When Karen Tibbals of Washington, N.J. heard that more than 100,000 volunteers would be needed for late-stage clinical trials of four Covid-19 vaccines, she wanted to roll up her sleeves and get one of the experimental shots.
Tibbals is 65 and has the autoimmune disease rheumatoid arthritis, raising her risk of suffering severe complications of Covid-19. But she also brings a unique perspective to the race to develop a vaccine: Tibbals is a retired pharmaceutical marketing executive who saw the clinical trial process up close during stints at Novartis and Merck
Some of the coronavirus vaccines entail delivering bits of genetic material from the virus to prompt the body to launch an immune response — emerging technology that hasn’t been widely deployed before. But that doesn’t scare Tibbals.
‘I Have a Chance of Helping Other People’
“This is really cool new technology; I trust it. I have a chance of helping other people,” Tibbals said, adding that she’s confident the companies will follow procedures for safe clinical trials. She has volunteered for the trials on the site for the Covid-19 Prevention Network (COVPN), an initiative of the National Institutes of Health’s National Institute of Allergy and Infectious Diseases.
“People with pre-existing conditions are a priority population, as are adults over age 65.”
COVPN is managing the recruitment of volunteers for clinical trials of vaccines being developed by AstraZeneca, Novavax, Moderna and the Johnson & Johnson unit Janssen. The Moderna trial is expected to begin later this month, with the other three trials starting between August and December.
Maybe you’re interested in participating in a Covid-19 clinical trial, too. Here’s what you need to know:
Each company will need about 30,000 volunteers for its trials, and more Covid-19 vaccine developers could be added if their products advance to late-stage clinical trials, said Michele Andrasik, a scientist in the vaccine and infectious disease unit at the Fred Hutchinson Cancer Research Center and one of the managers of community outreach for COVPN.
Who the Vaccine Developers Want
Covid vaccine developers are particularly interested in recruiting clinical trial participants who are considered to be most vulnerable to Covid-19, Andrasik said.
“People with pre-existing conditions are a priority population, as are adults over age 65,” she noted. African Americans, Native Americans and Latinos also have a high chance of being admitted to a vaccine trial. So do people who are most likely to contract the disease because they work at health care facilities or in open work spaces, such as meatpacking plants.
Some people, however, might not qualify for the vaccine trials because of medications they’re taking to treat chronic diseases or other factors.
But because of the sheer number of participants who’ll be needed, Andrasik said, anyone who’s interested should volunteer. “Even if someone is not eligible, for example, for the Moderna trial, they may be eligible for a future trial,” she said.
Before signing up, though, you’ll want to understand what being in a Covid-19 vaccine trial will entail.
The Chance of Getting a Placebo
First and foremost, don’t assume you’ll be able to throw away your mask and stop social distancing after you get the shot. These trials will be placebo-controlled. That means every participant will have a 50-50 chance of getting a sham shot rather than an actual vaccine.
In fact, the vaccine developers are counting on some trial participants to actually get sick with Covid-19, said Dr. Richard Novak, professor of medicine and chief of the infectious disease unit at the University of Illinois and one of the clinical trial investigators for Moderna. All participants will be warned that they could get the coronavirus.
“We’re not exposing people to Covid-19 or giving it to them, but we do have to find people who have a high risk of getting it,” Novak said. That’s how the companies will be able to compare infection rates among people who received the vaccine and those who didn’t.
The protocol for each study will differ slightly depending on the company and vaccine being tested. But all volunteers selected for a trial will be expected to complete the enrollment process in person at one of the more than 80 sites running the trials.
Clinical trial volunteers will be asked to sign “informed consent” documents saying they understand they may get a placebo and that if they get the vaccine, they could suffer side effects.
Possible Side Effects for Covid-19 Vaccine Trial Participants
What kind of side effect? Sore arm, low fever and muscle aches — the typical side effects for all vaccines. Moderna said that chills, headache and fatigue were reported in its 45-person trial of the vaccine, too.
Patients in the trials will likely receive some compensation to cover their time and basic expenses. That will vary based on the location and trial sponsor.
Participants will be followed with phone calls and further visits to the study sites.
The Moderna trial, for example, will likely require about seven follow-up visits, weekly phone conversations and electronic diaries that participants will be expected to complete, Novak said. “If they develop symptoms consistent with Covid-19, we’ll bring them in or go to their home for an interim visit, collect samples, then keep tabs on them to see how they do,” he added. (Moderna did not respond to requests for details about the study protocols.)
Although Moderna’s entire process will last two years, Novak estimated, the frequency of face-to-face contact between participants will go way down over time, to once a month or potentially less.
Safety First
Despite the urgent demand for Covid vaccines that work, trial volunteers shouldn’t worry that corners are being cut on safety, said Dr. William Schaffner, professor of infectious diseases at Vanderbilt University.
That’s because clinical trials always have data safety monitoring boards, panels of independent experts with access to information about how the people who receive the actual vaccines are doing compared to those who get placebos.
“If adverse reactions of a certain seriousness start to occur in the vaccinated group, but not the [placebo] group, the trial can be stopped,” said Schaffner, who is not involved in the Covid-19 trials.
Or if the monitoring board looks at the interim data and determines there’s little chance the vaccine is effectively preventing the disease, it can end the trial, “because there’s no need to recruit additional volunteers and expose them to a vaccine that’s not working,” Schaffner said.
As of late July, more than 154,000 people had already volunteered to participate in the Covid-19 vaccine trials through the COVPN website. People who are interested in volunteering for trials that aren’t listed there can also find opportunities by visiting Clinicaltrials.gov and searching the keyword Covid-19.
Tom Smith, a 62-year-old technology research analyst in Raleigh, N.C., is eager to enroll in a Covid-19 vaccine trial, even though he knows it will be a source of anxiety for some of his family members — especially his 87-year-old dad.
“They would be very wary of me doing this,” Smith said. “But you’ve got to have people who are willing to test the different technologies. Anything I can do to help, I want to do.”
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.
