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Canadian company says its COVID-19 vaccine spurred 'promising antibody response' in Phase 1 of clinical trials – CTV News

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TORONTO —
The Canadian company behind a new plant-derived COVID-19 vaccine candidate has released the results of their Phase 1 clinical trials, saying two doses of their adjuvanted vaccine spurred a significant antibody response in 100 per cent of the trial subjects.

“They’re even better than we had hoped,” Nathalie Landry, executive vice president of scientific and medical affairs at Medicago, said of the results.

“When we talk about neutralizing antibody responses, we say it’s quite remarkable, especially when we compare with a subject that recovered from the disease.”

Those who received the Medicago adjuvanted vaccine in the Phase 1 trial actually had higher antibody levels than the levels found in those who had contracted COVID-19, Landry told CTVNews.ca in a phone interview.

Medicago, a company based in Quebec, launched their first human trials in July.

In Phase 1, they looked at around 180 healthy subjects between the ages of 18 and 55. Participants were given either the vaccine on its own, or the vaccine with one of two adjuvants mixed in: GlaxoSmithKline (GSK)’s pandemic adjuvant or Dynavax’s CpG 1018.

An adjuvant is a substance that is added to vaccines in order to boost the effects and enable a higher immune response. They can be made from a variety of materials, including plants, aluminum and squalene oil, derived largely from sharks. Researchers wanted to measure what difference adding each adjuvant would make for the immune response.

They found that the vaccine candidate on its own did produce antibodies in the subjects, but demanded a much higher dosage level in order to get proper results.

It was the adjuvanted vaccines that really had an effect.

After two doses of adjuvanted vaccine — no matter which adjuvant was used — the antibody response rose significantly. However, subjects developed anti-spike IgG antibodies after a single dose of the vaccine when mixed with the GSK adjuvant, according to the press release.

“[GSK’s was] the adjuvant that provided us with the best immune response at [a] very low dose,” Landry said.

She explained that although they tested three doses at 3.75, 7.5 and 15 micrograms, the antibody response did not increase as the dosage went up.

“We only need 3.75 micrograms to get to a very significant level of antibody and cellular immune responses,” she said.

Being able to spur an immune response at a lower dose means they would be able to manufacture more of the vaccine — if it clears the rest of the phases.

In October, the company announced that they had reached an agreement with the federal government to supply Canada with up to 76 million doses of their vaccine, subject to approval from Health Canada.

The success of the GSK adjuvant means that moving forward, Medicago will be using only their vaccine candidate mixed with GSK’s pandemic adjuvant in further trials.

This phase also proved the safety of the vaccine candidate to proceed to further trials, as no subjects had any severe adverse side-effects, only mild and short-lived side-effects, according to the release.

 

HOW PLANTS PLAY INTO VACCINE DEVELOPMENT

Medicago’s vaccine candidate is different from many of the others currently in human trials in that it uses “coronavirus virus-like particles” (CoVLP), which mimic the virus to spur an immune response without introducing any form of the actual virus to the human body.

“In general, when developing a vaccine for COVID, you’re looking for two things,” Landry said. “You’re looking for neutralizing antibody responses, and cellular immune responses.”

Their adjuvanted vaccine can trigger both of these, she said.

In order to make their vaccine, Medicago uses plants as, essentially, living factories to produce the antigen in the vaccine that spurs an immune response. This is achieved through recombinant technology: genetic code is transferred to a plant, at which point “the plant will start expressing that antigen like if it was its own,” according to Landry.

The plant they use is called nicotiana benthamiana, a relative of tobacco plants, which grows quickly and can “produce a huge amount of proteins,” she said, making it a prime host for biopharmaceuticals.

“This is 20 years of development, that is behind this innovative manufacturing technology,” Landry said. “And this is something that has been developed in Canada.”

 

NEXT STEPS

In Phase 2, they will be studying more subjects, as well as those in other age groups not included in the first trial. It will involve around 600 subjects, between the ages of 18 and 64.

“We also evaluate elderly people, make sure that we actually took the right dose, and we have a group safety and immunogenicity profile,” Landry said.

In the final phase of the clinical trials, Medicago hopes to enrol around 30,000 subjects in different regions across the globe.

“Why we need to go global is that to prove the efficacy of the vaccine, you need to go in regions where the virus is circulating,” she explained.

She said they’re on track with their trials so far in terms of timeline. Medicago is aiming to launch Phase 2 soon, pending approval. According to Landry, we could hear the early results from that clinical trial in early 2021, around the same time that they are aiming to launch Phase 3 of the trials.

Phase 3 is when the efficacy of the vaccine really gets tested, she said, so while the results from Phase 1 are promising, and support further trials, they don’t know yet if the vaccine will actively prevent transmission of the virus.

“But that’s the idea,” she said. “You have a high level of antibodies that can neutralize the virus, so you will prevent infection and therefore, hopefully transmission of the virus as well.”

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What provinces and territories have said about their COVID-19 vaccine plans – CBC.ca

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The federal government is laying plans for the procurement and distribution of COVID-19 vaccines, inking contracts with seven potential manufacturers and saying six million doses could arrive in the country in the first quarter of 2021.

The most recent development from Ottawa came Friday when Prime Minister Justin Trudeau tapped former NATO commander Maj.-Gen. Dany Fortin to lead the national distribution effort.

But various provinces have started spelling out their plans as well. Here’s a look at what they’ve said so far:

Nova Scotia

The province’s chief medical officer of health says he will release a detailed plan for the distribution of a COVID-19 vaccine once Ottawa shares more information.

Dr. Robert Strang said Friday there is no certainty yet about the availability of a vaccine, but expressed hopes an initial supply will trickle into Nova Scotia early in the new year.

Dr. Robert Strang, Nova Scotia’s chief medical officer of health, said a detailed provincial plan, to be released once the federal government has shared more specifics on its end, will include tight control of the supply and clear rules dictating who can be first in line for immunization. (Communications Nova Scotia)

Strang said a detailed provincial plan, to be released once the federal government has shared more specifics on its end, will include tight control of the supply and clear rules dictating who can be first in line for immunization.

He said he’s waiting for more federal guidance on issues ranging from priority groups to transportation and storage logistics.

Quebec

The province will be ready to start rolling out its vaccine plan as of Jan. 1, say senior politicians.

Premier François Legault said Thursday that public health officials have already settled on the list of priority vaccine recipients, but did not release details. Legault said the province is also working to put the necessary infrastructure in place to support a vaccine rollout.

That includes obtaining refrigerators capable of maintaining the extremely low temperatures needed by one of the most promising potential vaccine options, currently in development through pharmaceutical giant Pfizer.

Quebec has also tasked assistant deputy health minister Jerome Gagnon and former provincial public health director Dr. Richard Masse to oversee the province’s vaccination effort.

Quebec has also tasked assistant deputy health minister Jerome Gagnon and former provincial public health director Dr. Richard Masse, pictured, to oversee the province’s vaccination effort. (Jacques Boissinot / Canadian Press)

Ontario

Premier Doug Ford is among those leaders calling on Ottawa to provide more clarity as officials scramble to develop a provincewide vaccination strategy.

Early speculation on the number of doses the province could receive was put to rest earlier this week when federal Health Minister Patty Hajdu said such details were still in the works.

But Ford has forged ahead, naming former chief of national defence, retired general Rick Hillier, to oversee the province’s vaccine rollout.

Hillier said on Friday he hopes to have a plan developed by year’s end, while Ford urged Ottawa to provide detailed information on potential vaccine delivery.

“We need a clear line of sight into the timelines of the shipments,” Ford said.

WATCH | Ontario prepares vaccine plan as daily case numbers hit record high:

Ontario reported a record-high 1,855 new cases of COVID-19 on Friday. The head of the province’s vaccine task force says he aims to be ready for vaccine distribution by the end of the year, though the vaccine may not yet have arrived. 5:04

Alberta

The province’s top medical official has said she expects to receive 680,000 doses of COVID-19 vaccine early in the new year, a figure not yet confirmed by the federal government.

Dr. Deena Hinshaw has also said a number of hurdles and unknowns remain as the province works to devise its vaccination scheme.

“These [vaccine] numbers, of course, depend on many factors,” Hinshaw said on Nov. 18.

“They depend on the final pieces of the trials that are underway going well. They depend on ensuring that the safety and the effectiveness of the early vaccines can be assured. All of those checks and balances must be cleared.”

WATCH | Hinshaw speaks about a potential vaccine:

Alberta’s chief medical officer of health says although a potential COVID-19 vaccine may be getting closer it is still “a lifetime away” and Albertans need to continue to follow health guidance. 1:50

On Friday, Hinshaw said the province is working with Ottawa to get vaccine, but it is “a bit of a moving target” on when vaccines might be available.

“But our goal is that whenever vaccine is available, we will be ready to start immunizing individuals on that highest priority list.”

British Columbia

Provincial health officials announced on Wednesday that a vaccine strategy for the province is already in the works.

Dr. Bonnie Henry, the province’s top doctor, said Dr. Ross Brown of Vancouver Coastal Health will join the group working to organize the logistics around the distribution of vaccines.

Henry said front-line workers as well as those in long-term care homes will likely have priority for vaccinations.

She cautioned that while the province has contracts with vaccine makers, there can be challenges with offshore manufacturing.

WATCH | Potential vaccine is ‘fantastic,’ Henry says:

B.C. provincial’s health officer Dr. Bonnie Henry said while she hasn’t seen the data from the Pfizer trial, it’s still good news, if the results hold. 1:40

“It’s very much focused on who is most at risk and how do we protect them best,” Henry said. “There’s a lot of discussion that needs to happen.”

Henry said the province hopes to have vaccines in hand by January.

Yukon

Premier Sandy Silver told the legislature on Wednesday that the territory has been in discussions with various levels of government on a vaccine rollout plan.

He said the goal will be to provide vaccines to elderly people and health-care providers.

Silver said rural and remote communities should also get priority status in northern regions, a fact he said he’s emphasized with federal authorities.

Yukon Premier Sandy Silver said rural and remote communities should also get priority status in northern regions, a fact he said he’s emphasized with federal authorities. (Wayne Vallevand/CBC)

The premier said he has joined the other provincial and territorial leaders in pushing for a national strategy to distribute the vaccine.

“How confusing would it be for 13 different strategies right across the nation?” he said.

Silver said the Pfizer vaccine could cause logistical problems for remote communities because of its cold-storage requirements, but those issues may not apply to other vaccines under development.

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Ontario reports record-breaking 1800 new COVID-19 cases as testing numbers rise – CTV Toronto

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TORONTO —
Ontario health officials are reporting more than 1,800 new COVID-19 cases after the province processed a record-breaking number of tests over the past 24 hours.

The province confirmed 1,855 new cases of the novel coronavirus on Friday. It’s the highest number of cases ever recorded in a single day in Ontario. The previous record high was on Saturday when officials logged 1,588 cases.

Officials said the province completed 58,037 tests over the past 24 hours, which is the highest number of tests processed since the pandemic began and the first time the province has surpassed its 50,000 capacity limit. The previous record-breaking number was on Oct. 8, when the province processed 48,488 tests in a 24-hour period.

The ministry of health said the province’s positivity rate on Friday now stands at about 3.7 per cent when including duplicate tests and errors.

Health officials also reported 20 new deaths on Friday. Seniors continue to be the age group hardest hit by the pandemic. According to the province’s epidemiology report, 13 of the 20 deaths were people living in long-term care homes.

Since the pandemic started in January, of the 3,595 people who have died in Ontario due to the disease, 2,494 were over the age of 80.

Provincial health officials deemed 1,451 more cases to be resolved as of Friday, bringing the total number of recovered patients in Ontario to 94,366.

The total number of lab-confirmed cases of COVID-19 in Ontario now stands at 111,216, including the deaths and the recoveries.

The province released updated COVID-19 projections on Thursday that showed that in the worst-case scenario, Ontario could see more than 9,000 new cases of the disease per day by the end of the year.

There are 541 people currently in Ontario hospitals due to COVID-19, with at least 151 of those patients in an intensive care unit and 101 of them breathing with the assistance of a ventilator.

The province previously stated that once the number of COVID-19 patients in the ICU reaches 150, it becomes harder to support medical needs not related to the disease. Furthermore, once 350 COVID-19 patients are in the ICU in the province, it becomes “impossible” to handle other medical needs.

Thursday’s projections also suggested that more than 200 COVID-19 patients will be admitted to Ontario intensive care units in December “under any scenario.”

Where are the COVID-19 cases in Ontario?

Ontario’s three COVID-19 hot spots continue to be the most impacted regions in the province. On Friday, Peel Region reported 517 new cases, Toronto reported 494 new cases and York Region reported 189.

Toronto and Peel Region entered the province’s lockdown phase on Monday, which forced most non-essential businesses, including gyms, malls and personal care services, to close for at least 28 days.

Several other regions in Ontario reported rising COVID-19 case numbers. Halton Region reported 130 cases, Hamilton reported 82 cases, Waterloo reported 74 cases, Durham Region reported 65 cases, Ottawa reported 55 cases, Windsor-Essex reported 52 cases and Simcoe-Muskoka reported 38 cases.

Most of the new cases of COVID-19 reported on Friday involve people under the age of 80.

There were 686 infections in people between the ages of 20 and 39, at least 564 in people between the ages of 40 and 59 and 249 in people between the ages of 60 and 79. There were 278 cases in people under the age of 19.

In total, Ontario has processed more than 6.1 million tests since the pandemic began in January. There are 54,241 COVID-19 tests still under investigation. 

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Friday's list of potential COVID-19 exposure locations – HalifaxToday.ca

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NEWS RELEASE
NOVA SCOTIA HEALTH
*************************
Nova Scotia Health Public Health is advising of potential exposure to COVID-19 at various locations across Halifax. In addition to media releases, all potential exposure notifications are now listed here: http://www.nshealth.ca/covid-exposures.
 
Anyone who worked or visited the following locations on the specified date and time to immediately visit covid-self-assessment.novascotia.ca/ to book a COVID-19 test, regardless of whether or not they have COVID-19 symptoms. People who book testing because they were at a site of potential exposure to COVID-19 are required to self-isolate before their test and while waiting for test results. You can also call 811 if you don’t have online access or if you have other symptoms that concern you.

  • Agricola Street Brasserie (2540 Agricola St, Halifax) on Nov. 16 between 2:00 p.m. and 10:00 p.m.; Nov. 17 between 2:00 p.m.-10:00 p.m.; Nov. 18 between 2:00 p.m.-10:00 p.m.; Nov. 21 between 11:30 a.m.-1:30 p.m. and between 6:00 p.m.-9:00 p.m.; Nov. 22 between 11:00 a.m.-3:00 p.m.; Nov. 23 between 6:00 p.m.-9:00 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 7.
  • *Corrected time* Orange Theory Fitness (6140 Young Street, Halifax) on Nov. 17 between 7:00 p.m. – 8:00 p.m.; Nov. 18 between 9:15 a.m. – 10:15 a.m.; Nov. 19 between 8:15 a.m.-9:15 a.m.; Nov. 20 between 8:15 a.m. – 10:45 a.m.; Nov. 21 between 7:00 a.m. – 9:15 a.m.; Nov. 22 between 8:15 a.m. – 9:15 a.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 6. 
  • Two Doors Down (1533 Barrington St, Halifax) on Nov. 20 between 5:00 p.m. and 7:00 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 4. 
  • Wendy’s Restaurant (720 Sackville Dr, Sackville) on Nov. 20 between 2:00 p.m. and 2:30 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 4. 
  • Antojos (1667 Argyle St, Halifax) on Nov. 21 between 12:00 p.m. and 4:00 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 5. 
  • Bicycle Thief (1475 Lower Water St, Halifax) on Nov. 21 between 7:15 p.m. and 9:45 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 5. 
  • Lion’s Head Tavern (3081 Robie Street, Halifax) on Nov. 22 between 12:45 p.m. and 2:30 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 6. 
  • A&W Restaurant (1748 Bedford Highway, Bedford) on Nov. 22 between 11:00 a.m. and 7:00 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 6. 
  • Fit4Less (1535 Dresden Row, Halifax) on Nov. 23 between 3:30 p.m. and 6:00 p.m.; and Nov. 25 between 6:00 p.m. and 7:30 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, Dec. 9.

Please remember:
Do not go directly to a COVID-19 assessment centre without being directed to do so.
 
Currently, anyone travelling to Nova Scotia from outside of the Atlantic Provinces is expected to self-isolate alone for 14 days after arriving. If a person travelling for non-essential reasons enters Nova Scotia from outside Atlantic Canada, then everyone in the home where they are self-isolating will have to self-isolate as well.
 
When Nova Scotia Health Public Health makes a public notification it is not in any way a reflection on the behaviour or activities of those named in the notification.
 
All Nova Scotians are advised to continue monitoring for COVID-19 symptoms and are urged to follow Public Health guidelines on how to access care. Up to date information about COVID-19 is available at novascotia.ca/coronavirus
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