Pfizer released an early snapshot of its Phase 3 trials for its coronavirus vaccine on Monday, and said the results look promising with data suggesting it’s 90 per cent effective at preventing the virus.
The company and its collaborator BioNTech may now be on track to file an emergency use application with U.S. regulators in late November, as previously stated.
However, the announcement does not mean a vaccine is fast approaching, experts warn.
“We aren’t doing terribly well in the fight against COVID-19. The numbers just keep rising in Canada and around the world,” said Kerry Bowman, a professor of bioethics and global health at the University of Toronto.
“This is wonderful news to hear. … Psychologically we needed some good news. However, we have to be quite cautious, as the data is not complete and there are still some lingering questions.”
This is because Pfizer provided only a glimpse of the data and cautioned the initial protection rate might change by the time the study ends.
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What does the Phase 3 COVID-19 data say?
Monday’s interim analysis, from an independent data monitoring board, looked at 94 confirmed cases of COVID-19 among the volunteers who had either received two doses of the vaccine or a placebo.
The Phase 3 clinical trial of the vaccine, called “BNT162b2” began on July 27 and has enrolled 43,538 participants — 38,955 of whom have received a second dose of the vaccine candidate as of Nov. 8.
“Approximately 42 per cent of global participants and 30 per cent of U.S. participants have racially and ethnically diverse backgrounds,” Pfizer said in its release.
According to the findings, the trial found that fewer than 10 per cent of infections were in participants who had been given the vaccine, a strong signal of efficacy. More than 90 per cent of the cases were in people who had been given a placebo.
Pfizer said that the vaccine provided protection seven days after the second dose and 28 days after the initial dose of the vaccine.
The company also said that — so far — no participant has become severely ill.
What wasn’t revealed?
“There are still some questions hanging in the air,” Bowman said. “How long does the vaccine work for? We don’t know that, but let’s hope it’s at least one year.”
Bowman said there is also a chance that participants in the trial may have contracted the virus but aren’t showing symptoms.
According to Pfizer, 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.
Coronavirus: Vaccine Hesitancy
Infection control epidemiologist Colin Furness, an assistant professor at the University of Toronto, said there is still a lot of data that needs to be reviewed. He said he would like to know what the experience was for participants who received the COVID-19 vaccine and still got the virus.
“I would like to know whether or not it was a mild case of coronavirus,” he said. “All of this data should be released, such as the demographics, who got sick, and obviously what the side effects of the vaccine are. Pfizer needs to be very transparent about this.”
The data has yet to be peer-reviewed or published in a medical journal. Pfizer said it would do so once it has results from the entire trial.
Although the data is promising, Bowman said it’s best that everyone remains “cautiously optimistic” as there are still a lot of unknowns.
“We have to be quite cautious. We are looking at public relations from a pharmaceutical company whose primary goal is marketing and profit,” he said. “I am not saying I don’t believe it, but you have to realize that the full data has not been released. They are telling us what the data says, so experts still need to review it.”
But, he said, by the end of November, Pfizer could be publishing more of the results, and then “we will be able to review the larger picture.”
He also stressed the importance of not rushing a vaccine due to “hesitancy” surrounding inoculation.
Because “political interference” could lead to rushing a vaccine, Furness said, companies like Pfizer are aware that “public trust may be shaky.”
“So they have to counter that by being very transparent, let everyone know the data, release all the information,” he said. “Usually pharmaceutical companies want to protect their research. It’s the way of the business … but transparency is very important in this case.”
What comes next?
Pfizer said it doesn’t plan to stop its study until it records 164 infections among all the volunteers, a number that the U.S. Food and Drug Administration (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 study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease,” the company’s statement said.
The company predicts that its “safety data” following the second and final dose of the vaccine, will be available by the third week of November.
Canada inks new deal to secure potential vaccines
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” the company said (enough to vaccinate 650 million people as it is a double dose).
Canada has signed a deal with Pfizer in August to secure 20 million doses of the coronavirus vaccine in 2021.
Speaking at a media conference on Monday, Prime Minister Justin Trudeau said he hopes to have the vaccine rollout in early 2021.
Bowman said because coronavirus rates are skyrocketing in places like the U.S. and Canada, this means there is a silver lining — more people can volunteer for the trials. He remains optimistic that not only with Pfizer have positive results, but other companies, too.
“This could be very good news, and other vaccines could start working too, so we may have a situation where there is a combination of vaccines or you can ‘take your pick,’” he said.
However, he stressed that despite Pfizer’s promising data, it does not mean that it’s over. It means we are on an “uphill trend,” he said.
“We are not going back to normal life yet. It’s going to take time and research — but boy, did we need this good news.”
— With files from the Associated Press
© 2020 Global News, a division of Corus Entertainment Inc.
Nova Scotia reporting 14 new COVID-19 cases on Thursday – CBC.ca
Nova Scotia is reporting 14 new cases of COVID-19 on Thursday, bringing the province’s total active cases to 114.
Twelve of the new cases are in the central health zone, with one case each in the northern and western zones.
Nova Scotia Health Authority labs completed 2,253 tests Wednesday.
An additional 856 tests were administered Wednesday at a rapid-testing pop-up in downtown Halifax with five positive results. Those people were directed to self-isolate and have been referred for a standard test.
In recent weeks, a small number of Nova Scotia Health employees have tested positive for COVID-19, spokesperson Brendan Elliot said in an email.
Elliot said it’s fewer than five people across the province, but declined to be more specific citing privacy reasons. All employees who test positive are required to immediate self-isolate away from the workplace.
Rapid testing coming to long-term care
The province has a large supply of rapid testing kits and the plan is to make them available in nursing homes so staff can be regularly tested.
“We know that the asymptomatic carrier was the problem in the first wave. Nursing home staff, if sick, would stay at home, but asymptomatic [people] can bring it in,” Leo Glavine, the province’s health minister, said Thursday.
Although he would like to see dedicated staff in each care home to minimize exposure, Glavine could not say whether some workers would need to move between more than one facility.
New restrictions in effect
New restrictions came into effect Thursday in most of the Halifax Regional Municipality and parts of Hants County.
The restrictions include stopping dine-in service at bars and restaurants and closing gyms, libraries, museums and casinos for at least the next two weeks. Masks are also mandatory in common areas of multi-unit dwellings like apartments and condos.
A list of what’s open and closed in the Halifax region can be found here.
Across the province, visitations to long-term care facilities are no longer allowed unless the person is a volunteer or designated caregiver.
All other Atlantic provinces, most recently New Brunswick, have brought back mandatory 14-day self-isolation for travellers. But as of Thursday evening, Nova Scotia’s policy on regional travel remained unchanged.
“We respect the decision of New Brunswick. At this time, Nova Scotia is focused on the new measures that came into effect [Thursday], including the strong recommendation from Public Health to avoid non-essential travel,” provincial spokesperson Marla MacInnis said in an email.
COVID cases in the Atlantic provinces
The latest numbers from the Atlantic provinces are:
Anyone with one of the following symptoms should visit the COVID-19 self-assessment website or call 811:
- Cough or worsening of a previous cough.
Anyone with two or more of the following symptoms is also asked to visit the website or call 811:
- Sore throat.
- Shortness of breath.
- Runny nose.
CDC may shorten coronavirus quarantine guidelines: WSJ – Yahoo Finance
Yahoo Finance’s Alexis Christoforous and Dr. Jennifer Cowart, internal medicine physician, discuss rising U.S. coronavirus cases.
ALEXIS CHRISTOFOROUS: The US is recording the highest number of deaths from the coronavirus since May. Continues to average close to 200,000 new cases a day. Why is the CDC thinking about shortening the quarantine time?
JENNIFER COWART: Yes, thank you. I think it’s a really good question. Looking at it, they’re looking at the evidence that most people who become positive after an exposure to COVID-19 become positive within that seven to 10-day window or before then. So it doesn’t mean that you may not have some folks who become positive on the later end of the 10 to 14-day window, but the vast majority are going to become positive earlier in that time frame, which is one reason they’re considering shortening the timeframe.
Looks like they’re also going to recommend that there be a negative test associated with that shorter quarantine. They’re looking at it also from a pragmatic perspective because 14 days of quarantine is really difficult for many people to adhere to for a variety of reasons. They’re trying to work and go to school and do other things. So I believe they’re looking at it in the sense of, we can maintain a high degree of safety and potentially even a higher degree of adherence with quarantining with a little bit shorter quarantine, still catch the majority of cases, and encourage a negative test in that– to try to keep things as safe as they can be.
ALEXIS CHRISTOFOROUS: I know that you’re working at a hospital there in Jacksonville, Florida. I’m hearing reports from hospitals across the country and clinics that they’re struggling to get that PPE. What’s your situation in your hospital? And is that becoming a problem?
JENNIFER COWART: I’m really grateful that we’ve had good access to PPE through the course of this pandemic. But I know that’s not the situation in every hospital across the country. So in order to keep health care workers safe, we really do need to be sure that everybody has access to surgical masks, to N95 respirators for those high-risk encounters, gloves, gowns, face coverings or face shields or goggles. Because we do see evidence that covering the eyes, it reduces the risk of health care transmission further.
So I’m grateful that my hospital, we’ve had good access to PPE. But every hospital, every clinic needs to have that same access.
JENNIFER COWART: You know, US officials planning to release 6.4 million COVID-19 vaccine doses nationwide. And its first distribution, of course, would be to frontline workers like yourself and to people who are at high risk, namely the elderly. Do you think the CDC is doing enough to prepare people for the possible side effects of these vaccines?
JENNIFER COWART: It’s a great question because it does look like this is a vaccine that, the Pfizer and Moderna versions, that produce a vigorous immune response. And so I think folks should be prepared to feel the effects of this vaccine. Not everybody will, and that does not mean the vaccine is not working. But in many patients, they will get two doses of the vaccine, and either or both doses may produce a day of feeling some mild flu-like symptoms, some headaches, some aches and pains and shells. And folks should be prepared for that.
I think it’s a positive thing because I’d rather have one day of feeling achy compared to two weeks of illness and the risk of passing it on to my friends, family, and co-workers. But I agree I would love to see all of us, myself included, getting that message out there that this vaccine may produce a vigorous response. You may not feel well for a day or so. Still, very crucial to take that second dose of vaccine because you need both doses to get the full effect of this vaccine.
JENNIFER COWART: That’s, I think, the worry, right, that you would get the first dose, you would have these side effects, you would get concerned about that and not go back for the second dose. What would that do if a large enough amount of people decided to forego the second dose?
JENNIFER COWART: Right. And I think the vaccine has tested and known to be effective with both doses. So I think the risk would be that folks would be in completely protected if they get one dose and not the second dose. So I think we need to be very clear in saying, from the vaccine trials, the experience is that both doses are needed and that you can have a response, that you may not feel great for a day, that you need to take some acetaminophen or some ibuprofen, maybe take the day off of work if you need to.
But it’s better to have one day of feeling achy after the vaccine, means you’re getting a good robust response. And then you need to do both times to get that in order to have that full protection. And that’s the best way to keep the COVID-19 from continuing to spread, devastating our communities, working on our economy in negative ways. The best way to keep us all safe and back to work is both doses. And it may make you feel not great for a day, but it’s still better than getting COVID-19.
ALEXIS CHRISTOFOROUS: And real quickly, doctor, your advice to people who are going to be seeing family over this Thanksgiving.
JENNIFER COWART: Absolutely. So I think of everything in terms of risk and benefit and harm reduction. So if you need to travel, if you need to see your family, ways to keep it safer would be limit the size of your gathering, so not very many people in a room, eat outside if you’re able to, if the weather is nice, go outdoors, have your Thanksgiving meal outside where folks can take their masks off for a moment to eat and eat outside. Third, as I just mentioned, masks.
I know it may not feel comfortable to have masks on around our family members, but that’s the best way that if you need to have a gathering, keep it small, wear your masks, and be outdoors as much as possible. If you do decide to get a COVID test before your trip, I think that’s a great way to show that if you have a negative test, maybe your risk right this second is lower. But do not take that negative test as a license to think, great, I’ll take my mask off, and I’ll have a massive gathering of 50 people where we all share the mashed potatoes.
The way to use that test is if you take that test and it’s positive, you cancel your trip. You don’t go meet with family if you have a positive test. If you have a negative test, it means you’re still going to wear your mask, you’re going to limit the size of your gathering, and you’re going to go outside as much as possible.
BMO, CIBC extend work from home to April as Canada cases surge – BNN
A recent surge in COVID-19 cases is derailing Canadian banks’ plans to bring employees back to offices, with one lender even asking some workers who had already returned to go back home.
Canada is now facing about 5,000 new COVID-19 cases a day, prompting provinces and cities including Toronto — home to the country’s five biggest banks — to implement new restrictions to limit the virus spread. Even Prime Minister Justin Trudeau recently returned to working from home in an attempt to set a national tone of caution.
Bank of Montreal and Canadian Imperial Bank of Commerce are extending work-from-home plans for some employees until at least April. Toronto-Dominion Bank hasn’t set a firm date for a return, but said in a memo last week that most people working from home won’t come back “until at least the spring.”
Royal Bank of Canada even encouraged employees who had gone back to offices to return to working from home as of Nov. 16, according to a memo from Chief Human Resources Officer Helena Gottschling. Canada’s second-largest lender by assets said it will continue pre-screening and requiring masks and distancing for those who can’t work remotely.
“For those in critical roles that cannot be done from home and who are working on premises today, please continue to work on site,” Gottschling said in the Nov. 12 memo. “Our ongoing protocols will continue to protect employees’ health and safety in the workplace.”
The bank hasn’t set a firm time for employees to return. Royal Bank also delayed plans to have employees retrieve personal items from work sites in and around Toronto until further notice.
Bank of Nova Scotia also hasn’t set a specific time for office employees to return because of “uncertainty around how the COVID-19 pandemic will unfold in the coming months,” according to a spokesman. Canada’s third-biggest bank said workers will receive at least four weeks notice before being asked to return.
Bank of Montreal doesn’t “foresee any broad-based changes for employees who are currently working from home any sooner than April 2021, unless a specific business need exists,” the company said in an emailed statement. The country’s fourth-largest lender previously said workers would remain out of the office until the end of this year. The bank will give employees 30 days notice before asking them to return.
Most CIBC employees who are already working off-site will continue to do so until at least April, Sandy Sharman, the executive who oversees human resources, said Wednesday in a memo to staff. The bank originally advised employees they’d be working from home until at least the end of the year.
CIBC, Canada’s fifth-largest lender, said it will give workers at least four-weeks’ notice before asking them back, Sharman said in the memo. The bank had planned to start relocating employees to its freshly built new headquarters at CIBC Square by the end of the year.
“With the majority of our team members working from home seamlessly, we have the flexibility to align our decisions and timing around our long-term real estate plans, including CIBC Square, and the guidance we receive from local governments and public health authorities,” she said.
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