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CORRECTING and REPLACING Medicago and GSK Announce Start of Phase 2/3 Clinical Trials of Adjuvanted COVID-19 Vaccine Candidate – Business Wire

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QUEBEC CITY, Quebec & LONDON–(BUSINESS WIRE)–Please replace the release with the following corrected version due to multiple revisions.

The updated release reads:

MEDICAGO AND GSK ANNOUNCE START OF PHASE 2/3 CLINICAL TRIALS OF ADJUVANTED COVID-19 VACCINE CANDIDATE

The COVID-19 vaccine candidate will contain GSK’s pandemic adjuvant

Phase 3 part of clinical trial to enroll over 30,000 volunteers worldwide

Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK are pleased to announce the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results and the approval of Canadian regulatory authorities, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant.

Our Phase 1 results of the adjuvanted vaccine candidate were very encouraging and fully support further clinical evaluation,” said Nathalie Landry, Executive Vice President, Scientific and Medical Affairs at Medicago.

Thomas Breuer, Chief Medical Officer GSK Vaccines said “This is the first of several GSK COVID-19 vaccine candidate collaborations to start Phase 2/3 clinical testing and an important step forward in our contribution to the global fight against the pandemic. We are delighted with the very promising Phase 1 results of Medicago’s COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant. Proven dose-sparing and a high immune response due to GSK’s adjuvant make us confident of delivering an efficacious vaccine with an acceptable safety profile in collaboration with Medicago.”

The Coronavirus-Like Particle COVID-19 vaccine candidate (CoVLP) is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).

The study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP (two doses of 3.75 µg CoVLP combined with GSK’s pandemic adjuvant given 21 days apart) has an acceptable immunogenicity and safety profile in healthy adults 18-64 years of age and in elderly subjects aged 65 and over.

The Phase 2 trial part is a randomized, observer-blind, placebo-controlled study to evaluate the safety and immunogenicity of the adjuvanted recombinant COVID-19 plant-derived vaccine candidate in subjects aged 18 and above. It will be conducted in multiple sites in Canada and, upon FDA allowance, in the United States and on a population composed of healthy adults (18-64y) and elderly adults (over 65y). Each age group will have over 300 subjects randomized 5:1 to receive the adjuvanted CoVLP vaccine candidate: placebo and with 2:1 stratification in older adults (65-74 and ≥75). All subjects will be followed for a period of 12 months after the last vaccination for the assessment of safety and durability of the immune responses to the vaccine candidate.

The Phase 3 part of the study should start before the end of 2020 and is an event-driven, randomized, observer-blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation, compared to placebo, in over 30,000 subjects in North America, Latin America and/or Europe and within the same population, or – alternatively – amongst a broader one pending approval by regulatory authorities.

About Medicago

Medicago is a biopharmaceutical company and pioneer in plant-derived therapeutics. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare.

Our mission is to improve global health outcomes by leveraging innovative plant-based technologies for rapid responses to emerging global healthcare challenges. Medicago is committed to advancing therapeutics against life-threatening diseases worldwide. Our team includes over 450 scientific experts and employees in Canada and the United States and academic affiliations in Europe and South Africa.

Medicago has previously demonstrated its capability to be a first responder in a flu pandemic. In 2009, the company produced a research-grade vaccine candidate against H1N1 in just 19 days. In 2012, Medicago manufactured 10 million doses of a monovalent influenza vaccine candidate within one month for the Defense Advanced Research Projects Agency (DARPA), part of the U.S. Department of Defense. In 2015, Medicago also demonstrated in principle that it could rapidly produce an anti-Ebola monoclonal antibody cocktail for the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

For more information: www.medicago.com

To learn more about our plant-based technology: Video / Website

About GSK and its commitment to tackling COVID-19

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

GSK is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of our innovative vaccine adjuvant technology. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people. GSK does not expect to profit from COVID-19 vaccines during the pandemic phase, and will invest any short-term profit in coronavirus related research and long-term pandemic preparedness, either through GSK internal investments or with external partners.

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A Canadian COVID-19 study that turned out to be wrong has spread like wildfire among anti-vaxxers – CBC.ca

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This is an excerpt from Second Opinion, a weekly roundup of health and medical science news emailed to subscribers every Saturday morning. If you haven’t subscribed yet, you can do that by clicking here.


An inaccurate Canadian study suggesting an extremely high rate of heart inflammation after COVID-19 vaccines has been retracted due to a major mathematical error — but not before it spread like wildfire on anti-vaccination websites and social media.

The preprint study, which was released by researchers at the Ottawa Heart Institute last week but has not been peer-reviewed, looked at the rate of myocarditis and pericarditis cases after Moderna and Pfizer-BioNTech vaccinations in Ottawa from June 1 to July 31.

The study identified 32 patients with the rare side effects out of a total of 32,379 doses of mRNA vaccines given in Ottawa in the two-month period, finding an inordinately high rate of close to 1 in 1,000 — significantly higher than other international data has shown.

But the researchers made a critical error that experts say caused the study to be “weaponized” by the anti-vaccination movement at a time when concern over COVID-19 vaccine side effects are top of mind for parents whose kids may soon get the shot.

Black Creek Community Health volunteer Jasleen Kambo, 18, gets her first dose of the Moderna COVID-19 vaccine at a clinic run by Humber River Hospital at the Yorkgate Mall, in Toronto, on Apr. 14, 2021. (Evan Mitsui/CBC)

Risk of heart inflammation after shot ‘not correct’ in study

The researchers mistakenly failed to record the accurate number of vaccinations given out during that two-month period, despite the data on total doses being publicly available, and the figure turned out to be astronomically higher than what was presented in the study. 

Instead of 32,379 mRNA vaccine doses administered in June and July, as the study suggests, there were actually more than 800,000 shots given out at that time, according to Ottawa Public Health

That means the true rate of side effects is closer to 1 in 25,000 — not 1 in 1,000. 

“We recalculated the rate, and the rate is not correct in that paper,” said Dr. Peter Liu, scientific director of the Ottawa Heart Institute and a co-author of the study, in an interview with CBC News. 

“We were doing this on the run, in a way, and we were getting kind of the preliminary vaccination rate data, and so it turns out that that number was not complete.” 

Dr. Andrew Crean, co-director of the cardiac MRI service at the Ottawa Heart Institute and the study’s lead author, confirmed to CBC News in an email Thursday that the preprint was being retracted.

Late Friday night, the study was officially marked as “withdrawn” on the medRxiv preprint server, with a link to a statement citing “a major underestimation” of the rate of occurrence.

“In order to avoid misleading either colleagues or the general public and press, we the authors unanimously wish to withdraw this paper on the grounds of incorrect incidence data,” the statement read.

“We thank the many peer reviewers who went out of their way to contact us and point out our error. We apologize to anyone who may have been upset or disturbed by our report.”

Crean said the authors uncovered the “significant error” days after posting it to the server, finding a “substantial overestimate” of the risk of heart inflammation after vaccination, then moved quickly to get the study withdrawn.

“As you know, preprints are not full peer-reviewed publications,” he said. “The peer-review process worked quickly and efficiently to detect our error and we were happy to retract this data once the error was confirmed.” 

And Crean is absolutely right — this is exactly how the process is supposed to work. 

Preprints are traditionally a way for academics to share early information on important subjects before the data is peer-reviewed and published, said Ivan Oransky, co-founder of Retraction Watch, a website that tracks errors in science journals. 

“If in fact this is retracted quickly and withdrawn quickly based on what seems to be a pretty significant error, then it’s actually science doing what it should,” he said. 

“The problem is not the preprint server, the problem is that nobody ever provides any context around it.” 

Side effect remains rare, treatable

The Ottawa Heart Institute issued a tweet late Wednesday night, a week after the study was released, saying the authors “have requested the retraction of the preprint” due to “incorrect data” that “vastly inflates the incidence of post-vaccine myocarditis.” 

“We are sorry a preprint paper citing incorrect data led to misinformation on the incidence of post-vaccine myocarditis,” a spokesperson for the institute said in a followup statement to CBC News on Friday morning.

“COVID-19 vaccines are safe and have been proven effective against the disease. We invite anyone who has not yet received the shot to please get vaccinated.”

While some real-world data has shown an increased risk of heart inflammation after COVID-19 vaccines among younger age groups, it’s important to remember the side effect is rare.

“Even if you took the worst-case scenario, it doesn’t happen in 99.9 per cent of cases,” said Montreal cardiologist and epidemiologist Dr. Christopher Labos. “So the vast majority of people, even young people, are going to get vaccinated and not have an issue with myocarditis.” 

A small proportion of people who do experience the side effect will experience mild symptoms that are treatable without hospital care, Labos said, and don’t appear to cause “any major heart damage.”

Benefits of COVID-19 vaccine outweigh low risk of heart inflammation, experts say

3 months ago

A small number of cases of heart inflammation — specifically, myocarditis and pericarditis — have occurred in teens and young adults following mRNA COVID-19 vaccination, but experts say the benefits of a vaccine far outweigh the risk. 2:00

“So it looks as if this is a relatively mild side effect that should not dissuade anybody from getting vaccinated,” he said. “Because the benefits really outweigh the risks.” 

One study from Israel published in the New England Journal of Medicine earlier this month showed a slight increased risk of myocarditis after vaccination — but the researchers stressed that COVID-19 is more likely to cause the side effect than the shot. 

Despite this reassuring conclusion, experts say the speed in which preliminary data is being uploaded, manipulated and disseminated in the pandemic means one error can cause a lot of damage. 

“Mistakes happen; I have no major criticisms to level against anybody here. They did exactly what they’re supposed to do: When you make a mistake — you fix it,” said Labos.

“The real problem here is that I worry that people are going to keep using the wrong version of the study to advance their agenda.” 

Cherry-picking ‘rotten’ data

Despite not getting any mainstream media coverage in Canada or anywhere else at the time it was published, the study quickly spread around the world on social media and anti-vaccination websites, where it was incorrectly claimed as evidence of the damage COVID-19 vaccines cause.

The preprint has been shared on Twitter more than 11,000 times in the week since it’s been published, according to Altmetric, a company that tracks where published research is posted online. That’s in the top five per cent of all research it’s ever tracked.  

One particularly damaging tweet that gained a massive response came from Robert Malone, an infectious-disease researcher and accused spreader of anti-vaccination misinformation who calls himself the “inventor” of mRNA vaccines despite evidence to the contrary.

The study also showed up on numerous anti-vaccination websites, misrepresented as evidence that the rate of myocarditis had been intentionally underestimated and that thousands of children could be at risk of heart failure after vaccination in the future. 

Timothy Caulfield, Canada Research Chair in health law and policy at the University of Alberta who has studied the challenges with preprints in the pandemic, says the way in which the erroneous study has been shared widely online to promote an anti-vaccination agenda is “incredibly frustrating.”

“First of all, the topic is so sensitive with parents, with young adults. When people are doing this risk-benefit calculus and they see a study like this, even if it just crosses their radar on social media, it can have an impact on their intentions,” he said. 

“So a mistake like this can do real, serious harm — and I think it probably already has, unfortunately.” 

The error highlights the challenges with preprints, Caulfield said. On the one hand, they can create an open dialogue with academics and get research into the public domain quickly on important topics, but on the other hand, they can do irreparable long-term damage.

“Preprints can quickly be weaponized by activists when the data seems to bolster their ideology, and they lend credibility to claims that might otherwise appear non-scientific,” added Jonathan Jarry, a biological scientist with McGill University’s Office for Science and Society in Montreal.

“And when a preprint gets retracted because it was fraudulent or just simply incorrect, that bell is hard to un-ring in the public square that is the internet.” 

Reports of heart inflammation among small number of children that got Pfizer vaccine

4 months ago

A small number of children who received the Pfizer-BioNTech vaccine have reported swelling in the heart. Researchers and officials are tracking the phenomenon closely, but so far they’ve found no cause for alarm. 2:03

Caulfield said that once an inaccurate preprint gets released, it can “take on a life of its own.” 

“And that’s exactly what has happened here,” he said. “I can guarantee that you are going to continue to see references to this version of the paper for a long time to come.”

These so-called “zombie papers” are often intentionally shared within anti-vaccination circles long after they’re retracted or corrected in order to disingenuously influence public opinion and fuel misinformation, said Caulfield. 

“It’s extreme cherry-picking,” he said. “And the cherry is rotten.”

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US President Joe Biden urges Covid-19 booster shots for those now eligible – Times of India

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WASHINGTON: President Joe Biden on Friday urged those now eligible for Covid-19 booster shots to get the added protection a day after the Centers for Disease Control and Prevention endorsed the doses for millions of older or otherwise vulnerable Americans.
Opening a major new phase in the U.S vaccination drive against Covid-19, CDC Director Dr. Rochelle Walensky signed off on a series of recommendations from a panel of advisers late Thursday. Biden praised the decision and aimed to set aside any unease about the vaccination, saying that he would get his own booster soon.
“It’s hard to acknowledge I’m over 65, but I’ll be getting my booster shot,” Biden said. “It’s a bear, isn’t it?”
The advisers said boosters should be offered to people 65 and older, nursing home residents and those ages 50 to 64 who have risky underlying health problems. The extra dose would be given once they are at least six months past their last Pfizer shot.
However, Walensky decided to make one recommendation that the panel had rejected.
The panel on Thursday voted against saying that people can get a booster if they are ages 18 to 64 years and are health-care workers or have another job that puts them at increased risk of being exposed to the virus. But Walensky disagreed and put that recommendation back in, noting that such a move aligns with an FDA booster authorization decision earlier this week. The category she included covers people who live in institutional settings that increase their risk of exposure, such as prisons or homeless shelters, as well as health care workers.
An administration official said the White House did not have input in Walensky’s decision nor was given a heads-up. Biden on Friday said “the decision is left to the scientists and the doctors. That’s what happened here.”
The panel had offered the option of a booster for those ages 18 to 49 who have chronic health problems and want one. But the advisers refused to go further and open boosters to otherwise healthy front-line health care workers who aren’t at risk of severe illness but want to avoid even a mild infection.
The panel voted 9 to 6 to reject that proposal. Walensky decided to disregard the advisory committee’s counsel, issuing a statement saying she had restored the recommendation.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Walensky said late Thursday night. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
It’s rare for a CDC director to overrule the panel recommendation; experts said it has only happened once this century.
Experts say getting the unvaccinated their first shots remains the top priority, and the panel wrestled with whether the booster debate was distracting from that goal. Biden stressed that the administration’s focus remained on getting people to get their first shots and that he intended to keep rolling out “vaccination requirements wherever I can.”
“The refusal to get vaccinated have cost all of us,” the president said. “It is not hyperbole: it is literally a tragedy. Don’t let it be your tragedy.”
All three of the Covid-19 vaccines used in the US are still highly protective against severe illness, hospitalization and death, even with the spread of the extra-contagious delta variant. But only about 182 million Americans are fully vaccinated, or just 55% of the population.
“We can give boosters to people, but that’s not really the answer to this pandemic,” said Dr. Helen Keipp Talbot of Vanderbilt University. “Hospitals are full because people are not vaccinated. We are declining care to people who deserve care because we are full of unvaccinated Covid-positive patients.”
Thursday’s decision represented a dramatic scaling back of the Biden administration plan announced last month to dispense boosters to nearly everyone to shore up their protection. Late Wednesday, the Food and Drug Administration, like the CDC panel, signed off on Pfizer boosters for a much narrower slice of the population than the White House envisioned.
The booster plan marks an important shift in the nation’s vaccination drive. Britain and Israel are already giving a third round of shots over strong objections from the World Health Organization that poor countries don’t have enough for their initial doses.
Walensky opened Thursday’s meeting by stressing that vaccinating the unvaccinated remains the top goal “here in America and around the world.”
Walensky acknowledged that the data on who really needs a booster right away “are not perfect.” “Yet collectively they form a picture for us,” she said, “and they are what we have in this moment to make a decision about the next stage in this pandemic.”
The CDC panel stressed that its recommendations will be changed if new evidence shows more people need a booster.
The CDC advisers expressed concern over the millions of Americans who received Moderna or Johnson & Johnson shots early in the vaccine rollout. The government still hasn’t considered boosters for those brands and has no data on whether it is safe or effective to mix-and-match and give those people a Pfizer shot.
“I just don’t understand how later this afternoon we can say to people 65 and older, ‘You’re at risk for severe illness and death, but only half of you can protect yourselves right now,’” said Dr. Sarah Long of Drexel University.
About 26 million Americans got their last Pfizer dose at least six months ago, about half of whom are 65 or older. It’s not clear how many more would meet the CDC panel’s booster qualifications.
CDC data show the vaccines still offer strong protection against serious illness for all ages, but there is a slight drop among the oldest adults. And immunity against milder infection appears to be waning months after people’s initial immunization.
For most people, if you’re not in a group recommended for a booster, “it’s really because we think you’re well-protected,” said Dr. Matthew Daley of Kaiser Permanente Colorado.
Public health experts not involved in Thursday’s decision said it is unlikely people seeking third doses at a drugstore or other site will be required to prove they qualify.
Even with the introduction of boosters, someone who has gotten just the first two doses would still be considered fully vaccinated, according to the CDC’s Dr. Kathleen Dooling. That is an important question to people in parts of the country where you need to show proof of vaccination to eat in a restaurant or enter other places of business.
Among people who stand to benefit from a booster, there are few risks, the CDC concluded. Serious side effects from the first two Pfizer doses are exceedingly rare, including heart inflammation that sometimes occurs in younger men. Data from Israel, which has given nearly 3 million people — mostly 60 and older — a third Pfizer dose, has uncovered no red flags.
The U.S. has already authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy or not, have managed to get boosters, in some cases simply by asking.

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B.C. records seven COVID-related deaths, 80% of those eligible fully vaccinated – News 1130

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VANCOUVER (NEWS 1130) – Seven more British Columbians have died due to COVID-19 in the past 24 hours, as Fraser Health once again recorded the most new cases in the province.

A total of 743 new infections were recorded on Friday, including 292 in Fraser Health and 177 in Interior Health. Vancouver Coastal Health recorded 111 cases and Northern Health saw 106. Island health recorded the remaining 57 cases.

Four of the latest deaths were within the Fraser Health Authority, while Interior Health, Northern Health, and Island Health recorded one each.

The Fraser Health region also has the most active cases, with 2,029 of the 5,979 province-wide.

Related articles: Province begins crack-down on businesses that ignore vaccine card enforcement

The province says 319 COVID-19 patients are in the hospital, including 149 in the ICU.

Earlier Friday, the health ministry issued a statement, confirming all COVID-19 patients who are hospitalized are counted in the daily totals once they enter the facility, but are removed from the total even if they remain hospitalized but are no longer infectious.

“Once a patient in critical care is no longer infectious with COVID-19, the patient is removed from daily critical-care totals. However, for planning purposes, these patients are still included in the overall COVID-19 counts for the hospital,” the ministry added in a statement.

It says some patients need to stay in the hospital for “difficulties with other health conditions … that are no longer directly tied to COVID-19,” or because they may have caught the virus while in the hospital and still need care for the original issue they were admitted for.

“This means some patients who entered hospital or critical care as a COVID-19 patient may no longer be counted as COVID-19 patients once they are no longer infectious, even though they remain in hospital.”

It says as of Sept. 21, 2021, there were 152 patients in B.C. hospitals in that category. “Discontinued isolation,” which is usually over after 10 days if the patient doesn’t have a fever and their symptoms are improving.

B.C. reaches 80% mark for those with two vaccine doses

In the past day, 7,858 British Columbians aged 12 and up received their second dose of a COVID-19 vaccine, bringing the total to an even 80 per cent. Another 6,778 people received their first dose bringing that percentage up to 87.5.

According to the province, people not fully vaccinated accounted for 75 per cent of cases between Sept. 16 and Sept. 22. It also says they accounted for 81.9 per cent of hospitalizations between Sept. 9 and Sept. 22.

Related articles:

There are 21 active outbreaks at health-care facilities:

Long-term care: Northcrest Care Centre, Westminster House, Menno Terrace East (Fraser Health), Arbutus Care Centre, Louis Brier Home and Hospital (Vancouver Coastal Health), Village at Mill Creek – second floor, Cottonwoods Care Centre, Spring Valley Care Centre, Kamloops Seniors Village, Hillside Village, The Hamlets at Westsyde, Joseph Creek Care Village, Overlander (Interior Health), Jubilee Lodge (Northern Health), and Victoria Chinatown Care Centre (Island Health)

Acute care: Chilliwack General Hospital (Fraser Health) and Fort St. John Hospital (Northern Health)

Assisted or independent living: Sunset Manor (Fraser Health), David Lloyd Jones, Sun Pointe Village, and Hardy View Lodge (Interior Health)

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