(CNN) — The global rollout of the Oxford-AstraZeneca Covid-19 vaccine has encountered another hurdle as a handful of countries paused their use of the shot following reports it could be connected to blood clots, despite no clear evidence of a link.
AstraZeneca has robustly defended its vaccine, saying Friday there was “no evidence of an increased risk” of blood clots, and European and UK medicines regulators have each said the link between the vaccine and blood clots has not been confirmed and that rollouts should continue.
After a group of European countries — including Denmark, Norway and Iceland — suspended use of the vaccine on Thursday, Thailand’s Prime Minister, Prayut Chan-o-cha, canceled plans to publicly get the AstraZeneca shot on Friday and the country also delayed its rollout.
“When there is an adverse event, we don’t need to be in rush,” said Piyasakol Sakolsatayadorn, a senior member of the country’s vaccination committee.
Bulgaria has become the latest country to suspend use of the vaccine on Friday pending investigations into safety. Prime Minister Boyko Borissov ordered a halt to all inoculation using the AstraZeneca Covid-19 vaccine until the European Medicines Agency “rejects all doubts” about the vaccine’s safety, according to a government statement.
The moves came in response to reports of blood clots in a few inoculated people in Denmark, including one fatality. Denmark was the first country to take the precautionary measure, announcing a 14-day break while authorities investigated further.
Norway and Iceland soon followed. The Norwegian Institute of Public Health said the country has also reported cases of blood clots shortly after receiving a Covid-19 vaccination in Norway but “mainly in the elderly where there is often another underlying disease as well.”
Other countries, including Austria and Italy, have suspended specific batches of the vaccine.
But a number of nations — including Germany, France, the UK, the Netherlands, Mexico and Nigeria — stood by the shot and reassured citizens of its safety.
Health agencies tell countries to keep rolling out
The European Medicines Agency (EMA) said Thursday that it did not recommend suspending use of the AstraZeneca vaccine, stating that there is “no indication” the vaccine caused the blood clots in the people who received the vaccine. The agency told countries they could keep rolling out the shot while investigations take place.
“The vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing,” the agency said.
The UK’s medicine regulator — the Medicines and Healthcare products Regulatory Agency (MHRA) — also issued a statement Thursday reassuring the public that the vaccine is still safe and that “people should still go and get their COVID-19 vaccine.”
The episode nonetheless poses another headache for the pharmaceutical giant, whose vaccine has been beset by political disputes, delivery delays and other concerns.
But the tone across most of Europe was one of calm, as other governments sought to put the reports into context.
“Investigations are carried out systematically each time serious adverse effects are declared,” France’s health minister Olivier Véran said in his weekly briefing on Thursday. “But what are we talking about? About 30 people out of more than five million Europeans having received an injection.”
The UK’s MHRA, where 11 million doses of the vaccine have been administered, said blood clots “can occur naturally and are not uncommon.” Its vaccines safety lead Phil Bryan added that the reports of blood clots “are not greater than the number that would have occurred naturally in the vaccinated population.”
And Germany confirmed late on Thursday that it would stick to its rollout plans. “We are planning to continue vaccinating with AstraZeneca, just like an overall majority of other European countries,” German health minister Jens Spahn said.
‘No evidence’ of clotting link
AstraZeneca said Friday that its analysis not only shows “no evidence of an increased risk” of blood clots in vaccine recipients, but demonstrates a lower number than in the general population.
“An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country with COVID-19 Vaccine AstraZeneca,” the company said in a statement.
“In fact, the observed number of these types of events are significantly lower in those vaccinated than would be expected among the general population,” it added.
Denmark’s health leaders had stressed their decision to announce a two-week pause on its use of the vaccine was a precautionary one, reminding people there is “good evidence that the vaccine is both safe and effective” but saying they would “act early” to investigate the reports of clotting.
Spain delayed giving the jab to those aged between 55 and 65 until a review is conducted, but Dutch health minister Hugo de Jonge said Thursday there is “no cause for concern,” and no reason to stop using the AstraZeneca vaccine.
Earlier this week, a number of EU nations paused the use of doses that came from a particular batch of AstraZeneca vaccine, after a 49-year-old woman in Austria died of multiple thrombosis on Sunday. The EMA said Wednesday there was “no indication” that vaccination had been behind the cases of clotting or death.
And on Thursday, Italian medicines agency AIFA also banned use of another batch of AstraZeneca vaccines. The agency said it was responding to “some serious adverse events” taking place around the time of vaccinations from one specific batch. It did not say what the events were and said no causal link between the events and the vaccine had been established.
Nigeria, which has started receiving millions of vaccine doses through the COVAX program, defended the vaccine Thursday, saying it is satisfied with the clinical evidence indicating the shot is “safe and effective” and urging its citizens to continue to participate in the rollout.
Real-world data has also shown that the vaccine is having a significant impact in reducing Covid-19 hospitalizations.
A single dose of the vaccine reduces the risk of hospitalization from Covid-19 by more than 80% in people aged over 80, data from Public Health England showed earlier this month. The vaccine is given in two doses, though countries differ in how far apart they are spreading those shots.
Concerns about the vaccine’s safety nonetheless come at an awkward time for AstraZeneca, with disputes over its supplies to the EU still unresolved. After announcing it would pause the vaccine, Denmark’s health authority said Thursday the country would now receive approximately 900,000 fewer doses of the shot.
“The fact that AstraZeneca is once again downgrading the number of doses delivered to the EU and thus Denmark is, of course, both unsatisfactory and a serious challenge,” Ole Jensen, deputy director at the Statens Serum Institut, said.
Polish officials also announced on Friday that AstraZeneca will reduce the number of coronavirus vaccine doses delivered there.
Job growth in Canada exceeded expectations in November – Canada Immigration News
With employment soaring beyond predictions and unemployment dropping to near pre-pandemic levels, new labour force data suggest that Canada is on its way to a full economic recovery.
This past November, Canadian employers added 154,000 jobs to the economy. Last month’s growth exceeded analysts’ predictions of 38,000, which was closer to October levels. The gains pushed employment a full percentage point higher than pre-pandemic levels. Also, unemployment dropped to 6%, which is within 0.3 percentage points of what it was in February 2020.
Data from Statistics Canada’s Labour Force Survey reflect labour market conditions during the week of November 7 to 13. Proof-of-vaccination policies and other public health measures were largely similar to those in October.
Labour shortages persist despite employment gains
Hiring in November was driven by the private sector both in full-time and part-time positions. Even so, Canada is still experiencing labour shortages across sectors like hospitality, retail, and health care. In September, there were roughly one million job vacancies across the country.
Most government COVID-19 financial assistance measures ended in late October. Some analysts say it may have pushed people to accept job offers. Among these measures was the Canadian Recovery Benefit for individuals, which had been accused of discouraging people from returning to work. The Conference Board of Canada says the lack of wage growth was an even greater disincentive, especially in low-wage service industries.
“November’s job growth suggests the withdrawal of the [Canadian Recovery Benefit] may have pushed some workers back into employment though alone this will not be sufficient to address the significant labour shortages affecting several industries,” writes economist Liam Daly.
RBC economist Nathan Janzen wrote that despite the surge in employment there were still “exceptionally low” levels of workers in the service sectors.
“Employment in accommodation & food services edged up 5k from October but is still more than 200k below pre-shock levels,” Janzen wrote. “Travel and hospitality spending has been rebounding, but with the unemployment rate now substantially lower, it is increasingly clear that there are not enough remaining unemployed workers out there to re-fill all of those jobs any time soon.”
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Bitcoin plunges overnight – CTV News
Bitcoin prices plummeted overnight to a low of about US$43,000.
As of 10:30 am EST Saturday, the cryptocurrency had dropped more than 13 per cent in the previous 24 hours, from US$56,294 to US$48,309 — a loss of almost US$8,000.
That’s a stark contrast from its all-time high of just last month, when Bitcoin reached almost US$69,000 on November 9.
It’s a slight rebound from a plunge of more than 17 per cent earlier in the day.
Ether, the second most popular cyrptocurrency, fell almost 10 per cent.
The drop for bitcoin follows a volatile week for financial markets. Global equities and benchmark U.S. bond yields tumbled on Friday after data showed US job growth slowed in November and the Omicron variant of the coronavirus kept investors on edge.
Data from another platform, Coinglass, showed that nearly US$1 billion worth of cryptocurrencies had been liquidated over the past 24 hours, with the bulk being on digital exchange Bitfinex.
Will psychedelics become mainstream? This Calgary company is betting on it – CBC.ca
Danny Motyka discovered his love for chemistry when he was high on LSD back in the mid-2000s. The single tab of blotter acid — emblazoned with images of tongues from the rock band Kiss — set him on a path to push psychedelics out of the shadows.
Now 31, Motyka is the CEO of Psygen, a Calgary business hoping to manufacture synthetic psychedelics for the pharmaceutical industry. While the application of hallucinogens in medicine is in its infancy and remains highly speculative, Motyka and his company of believers are encouraged by renewed interest in the field.
“There’s a huge market opportunity here,” Motyka said.
A spate of early scientific research — along with big injections of cash from wealthy and celebrity investors — has triggered a renaissance of sorts for psychedelics, which for decades were pushed underground by the war on drugs.
Companies want to be the next psychedelic unicorn
Dozens of companies have emerged in recent years, seeking to get in on the ground floor of a fledgling industry they bet will take them higher. Some, like Germany-based Atai Life Sciences and the U.K.’s Compass Pathways, have become unicorns — not some kind of hallucination, but the type of startups worth more than $1 billion.
“We’re really breaking ground here in that psychedelic chemistry has been illegal, and now we’re able to do it in a legal context,” said Peter van der Heyden, Psygen’s co-founder and chief science officer.
“It’s never been done before.”
Potential for a new industry
Magic mushrooms, LSD and other psychedelics are hallucinogenic drugs that remain illegal to possess for recreational use. But some regulators such as Health Canada have allowed for research into them as possible treatments for mental health conditions, sending companies and investors on a trip to a new industry.
While the sector initially attracted an early rush of investor enthusiasm, some of the euphoria has already begun to fade as shareholders come to grips with the long and uncertain road ahead.
Researchers are still running clinical trials looking into whether substances like psilocybin, the active ingredient in magic mushrooms, can effectively and safely treat depression, or whether MDMA, often found in ecstasy or molly, can help patients with post-traumatic stress disorder.
“We have to go through the entire drug approval pathway and demonstrate safety and demonstrate efficacy,” van der Heyden said. “So it’s too early, really, to say we know that these things work.”
Production expected early 2022
Psygen’s lab, currently under construction, would initially manufacture psychedelics for research and clinical trials, though it still needs Health Canada approval. The company hopes those trials lead to the creation of new therapeutic drugs, allowing its lab to expand to commercial-scale production of medical-grade substances.
They’ve asked Health Canada for a dealer’s license, which gives special permission to handle and produce controlled drugs that are otherwise illegal to possess. The designation comes with a strict set of rules, including security measures to prevent theft, proper record keeping and reporting.
For now, company officials are optimistic the first phase of the project will secure the green light from federal regulators and they can start producing psychedelics by the end of March 2022.
By then, the facility would be capable of producing 12 to 15 kilograms of synthetic psilocybin a year, enough to fill demand from clinical research, Motyka said.
Marijuana paves the way for mushrooms
The Alberta business has applied to handle eight different psychedelic drugs, though its CEO said psilocybin is the substance most in demand from drug development companies, likely because of loosening cannabis laws.
“That’s reflective of this liberalization of plant medicines. It’s easy to go from cannabis as a medicine to mushrooms as a medicine,” Motyka said. “It’s a bit harder to make that next jump to LSD, especially with the amount of stigma that’s associated.”
Researchers are looking at psilocybin’s potential to treat various conditions, from anxiety and obsessive-compulsive disorder, to problematic substance use. Health Canada, which has approved three clinical trials testing the drug in treatment of depression, said psilocybin has so far shown some promise in some cases, but further research is needed.
“Clinical trials are the most appropriate and effective way to advance research with unapproved drugs such as psilocybin,” the regulator said in a statement.
“Clinical trials ensure that the best interests of patients are protected and that a product is administered in accordance with national and international ethical, medical and scientific standards.”
‘Hungry for something new’
Industry observers say the legalization of cannabis for recreational or strictly medical purposes in many parts of the world has helped to ease stigmas and convince investors to pump hundreds of millions of dollars into psychedelics.
Plus, the outbreak of the deadly COVID-19 virus — and the rounds of restrictions that came with it — triggered a fresh wave of mental health concerns. And it’s happening at a time when people are interested in unconventional ways of looking at problems, said Leila Rafi, a Toronto lawyer with clients in the industry.
“There’s a lot of investors out there who are willing to put a little bit of money into this industry and see what happens — and even take a bit of a hit,” said Rafi, a partner in McMillan’s capital markets group.
“And I think investors are just hungry for something new.”
Psychedelic stocks in a lull
Steve Hawkins, the CEO of financial services company Horizons ETFs, runs a fund that allows people to invest in the broader psychedelics market. The exchange traded fund (ETF) tracks a couple dozen publicly traded companies that are heavily involved in, or have significant exposure to, the industry.
So far, it’s individual investors, rather than big pension funds, that have parked money in the fund, Hawkins said.
“This is still a very early stage investment proposition.”
An initial burst of investor excitement has given way to a lull in recent months, with share prices for drug development firms plunging. The Horizons psychedelics ETF has lost half of its value on the stock market since hitting a peak in February.
In an industry where companies are not making money, stock prices are driven by other developments, including news of breakthroughs in research. But there haven’t been enough intoxicating incentives to lure investors back, Hawkins said, noting that while share prices have fallen from their peaks, they are still above where they were in 2020.
Investors hooked on psychedelic ventures also face plenty of risk.
“All investors who are investing in early stage drug development companies need to be prepared to lose a substantial amount of money– Eric Foster, Dentons lawyer
Firms that are attracting troves of investment dollars are often burning through all that cash researching drugs that may not materialize, Hawkins said. “These are very risky companies.”
Some could fail, similar to what happened in the cannabis industry.
“All investors who are investing in early stage drug development companies need to be prepared to lose a substantial amount of money,” said Eric Foster, a partner at Dentons law firm who helps investment banks finance psychedelic ventures.
“The (potential) upside is that they will be able to take a candidate all the way through the regulatory approval process, and effectively get to a drug that’s been approved … Then, all of a sudden, it’s going to be worth significantly more.”
A new frontier
The very idea that psychedelics could emerge from the shadows of a decades-long drug war and pave the way to a new frontier of medicine has inspired other investors with deep pockets.
Liam Payne, the British One Direction singer, along with PayPal co-founder and billionaire Peter Theil are on the growing list of celebrity investors. New York Mets owner Steven Cohen, Shark Tank’s Kevin O’Leary and Tim Ferriss, the podcaster and author of The 4-Hour Workweek, are also on the roster.
Then there’s Sa’ad Shah. Convinced that researchers are only scratching the surface of psychedelics’ potential power to reshape mental healthcare, he co-founded a venture capital player focused on the industry.
Shah has been raising money from friends, various CEOs and ultra-high-networth investors to build a warchest to unleash on dozens of companies. The Noetic Fund, based in Toronto, raised $32 million US in its first round and invested it into 22 ventures, including Calgary’s Psygen. Now, it’s on the hunt for another $200 million.
Nearly halfway there, Shah said he’s not facing the same kind of investor burnout that has sent stock prices tumbling. He said most of the “crown jewels” in the industry remain privately held companies that continue to raise funds.
“It’s a burgeoning industry,” Shah said. “It’s an incredibly exciting industry. It is a bit of the Wild West.”
An opportunity and a business venture
Van der Heyden, Psygen’s co-founder, says he found a gap in this Wild West landscape when he spoke with researchers who couldn’t get their hands on pharmaceutical-grade psychedelics for their studies. He saw an opportunity.
A child of the hippie era of the 1960s and early 1970s, he said the counterculture movement exposed him to drugs like LSD. But it wasn’t until his retirement that psychedelics became a possible business venture.
And it’s made for some unusual conversations.
“I might be sitting at the barber and he asks me, ‘What do you do?’ And so I say, ‘Hey, guess what? We make psychedelic drugs.'”
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