Janssen Pharmaceutical Companies, a division of Johnson & Johnson, plans to begin human trials of its COVID-19 vaccine this month.
The first clinical trial participants will be healthy adults.
Moving to the next phase of clinical trials depends on both the results of this phase and the progression of the pandemic.
Clinical trials are well underway for three COVID-19 vaccine candidates being funded by the United States. Moderna and AstraZeneca have begun human trials, and Johnson & Johnson plans to do so by the end of July.
Even with over $2 billion worth of funding from the government’s Biomedical Advanced Research and Development Authority (BARDA), getting a vaccine through human trials isn’t easy. Large-scale testing must show a vaccine is both safe and can actually provide immunity against the SARS-CoV-2 virus that causes COVID-19.
Verywell talked to Jerome Custers, Senior Scientific Director of Vaccine Research at Johnson & Johnson, to learn what the process involves and what will make human trials successful.
Markers of Success
The most important parameter in a human trial, according to Custers, is safety.
“In our first clinical trial, we will vaccinate healthy adults, and those people will be monitored very strictly for safety,” Custers says. “In addition to that, we’re looking to see if our vaccine is able to induce a strong immune response and produce antibodies against the coronavirus.”
Custers says antibodies can be measured from blood samples. Researchers will take blood samples from trial participants before they are given the vaccine, a week or two after vaccination, and then at regular intervals after that.
“We have data from animals—monkeys, mice, and hamsters—that confirmed what we thought we would see and are encouraging us to continue in this direction.”
Creating and Testing a Vaccine
The direction Custers refers to is the use of something called AdVac technology. Using this vaccine platform, Johnson & Johnson scientists remove a piece of the genetic sequence from the adenovirus, which causes the common cold. Then, they insert genetic code from COVID-19.
Johnson & Johnson has used the same AdVac platform to develop vaccines for Ebola, HIV, RSV, and Zika, which combined, have been trialed safely in over 50,000 people. With COVID-19, however, the company is trying to do it on a much larger scale and a much more abbreviated timeline.
“A billion vaccines is still the goal,” Custers says.
While the first in-human clinical trials were initially slated for September, the company announced on June 10 that it would bump them up to the second half of July. This phase, considered a Phase 1/2a clinical trial, will involve 1,045 volunteers. Typically, this takes several months to years. But Johnson & Johnson is already looking ahead to Phase 3, which Moderna and AstraZeneca plan to enter this summer.
Beginning Phase 3 clinical trials is contingent on good results from Phase 1/2a.
“We are thinking that Phase 3 trials will include several tens of thousands of people,” Custers says. “But that will largely depend on how that pandemic develops. The incident rate of infection is going down.”
Currently, Phase 1/2a clinical trials are planned to take place in the U.S. and Belgium. Belgium has seen a steady decline in confirmed COVID-19 cases since April, when cases peaked at over 2,000 on a single day. Throughout the month of June, new cases hovered around 100 per day.
“Of course, we are happy that’s happening, but it will also make showing that the vaccine can prevent infection much more difficult,” Custers says. “You need a certain incidence rate to be able to do that.”
Custers says that, if needed, Johnson & Johnson could move testing to areas where infection rates are still high.
“It’s very hard to assess what the situation will be like in a couple months when we actually need to decide,” Custers says. “We’re monitoring the situation. We think it will be a potential issue for all the COVID-19 vaccines in development.”
Learning From Other Vaccines
In addition to the vaccines receiving BARDA funding in the US, there are approximately 140 COVID-19 vaccines in development around the world. Custers explains the race for a vaccine isn’t a competition—it’s a collaboration.
“No one knows who will be successful, so it’s important for the world to have multiple shots on goal, as we tend to say,” he says. “It’s also important because we learn from each other. We’re all in different stages and have slightly different approaches. The data we generate—in preclinical data, animal studies, and clinical studies—will enable all of us to move as quickly as possible.”
Timeline Challenges
While Johnson & Johnson and other biopharmaceutical companies are working as quickly as possible to create a usable vaccine, a definitive timeline is still impossible to give.
Custers says a number of factors influence timing. “Will the vaccines currently in development be successful?” he says. “Will we be able to show those vaccines work—is the COVID-19 incidence somewhere in the world high enough to be able to show the vaccine can protect people sufficiently?”
Even if both of those answers are yes, the scale of production is another challenge.
“We need to make a sufficient amount of vaccine,” Custers says. “At the beginning, there won’t be enough of the vaccine to offer it to the general public. I imagine healthcare workers and people at an increased risk of contracting COVID-19 will get the vaccine first. It’s not really up to us as a company.”
Custers says deploying a vaccine—assuming it has proven safe and effective—depends on when Johnson & Johnson receives emergency use authorization at a government level, like from the Food and Drug Administration.
Custers says his team is working hard to meet these supply demands.
“We are doing things in parallel. Manufacturing is ongoing, and we’re upscaling to be able to make as many vaccine doses as soon as possible,” he says. “Usually, you only do that when you know the vaccine is working.”
He says that while much remains uncertain, Johnson & Johnson is optimistic about their vaccine candidate.
“It’s very rewarding and motivating to work on this vaccine and be able to contribute something,” he says. “It’s a once in a lifetime opportunity—hopefully.”
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.
