Should everyone now be offered a vaccine? Or should the two groups in the Pfizer and Moderna studies remain intact in order to collect long-term data on how well the vaccines work?
“There’s a real tension here,” said Dr. Jesse Goodman, an infectious disease specialist and former chief scientist at the U.S. Food and Drug Administration. “There’s not an easy answer.”
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How vaccine studies work
New drugs, vaccines or treatments usually go through rigorous tests and evaluations before reaching regulators for approval.
For vaccines, researchers compare what happens when a large group of volunteers gets the shots, versus what happens to another large group that doesn’t. They compare side effects in each group. And they measure the vaccine’s effectiveness by looking at how many in each group pick up infections.
To do this fairly, researchers randomly assign participants to receive a vaccine or a dummy shot, usually a dose of salt water.
Volunteers know there’s a 50-50 chance they could be put in either group — and they are not told which group they landed in. Often, the researchers or others involved in the testing are also “blinded” and don’t know either.
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Should test volunteers be told?
About 17,000 of Moderna’s study participants received a placebo, as did about 22,000 people in Pfizer’s trial.
With the ongoing coronavirus crisis, health experts worry about leaving them in the dark and unprotected. They argue they should be given a vaccine now in recognition of their willingness to be a part of the trials during the pandemic.
“Volunteers have been instrumental,” said Moncef Slaoui, chief scientist of the government’s Operation Warp Speed program. “They should be rewarded for it.”
1:46 Coronavirus: Experts call for quick roll-out as COVID-19 vaccines sit in freezers
Coronavirus: Experts call for quick roll-out as COVID-19 vaccines sit in freezers
The companies would have to “unblind” or “unmask” the studies, revealing whether participants got the vaccine or the dummy shot.
Unmasking is usually done at the end of testing. Moderna and Pfizer, though, designed their studies to last two years to do long-term follow-up.
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“I don’t think there’s anybody who thinks it’s reasonable or feasible to keep the people blinded for two years,” said Susan Ellenberg, an expert in clinical trials at the University of Pennsylvania.
“Given we have a pandemic, people are ready to settle for the short-term results.”
Pros and cons of “unmasking’
With the rollout of vaccines and the uncertainty of their status, volunteers could decide to drop out once they are eligible to get one. They might stay in the study if they’re told what they got, said Dr. Ana Iltis, a bioethicist at Wake Forest University.
“Participants could leave in droves. They could say, ‘If you don’t tell me what I got, I’m out of here,’” said Iltis. “You cannot force people to stay.”
In an ideal world, participants could hold off to discover whether they received the dummy shot or the vaccine. But experts agree the current circumstances are extraordinary.
Still, unmasking participants would undoubtedly affect the trials’ scope and results.
If someone learns they’ve already been vaccinated, for example, they may stop social distancing or wearing masks — increasing their potential exposure to the virus and possibly spreading it. It’s not yet known if vaccinated people can still carry and transmit the virus.
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2:56 A look back at pandemic-inspired inventions
A look back at pandemic-inspired inventions
On the flip side, if a person finds out they only received the dummy shot, they might take precautions they wouldn’t otherwise.
Either outcome, Goodman said, “means the trial has basically come to an end.”
Before granting its emergency use approval, the FDA required Pfizer and Moderna to provide two months of follow-up data. If studies are cut short, it becomes harder to get long-term effects, including how long immunity lasts.
“There’s a reason we do clinical research in a certain way,” Iltis said. “We should not abandon our norms and our principles. Are we going to be happy with short-term evidence in a year?”
What the companies say
Pfizer plans to eventually vaccinate all its study participants. It’s opting for a more gradual, voluntary process. The company will offer that option to those who got dummy shots as soon as they would have access to the vaccine outside of the study.
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Moderna is considering immediately offering the vaccine to all who got dummy shots. More than one-quarter of them are health-care workers and first in line for the vaccine anyway, the company noted.
“Many have already left. Sadly, it’s not a small number,” said Dr. Lindsey Baden, who’s involved in testing Moderna’s vaccine at Brigham and Women’s hospital in Boston. “This is not theoretical. It’s happening.”
3:42 More than half of Canadians feel more lonely due to pandemic, polling shows
More than half of Canadians feel more lonely due to pandemic, polling shows
British pharmaceutical company AstraZeneca, which has enrolled at least 23,000 so far in its ongoing U.S. study, recently decided to offer individual participants the opportunity to be unmasked as they become eligible for the approved vaccines.
“You never really want to unblind,” said Dr. William Hartman, a researcher for AstraZeneca’s trial at the University of Wisconsin-Madison.
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However, he added, the pandemic has complicated things.
“A lot of people are nervous and scared,” Hartman said. “And everyone comes into the trial hoping they’ll get the vaccine.”
The Canadian government says it will donate up to 200,000 vaccine doses to fight the mpox outbreak in Congo and other African countries.
It says the donated doses of Imvamune will come from Canada’s existing supply and will not affect the country’s preparedness for mpox cases in this country.
Minister of Health Mark Holland says the donation “will help to protect those in the most affected regions of Africa and will help prevent further spread of the virus.”
Dr. Madhukar Pai, Canada research chair in epidemiology and global health, says although the donation is welcome, it is a very small portion of the estimated 10 million vaccine doses needed to control the outbreak.
Vaccine donations from wealthier countries have only recently started arriving in Africa, almost a month after the World Health Organization declared the mpox outbreak a public health emergency of international concern.
A few days after the declaration in August, Global Affairs Canada announced a contribution of $1 million for mpox surveillance, diagnostic tools, research and community awareness in Africa.
On Thursday, the Africa Centres for Disease Control and Prevention said mpox is still on the rise and that testing rates are “insufficient” across the continent.
Jason Kindrachuk, Canada research chair in emerging viruses at the University of Manitoba, said donating vaccines, in addition to supporting surveillance and diagnostic tests, is “massively important.”
But Kindrachuk, who has worked on the ground in Congo during the epidemic, also said that the international response to the mpox outbreak is “better late than never (but) better never late.”
“It would have been fantastic for us globally to not be in this position by having provided doses a much, much longer time prior than when we are,” he said, noting that the outbreak of clade I mpox in Congo started in early 2023.
Clade II mpox, endemic in regions of West Africa, came to the world’s attention even earlier — in 2022 — as that strain of virus spread to other countries, including Canada.
Two doses are recommended for mpox vaccination, so the donation may only benefit 100,000 people, Pai said.
Pai questioned whether Canada is contributing enough, as the federal government hasn’t said what percentage of its mpox vaccine stockpile it is donating.
“Small donations are simply not going to help end this crisis. We need to show greater solidarity and support,” he said in an email.
“That is the biggest lesson from the COVID-19 pandemic — our collective safety is tied with that of other nations.”
This report by The Canadian Press was first published Sept. 13, 2024.
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
HALIFAX – The Nova Scotia government says it could be months before it reveals how many people are on the wait-list for a family doctor.
The head of the province’s health authority told reporters Wednesday that the government won’t release updated data until the 160,000 people who were on the wait-list in June are contacted to verify whether they still need primary care.
Karen Oldfield said Nova Scotia Health is working on validating the primary care wait-list data before posting new numbers, and that work may take a matter of months. The most recent public wait-list figures are from June 1, when 160,234 people, or about 16 per cent of the population, were on it.
“It’s going to take time to make 160,000 calls,” Oldfield said. “We are not talking weeks, we are talking months.”
The interim CEO and president of Nova Scotia Health said people on the list are being asked where they live, whether they still need a family doctor, and to give an update on their health.
A spokesperson with the province’s Health Department says the government and its health authority are “working hard” to turn the wait-list registry into a useful tool, adding that the data will be shared once it is validated.
Nova Scotia’s NDP are calling on Premier Tim Houston to immediately release statistics on how many people are looking for a family doctor. On Tuesday, the NDP introduced a bill that would require the health minister to make the number public every month.
“It is unacceptable for the list to be more than three months out of date,” NDP Leader Claudia Chender said Tuesday.
Chender said releasing this data regularly is vital so Nova Scotians can track the government’s progress on its main 2021 campaign promise: fixing health care.
The number of people in need of a family doctor has more than doubled between the 2021 summer election campaign and June 2024. Since September 2021 about 300 doctors have been added to the provincial health system, the Health Department said.
“We’ll know if Tim Houston is keeping his 2021 election promise to fix health care when Nova Scotians are attached to primary care,” Chender said.
This report by The Canadian Press was first published Sept. 11, 2024.
ST. JOHN’S, N.L. – Newfoundland and Labrador‘s chief medical officer is monitoring the rise of whooping cough infections across the province as cases of the highly contagious disease continue to grow across Canada.
Dr. Janice Fitzgerald says that so far this year, the province has recorded 230 confirmed cases of the vaccine-preventable respiratory tract infection, also known as pertussis.
Late last month, Quebec reported more than 11,000 cases during the same time period, while Ontario counted 470 cases, well above the five-year average of 98. In Quebec, the majority of patients are between the ages of 10 and 14.
Meanwhile, New Brunswick has declared a whooping cough outbreak across the province. A total of 141 cases were reported by last month, exceeding the five-year average of 34.
The disease can lead to severe complications among vulnerable populations including infants, who are at the highest risk of suffering from complications like pneumonia and seizures. Symptoms may start with a runny nose, mild fever and cough, then progress to severe coughing accompanied by a distinctive “whooping” sound during inhalation.
“The public, especially pregnant people and those in close contact with infants, are encouraged to be aware of symptoms related to pertussis and to ensure vaccinations are up to date,” Newfoundland and Labrador’s Health Department said in a statement.
Whooping cough can be treated with antibiotics, but vaccination is the most effective way to control the spread of the disease. As a result, the province has expanded immunization efforts this school year. While booster doses are already offered in Grade 9, the vaccine is now being offered to Grade 8 students as well.
Public health officials say whooping cough is a cyclical disease that increases every two to five or six years.
Meanwhile, New Brunswick’s acting chief medical officer of health expects the current case count to get worse before tapering off.
A rise in whooping cough cases has also been reported in the United States and elsewhere. The Pan American Health Organization issued an alert in July encouraging countries to ramp up their surveillance and vaccination coverage.
This report by The Canadian Press was first published Sept. 10, 2024.
