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What does emergency use of a COVID-19 vaccine mean? – St. Albert Today

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What does emergency use of a COVID-19 vaccine mean?

It’s when regulators allow shots to be given to certain people while studies of safety and effectiveness are ongoing.

Before any vaccine is permitted in the U.S., it must be reviewed by the Food and Drug Administration, which requires study in thousands of people. Normally, the process to approve a new vaccine can take about a decade. But the federal government is using various methods to dramatically speed up the process for COVID-19 vaccines.

During a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products. The first vaccines to get the provisional green light in the U.S. are almost certain to be made available under this process, known as emergency use authorization.

Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks. It has already used its emergency powers to authorize hundreds of coronavirus tests and a handful of treatments during the pandemic.

But the agency has almost no experience granting emergency use for vaccines and has laid out extra standards it will use to make decisions on upcoming COVID-19 shots.

In October, FDA officials told vaccine makers they should have two months of safety follow-up from half of the people enrolled in their studies before requesting emergency authorization. That data is expected to be enough for FDA to allow vaccinations of certain high-risk groups, such as front-line health workers and nursing home residents.

Full approval of a vaccine will likely require six months of safety follow-up as well as extensive inspections of company manufacturing sites. The leading vaccine makers are not expected to complete that process until next spring or summer. Only then is the FDA expected to grant full approval, which would allow vaccinations of the general population.

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The AP is answering your questions about the coronavirus in this series. Submit them at: [email protected]

Who will be the first to get COVID-19 vaccines?

What does COVID-19 vaccine effectiveness mean?

How can I volunteer for a COVID-19 vaccine study?

The Associated Press

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Ottawa Public Health removes two deaths from pandemic death toll; 1 new death, 46 new cases reported – CTV Edmonton

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OTTAWA —
Ottawa Public Health is reporting a decline in the number of COVID-19 deaths in the capital after an investigation showed a link to COVID-19 could not be proven in two cases.

In a statement on its COVID-19 dashboard, OPH said, “Following case investigation, two deaths could not be confirmed to be related to COVID-19. As such, these deaths were removed from the dashboard.

However, OPH notes that since Friday’s update, an additional person has died.

“Since the previous refresh, however, one additional person with confirmed COVID-19 has passed away,” OPH said. “Thus, the total change in deaths since the previous refresh is -1.”

The city’s death toll from COVID-19 now stands at 372 residents.

OPH reported 46 new people with COVID-19 in Ottawa on Saturday, bringing the city’s pandemic total to 8,379 cases. 

In the past seven days, Nov. 22 to 28 inclusive, OPH has reported an average of 34.3 new cases of COVID-19 per day. In the previous seven days, Nov. 15 to 21 inclusive, OPH reported an average of 42.1 new cases of COVID-19 per day.

Across Ontario, more than 1,800 new cases of COVID-19 were reported for a second straight day, Health Minister Christine Elliott said, with 1,822 new cases.

On Friday, a record-breaking 1,855 infections were logged across the province.

A majority of the new cases reported on Saturday were from the locked down regions of Toronto and Peel.

Twenty-nine new COVID-19 deaths have also been reported across Ontario.

HOSPITALIZATIONS IN OTTAWA

The number of people in Ottawa hospitals with COVID-19 complications fell slightly on Saturday to 20, from 21 on Friday.

There are three people in the intenstive care unit.

Of the people in hospital, three are in their 60s (two in the ICU), six are in their 70s, seven are in their 80s (one in the ICU), and four are 90 or older.

ACTIVE CASES OF COVID-19 IN OTTAWA

The number of people with active cases of COVID-19 in the city climbed back above 300 on Saturday after three days below that figure.

OPH reports 309 active cases in Ottawa in its latest update, 16 more than what was reported on Friday.

Thirty-one additional recoveries have been added to the dashboard, bringing the city’s number of resolved cases to 7,698. 

The number of active cases of COVID-19 is the number of total laboratory-confirmed cases minus the numbers of resolved cases and deaths. A case is considered resolved 14 days after known symptom onset or positive test result.

CASES OF COVID-19 IN OTTAWA BY AGE CATEGORY 

Here is a breakdown of all known COVID-19 cases in Ottawa by age category:

  • 0-9 years old: Five new cases (565 cases total)
  • 10-19 years-old: 11 new cases (967 cases total)
  • 20-29 years-old: Five new cases (1,711 cases total)
  • 30-39 years-old: Five new cases (1,120 cases total)
  • 40-49 years-old: Five new cases (1,060 cases total)
  • 50-59 years-old: Seven new cases (981 cases total)
  • 60-69-years-old: Three new cases (652 cases total)
  • 70-79 years-old: Two new cases (430 cases total)
  • 80-89 years-old: Two new cases (527 cases total)
  • 90+ years old: Zero new cases (365 cases total)

The age of one person who has tested positive for COVID-19 is presently unknown.

CASES OF COVID-19 AROUND THE REGION

The number of new COVID-19 cases in the Eastern Ontario Health Unit’s (EOHU) region climbed into the double digits on Saturday, according to provincial figures.

The province reports 13 more people in the EOHU have tested positive for COVID-19.

In the Hastings Prince Edward Public Health region, which is moving to the “Yellow-Protect” zone under the provincial framework, reported three new cases.

There are five new cases in Kingston, Frontenac, Lennox & Addington Public Health’s region.

The Renfrew County and District Health Unit has added one new case.

No new cases were reported in the Leeds, Grenville & Lanark District Health Unit on Saturday.

The Quebec government reported 33 new cases of COVID-19 in the Outaouais region, which includes Gatineau. An 80th death from the virus was also reported in the region.

INSTITUTIONAL OUTBREAKS

Ottawa Public Health is reporting COVID-19 outbreaks at 27 institutions in Ottawa, including long-term care homes, retirement homes, daycares, hospitals and schools.

New outbreaks were declared at Gabrielle Roy French public school, an Association Intégration Sociale d’Ottawa (AISO) location, the Garden Terrace long-term care home and the Ravines retirement home.

Outbreaks have ended at the Esther By Child Care Centre, St. Bernard School, St. Stephen Elementary School, an unspecified residential program and the Montfort Long-term Care Centre.

There are two open community outbreaks involving unspecified social events.

The schools and childcare spaces currently experiencing outbreaks are:

  1. Cedarview Middle School
  2. École élémentaire catholique Terre-Des-Jeunes
  3. École élémentaire publique Gabrielle Roy (NEW)
  4. Manordale Public School
  5. Ottawa Technical Secondary School

The long-term care homes, retirement homes, hospitals, and other spaces currently experiencing outbreaks are:

  1. Alta Vista Manor
  2. Amica Westboro Park
  3. Association Intégration Sociale d’Ottawa – 21034 (NEW)
  4. Beacon Heights retirement home
  5. Bearbrook Retirement Residence
  6. Bridlewood Trails Retirement Home
  7. Carlingview Manor
  8. Courtyards on Eagleson
  9. Extendicare Medex
  10. Extendicare New Orchard Lodge
  11. Extendicare Starwood
  12. Forest Hill long-term care home
  13. Garden Terrace long-term care home (NEW)
  14. Park Place
  15. Peter D. Clark long-term care home 
  16. Shelter – 20868
  17. St. Patrick’s Home
  18. Stirling Park Retirement Home
  19. The Glebe Centre
  20. The Ravines retirement home (NEW)
  21. The Ottawa Hospital Rehab Centre – Special Rehab – Ward B
  22. Waterford Retirement

A single laboratory-confirmed case of COVID-19 in a resident or staff member of a long-term care home, retirement home or shelter triggers an outbreak response, according to Ottawa Public Health. In childcare settings, a single confirmed, symptomatic case in a staff member, home daycare provider, or child triggers an outbreak.

Under provincial guidelines, a COVID-19 outbreak in a school is defined as two or more lab-confirmed COVID-19 cases in students and/or staff in a school with an epidemiological link, within a 14-day period, where at least one case could have reasonably acquired their infection in the school (including transportation and before or after school care).   

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All sheriffs at Surrey courthouse tested for COVID-19 after 20 days of possible exposure – CTV News Vancouver

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VANCOUVER —
Fraser Health has implemented ‘widespread’ testing of Surrey Courthouse staff, including all sheriffs, after people connected to the worksite tested positive for COVID-19, according to the B.C. Ministry of the Attorney General.

The ministry also reports that exposures to COVID-19 at the courthouse took place over a period of twenty days, but says the health authority has found no evidence transmission is happening at the worksite.

Details of the testing and response comes from a news statement released late Friday night by the Ministry of the Attorney General, after the courthouse staff’s union confirmed eight cases of COVID-19 among people connected to the court. The union also said an additional 25 people are self-isolating due to exposure, twenty-three of whom are sheriffs.

“On Nov. 26, 2020, Fraser Health provided widespread testing at the Surrey Courthouse, including all sheriffs,” reads the statement from the Attorney General’s office.

Despite the numerous cases, Fraser Health has not declared the site an “outbreak.”

“We understand that this has been a stressful situation for the staff,” continues the statement.

“Recently, Fraser Health notified Court Services Branch staff at the Surrey Courthouse that they may have been exposed to COVID-19 from Nov. 5, 2020 to Nov. 25, 2020.”

The ministry says that all close contacts have been directly notified and told to self-isolate and that “self-monitoring letters have been issued to all staff in the BC Sheriff Service department at the Surrey Courthouse.”

The Fraser Health region has been the hardest hit by COVID-19 infections, and despite 8 cases among staff and 20 days of possible COVID-19 exposure at the courhouse, the ministry says the health authority reports that there are no indications that transmission is happening at the courthouse.

“COVID-19 cases are occurring in the broader community. According to Fraser Health, there is no evidence that there is transmission occurring at the work site.”

The court is continuing to operate and has many COVID-19 precautions in place.

This is a developing story and will be updated as more information becomes available.

Correction:

Nov. 28, 2020: This story has been updated from a previous version that incorrectly identified the Fraser Health Authority of releasing the referenced statement. It has been updated to reflect the correct author of the statement, which is the B.C. Ministry of the Attorney General.

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Deaths due to coronavirus in Quebec surpass 7,000 | CTV News – CTV News Montreal

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MONTREAL —
Quebec had a double dose of bad news in its battle against the COVID-19 pandemic Saturday.

The province broke its record for the number of new cases in a 24-hour period when officials reported 1,480 new cases. The prior record was set Thursday when 1,464 new cases were reported.

The total number of deaths due to the disease reached a grim milestone as well, as they surpassed 7,000 to start the weekend.

The province reported 37 new deaths bringing the total number of people who have died due to the novel coronavirus to 7,021.

Quebec reported that 10 of those deaths occurred in the past 24 hours, 23 were reported between Nov. 21 and Nov. 26, two occurred before Nov. 21 and two occurred at an unknown date.

The total number of positive COVID-19 cases in the province since the start of the pandemic is now 139,643.

The Quebec Institute of Public health reports that there are now 11,716 active cases, and that 1,179 more people have recovered from the disease, bringing that total to 120,906.

The number of hospitalizations increased by nine Saturday, and there are now 678 people being treated in the province’s hospitals for COVID-19. Of those, 93 are in the intensive care ward, an increase of three.

Health-care professionals analyzed 29,652 samples on Nov. 26. (Quebec releases its testing data from two days prior to its daily updates).

REGIONAL DATA

The Island of Montreal also set a grim milestone Saturday, surpassing 50,000 positive cases.

Montreal reported 429 new cases, and 50,319 people have now tested positive for the novel coronavirus on the island since the start of the pandemic. 

Other regions with triple-digit increases in cases were Monteregie with 215 new (19,800 total), Quebec City with 128 new cases (11,449 total), Lanaudiere with 120 new cases (11,077 total), Saguenay-Lac-Saint-Jean with 117 new cases (4,988 total), and Mauricie-et-Centre-du-Quebec with 107 new cases (6,825 total).

Montreal also reported the highest increase in deaths due to the disease Saturday.

Eight deaths were reported in Montreal (3,618 total); seven in Quebec City (433 total); six in Saguenay-Lac-Saint-Jean (122 total); four in Monteregie (856 total); three in Mauricie-et-Centre-du-Quebec (266 total), and Lanaudiere (324 total); two in the Eastern Townships (62 total), and the Laurentians (336 total); and one death was reported in Bas-Saint-Laurent (18 total), and Outaouais (80 total).

ACROSS CANADA

As of noon EST on Saturday, there are 362,362 confirmed COVID-19 cases across Canada. 

The following is a regional breakdown of cases and deaths:

  • Quebec: 139,643 confirmed (including 7,021 deaths, 120,906 resolved)
  • Ontario: 113,038 confirmed (including 3,624 deaths, 95,876 resolved)
  • Alberta: 53,105 confirmed (including 519 deaths, 38,369 resolved)
  • British Columbia: 30,884 confirmed (including 395 deaths, 21,304 resolved)
  • Manitoba: 15,632 confirmed (including 280 deaths, 6,487 resolved)
  • Saskatchewan: 7,691 confirmed (including 44 deaths, 4,384 resolved)
  • Nova Scotia: 1,257 confirmed (including 65 deaths, 1,078 resolved)
  • New Brunswick: 481 confirmed (including 7 deaths, 363 resolved)
  • Newfoundland and Labrador: 331 confirmed (including 4 deaths, 296 resolved)
  • Nunavut: 159 confirmed (including 8 resolved)
  • Prince Edward Island: 70 confirmed (including 68 resolved)
  • Yukon: 42 confirmed (including 1 death, 29 resolved)
  • Northwest Territories: 15 confirmed (including 15 resolved)
  • Repatriated Canadians: 13 confirmed (including 13 resolved)

Total: 362,361 (0 presumptive, 362,361 confirmed including 11,960 deaths, 289,196 resolved)

— with files from The Canadian Press.   

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