Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until after a long, hard winter.
The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study.
The vaccine is among seven that Canada has pre-ordered.
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the U.S. Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, the company has already started “rolling” applications in Europe, the U.K. and Canada, and intends to submit similar information soon.
With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.
“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert, said on the eve of Pfizer’s announcement, noting that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”
Friday’s filing sets off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.
How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart.
Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.
‘We’ll drill down on these data’
The public’s first chance to see how strong Pfizer’s evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.
So far, what’s known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cite results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.
“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.
A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.
They’ll recommend not just whether the FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?
There’s still no guarantee.
“We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.
Nova Scotia reports 14 new cases of COVID-19 Saturday – HalifaxToday.ca
As of today, Nov. 28, Nova Scotia has 125 active cases of COVID-19. Fourteen new cases are being reported today.
Twelve cases are in Central Zone, one is in Western Zone and one in Northern Zone.
“Black Friday weekend usually draws crowds from across the province to the Halifax area to shop, but that must change this year,” said Premier Stephen McNeil. “I want to remind all Nova Scotians that we are asking you to avoid non-essential travel in and out of western and central HRM and parts of Hants County. If you are doing some shopping this weekend, it’s best to stay close to home and buy local. You’ll be supporting the businesspeople in your community and doing your part to slow the spread of COVID-19.”
Nova Scotia Health Authority’s labs completed 3,644 Nova Scotia tests on Nov. 27.
There were 670 tests administered at the rapid-testing pop-up site in Dartmouth yesterday and three positive results. The individuals were directed to self-isolate and have been referred for a standard test.
Since Oct. 1, Nova Scotia has had 42,989 negative test results, 190 positive COVID-19 cases and no deaths. No one is currently in hospital. Cases range in age from under 10 to over 70. Sixty-five cases are now resolved. Cumulative cases may change as data is updated in Panorama.
“A few days ago, we introduced new restrictions in Halifax and Hants County. I know it’s not easy, but it will allow us to slow the spread of COVID-19,” said Dr. Robert Strang, Nova Scotia’s chief medical officer of health. “The retail sector and restaurant and bar owners have all stepped up and adapted to ensure they continue to follow all public health measures. Now it is up to Nova Scotians to ensure they are doing their part to limit the spread of COVID-19.”
Visit https://covid-self-assessment.novascotia.ca/ to do a self-assessment if in the past 48 hours you have had or you are currently experiencing:
— fever (i.e. chills/sweats) or cough (new or worsening)
Two or more of the following symptoms (new or worsening):
— sore throat
— runny nose/ nasal congestion
— shortness of breath
Call 811 if you cannot access the online self-assessment or wish to speak with a nurse about your symptoms.
When a new case of COVID-19 is confirmed, public health works to identify and test people who may have come in close contact with that person. Those individuals who have been confirmed are being directed to self-isolate at home, away from the public, for 14 days.
Anyone who has travelled outside of Atlantic Canada must self-isolate for 14 days. As always, any Nova Scotian who develops symptoms of acute respiratory illness should limit their contact with others until they feel better.
It remains important for Nova Scotians to strictly adhere to the public health order and directives — practise good hand washing and other hygiene steps, maintain a physical distance when and where required. Wearing a non-medical mask is mandatory in most indoor public places.
Rules concerning interprovincial travel within Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland and Labrador have changed. The premiers of all four Atlantic provinces are cautioning against non-essential travel into neighbouring provinces. Currently, all non-essential travel into Prince Edward Island, New Brunswick and Newfoundland and Labrador requires a 14-day self-isolation. All public health directives of each province must be followed. Under Nova Scotia’s Health Protection Act order, visitors from outside Atlantic Canada must self-isolate for 14 days unless they completed their self-isolation in another Atlantic province.
Nova Scotians can find accurate, up-to-date information, handwashing posters and fact sheets at https://novascotia.ca/coronavirus. Due to technical difficulties, the website will not be updated today.
Businesses and other organizations can find information to help them safely reopen at https://novascotia.ca/reopening-nova-scotia.
— testing numbers are updated daily at https://novascotia.ca/coronavirus
— a state of emergency was declared under the Emergency Management Act on March 22 and extended to Dec. 13
— online booking for COVID-19 testing appointments is available for Nova Scotians getting a test at all primary assessment centres or at the IWK Health Centre in Halifax
— ongoing voluntary testing has been introduced to monitor, reduce and prevent the spread of COVID-19 in long-term care. Volunteers, designated caregivers and employees who provide direct care to residents will be tested every two weeks. The ongoing testing will start at three long-term care locations: Northwood, Ocean View and St. Vincent’s and will expand to six more facilities over the next two weeks
Government of Canada: https://canada.ca/coronavirus
Government of Canada information line 1-833-784-4397 (toll-free)
The Mental Health Provincial Crisis Line is available 24/7 to anyone experiencing a mental health or addictions crisis, or someone concerned about them, by calling 1-888-429-8167 (toll-free)
Kids Help Phone is available 24/7 by calling 1-800-668-6868 (toll-free)
For help or information about domestic violence 24/7, call 1-855-225-0220 (toll-free)
For more information about COVID-19 testing and online booking, visit https://novascotia.ca/coronavirus/symptoms-and-testing/
The COVID-19 self-assessment is at https://covid-self-assessment.novascotia.ca/
What happens if someone refuses vaccination? Ethicists urge clarity on COVID-19 rollout – CTV News
When the first doses of COVID-19 vaccines finally arrive in Canada, the country will need to grapple with a series of difficult questions that ethicists fear we haven’t spent enough time answering.
For example, which groups should get vaccinated after those most vulnerable? How long will it take for everyone to get their shot? And what happens if a person refuses to get vaccinated?
The clock is ticking to address those questions. Pfizer’s vaccine candidate, which is more than 90-per-cent effective according to the company’s preliminary results, could be approved for use in Canada before Christmas, according to Health Canada’s chief medical adviser.
Kerry Bowman, a bioethicist and assistant professor at the University of Toronto’s faculty of medicine, said the lack of clarity on a number of key issues involving Canada’s rollout is “beginning to make people very anxious.”
“Because we don’t really have a clear plan yet. Or if we do, it’s not available and transparent to the majority of Canadians,” Bowman told CTV News.
WHO GETS VACCINATED FIRST?
Federal health authorities have not released a comprehensive list of what order the vaccine will be delivered. For now, four key groups have been given priority to receive the vaccine, according to recommendations from the National Advisory Committee on Immunization.
Those groups include those at risk of severe illness and death (such as the elderly or those with pre-existing conditions), essential workers most likely to transmit the disease (such as health-care workers), those at risk who live in communities that could suffer disproportionate consequences (such as isolated Indigenous communities), and other workers providing services that contribute to “the functioning of society.”
The committee purposefully left those definitions broad so that policy-makers tasked with plotting provincial roll-outs could define them as they see fit.
But after those groups, who comes next?
Research suggests racialized Canadians are at higher risk than white Canadians of having pre-existing conditions that could put them at risk of severe outcomes from COVID-19.
Employers whose businesses have been sidelined due to COVID-19 will also be among those most keen to get vaccinated. A recent Statistics Canada survey suggested that five per cent of businesses were actively considering bankruptcy or closure this fall. Anxieties are running highest among the arts, entertainment and hospitality industries, with nearly 30 per cent worried they’ll need to resort to layoffs, bankruptcy or closure within six months.
Whatever happens, there will inevitably be a period of time in 2021 when the limited supply of vaccines will create a society of haves and have-nots. Those months will be challenging, says Alison Thompson, an ethicist with the University of Toronto.
“This is very concerning because then we have a society that is really a two-tiered society that is based on some kind of biological grounds,” she said.
CAN YOU REFUSE THE VACCINE?
It’s impossible for anyone to be forced to take the COVID-19 vaccine once it’s available. But there could be real-life consequences to refusal.
“People that don’t want the vaccine, we all know, have an absolute right not to have it. I mean, it is their bodies without question,” Bowman said. “But that is an ethical concern because what will likely happen to people within that group is more and more opportunities may slowly be shut off to them.”
For instance, individuals who aren’t vaccinated may miss out on returning to the workplace or could face other restrictions involving group gatherings.
To make matters trickier, the vaccine will not be immediately available for certain groups. Pregnant women and children, who are not involved in clinical trials of the experimental vaccines, will be excluded from vaccination until more clinical trial data is available.
This exemption may be inconvenient, but it’s standard in these sorts of trials for safety reasons, Thompson said.
“Pregnant women are often excluded from clinical trials on many pharmaceutical products, including vaccines, because of the risk to the fetus that she carries and her own health,” she said.
The idea of “immunity passports” was floated early on in the pandemic as some governments expressed optimism that individuals who’d recovered from COVID-19 and tested positive for virus-fighting antibodies could be given greater freedoms to travel or return to work.
However, the World Health Organization dismissed the idea, saying there wasn’t enough evidence yet on the effectiveness or longevity of immunity through antibodies.
Vaccines may give new attention to the notion of “immunity passports” — a possibility that Thompson said needs to be handled thoughtfully.
“I think we need to think very carefully about how we use people’s immune status to grant them access to employment and travel and things like that,” she said.
WHAT HAPPENS IF SOMEONE SUFFERS SIDE EFFECTS?
All vaccines currently being study are tested for both their effectiveness and safety. Before reaching the general public, Health Canada needs to approve that the vaccine is safe enough for public use. Even so, there’s a chance that some individuals could suffer long-term side effects from a COVID-19 vaccine, Bowman said. It’s simply too early to know for certain.
“I have never heard of a vaccine that is 100-per-cent bulletproof safe, and I have no belief that this will be any different.”
However, he added: “It all sounds very good so far.”
In the event that someone suffers negative side effects of the vaccine, some advocates believe they should be financially compensated. At least 19 countries already have programs in place that compensate individuals injured by vaccines, but Canada does not, except for Quebec.
Thompson said it’s time for Canada to consider its own national compensation program.
“There are things we can be doing from the government side, to really help people view (vaccines) as more trustworthy,” she said, pointing to such a program.
CAN YOU CHOOSE WHICH VACCINE YOU WANT?
With several vaccine candidates in the race to be approved first, with Pfizer and Moderna leading the pack, it’s possible that Canada could have several different vaccines on the market in 2021. However, experts told CTVNews.ca last week that there is no health benefit to receiving more than one type of vaccine. As for personal choice, it’s unlikely that Canadians will have the option to choose which vaccine they want.
“I suspect that choice will not be an issue as the vaccines arrive in Canada. There will be a strategy to roll out vaccination, prioritizing the most vulnerable and front-line workers,” said Dr. Eleanor Fish, an immunology professor at the University of Toronto.
In the face of so many looming questions, Bowman said it’s important to “get this right.”
“So much of vaccine distribution is tied to ethics now,” he said. “It’s going to be a challenge.”
Latest COVID update Nov. 28: 1 death, 197 new cases – CKOM News Talk Sports
One more Saskatchewan resident who tested positive for COVID-19 has died.
In a media release Saturday, the provincial government said a person from the northwest zone in the 80-and-over age group had died.
Twelve people who had tested positive for COVID have died in the province in the past six days. There have been 45 deaths linked to the virus in Saskatchewan since March.
The government also announced 197 new cases in the province, increasing the total to date to 7,888. The seven-day average of new cases is 234, or 19.3 per 100,000.
There are now 3,322 cases considered active in the province. On Oct. 29 there were 707 active cases, representing a 370 per cent jump in active cases in the last 30 days.
The cases reported Saturday were in the Saskatoon (56), Regina (73), northwest (five), north-central (17), southwest (16), southeast (two), central-east (five), far northwest (six), central-west (one), far northeast (four), northeast (five) and south-central (five) areas.
The hometowns of two cases are still being investigated.
A total of 137 recoveries were reported Saturday, bringing that total to date to 4,521.
There are 18 people in intensive care units across the province. One patient in north-central, 11 in Saskatoon, one in the southwest and five in Regina.
Eighty-eight people are receiving inpatient care at hospitals across the province. One in the far northwest, nine in the northwest, seven in north-central, one in the northeast, 30 in Saskatoon, one in central-east, 18 in Regina, one in the southwest, one in south-central and 19 in the southeast zone.
The province is reminding people that community transmission can happen quickly with the potential to impact multiple settings.
There was a recent outbreak on a teenage hockey team which resulted in nine players and a coach testing positive. The province said there are multiple teams currently isolating as a result.
An outbreak was also reported from a curling bonspiel which resulted in positive cases on teams from multiple cities and towns across the province.
Positive cases from people attending a recent funeral have led to the potential exposure of more than 200 people, according to the province.
Sporting events and community transmission have also impacted a hospital. Seventeen nurses at the unidentified hospital were required to isolate after being identified as close contacts to positive cases linked to those events.
The effort needed to investigate and contact trace as a result of these events causes delayed notification of possible exposure resulting in more cases.
With “significant outbreaks” happening at large gatherings and sporting events, people are urged to follow public health orders in place. They are enforceable.
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