Medicago said on Tuesday it has begun testing its plant-based coronavirus vaccine in an early-stage clinical trial as the Canadian company, backed by tobacco company Phillip Morris, races against larger drugmakers to develop a treatment option to battle the COVID-19 pandemic.
Medicago said it dosed the first healthy volunteers on Monday in a 180-person study, making it the first vaccine from Canada among the more than 20 experimental coronavirus vaccines being tested in humans.
Experts have cautioned that more than one vaccine may be necessary to combat the COVID-19 pandemic, with drugmakers such as AstraZeneca Plc and Moderna Inc ahead in the race and gearing up to test their vaccine candidates in large trials.
Countries have spent billions to aid the development of safe and effective vaccines and to secure access to them.
Initial doses of Medicago’s vaccine could go to the United States and Canada, Chief Executive Officer Bruce Clark told Reuters.
“Our research base is in Canada and we have commercialization in the U.S., so it seems to be most likely the first countries will be in North America.”
Medicago’s vaccine is being tested with adjuvants, or vaccine boosters, from GlaxoSmithKline, the world’s largest vaccine-maker, and Dynavax Technologies Corp.
Medicago’s potential vaccine uses the leaves of a plant from the tobacco family to produce the S-spike protein, one of the three spike proteins of the novel coronavirus.
The company has already used this approach in a flu vaccine that is awaiting Canadian approval.
Medicago, which expects to make about 100 million doses of the vaccine by the end of 2021, is also building a facility in Quebec City, Canada. The facility is expected to be ready by 2023 and make a billion units a year.
The company, headquartered in Quebec City, is privately owned. Philip Morris owns 33% of Medicago and Mitsubishi Tanabe Pharma the remaining stake.
Source: – Globalnews.ca
23 Died After Getting Covid Shot in Norway. Here's the Rest of the Story – TheStreet
After a striking headline circulated over the weekend — that 23 patients in Norway died after getting a Covid-19 shot — TheStreet reached out to the Norwegian Medicines Agency to find out more details of what happened.
Norwegian health officials say they have now revised guidelines on who should get the Covid-19 shots made by Pfizer (PFE) – Get Report and BioNTech (BNTX) – Get Report, after 23 deaths among the frail and elderly were believed to be “associated with” recent Covid-19 vaccinations. More than half of those who died, 13, have been assessed. The agency believes those fatalities might be linked to common adverse reactions from the vaccine, known as BNT162b2.
A Pfizer spokesperson said that the company and its partner, BioNTech, are “aware” of the deaths and are working with the Norwegian agency to collect necessary information. Pfizer’s “immediate thoughts are with the bereaved families,” said Jerica Pitts, Pfizer’s director of global media relations, in an email to TheStreet on Sunday. But Pitts pointed out that the number of incidents is so far not alarming and to be expected, according to Norwegian health officials.
For perspective, 42,003 people have been given the first dose of the vaccine in Norway as of Friday, so the deaths are a tiny fraction of the total vaccinated. Also, Norway, which has a population of slightly more than 5 million, has fewer than 58,600 total known cases of Covid-19 and under 517 deaths attributed to the virus, according to Johns Hopkins data. That ratio alone appears far worse one than that of the vaccinated vs. deaths potentially linked to the vaccine.
Still, the reports of deaths “suggest” that common adverse reactions to the messenger RNA vaccine may have contributed to a fatal outcome in some frail patients, says Norwegian health officials.
Following is a lightly edited exchange between TheStreet and the Norwegian Medicines Agency about the deaths, which occurred after the first dose of the vaccine, which began getting distributed in Norway on Dec. 27.
TheStreet: Why did the agency put out this notice?
Norwegian Medicines Agency: The Norwegian Adverse Drug Reaction registry is a national health registry, obliged to report statistics to the public. At the highest political level, the public has been promised full transparency of the reported ADRs of the Covid-19 vaccines. … In Norway, we have a “reporting culture” for vaccine ADRs, where the normal procedure is to report all suspected adverse reactions for new vaccines. Health care professionals in Norway have a low threshold for reporting possible adverse reactions, even when the causal relationships appear very unclear.
TheStreet: It sounds like you believe these deaths were likely linked to common adverse side effects of the shots. Could you expand on that? Is there any side effect that you find most concerning?
Norwegian Medicines Agency: For privacy reasons, we can not provide detailed information about this, but … all reports are about elderly people with serious underlying disorders. Most of them have experienced the expected side effects of the vaccine, such as nausea, vomiting, fever and local reactions at the injection site.
All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination may contribute to more serious course and fatal outcome in patients with severe underlying disease.
TheStreet: How old were those who died after getting the shots?
Norwegian Medicines Agency: All deaths fall into the age group of 75 years or older.
TheStreet: Do these deaths make you question how the vaccine is given to that population of the elderly who are sick?
Norwegian Medicines Agency: The Norwegian Medicines Agency approves the vaccine, but the National Institute of Public Health is responsible for the distribution. The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the Covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.
We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.
Toronto opening mass COVID-19 vaccine clinic as ICUs move patients around province – CBC News: The National
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- Toronto opening mass COVID-19 vaccine clinic as ICUs move patients around province CBC News: The National
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London health chiefs today pledged to speed up vaccinations by opening up to 25 new centres in the capital this week, including a major site in the shadow of Wembley Stadium. With the number of centres due to hit 170 by the weekend, the capital’s most senior doctor urged people to come forward “without delay” for the jab when called. “We’re adding more and more sites as vaccine supplies become available, and staff and volunteers are going the extra mile to vaccinate to those who need it most,” said Dr Vin Diwakar, Medical Director for the NHS in London.
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