Pfizer says an early peek at its vaccine data suggests the shots may be 90 per cent effective at preventing COVID-19, indicating the company is on track later this month to file an emergency use application with U.S. regulators. The vaccine is among seven that Canada has pre-ordered.
Monday’s announcement doesn’t mean a vaccine is imminent: This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries.
Pfizer Inc. did not provide any more details about those cases, and cautioned the initial protection rate might change by the time the study ends. Even revealing such early data is highly unusual.
“We’re in a position potentially to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice-president of clinical development, told The Associated Press. “We’re very encouraged.”
Authorities have stressed it’s unlikely any vaccine will arrive much before the end of the year, and limited initial supplies will be rationed.
Both U.S. President Donald Trump and president-elect Joe Biden commented on the news from Pfizer early Monday.
Biden greeted the early results with enthusiasm, but warned that widespread vaccination remains months away and Americans need to continue wearing masks and maintain physical distancing.
“Today’s news is great news, but it doesn’t change that fact,” Biden said in a statement. “Today’s announcement promises the chance to change that next year, but the tasks before us now remain the same.”
Trump hailed the development on Twitter.
STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!
Prime Minister Justin Trudeau said the announcement was “very encouraging.”
“We hope a vaccine is coming early next year. We’re seeing a light at the end of the tunnel,” he told a news conference.
Canada has a deal with Pfizer for a minimum of 20 million doses of the vaccine.
No serious safety concerns reported
The shots made by Pfizer and its German partner BioNTech are among 10 possible vaccine candidates in late-stage testing around the world — four of them so far in huge studies in the U.S. Another U.S. company, Moderna Inc., also has said it hopes to be able to file an application with the Food and Drug Administration later this month.
Volunteers in the final-stage studies, and the researchers, don’t know who received the real vaccine or a dummy shot. But a week after their second required dose, Pfizer’s study began counting the number who developed COVID-19 symptoms and were confirmed to have the coronavirus.
Because the study hasn’t ended, Gruber couldn’t say how many in each group had infections.
Pfizer did not break down exactly how many of those who fell ill received the vaccine. The 90 per cent effectiveness implies that no more than eight of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.
Pfizer doesn’t plan to stop its study until it records 164 infections among all the volunteers, a number that the FDA has agreed is enough to tell how well the vaccine is working. The agency has made clear that any vaccine must be at least 50 per cent effective.
The results have not been peer-reviewed by outside experts or published in a medical journal. The vaccine developers have not publicly shared details about how the vaccine performed according to independent monitors overseeing the study.
Pfizer said its data would be peer reviewed once it has results from the entire trial.
WATCH | Early data on vaccine effectiveness
Montreal epidemiologist cardiologist Dr. Christopher Labos said the results so far are “encouraging.”
“Now the one question, the one caveat that we’re going to have with this vaccine is how long does the immunity last?” he said.
No participant so far has become severely ill, Gruber said. He could not provide a breakdown of how many of the infections had occurred in older people, who are at highest risk from COVID-19.
Paul Hunter, a professor of medicine at the University of East Anglia, said the company’s press release suggests the vaccine’s effectiveness seven days after the second dose at preventing infection.
“If this remains the case after the final analysis and the paper passes peer review, then this is a remarkable result,” Hunter said. “The press release suggests that the 90 per cent effectiveness is at preventing infection and not just serious illness. A vaccine that prevents infection would also dramatically reduce transmission of the virus providing that immunity lasts for at least a year or more.”
U.S. vaccines must be studied in at least 30,000 people
Participants were tested only if they developed symptoms, leaving unanswered whether vaccinated people could get infected but show no symptoms and unknowingly spread the virus.
The FDA has required that U.S. vaccine candidates be studied in at least 30,000 people. In addition to adequate numbers of older adults, those studies must also include other groups at high risk, including minorities and people with chronic health problems.
And it told companies they must track half their participants for side effects for at least two months, the time period when problems typically crop up. Pfizer expects to reach that milestone later this month, but said Monday no serious safety concerns have been reported.
Because the pandemic is still raging, manufacturers hope to seek permission from governments around the world for emergency use of their vaccines while additional testing continues — allowing them to get to market faster than normal but raising concerns about how much scientists will know about the shots.
The FDA’s scientific advisers last month said they worry that allowing emergency use of a COVID-19 vaccine could damage confidence in the shots and make it harder to ever find out how well they really work. Those advisers said it’s critical these massive studies are allowed to run to completion.
Canada announced on Aug. 5 that it had preordered the Pfizer/BioNTech vaccine. It later specified that it had reserved 20 million doses, with the option to purchase more. Given that the vaccine is administered as two doses, 28 days apart, Canada would initially have enough to vaccinate 10 million people if it is approved.
Distributing the Pfizer/BioNTech vaccine could be logistically challenging. BioNTech said the genetic component of the messenger RNA vaccine would have to be shipped and centrally stored at minus 70 degrees C.
For transport to and at the site of administration it can be kept for up to five days at fridge temperatures, CEO Ugur Sahin told Reuters, adding he was confident logistics would work very well.
Have a question?
Send your questions about this and other COVID-19 vaccine candidates to COVID@cbc.ca
Why international travellers are allowed to connect to domestic flights without quarantine – CBC.ca
Jacob Frey never thought international travellers would be on his WestJet flight from Calgary to Edmonton — until he spotted several passengers wearing sombreros in the waiting area.
After boarding the Nov. 22 flight, Frey said he learned that the passenger seated next to him and three passengers in the row behind were returning from vacation resorts in Mexico.
“I was shocked,” said Frey, a laid-off sewer construction worker from Saskatoon who was flying to Edmonton to scope out job prospects.
Frey worried that sitting near passengers who had visited resorts in Mexico could increase his chances of being exposed to the virus.
“People going to an all-inclusive resort during a pandemic, that’s inherently irresponsible,” he said. “So it’s obvious that health is not their primary concern.”
When Canadian passengers take domestic flights during the COVID-19 pandemic, they may be sharing the cabin with international travellers on a connecting flight who have yet to quarantine.
Although many travellers entering Canada must quarantine for 14 days, they don’t have to start the process until reaching their final destination — as long as they have no COVID-19 symptoms.
When asked about this policy, the Public Health Agency of Canada (PHAC) told CBC News that the risk of COVID-19 transmission on a plane is relatively low compared to other enclosed settings.
Many travellers take connecting flights
Since Canada closed its borders to most non-essential travel in late March, more than 1.5 million Canadians and foreigners have entered the country by air.
Between March and September, an estimated 17 per cent of air passengers arriving in Canada took a connecting domestic flight, according to data compiled by Transport Canada.
Several countries, including Australia and New Zealand, require travellers to quarantine at their first point-of-entry before taking connecting flights.
Dr. Isaac Bogoch, an infectious diseases specialist, says that’s an extreme approach to combating the virus’ spread that may not go over well with Canadian travellers.
“I think in general, many people would not be accepting of having to stay in a quarantine hotel at that point of arrival.”
Dr. Bogoch, based at Toronto General Hospital, also said it’s unclear how beneficial a point-of-entry quarantine policy would be in Canada, considering the number of COVID-19 infections associated with international travel is small.
“It’s a drop in the bucket. So you have to ask yourself, would a policy like that significantly contribute to our pandemic response?”
Over the past eight months, the percentage of COVID-19 cases linked to international travel has ranged from 0.4 per cent in May to 2.9 per cent in July, according to PHAC. Last month it was 0.6 per cent.
Passenger tests positive
PHAC data also shows that, since March 25, more than 2,000 domestic and international flights in Canada have carried at least one passenger who, shortly afterwards, tested positive for COVID-19.
Frey learned five days after his WestJet flight that someone seated near him had tested positive.
He said he got tested and was negative, but Alberta Health Services still directed him to quarantine for 14 days.
“Basically, I’m sidelined for two weeks,” said Frey who’s self-isolating at a friend’s place in Edmonton. “It’s frustrating.”
He doesn’t know if the COVID-19-positive passenger was returning from Mexico. Even so, Frey said if he had known that international travellers would be on his flight, he would have cancelled it — unless Westjet provided assurances they’d be seated in a separate section.
“They can be the first ones on the plane, last ones off and keep them separate from everyone else,” he said.
WestJet told CBC News that it’s not necessary to separate international and domestic passengers on a plane, because the airline has implemented stringent health and hygiene policies, and Canadian health officials have found that the risk of transmission on an aircraft is low.
Canada’s chief medical officer, Dr. Teresa Tam said last month that protective measures such as mandatory mask policies, health screenings and effective ventilation systems have made planes a relatively safe place to be during the pandemic.
“The modern aircraft is actually really good in terms of air exchanges and the way airflow occurs in the cabin,” she said. “There have been very few reports — extremely rare reports, actually — of transmission aboard aircraft.”
WATCH | How airborne transmission increases the need for ventillation:
Dr. Bogosh agrees that the actual plane ride is fairly safe, but said there are other aspects of air travel that pose a danger such as boarding and exiting the aircraft, and picking up checked luggage.
“There is a risk because there’s more bottlenecks and people crowding together.”
He added that domestic passengers also pose a threat due to surging COVID-19 infections in Canada, so the best way to avoid exposure is not to travel.
“We should be staying as close to home as possible, avoiding non-essential trips.”
Why some say Canada needs to do more to protect essential workers until COVID-19 vaccine arrives – CBC.ca
As Canadians await the rollout of the first round of COVID-19 vaccines, experts say Canada needs to double down on protecting essential workers most at risk of exposure to the coronavirus in the coming months.
Canada will only have a limited supply of vaccines to start, with just 3 million expected to be vaccinated in the first few months of 2021, but the news of COVID-19 vaccines on the horizon could not come at a more critical time.
Over 400,000 Canadians have tested positive for the coronavirus since the pandemic began and the situation in our hardest-hit provinces shows no signs of slowing down.
The percentage of COVID-19 tests across the country that have come back positive during the past week has skyrocketed to 7.4 per cent — up from 1.4 per cent in mid-September and 4.7 per cent in early November. A rising positivity rate can signal that cases are being missed and more people could unwittingly be spreading the virus.
“There’s a light at the end of the tunnel, but we still have to get through the tunnel to get there,” said Dr. Sumon Chakrabarti, an infectious disease specialist at Trillium Health Partners in Mississauga, Ont.
“You also don’t want to be in a situation where you have a raging fire that’s going on and when you’re trying to roll out a vaccine, you’re doing it in a setting where the hospital is overwhelmed and health-care workers are getting sick.”
Alberta positivity rate tops 10 per cent
Of all the COVID hotspots, Alberta has the biggest fire to put out at the moment, and this week asked the federal government and the Red Cross to supply field hospitals to help offset the strain COVID-19 is having on the health-care system.
There, the percentage of COVID-19 tests coming back positive hit an astonishing 10.5 per cent on Friday.
COVID-19 cases in Alberta are growing at such an explosive rate they’ve even outpaced Ontario, a province with 10 million more people, for the first time in the pandemic — with cases in Edmonton alone totalling more than those in Toronto and Peel Region combined.
“If you think this is a hoax, talk to my friend in the ICU, fighting for his life,” Alberta Premier Jason Kenney said during a Facebook livestream Thursday.
“If you’re thinking of going to an anti-mask rally this weekend, how about instead send me an email, call me all the names you want, send me a letter, organize an online rally.”
Yet while much of the focus on public health messaging throughout the pandemic has been focused on individual actions, experts say Canada isn’t doing enough to protect those most in need of support in the coming months.
Ontario, Quebec see surge in workplace outbreaks
While elderly Canadians are most at risk for severe outcomes from COVID-19, totalling close to 90 per cent of all deaths, essential workers on the front lines are facing a worsening situation.
For the first time in the pandemic, active outbreaks in workplaces in Canada’s biggest provinces have outpaced those in long-term care facilities — accounting for 30 per cent of the outbreaks in Ontario and 40 per cent in Quebec, as first reported by The Globe and Mail.
While limited information is available on exactly where the spread of COVID-19 is occurring, Ontario’s ministry of health said in a statement to CBC News the hardest-hit industries include construction, manufacturing, mining, warehousing and transportation.
WATCH | Essential workers talk about being on the front lines of the COVID-19 pandemic
Because of the disproportionate risk of exposure they face, the union for workers in food retail, manufacturing, long-term care, home care and security said Friday that frontline workers should also be among the first recipients of COVID-19 vaccines.
“Workplaces are a big deal,” said Dr. Zain Chagla, an infectious diseases physician at St. Joseph’s Healthcare Hamilton and an associate professor at McMaster University.
“There are people that need to go to work, unfortunately, for us to support society, and again we have to be willing and able to give them at least some measures of safety in their workplace.”
Paid sick leave key to stopping spread of COVID-19
Chakrabarti says one area that could help address rising transmission rates in workplaces is more paid sick leave for those who are unable to miss work due to COVID-19.
Unlike policing people’s contacts in their own homes, it’s a problem policy could tackle, he said.
“Workplaces are things that are really important because you can only do so much to keep things safe.”
If people are going to decide between putting food on their table … or going into isolation … they’re going to show up to work sick.– Dr. Zain Chagla
Chakrabarti says mask wearing and physical distancing aren’t always possible in certain situations in workplaces, especially those that involve workers in close quarters indoors — as evidenced by outbreaks in meatpacking plants, warehouses, and mines.
“Many people are financially unstable and they’re scared because if they do have to go off work, they’ll end up losing income,” he said. Undocumented workers may also be hesitant to speak up about symptoms for fear of being deported.
“So you have a lot of these kinds of factors that I think are barriers for people getting tested.”
Chagla says more targeted education, oversight and internal audits to control COVID-19 transmission are needed in high-risk workplaces, in order to ensure compliance and accountability.
“There’s certainly tons of essential workplaces that will continue to have issues unless people actually intervene and do this type of stuff,” he said.
Last month, the federal government created Canada Recovery Sickness Benefit to give up to $1,000 of support to workers with COVID-19 over two weeks, but Chagla said more could be done.
“You have to incentivize people to get tested,” Chagla said. “If people are going to decide between putting food on their table and paying their rent, going to work or going into isolation … they’re going to show up to work sick.”
Isolating, outreach better than ‘finger wagging’
Chakrabarti says another way to protect essential workers is through the creation of more dedicated isolation facilities for those recovering from COVID-19.
“One big place that amplification is happening is in large families,” he said. “So if you have a place for people to have their meals covered and they can isolate away from their family, that’s going to really help to reduce amplification of the cases that we’re seeing in workplaces.”
Chakrabarti says the “condescension and finger wagging” in public health messaging across the country against individual actions isn’t always effective — especially nine months into the pandemic.
“Community outreach often helps,” said Chakrabati, who is also a member of a recently formed South Asian task force to connect with and inform people in Peel Region.
“I think that a lot of the focus right now is on people. ‘Hey, you stay home, stay home, stop partying,’ that kind of stuff. Whereas we don’t hear a lot of what’s happening in these workplaces.”
“This is going to be a problem throughout the entire pandemic,” said Chagla. “Because they have to stay open.”
How the COVID-19 vaccines are being approved in Canada – CBC.ca
The approval of a COVID-19 vaccine in Canada could potentially be days away with the initial supply to be limited to about three million Canadians, in the first three months of 2021. But what approval processes have the vaccines gone through? CBC explains:
Is the approval process for the COVID-19 vaccine different than for other vaccines?
Due to the immediate need for the COVID-19 vaccine, some flexibility has been introduced to the approval process. Typically, a vaccine manufacturer will do all their clinical trials, gather all their data, prepare a submission package and put that forward for approval, said John Greiss, a Toronto-based intellectual property lawyer with Norton Rose Fulbright, who advises companies in the life sciences sector that are regulated by Health Canada.
“Health Canada will comment on it or ask for additional information and it will go back and forth until they come to a decision, he said.
But with COVID-19, Health Canada has accepted what’s known as a “rolling submission.”
“The new process allows for a company to start an application process, submit the information that they have available, as of that date and add new data and new information as it becomes available, Greiss said
Supriya Sharma, chief medical adviser to Health Canada, said this enables the organization to start reviewing the potential vaccine and will shorten the overall review process “while still maintaining those same standards for the safety and the efficacy.”
What’s included in the submission?
That really hasn’t changed, Greiss said. Vaccine manufacturers have to submit all of the scientific data that they have, which includes any kind of lab data that demonstrates how the vaccine works, any kind of clinical trial data that they have obtained, along with Phase 1 to Phase 3 clinical trial data.
WATCH | Vaccines are coming soon
They also have to submit information about the manufacturing process and standards and procedures that demonstrate they’re meeting good manufacturing processes in their facilities, Greiss said.
How is the vaccine reviewed?
One vaccine submission is hundreds of thousands of pages long and can take, on average around 2,000 person hours to review, Sharma said. For COVID-19, Health Canada is employing specialized teams of seven to 12 people who have experience in areas like toxicology, infectious diseases, clinical medicine, microbiology and epidemiology to review the vaccine.
“Each vaccine submission has its own team that’s dedicated to it. And they will go through all of that information,” she said.
Reviewers must confirm there are no significant safety concerns, determine that the vaccine is able to prompt an adequate immune response in vaccinated people and show that it can protect against disease, she said.
“We go through all of that to see if it actually meets our standards for safety, efficacy, quality,” Sharma said.
“We need to make sure that the benefits of the vaccine outweigh the potential risks and that we know that it’s being made in at a licensed place that’s up to standards and up to code.”
Greiss said that during the review process, Health Canada officials might, for example, ask for further clarification about the clinical trial procedure, or how patients were recruited.
“Or if they see anomalies in the data, they’ll ask the company to justify or clarify that information,” he said. “So there is still that back and forth in terms of Health Canada sort of digesting and analyzing the data and the company having to provide answers for that before they get an approval.”
Are the vaccine manufacturing facilities inspected?
For manufacturing facilities around the world, not just for vaccines, but for medications as well, Health Canada has entered into mutual recognition agreements with other regulators, Sharma said.
“We actually have sent our inspectors over to their country,” she said. “They’ve sent inspectors over to our country. We make sure that our standards are the same, our processes are the same.”
Every facility that manufactures vaccines needs to have an inspection before it’s licensed. And there are ongoing inspections to make sure standards are maintained, she said.
What are they looking for in these facilities?
They’re looking at key factors, known as the four Ps, Sharma said.
- Product: What’s being made there.
- Premises: There are very detailed specifications on the facilities themselves. For example, special flooring and ventilation systems have to be in place.
- Process: All the processes that go into manufacturing the product.
- People: The qualifications and training of the people that work there.
All of those things are really important in terms of making sure that standards are met, she said.
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Why international travellers are allowed to connect to domestic flights without quarantine – CBC.ca
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