Moderna is actively promoting a combined COVID-19, flu and RSV vaccine, something that aims to target three of the most serious respiratory illnesses circulating each year in a single shot.
But while a safe and effective vaccine would be welcome as Canada faces asurge in pediatric RSV cases, stubbornly high COVIDhospitalizations anddeaths andsteeply rising flu cases, the pharmaceutical company hasn’t released data to support the vaccine’s safety or efficacy.
Moderna president Stephen Hoge told CBC News he hoped the three-in-one vaccine would be submitted to Health Canada for regulatory approval within a year.
“We really do think that the triple combo — the flu, plus COVID, plus RSV — is really going to be the ideal shot for us to get every year,” he said in an interview this week.
“And honestly it just takes one shot to try and prevent all of that, and so we’ll try and add as much bang for the buck into that shot as we can and hopefully help protect people through winter seasons in the years to come.”
A child gets a COVID-19 vaccine at a Vancouver clinic in August. Fewer than seven per cent of kids under five have received one dose of vaccine — while just one per cent have received two doses. (Ben Nelms/CBC)
‘More questions than answers’
But without solid data from clinical trials this combined vaccine may never come to fruition.
Moderna’s decision to promote its vaccine before completing Phase 3 clinical trials — in which the vaccine would be tested on a larger group as part of a randomized, double-blind study — is controversial. It’s also raised concerns from vaccine researchers and infectious diseases experts about the motivations behind prematurely marketing the shot.
“There’s still more questions than answers, obviously, with releases like this that come from companies without accompanying data,” said Matthew Miller, a vaccine researcher and associate professor of infectious diseases and immunology at McMaster University.
“I think we need to be really cautious. We have no data on safety, no data on effectiveness or efficacy or age groups. How would you handle updating various components of that vaccine? Lots and lots of questions.”
Alyson Kelvin, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, said that while the flexibility of mRNA technology for future vaccines is “exciting,” it’s essential to see safety and efficacy data from clinical trials.
“What is it claiming to do? Is it claiming to reduce disease, or block infection or reduce hospitalization? And is it effective in what it’s saying it’s supposed to do?” she said. “It’s always best to have the data to back up your claims.”
Dr. Isaac Bogoch, an infectious diseases physician at Toronto General Hospital and member of Ontario’s COVID-19 vaccine task force, said it’s not yet known what level of protection an RSV vaccine would provide or how frequently shots would be needed.
“I would be very careful now to assume that making a three-in-one vaccine that’s administered annually is needed,” he said. “Clearly, we need vaccines for all three, but we don’t know what the frequency of vaccination is going to be.”
Health Canada said in a statement to CBC News it would only authorize new vaccines if the independent and thorough scientific review of all data included in the submission showed that the benefits of the vaccine outweighed the potential risks for the Canadian population.
Hoge said Moderna is also developing standaloneRSV andflu vaccines, a combination COVID and flu shot and a combined COVID and RSV shot — all of which are still in clinical trials.
The Ontario Medical Association is urging people to wear masks indoors and get their flu and COVID-19 shots as concern builds that a spike in flu cases could overwhelm a health-care system already seeing an influx of RSV and COVID patients.
“We’ve got all kinds of combinations, all in clinical trials,” he said. “Beyond that, we’re actually expanding into a range of other viral infections.”
Hoge said the biotechnology company hopes to use the mRNA platform to develop vaccines that target viruses that cause certain types of cancer, multiple sclerosis and birth defects, among others — in addition to developing treatments for cancer and some rare diseases.
But while it all sounds promising, Moderna’s claims should be taken with a grain of salt until there is concrete data to back them up.
Lower COVID vaccine uptake in past 6 months
Pharmaceutical companies typically wait until Phase 3 trials are finished before actively promoting their products in the media, but the urgent need for vaccines and treatments in the pandemic has accelerated the controversial strategy ofscience by press release.
Moderna’s comments come just days after Pfizer announced Phase 3 clinical trial results for its RSV vaccine in apress release, which suggested the shot was 81.8 per cent effective in infants from birth to the first 90 days of life and remained almost 70 per cent at six months.
It also comes after the company’s stock price dropped close to 30 per cent since January followingweaker-than-expected third-quarter earnings and a decline in COVID-19 vaccine uptake in Canada and around the world.
Fewer than one in five Canadians have gotten a booster or completed an initial vaccine series in the last six months, though more than 84 per cent of Canadian five and older have received at least two doses. But for kids under five, fewer than seven per cent have received one dose of vaccine — while just one per cent have received two doses.
“It’s obviously tremendously concerning and disappointing because there still are large numbers of hospitalizations and deaths among Canadians as a result of the virus and these are preventable really with boosters and vaccines,” Hoge said.
“I do hope that over time, as we kind of work through the pandemic phase and into the endemic phase, [prevention] becomes something people are more used to and normally accept.”
But it’s important to note that Moderna is still a for-profit company selling a product to consumers, with Hoge reportedlycashing out more than $165 US million in stock options last year on top of his $18.2 US million salary — over 40 per cent higher than in 2020.
Fewer than one in five Canadians have gotten a COVID-19 booster or completed an initial vaccine series in the last six months. (Evan Mitsui/CBC)
Challenges with developing vaccine
Developing a vaccine for RSV, let alone combining one with COVID and flu, is no small feat — and the complications around dosing, timing and age considerations could pose major challenges for the vaccine maker down the road.
“Having a single formulation increases the complexity of updating that formulation annually,” said Miller, at McMaster University in Hamilton.
“So now, instead of dealing with four flu strains, you’re adding in RSV and COVID and having a combined shot might actually be more complex in some ways than having separate formulations that are co-administered at the same time.”
Miller said it’s also unknown if getting one combined shot would be as effective as multiple shots and what age groups would be most appropriate for an RSV vaccine given that adults under 65 don’t tend to experience severe disease from it like infants and the elderly do.
“It’s not as simple as just saying, ‘Let’s just vaccinate everybody once a year with this’ … and so I don’t think that having a combined vaccine is going to be a panacea,” he said.
“There are differences both in conventional flu vaccines and in mRNA-based COVID vaccines in doses. Elderly people benefit from higher doses, we have other doses for adults, we have other doses for children — so there’s a lot of nuance and complexity.”
Kelvin said that while it’s true RSV might be inconsequential to healthy adults in terms of severity of disease, they are still part of the transmission chain that affects vulnerable infants and seniors.
“It’s important that everyone else who can be infected and transmit the virus is addressing that they’re a link in the transmission chain,” the virologist said. “And being protected will help stop the virus from infecting vulnerable people.”
Bogoch said that while there’s nothing inherently wrong with combining multiple targets into one vaccine, it’s important to prove that strategy is safe and effective before pharmaceutical companies start bundling them together and promoting an annual shot.
A person draws out a Moderna dose during a drive-through COVID-19 vaccine clinic at St. Lawrence College in Kingston, Ont., on Jan. 2. (Lars Hagberg/The Canadian Press)
“Look, we have measles mumps and rubella, diphtheria, tetanus, and pertussis like this is fantastic. Fewer needles, greater uptake — it’s remarkable,” he said.
“The real issue here is we don’t know what the future lies for with regards to COVID-19 booster vaccines, and even less we know about RSV.”
Previous attempts at an RSV vaccine have proved disastrous in the past, whentwo infants died in the 1960s after experiencing severe lung inflammation during their first RSV infection following vaccination.
Though concerns over the early vaccine slowed development of others for RSV, the World Health Organization said that recent advances in the understanding of the biology of the virus have led to the clinical development of several potential vaccines — though none have yet received regulatory approval.
While the mRNA vaccine technology has saved countless lives around the world from COVID during the pandemic and succeeded at keeping many Canadians out of hospital, it will take time to see whether the platform is as successful with other viruses.
“It is great that we have this brand-new vaccine platform that’s really flexible and can be deployed quite readily against multiple classes of pathogens,” said Miller.
“But we still need to see data, we still need to see the vaccine’s effectiveness, we need to see that the safety profile is acceptable and we need to understand things about doses and frequency of boosters.”
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.
