COVID-19 has upended our lives, and we’ve all heard that there will be no return to “full normal” until there is a vaccinefor SARS-CoV-2, the coronavirus that has caused the pandemic. But how long will that take? What steps need to happen along the way? And where are we now? Here’s a closer look.
How long will it take to develop a vaccine against the coronavirus?
Chris Glover looks at the process involved in developing a vaccine the whole world is waiting on. 3:03
How is vaccine development going for COVID-19?
The good news: it’s going much faster than normal.
The first human vaccine trials began in March, just two months after the virus and the disease were identified. With the SARS epidemic in 2003, it took 20 months for a vaccine to get to the stage where it was ready for human testing —although the vaccine was never developed, as the epidemic was over by then.
How do scientists come up with vaccine candidates?
Vaccines work by introducing your immune system to a germ or a piece of a germ so it will recognize it and learn to fight it off. Strategies for targeting the new coronavirus include using:
A weakened but “live” virus.
A dead or inactivated virus.
A recognizable component or piece of the virus such as a protein or sugar.
Genetically engineered RNA or DNA — this is a new approach being tried for this coronavirus. In most cases, it targets genetic material with instructions for making the S-protein, which forms the crown-like spikes on the surface that gives coronavirus its name and bind to human cells to infect them.
Initial lab tests in petri dishes and test tubes show whether a particular approach has the potential to be effective as a vaccine.
As of May 15, the World Health Organization reported that there were 110 candidate vaccines in preclinical evaluation around the world, and eight in human phase 1 and phase 2 trials. (Dado Ruvic/Illustration/Reuters)
What is preclinical evaluation?
Tests that don’t involve humans are called “preclinicial.”
Once a vaccine candidate shows promise in the lab, tests are run in animals to show it is safe and effective.
The World Health Organization says those tests are used to help:
Ensure none of the ingredients are toxic or react with trace impurities to produce toxic effects, and they don’t interact negatively with other vaccines given at the same time.
Determine the dose needed to induce an immune response.
However, animals don’t necessarily react the same way as humans to either an infectious agent such as a virus or to a vaccine. That’s why vaccines that make it through preclinical evaluation don’t necessarily go on to become vaccines.
What is a phase 1 clinical trial?
Once a vaccine has been shown to be safe and effective in animals, the first tests on human volunteers — phase 1 clinical trials — are run primarily to test for safety.
They typically involve10 to 100 healthy adults, even if they aren’t the target age group. According to the U.S. Centers for Disease Control, they’re intended to find out:
Is the vaccine safe?
Does it work?
Are there any serious side effects?
How is the size of the dose related to the side effects?
The phase 1 coronavirus vaccine trial being run in Halifax began with “very healthy volunteers” between the ages of 18 and 55. Volunteers older than 65 will be added if early trials show the vaccine is safe.
Volunteers are typically monitored for six to 12 months, but phase 2 trials can begin before phase 1 is complete if the vaccine seems safe. That’s what is happening with some coronavirus vaccine trials, which are starting phase 2 after only a few weeks of successful phase 1 trials.
This is a medical illustration of the new coronavirus, SARS-CoV-2. Many vaccine researchers are focusing on the virus’ spike protein, the cone-shaped structures shown here in green. (Maria Voigt/RCSB PDB)
What is a phase 2 clinical trial?
The larger phase 2 trial involves several hundred healthy volunteers, this time from the group targeted for the vaccine. The key questions at this stage are:
What are the most common short-term side effects?
How are the volunteers’ immune systems responding?
What is the optimal dose for the vaccine and when should it be administered?
This phase usually involves even more volunteers —up to 30,000 people — from the population susceptible to the disease, which includes all ages in the case of COVID-19. Key questions at this point are:
Is the vaccine effective in protecting against the disease in the type of patient likely to use it?
Is the dose correct?
Is the vaccine safe?
What are the most common side effects?
Are there any side effects or reasons why certain people should not be given the vaccine?
Phase 3 can last years.
A scientist examines COVID-19 infected cells under a microscope during research for a vaccine against the coronavirus disease at a laboratory of BIOCAD biotechnology company in Saint Petersburg, Russia on May 20, 2020. (Anton Vaganov/Reuters)
After that, how does a vaccine get approval?
In Canada, manufacturers apply for approval by filing a New Drug Submission with Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. It needs to include:
Scientific and clinical evidence that the vaccine is safe, effective and of high quality.
Information about the manufacturing facility, method of production and quality controls for making the vaccine.
Health Canada evaluates the data to verify that:
The vaccine is safe.
It is effective.
The benefits outweigh the risks.
It also reviews procedures for safety monitoring once the vaccine is in use.
If the vaccine meets requirements, it is issued a Drug Identification Number (DIN) and a Notice of Compliance (NOC) and authorized for sale in Canada.
Can a vaccine that isn’t approved be distributed in Canada in emergencies?
Yes, during public health emergencies such as pandemics, Health Canada can issue special authorizations for vaccines that aren’t approved in Canada. For example, in 2009, Health Canada used an interim order to approve an H1N1 vaccine based on clinical trial data in Europe, even though clinical trials had only just started that same week in Canada.
In this March 16, 2020 file photo, Neal Browning receives a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle. The vaccine by Cambridge, Mass.-based Moderna Inc., generated antibodies similar to those seen in people who have recovered from COVID-19 in a study of volunteers who were given either a low or medium dose. (Ted S. Warren/The Associated Press)
Once a vaccine is approved, is the research over?
No. Vaccines need to be monitored after use, partly because some side effects happen so rarely that they’re only detectable in a very large population, bigger than any clinical trial.
Health-care providers are asked to report adverse reactions to their local health units, and manufacturers must report all serious adverse reactions both in Canada, and internationally, to Health Canada within 15 days. The public can also voluntarily report adverse reactions to Health Canada.
Many vaccines also have formal ongoing “phase 4” studies that continue after the vaccine is approved and in use.
In response to safety reports or other new information, Health Canada can also order manufacturers to assess their product’s risks and benefits or perform further tests and studies on its safety and effectiveness at any time.
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.
