As with other aspects of the COVID-19 vaccine process, the approval process has been sped up, said Chagla. Normally, pharmaceutical companies would send completed data sets to Health Canada for approval. Now, analysis of data that would typically be under embargo at this stage is happening in “real time,” he said.
U.S. health officials are expected to meet on Dec. 10 to determine emergency authorization for the Pfizer vaccine candidate, in which case distribution could begin on Dec. 11. Chagla doesn’t expect Canada to take much longer for the approval process, and thinks a vaccine could “start drizzling in at the end of the year.”
“I don’t think Canada is going to let themselves fall that far behind, noting that hopefully most of that data or some of that data is already being fed back to Health Canada right now and it’s really just crossing the T’s and dotting the I’s,” he said. “This is a global emergency that’s shutting down society and relatively so, this is probably the biggest intervention to date that might actually reduce some of the burden in our communities.”
The Canadian government assembled a team of experts and officials months ago to prepare for vaccine rollout, including logistics and prioritization. From an operations standpoint, a Canadian military general is heading the rollout. From a prioritization standpoint, the National Advisory Committee on Immunization (NACI), a long-established body that includes public health, infectious disease, and immunization policy experts, created a vaccine prioritization framework, released in early November. The framework determined that people and staff at long-term care facilities should be immunized first, then other health care workers and vulnerable populations, and finally the general population.
It’s possible that vaccination could be required in certain education, health care and travel circumstances, said Chagla, and there is precedent for it.
In parts of South America and Africa, travellers are required to present a “yellow fever vaccination certificate” to prove they are immune from the virus and won’t set off an outbreak. In Canadian schools, some provinces require children and adolescents to be immunized from a variety of illnesses before they can attend school, unless they have a medical exemption.
“I think you’re going to see some fairly forward-facing industries like travel industries, health care, schools, where this is probably going to be part of the mandate,” said Chagla, noting that mandatory vaccinations get “dicey” when it comes to employment law.
While no one can be forced to get an eventual COVID-19 vaccine, ethicists have urged for more clarity around what the rollout of vaccines will mean, including for millions of people who may choose not to get one.
“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,” Kerry Bowman, a bioethicist and assistant professor at the University of Toronto’s faculty of medicine, told CTV National News.
Common side-effects will have already been identified since most adverse events associated with vaccines occur within a day of receiving the shot, said Bogoch, the most common of which is a sore arm.
“There are certain rare vaccine side effects that can occur two to four weeks after vaccination. They’re not very common at all,” he said, adding that early data suggests the Pfizer and Moderna vaccine candidates, which use a relatively new mRNA technology, have not resulted in any notable side effects other than people feeling “fatigued or a little unwell” in the day following vaccination.
The Pfizer and Moderna vaccines are both “messenger RNA” or mRNA vaccines, which is a new kind of vaccine technology that is like “giving an instruction booklet for your cells to make antigens,” said Chakrabarti in a phone interview with CTVNews.ca last month. In the absence of the coronavirus, a person’s cells would still be programmed to develop the antibodies that fight the virus off.
The AstraZeneca vaccine, developed by Oxford University scientists in England, uses a more well-established approach that introduces a cold virus common in chimpanzees. The vaccine alters the chimp virus, called a modified adenovirus vector, to mimic COVID-19 and thereby produce an immune response in the human body.
Probably not. While study participants represented a wide spectrum of ages and ethnicities, they were also all generally healthy people, said Chagla in a phone interview with CTVNews.ca in November. In the past, when vaccines for other illnesses rolled out, they may have had strong data from clinical trials too. “But they’re not necessarily as good as patients get more complex, as their medications get more complex and their immune system diseases are more complex,” he said, so defining the efficacy of a vaccine after rollout becomes a difficult task. “More surveillance, more data, once it comes to the market, will probably tell us what the real life efficacy of these vaccines are,” he said. “I would suggest it will probably be a little less than this 95 per cent.”
It’s too early to know. The Pfizer and Moderna vaccines require two doses, separated by two weeks, but the second is not considered a “booster” shot, which are given to prevent immunity from waning.
“We don’t have a clue how long immunity will last,” said Bogoch over the phone with CTVNews.ca in November. “We’ll have clues about this longer-term after people are vaccinated to see how long immunity will last.”
Booster shots are typically given several years after the first, though children will often receive them earlier to provide a more “robust immune response,” said Chagla. “For most adult vaccinations you have a series [of doses], and things like the pneumonia shot or tetanus shot you do at five, 10-year intervals after getting it just knowing that immunity wanes in some of the older populations,” he said.
The Pfizer, Moderna and AstraZeneca vaccine candidates all have different requirements for transportation and storage. Pfizer’s vaccine needs to be kept at -70 C during those stages to remain effective, but it is not administered into someone’s veins at that temperature, assured Bogoch.
“God, that would suck. You’d get frostbite. That would cause tremendous damage,” he said. “The Pfizer vaccine is stable for about five days in a conventional refrigerator. The Moderna vaccine needs to be stored at -20 C but it’s stable in a refrigerator for about 30 days.”
The AstraZeneca vaccine candidate can be stored between 2 C and 8 C, which experts consider a major logistical advantage for areas of the country that don’t have access to ultra-cold freezers.
The specifics of the rollout are still being developed or have not yet been announced to Canadians, but experts expect there to be a variety of methods by which people will be vaccinated. Where someone lives may determine which vaccine they receive by which method.
“It’s going to depend on what vaccine is locally available, what resources are in that region to actually administer them,” said Chagla, noting the different storage temperatures required of the Pfizer, Moderna and AstraZeneca candidates.
“I think you’re going to see a lot of different models. You’re going to see family doctor models, drive-thru models, hospital models, models where people are going into long-term care facilities and plastering it among patients and staff,” he said. “You might get other ways of administering it, like mass vaccination clinics.”
Recent lessons from the administration of influenza vaccines may be informing how a COVID-19 vaccine is rolled out, said Chagla, who expects there to be less reliance on lining up at local pharmacies.
“We can’t have people standing in long lineups, particularly in the era of COVID-19,” he said. “People getting COVID waiting for a COVID vaccine seems like fairly poor optics in that sense.”
If someone is vaccinated and they come into contact with the virus, one of two things is going to happen, said Bogoch: “You’re either going to get the infection, or you’re not.”
Early data from COVID-19 vaccine trials suggests that the probability of getting the infection is significantly lower in vaccinated people than in unvaccinated people. Similarly, the early data suggests severe illness is also less common in people who are vaccinated.
“It’s extremely important to note that we don’t have the data available, and we’re only going by the snippets of data that we do have available,” he added.
Yes. While a minority of people get sick and die from COVID-19, that small group of people can still overwhelm the hospital system, said Chakrabarti.
“Once that happens, there’s a ripple affect that has effects on everybody’s health,” he said, noting cancer screening appointments are cancelled and elective operations are postponed. As of Dec. 1, some of the largest hospitals in Canada were nearing capacity, threatening widespread cancellations of non-emergency surgeries that would further extend a health care backlog.
While some have suggested protecting the elderly and letting the virus “rip” through society to allow for natural herd immunity, Chakrabarti says it’s very difficult to protect all vulnerable people and the consequences of such a strategy can’t be understated.
“The cost of doing that is that you would overrun hospitals and there would be all sorts of collateral damage,” he said.
Maybe, but it’s unlikely that individual people will get each of the Pfizer, Moderna and AstraZeneca vaccines, or some other combination of vaccines, during the first rollout, said Chakrabarti.
“This stuff will be honed in the coming years as we start to get to know more and more. There is a precedent for using vaccines of slightly different mechanisms to give you a synergistic type of effect,” he said, noting that high-risk populations are inoculated with both pneumonia vaccines on the market for a more powerful affect.
There’s also added benefit to having multiple vaccines on the market, whether or not an individual person receives multiple shots. The differences in the storage requirements alone provide important benefits, particularly to the developing world, noted Chagla.
“Right now it’s just a race to get a vaccine on the market rather than necessarily saying ‘What’s the optimal strategy?’” he said. “As things go on, we’re probably going to get more and more data to say which one is better in kids, which one is better in the elderly, which one is better in certain settings, or with certain medications. That’s the benefit fo having multiple on the market.”
While some experts expect a feeling of “normal” to return at some point next year, a complete return to normal might not come until 2022.
“The rollout of the vaccine is a gargantuan task,” said Chakrabarti. “I do completely expect that things will be back to normal sometime in 2022. I think 2021 will be a gradual and stepwise improvement in our daily lives and the case count.”
Chagla expects people will begin to “step off the break” once the most vulnerable populations are vaccinated in the early months of 2021. Summer could be close to normal, he added. “We’re going to see ‘normal’ starting to show up more and more and more as some of those higher-risk settings get more and more vaccinated,” he said.
Ontario seniors 'living in fear' of COVID-19 feel forgotten in vaccine rollout plan – CBC.ca
When the first COVID-19 vaccine was approved in Canada, Ketty Samel and her 76-year-old husband Morris believed the end to the long months of isolation was in sight. Since last March, the Thornhill, Ont., couple has been hunkering down in their home.
“We’re living in fear. For me to go to a grocery store right now, I’m in a total sweat. I’m stressed, I walk in and I walk out. I grab whatever I need off the shelves and that’s it.”
Under Ontario’s vaccination rollout plan, Samel, 71, and her husband will be vaccinated in Phase 2 — a phase that could begin as early as March, according to government officials, and will continue through to July. It’s a tiered system by age groups, starting with those 80 years of age or older, then decreasing by five-year increments.
“They’ve told us from the beginning of this pandemic that we were vulnerable. [After] long term care we were the next vulnerable population,” said Samel.
“And all of a sudden we’re expendable. That’s our feeling.”
The Ontario Ministry of Health says the roadblock to vaccinating more people faster is supply, which is expected to increase in Phase 2.
But in the meantime, some are questioning whether everyone getting a dose in Phase 1 is as vulnerable as seniors in the community, with figures from Public Health Ontario showing that more than a third of COVID-19 deaths are adults over 60 who aren’t in long-term care.
The National Advisory Committee on Immunization (NACI) recommends adults 70 and older to be part of the first stage of immunization rollout, alongside residents and staff in seniors’ congregate living settings, health-care workers, and adults in Indigenous communities “where infection can have disproportionate consequences.”
Actual plans vary by province. In Ontario, Phase 1 of the rollout involves vaccinating all residents, staff, essential and other workers in long term care and retirement homes, health care workers, adults in First nations, Metis and Inuit populations and recipients of adult chronic home care.
Seniors in the community aren’t slated to be vaccinated until Phase 2.
This discrepancy between federal guidelines and Ontario’s planned rollout is one that 76-year-old Toronto resident Brian Corcoran calls frustrating.
“We’re not considering elderly people. They don’t have that criteria in Ontario,” said Corocoran.
Corcoran, like many other seniors in Ontario, has called his local health clinic to try to find out when he’d be vaccinated, only to be told staff have received no direction.
“By having the seniors in limbo is not good for a lot of people. A lot of people will get depressed. A lot of people will be isolated.”
Corcoran said he believes in the importance of vaccinating seniors in long-term care homes and front line workers first, but said he doesn’t understand why older adults like him aren’t included in the first phase after them.
It’s a sentiment shared by Samel and her husband.
“If we should contract COVID, it’s most likely that we are going to end up taking up a hospital bed and end up not surviving. That’s the bottom line,” she said.
‘The numbers don’t lie’
According to Public Health Ontario’s figures as of Friday, there have been 5289 COVID deaths in the province.
A closer look at the numbers show that of the estimated 5289 deaths, 96 per cent — 5064 people — are aged 60 and over. (The majority — 3137 deaths — have been seniors in long-term care homes, but nearly 2000 estimated deaths have been seniors not in long-term care.)
Those figures are prompting some medical professionals and advocates to call for Ontario’s vaccination plan to look more closely at older adults.
“The numbers don’t lie,” said Dr. Samir Sinha, director of Geriatrics at at Mount Sinai and the University Health Network Hospitals in Toronto.
“And yet our government is basically following a kind of a plan that I don’t actually think really follows the science.”
Sinha questions why some essential workers in hospitals — who don’t interact with patients — are being vaccinated before older adults.
“The science says that when 96 per cent of the people dying in this pandemic are people older than 60. Why would you make that make that population wait until April, that 3.5 million people, and start vaccinating 1.5 million essential workers months in advance of that?”
Sinha pointed to other countries — such as Israel — that he said have already vaccinated more than 70 per cent of its population over the age of 60 in a matter of weeks.
Each province has its own timeline for vaccinating seniors. In British Columbia for example, only those 80 years of age or older who live in the community will be vaccinated before April.
In Quebec, the provincial government plans to start vaccinating those 70 years and older by February 15 with the hope that all Quebecers over 70 will get vaccine by April. In Alberta the plan is to start offering vaccines to seniors 75 and older by February.
Some seniors’ advocates say older adults must be prioritized regardless of where they live.
“There is great risk to people who are living in their own homes. They’re still visited … by caregivers, by their own family,” said Bill VanGorder, chief policy officer with the Canadian Association for Retired Persons (CARP)
“And we know how bad community spread is right across [Ontario]. Why would we not want to vaccinate them just as quickly as possible first?”
WATCH | Why some provinces are delaying 2nd dose of vaccine against recommendations:
CBC News reached out to the Ontario Ministry of Health to ask why older adult aren’t part of Phase 1 and why the province hasn’t moved to vaccinate them sooner.
In a statement it said the province has the ability to ramp up its capacity to vaccinate more people, but the problem is supply.
“We continue to urge the federal government to deliver more COVID-19 vaccines as soon as possible to keep up with Ontario’s capacity to administer.”
It added: “As the province continues to receive more doses, we will continue to expand locations across the province to vaccinate our most vulnerable and over time every Ontarian who wishes to be immunized.”
For Ketty Samel and her husband, that’s not good enough. They’ve started a letter-writing campaign to the provincial government.
“They’ve told us and warned us that we are so vulnerable,” said Samel. “If we’re so vulnerable, why is nobody looking at this?”
23 Died After Getting Covid Shot in Norway. Here's the Rest of the Story – TheStreet
After a striking headline circulated over the weekend — that 23 patients in Norway died after getting a Covid-19 shot — TheStreet reached out to the Norwegian Medicines Agency to find out more details of what happened.
Norwegian health officials say they have now revised guidelines on who should get the Covid-19 shots made by Pfizer (PFE) – Get Report and BioNTech (BNTX) – Get Report, after 23 deaths among the frail and elderly were believed to be “associated with” recent Covid-19 vaccinations. More than half of those who died, 13, have been assessed. The agency believes those fatalities might be linked to common adverse reactions from the vaccine, known as BNT162b2.
A Pfizer spokesperson said that the company and its partner, BioNTech, are “aware” of the deaths and are working with the Norwegian agency to collect necessary information. Pfizer’s “immediate thoughts are with the bereaved families,” said Jerica Pitts, Pfizer’s director of global media relations, in an email to TheStreet on Sunday. But Pitts pointed out that the number of incidents is so far not alarming and to be expected, according to Norwegian health officials.
For perspective, 42,003 people have been given the first dose of the vaccine in Norway as of Friday, so the deaths are a tiny fraction of the total vaccinated. Also, Norway, which has a population of slightly more than 5 million, has fewer than 58,600 total known cases of Covid-19 and under 517 deaths attributed to the virus, according to Johns Hopkins data. That ratio alone appears far worse one than that of the vaccinated vs. deaths potentially linked to the vaccine.
Still, the reports of deaths “suggest” that common adverse reactions to the messenger RNA vaccine may have contributed to a fatal outcome in some frail patients, says Norwegian health officials.
Following is a lightly edited exchange between TheStreet and the Norwegian Medicines Agency about the deaths, which occurred after the first dose of the vaccine, which began getting distributed in Norway on Dec. 27.
TheStreet: Why did the agency put out this notice?
Norwegian Medicines Agency: The Norwegian Adverse Drug Reaction registry is a national health registry, obliged to report statistics to the public. At the highest political level, the public has been promised full transparency of the reported ADRs of the Covid-19 vaccines. … In Norway, we have a “reporting culture” for vaccine ADRs, where the normal procedure is to report all suspected adverse reactions for new vaccines. Health care professionals in Norway have a low threshold for reporting possible adverse reactions, even when the causal relationships appear very unclear.
TheStreet: It sounds like you believe these deaths were likely linked to common adverse side effects of the shots. Could you expand on that? Is there any side effect that you find most concerning?
Norwegian Medicines Agency: For privacy reasons, we can not provide detailed information about this, but … all reports are about elderly people with serious underlying disorders. Most of them have experienced the expected side effects of the vaccine, such as nausea, vomiting, fever and local reactions at the injection site.
All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination may contribute to more serious course and fatal outcome in patients with severe underlying disease.
TheStreet: How old were those who died after getting the shots?
Norwegian Medicines Agency: All deaths fall into the age group of 75 years or older.
TheStreet: Do these deaths make you question how the vaccine is given to that population of the elderly who are sick?
Norwegian Medicines Agency: The Norwegian Medicines Agency approves the vaccine, but the National Institute of Public Health is responsible for the distribution. The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the Covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.
We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.
Toronto opening mass COVID-19 vaccine clinic as ICUs move patients around province – CBC News: The National
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