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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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Indoors or out, Dr. Henry shuts down sports games – Times Colonist

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“It will be an early ­Christmas break for our players,” ­Vancouver Island Soccer League executive director Vince Greco said Thursday after hearing the news adult and youth sports games on the Island — indoor or outdoor — are shut down due to the pandemic. Youth sports can still practice and train on a ­limited basis.

“There is a lot of work to be done in making up a new ­schedule with new cohorts. We are starting from scratch,” added Greco of the largest adult league on the Island. “We are hopeful of a Jan. 8 return.”

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Provincial health officer Dr. Bonnie Henry said the order is for the “next few weeks.” She added that sport and physical activity accounts for 10 to 15 per cent of COVID-19 transmissions in B.C. and that may be an underestimate.

Henry announced Wednesday that all indoor adult team sports were prohibited. Further orders Thursday included outdoor sports.

Bringing people together is what sport does best and is its greatest attribute and appeal. The pandemic has, ironically, turned that into sport’s greatest detriment.

“When people come together is when this virus can spread,” said Henry, during her briefing Thursday.

“A lot of adult sports are really very much social gatherings as well as sport. Those types of gatherings are leading to transmission events. We’ve seen it in a number of adult team sports. We need to step back from those. It’s the locker-room. It’s the before, it’s the after, and the going out for coffee or beer after a game that has been the most source of transmission. It’s difficult because much of that is built into the culture of adult team sports. So let’s focus on our children. Supervised sports for young people have not been a source of the same type of risk and transmission.” Island sports organizations have reacted to the new orders.

The Victoria Minor Hockey Association, emerging from a voluntary two-week shutdown with the other 16 minor hockey associations on the Island, had just sent out its new schedule to parents and players on Tuesday. But those re-scheduled games, set to begin this weekend, are now cancelled because of the new orders. Practices are still allowed for youth sports but they have gone back to individually distanced skills and drills.

“We will be hosting a skills competition so at least we can get something competitive in,” said Nicki Reich, president of the Victoria Minor Hockey ­Association.

Juan de Fuca Minor Soccer Association president Kevin Allen informed his members by Facebook on Thursday: “Due to the just announced updated provincial health order … all games are now cancelled until further notice. As we are to move back to Phase 1, non-contact, social distanced soccer. We are hopeful that we will be able to get back on the field in the new year, but only time will tell. Hopefully, better days are ahead.”

With the vaccines coming, Henry touched on those better days.

“It may feel like it but it’s not forever. It will change,” she said.

“We will get back to having games and back to travel and playing against people from other communities. But right now we’re still having challenges. It’s not so much the kids on the field. It’s the away from the field of play. We’ve looked at not having travel and no spectators to reduce those ­probabilities. But we’re finding it’s still a challenge.”

There is a separate high-performance model that pertains to the guidelines, which includes exemptions for athletes training on the Island, Richmond and Whistler for next summer’s delayed Tokyo Olympics and the 2022 Beijing Winter Games.

It is not clear, however, how this affects other higher-performance sports. University of Victoria Vikes, Camosun College Chargers and Vancouver Island University Mariners team sports have already been cancelled for the season. But the B.C. Hockey League, with five teams in the Island Division, is scheduled to open the regular season Dec. 8 and the Victoria Royals of the WHL on Jan. 8.

The governor of a BCHL Island Division team, who did not want to be identified, said it is highly doubtful the league will begin the season as planned Dec. 8.

BCHL commissioner Chris Hebb could not be reached for comment.

cdheensaw@timescolonist.com

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SHA activating COVID-19 surge plan – Prince Albert Daily Herald

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Saskatchewan Health Authority CEO Scott Livingstone. (Brandon Harder/Regina Leader-Post)

The Saskatchewan Health Authority (SHA) announced plans on Thursday to slow down specific services in order to respond to a surge in COVID-19 patients.

There are currently 128 people in hospital. 104 people are receiving inpatient care and 24 people are intensive care in hospitals across the province.

Services that will be slowed down include some primary health care services, elective surgeries in urban centres, endoscopy/cystoscopy procedures, women and children’s programming, diagnostics, therapies, ambulatory care, registrations resources, environmental and food and nutrition services, rehab services, and home care services.

These services will still be available just at reduced volumes or levels.

There are also limited exceptions where services will be temporarily paused in highly localized programs such as dental programs, therapeutic and rehabilitation programs and active living programs.

Derek Miller, executive director of infrastructure management at the SHA said decisions were not made lightly about what services could be slowed down.

“We asked our frontline clinical leaders and operational leaders to review each service line and assess it with a lens of what is the impact on patient care by reducing and slowing down that service and also what are the resources that become available by doing that in terms of numbers and also skill set,” Miller explained.

He added this is how the SHA identified what services could be slowed down with minimal impact on patient care.

“This is not a broad reduction of services like what was undertaken in the spring slowdown but rather much more finely tuned adjustments in multiple areas that allow us to achieve the capacity and resources that we need.”

The slowdown in services will result in the redeployment of 588 full-time equivalent (FTE) positions across the province. This number includes 175 registered nurses, 74 licensed practical nurses, and 15 continuing care assistants.

The SHA is also obtaining additional resources through supplementary workforces provided by provincial government staff, federal government staff, and Statistics Canada staff.

The nearly 600 FTE staff will be redeployed to contact tracing and hospitals to address a surge in COVID-19 hospitalizations.

As to where those staff will be deployed, Miller explained that if a hospital unit is converted to a COVID unit, the staff would continue to work in that unit as COVID support staff. Some new spaces are also being created in hospitals where beds didn’t exist before and will need to be staffed.

“They’re being matched based on their skill sets and what training they have as to where we can best deploy them as part of the response,” Miller said.

The need to slow down services and redeploy staff is due to a spike in COVID-19 hospitalizations and overall capacity.

In the last month there has been a 400 per cent increase in the hospitalizations, and 31 per cent of ICU capacity is being used for COVID-19 patients.

Considering the potential lab confirmed cases in the current timeline, Miller says we could see over 500 cases a day. Hospital census and ICU census will continue to rise over the next week as well.

“We are moving forward to immediately create capacity and resources that allow us to meet the demand,” Miller said.

The SHA is planning for up to 250 COVID patients in hospitals within the next two week period. This represents a capacity equivalent to the Cypress Regional Hospital in Swift Current and the Victoria Hospital in Prince Albert, combined.

They are also planning for 64 potential COVID patients in the ICU, which is equivalent to about 28 per cent more ICU bed capacity that currently exists in Saskatoon and Regina combined.

The SHA will be meeting this demand by creating additional spaces in hospitals to care for ventilated patients and surging resources like staff and physicians to care for patients.

Miller explained that capacity needs to be a step ahead of current demands.

“We don’t want to be in a situation where we’re riding the demand curve and where we’re at risk of quickly becoming overwhelmed by COVID demand,” he said.

When asked why the slowdowns are only occurring now even though cases and hospitalizations have gone up over the last two weeks, SHA CEO Scott Livingstone said existing resources have been used to deal with contact tracing.

Livingstone added that during the pandemic, and particularly in the summer, the SHA added 627 FTE to support COVID response.

“You’ve seen our testing capacity expand, you’ve seen our contact tracing expand, but we are pushing our teams to the limit,” Livingstone said on Thursday.

“We need to act now to not only strengthen their response both on the offensive and defensive strategy, but to build a labour pool that gives us more flexibility to deal with outbreaks that we can’t predict in long-term care facilities and hospitals where we’re required to immediately replace staff, because the only other option is to reduce services immediately if we can’t replace them.”

Livingstone also addressed the rising case numbers in northern Indigenous communities in Thursday’s press conference.

He said the SHA has been working with the federal government and First Nations leadership since the beginning of the pandemic to determine what supports they need.

Livingstone said a liaison was added to First Nations and Métis communities in the beginning of the pandemic to identify their needs and the SHA responds the best they can.

SHA officials were also asked how testing was going, particularly how busy it is and how people without transportation are accessing test centres.

Livingstone said the SHA is continuing to expand testing with drive-thrus in Saskatoon, Regina, and Prince Albert. They are looking at expanding hours, particularly in Saskatoon and Regina, putting more staff in place, and adding second drive-thru testing locations in both cities because of popularity.

“In the most extreme examples of the things that we’ve done to bring testing to people, in La Loche and in other communities, with communal living settings in the summer, we went door-to-door with testing to try to get as many people tested as we could.”

SHA official also said that they have plans in place to open field hospitals if required.

“I’ll just confirm at this point in time we are not in the process of opening the field hospitals, but we are preparing teams,” Livingstone said.

He added that as hospitalizations and specifically ICU numbers go up, the SHA will continue to use a stepwise approach and forecasting models in determining when to escalate services, including opening field hospitals.

Miller added that over the past few weeks the SHA has worked to reduce the amount of time it would take to activate field hospitals by ensuring equipment and oxygen systems are set up.

“We’re as close as we possibly can without actually pulling the trigger on activation,” Miller said.

The type of patient that would be admitted into the field hospital would be individuals who require care but not necessarily at the level received in acute care, Miller said.

Livingstone started his remarks on Thursday by asking the public to reach out to health care workers they know and thank them for the work they do every day.

SHA Chief Medical Officer Dr. Susan Shaw said the biggest emotion she and her co-workers are feeling now is concern.

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COVID-19 vaccine for B.C. expected to roll out in 1st week of January, provincial health officer says – CBC.ca

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If everything goes according to plan, everyone in B.C. who wants the COVID-19 vaccine will be immunized by next September, Dr. Bonnie Henry said Thursday.

The provincial health officer explained that a more detailed plan for vaccine rollout will be available early next week, but the first shots should be available early in the new year.

“We’re going to make sure we are absolutely ready by then,” Henry said. “We are planning to be able to put vaccine into arms in the first week of January.”

She expects that two vaccines produced by Pfizer and Moderna will begin arriving in B.C. early in the new year but only about six million doses will be available across Canada.

“That’s not enough for everybody,” Henry said.

The first priority will likely be to immunize the most vulnerable populations, including residents of long-term care homes, as well as health-care workers.

Two other vaccines produced by AstraZeneca and Janssen are anticipated in the second quarter of 2021.

“By the time we get into April of 2021, we’re expecting increased numbers of all the vaccines to be available and that’s when we can start offering it to more people across British Columbia,” Henry said.

It won’t be possible to reach everyone at once, so there will have to be a strategy for sequencing who receives it.

“As long as the vaccine continues to come in, as long as the safety and the effectiveness is good … we hope to have everybody done by September of next year,” Henry said.

She has repeatedly said the vaccine will not be mandatory.

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