The United States’ effort to produce a coronavirus vaccine is in full throttle, and drugmakers are now seeking hundreds of thousands of volunteers to test their experimental candidates. Writing for the New York Times, Heather Murphy addresses five things patients should know before volunteering for a coronavirus vaccine trial.
Vaccine clinical trials have three phases, Murphy notes, and participating in a Phase 1 trial would mean you’re one of the first people to receive an experimental vaccine. According to Murphy, Phase 1 vaccine trials typically focus on safety, looking to see whether the vaccine candidate causes humans to experience negative side effects. If you participate in a Phase 1 vaccine trial, researchers “[t]ypically … will monitor you and a few dozen other subjects closely after each dose, and then check in periodically for about a year,” Murphy writes.
Researchers usually use Phase 2 trials to further observe any potential side effects of experimental vaccines and to see whether a vaccine candidate generates an immune response, Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center and leader of the Covid-19 Prevention Network, told Murphy. These trials typically involve a few hundred participants.
But even if vaccine candidates in Phase 2 trials cause participants to generate an immune response, that doesn’t necessarily mean the experimental vaccines will protect participants against infection from the targeted pathogen—in this case, the novel coronavirus.
That’s where Phase 3 clinical trials come in, according to Murphy. For Phase 3 trials, researchers look to enroll up to hundreds of thousands of participants and seek to determine whether the vaccine effectively prevents infection. Researchers will administer their vaccine candidates to at least half of the participants, forming a test group. The remaining participants receive a placebo or alternative treatment and serve as the trial’s control group.
In Phase 3 trials for coronavirus vaccine candidates, researchers won’t expose any of the participants to the virus intentionally. Instead, researchers intend to enroll a lot of participants from locations with high numbers of coronavirus cases. The researchers will track participants in both the test and control groups to see how many contract the new coronavirus. The researchers then will try to determine whether the experimental vaccine reduced the frequency of infection or the severity of Covid-19, the disease caused by the coronavirus, among the test group when compared with the control group.
Currently, there are no ongoing trials in which participants are intentionally exposed to the novel coronavirus, Murphy writes. Clinical trials in which participants are intentionally exposed to pathogens, which are known as challenge trials, have been the subject of a long-standing debate—and they’ve invoked particular concern when it comes to the new coronavirus, because there currently is no proven treatment or cure for Covid-19, which can be deadly.
However, some public health experts have argued that challenge trials could speed up the vaccine development and approval processes, and researchers at Oxford University in July announced that they would soon start recruiting participants for a coronavirus vaccine challenge trial. Some drugmakers in the United States have said they, too, are considering conducting such trials.
2. You can’t guarantee you’ll be in a test group
Murphy notes that, because vaccine candidates are experimental, “there’s no guarantee that you’ll actually be protected from the coronavirus at any phase” of a vaccine clinical trial. Moreover, if you participate in a Phase 3 trial, you may end up in the control group, meaning you won’t receive the vaccine candidate.
Nir Eyal, director of the Center for Population-Level Bioethics at the Rutgers School of Public Health, explained that control groups are a required to assess the effectiveness of an experimental vaccine. Without a control group, the trial would tell researchers “basically nothing,” Eyal told Murphy.
3. You’ll get paid—but you’ll also face risks
Participants in clinical trials for coronavirus vaccine candidates will be compensated, Murphy writes, and the amount participants will receive “varies by the trial.” According to Murphy, the amount can range from between a few hundred dollars to a few thousand dollars.
Daniel Hoft, director of the Saint Louis University Center for Vaccine Development, told Murphy that researchers pay trial participants to compensate them for their “time and trouble.”
But Arthur Caplan, a bioethicist, warned that people who find the compensation as an “extraordinarily attractive” incentive to participate in a vaccine trial also need to consider the risks associated with receiving an experimental vaccine. “You don’t want to let compensation blind you to the need to pay attention to the risks.”
4. You may end up paying the costs for care if you have an adverse reaction
While participants will be compensated for taking part in a vaccine clinical trial, if they have an adverse reaction to a vaccine candidate, it’s possible that they’ll be on the hook for the costs of any care they receive for the reaction.
“Insurance companies will rarely pay anything if you are hurt in an experiment,” Caplan said. And if the vaccine developer agrees to cover any costs related to care for an adverse reaction, they typically commit only to reimbursing a participant’s health insurer for those costs, he explained.
Corey recommends that people ask trial administrators about what compensation or support they’ll receive if they are harmed by the vaccine candidate.
Corey also noted that, in some instances, participants who are harmed by an experimental vaccine may be eligible for restitution under the Public Readiness and Preparedness Act or, in the case of experimental coronavirus vaccines, under the federal government’s epidemic relief fund.
5. How to enroll
People looking to enroll in a coronavirus vaccine trial can visit ClinicalTrials.gov, which lists all coronavirus vaccine studies that are currently active. In addition, the National Institute of Allergy and Infectious Diseases has established the Covid-19 Prevention Network website to connect volunteers to coronavirus vaccine trials.
Further, COVID Dash—which is managed by a group of clinical researchers, doctors, and students trying to encourage people to volunteer in coronavirus clinical trials—is a portal that helps people volunteer for coronavirus-related studies throughout the world, Murphy writes.
Murphy also notes that people can visit the 1 Day Sooner website to sign up for future coronavirus vaccine challenge trials (Murphy, New York Times, 8/5).
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.
