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Moderna is developing a three-in-one vaccine against COVID-19, influenza and RSV.
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The vaccine maker is actively promoting the vaccine and expects regulatory approval next year.
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But without solid safety and efficacy data from clinical trials, it may never come to fruition.
Moderna is actively promoting a combination vaccine against COVID-19, influenza, and RSV, something that aims to address three of the most serious respiratory diseases circulating each year in one go.
But while a safe and effective vaccine would be welcome as Canada faces a Increase in pediatric RSV casesStubbornly high COVID hospitalizations i deaths i going up strong flu cases, the drug company has not released data to support the vaccine’s safety or effectiveness.
Moderna president Stephen Hoge told CBC News he expected the three-in-one vaccine to be submitted to Health Canada for regulatory approval within a year.
“We really think the triple combination (influenza, COVID, plus RSV) is really going to be the ideal vaccine for us every year,” he said in an interview this week.
“And honestly, it only takes one strike to try to prevent all of this, so we’re going to try to add as much money as possible to that dam and hopefully help protect people during winter seasons in the years to come.”
A child receives a COVID-19 vaccine at a Vancouver clinic in August. Less than seven percent of children under the age of five have received one dose of the vaccine, while only one percent have received two doses. (Ben Nelms/CBC)
“More questions than answers”
But without solid data from clinical trials, this combination 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 in a larger group as part of a randomized, double-blind study, is controversial. It has also raised concerns among vaccine researchers and infectious disease experts about the motivations behind the premature commercialization of the vaccine.
“There are still more questions than answers, obviously, with publications like this coming from companies without accompanying data,” said Matthew Miller, a vaccine researcher and associate professor of infectious disease and immunology at McMaster University.
“I think we have to be very cautious. We don’t have safety data, we don’t have efficacy or effectiveness data or age groups. How would you handle updating various components of this vaccine? Lots and lots of questions.”
Alyson Kelvin, a virologist at the University of Saskatchewan’s Infectious Diseases and Vaccines Organization, said that while the flexibility of mRNA technology for future vaccines is “exciting,” it is essential to see safety data and efficacy of clinical trials.
“What does it aim to do? Does it aim to reduce disease, block infection or reduce hospitalization? And is it effective at what it says it’s supposed to do?” she said “It’s always better to have the data to back up your claims.”
Dr. Isaac Bogoch, an infectious disease physician at Toronto General Hospital and a member of Ontario’s COVID-19 vaccine task force, said it is not yet known what level of protection a vaccine would provide against RSV or how often vaccinations would be needed.
“Now I would be very careful to assume that you need to make a three-in-one vaccine that is given annually,” he said. “Clearly, we need vaccines for all three, but we don’t know what the vaccination frequency will be.”
Health Canada said in a statement to CBC News that it would only authorize new vaccines if the independent and comprehensive scientific review of all the data included in the submission showed that the benefits of the vaccine outweigh the potential risks to the Canadian population.
Hoge said Moderna is also being developed independently RSV i flu vaccines, a combined COVID-flu vaccine and a combined COVID-RSV vaccine, which are still in clinical trials.
LOOK | Concerns are growing over the triple threat of rising COVID, flu and RSV
Concerns are growing over the triple threat of an increase in respiratory diseases
The Ontario Medical Association is urging people to wear masks indoors and get vaccinated against the flu and COVID-19 as concerns grow that a surge in flu cases could overwhelm an already overwhelmed health care system sees an influx of RSV and COVID patients.
“We have all kinds of combinations, all in clinical trials,” he said. “More than that, we’re actually expanding into a number of other viral infections.”
Hoge said the biotech company hopes to use the mRNA platform to develop vaccines targeting viruses that cause certain types of cancer, multiple sclerosis and birth defects, among others, as well as 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’s concrete data to back them up.
Reduction in vaccination against COVID in the last 6 months
Drug companies usually wait until Phase 3 trials are completed before actively promoting their products in the media, but the urgent need for vaccines and treatments in the pandemic has accelerated the controversial strategy of science by press release.
Moderna’s comments come just days after Pfizer announced the results of phase 3 clinical trials of its RSV vaccine in a Press releasewhich suggested that the vaccine was 81.8% effective in infants from birth to the first 90 days of life and remained nearly 70% effective at six months.
It also comes after the company’s share price fell nearly 30 percent since the following January third quarter earnings weaker than expected and a decline in the uptake of the COVID-19 vaccine in Canada and around the world.
Fewer than one in five Canadians have received a booster or completed an initial series of vaccines in the last six months, although more than 84% of Canadians aged five and over have received at least two doses. But for children under five, less than seven percent have received one dose of the vaccine, while only one percent have received two doses.
“Obviously, it’s tremendously concerning and disappointing because there are still a large number of hospitalizations and deaths among Canadians as a result of the virus and those are actually preventable with boosters and vaccines,” Hoge said.
“I hope that over time, as we work through the pandemic phase and the endemic phase, [prevention] it becomes something that people are more used to and usually accept.”
But it’s important to note that Moderna is still a for-profit company that sells a product to consumers, according to Hoge. cashing in over US$165 million in stock options last year, on top of his $18.2 million salary, up more than 40% from 2020.
Fewer than one in five Canadians have received a COVID-19 booster or completed an initial round of vaccines in the past six months. (Evan Mitsui/CBC)
Challenges with vaccine development
Developing a vaccine for RSV, let alone combining one with COVID and influenza, is no small feat, and complications around dosing, timing, and age considerations could pose major challenges for the vaccine maker in the future
“Having a single formulation increases the complexity of updating that formulation annually,” said Miller of McMaster University in Hamilton.
“So now instead of dealing with four strains of flu, you’re adding RSV and COVID and having a combination vaccine could be more complex in some ways than having separate formulations that are given together at the same time.”
Miller said it’s also unknown whether getting a combination shot would be as effective as multiple shots, and which age groups would be best suited for an RSV vaccine, given that adults younger than 65 don’t usually get serious illnesses like babies and the elderly do. .
“It’s not as simple as saying, ‘Let’s vaccinate everybody once a year with this’ … and so I don’t think having a combination vaccine is a panacea,” he said.
“There are differences in both conventional flu vaccines and mRNA-based COVID vaccines in the doses. Older 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 is true that RSV may be irrelevant to healthy adults in terms of the severity of the disease, they are still part of the chain of transmission that affects vulnerable infants and the elderly.
“It is important that everyone else who can be infected and transmit the virus is addressed who are a link in the chain of transmission,” said the virologist. “And being protected will help prevent the virus from infecting vulnerable people.”
Bogoch said that while there’s nothing inherently wrong with combining multiple targets in a vaccine, it’s important to show that the strategy is safe and effective before drug companies start bundling them together and promoting an annual vaccine.
A person draws a dose of Moderna during a COVID-19 vaccination clinic in St. Lawrence College in Kingston, Ontario on January 2. (Lars Hagberg/The Canadian Press)
“Look, we have measles, mumps and rubella, diphtheria, tetanus and whooping cough like this is great. Fewer needles, more uptake, it’s remarkable,” he said.
“The real problem here is that we don’t know what the future holds for booster vaccines for COVID-19, and we know even less about RSV.”
Previous attempts at an RSV vaccine have been disastrous in the past, when two infants died in the 1960s having experienced severe lung inflammation during their first RSV infection after vaccination.
While concerns about early vaccines slowed the development of others against RSV, the World Health Organization said recent advances in understanding the biology of the virus have led to the clinical development of several potential vaccines , although none have yet received…