms, analysts said, noting the absence of large block trades indicated that institutions were likely staying on the sidelines.
James Quinn, managing partner at Q9 Capital, a Hong Kong-based cryptocurrency private wealth manager, said the launch of the new product was “meaningful” for bitcoin.
Theoretically, any licensed brokerage firm in the United States which wants to take on this ETF can do so as easily as any other ETF, which “should make it available to a lot of folks,” said Quinn.
While the ETF is based on bitcoin futures, Quinn said the trades and hedges underpinning the ETF means activity will flow into the spot market and the bitcoin price.
Crypto ETFs have launched this year in Canada and Europe amid surging interest in digital assets. VanEck is also among fund managers pursuing U.S.-listed ETF products, although Invesco on Monday dropped its plans for a futures-based ETF.
Ether, the world’s No. 2 cryptocurrency, was up 3.63 per cent on the day at US$4,018.75, after hitting a high of US$4,080, nearing its record high of US$4,380 reached on May 12.
© 2021 Reuters
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