Moderna is developing a three-in-one vaccine against COVID-19, influenza and RSV. The vaccine manufacturer is actively promoting the vaccine and hopes for regulatory approval next year. But without solid safety and efficacy data from clinical trials, it may never come to fruition.
Moderna is actively promoting a combined vaccine against COVID-19, influenza and RSV, which targets three of the most serious respiratory diseases released each year with a single vaccine. But while a safe and effective vaccine would be welcome as Canada faces a increase in pediatric RSV casesstubbornly high COVID hospitalization and deaths and rises sharply flu cases, the drug company has not published data to support the vaccine’s safety or effectiveness. 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 think that the triple combination — influenza, plus COVID, plus RSV — is really going to be the ideal shot to get every year,” he said in an interview this week. “And frankly it only takes one shot to try to prevent all of that, and so we’re going to try to add as much money as possible to that plan and hopefully help protect people during the winter periods in the coming years. “ A child gets a vaccine for COVID-19 at a Vancouver clinic in August. Less than seven percent of children under five have received one dose of vaccine – while just 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 be realized. Moderna’s decision to promote its vaccine before the completion of Phase 3 clinical trials — in which the vaccine will be tested on a larger group as part of a randomized, double-blind study — is controversial. It has also raised concerns from vaccine researchers and infectious disease experts about the motivations behind making the vaccine available early. “There are even more questions than answers, obviously, with releases like this coming 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 have to be very careful. We have no data on safety, no data on efficacy or effectiveness or age groups. How would you handle updating the various components of this vaccine? Lots and lots of questions.” Alyson Kelvin, a virologist at the Vaccine and Infectious Diseases Agency at the University of Saskatchewan, said that while the versatility of mRNA technology for future vaccines is “exciting,” it is necessary to see safety and efficacy data from clinical trials. “What does it claim to do? Does it claim to reduce disease, or prevent infection, or reduce hospitalization? And is it effective at what it says it’s supposed to do?” he 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 an RSV vaccine will provide or how often shots will be needed. “I would be very cautious now to assume that a three-in-one vaccine that is given annually needs to be created,” he said. “Clearly, we need vaccines for all three, but we don’t know what the frequency of vaccination will be.” Health Canada said in a statement to CBC News that it would only approve new vaccines if an independent and thorough scientific review of all the data included in the submission showed that the benefits of the vaccine outweighed the potential risks to the Canadian population. Hoge said Moderna is also growing autonomously RSV and flu vaccines, a combination vaccine for COVID and influenza, and a combination vaccine for COVID and RSV — all of which are still in clinical trials. WATCHES | Concerns are growing about the triple threat increase of COVID, influenza and RSV
Concerns are growing over the triple threat of rising respiratory diseases
The Ontario Medical Association is urging people to wear masks indoors and get their flu and COVID-19 shots, as it worries a surge in flu cases could overwhelm a health care system already seeing an influx of patients with RSV and COVID-19. “We have all kinds of combinations, all in clinical trials,” he said. “Beyond that, we’re actually expanding to a number of other viral infections.” Hoge said the biotech 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 seriously until there’s concrete data to back them up.
Lowest uptake of COVID vaccine in last 6 months
Drug companies typically wait until Phase 3 trials are complete before actively promoting their products to the media, but the urgent need for vaccines and treatments in the pandemic has accelerated its controversial strategy science with press release. Moderna’s comments come days after Pfizer announced results of Phase 3 clinical trials for its RSV vaccine in Press releasewhich suggested the vaccine was 81.8 percent effective in infants from birth to the first 90 days of life and remained nearly 70 percent effective at six months. It also comes after the company’s share price has fallen nearly 30% since the following January lower than expected third quarter earnings and declining uptake of COVID-19 vaccines 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 per cent of Canadians five years and older have received at least two doses. But for children under five, less than seven percent have received one dose of the vaccine – while just one percent have received two doses. “It’s obviously terribly concerning and disappointing because there are still high numbers of hospitalizations and deaths among Canadians as a result of the virus, and those are actually preventable with boosters and vaccines,” Hogg said. “I hope that over time, as we work through the pandemic phase and the endemic phase, [prevention] it becomes something that people get 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, with Hoge reportedly cashing in more than US$165 million in stock options last year on top of his $18.2 million salary — more than 40 percent higher than in 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 related to dosing, timing, and age could pose major challenges for the vaccine maker in Continuity. “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 strains of flu, you add RSV and COVID, and getting a combination vaccine can actually be more complicated in some ways than having separate formulations co-administered at the same time.” Miller also said it’s unknown whether getting a combination vaccine would be as effective as multiple shots, and which age groups would be best suited for an RSV vaccine, given that adults under 65 don’t tend to get severe disease from it as infants and the elderly. . “It’s not as simple as just saying, ‘Let’s vaccinate everybody once a year with this’ … and so I don’t think having a combination vaccine is going to be a panacea,” he said. “There are differences in both conventional flu vaccines and mRNA-based COVID vaccines in doses. The elderly benefit from higher doses, we have different doses for adults, we have different doses for children — so there’s a lot of difference and complexity.” Kelvin said that while it is true that RSV may be insignificant to healthy adults in terms of disease severity, they are still part of the chain of transmission that affects vulnerable infants and the elderly. “It is important that everyone else who can become infected and transmit the virus should consider that they are a link in the chain of transmission,” the virologist said. “And protection will help stop the virus from infecting vulnerable people.” Bogoch said that while there is nothing inherently wrong with combining multiple targets in a vaccine, it is important to prove that the strategy is safe and effective before drug companies start combining them and promoting an annual vaccine. A person draws a dose of Moderna during a COVID-19 vaccine clinic at the College of St. Lawrence in Kingston, Ont., on Jan. 2. (Lars Hagberg/The Canadian Press) “Look, we’ve got measles, mumps and rubella, diphtheria, tetanus and whooping cough like that which is fantastic. Fewer needles, more uptake – it’s remarkable,” he said. “The real issue here is that we don’t know what the future holds for booster vaccines for COVID-19, and we know even less for RSV.” Previous attempts at an RSV vaccine have proven disastrous in the past, when two infants died in the 1960s after severe lung inflammation during the first RSV infection after vaccination. Although concerns about an early vaccine have slowed the development of others for 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 — though none have yet taken off. .
