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Moderna is banking on a combined COVID, flu and RSV vaccine. Will it work?

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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 a surge in pediatric RSV cases, stubbornly high COVID hospitalizations and deaths and steeply 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 standalone RSV and flu 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 of science by press release.

Moderna’s comments come just days after Pfizer announced Phase 3 clinical trial results for its RSV vaccine in a press 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 following weaker-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 reportedly cashing 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, when two 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.”

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Helping people living with dementia ‘flourish’ through dance

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Dr. Pia Kontos, a Senior Scientist at UHN’s KITE Research Institute, is co-leading an initiative to help people living with dementia flourish. (Photo: Tim Fraser/UHN KITE Studio)

Dr. Pia Kontos believes in the power of the arts to support people to live well with dementia.

The Senior Scientist at UHN’s KITE Research Institute focuses on challenging policies and practices that discriminate against those living with dementia and developing and evaluating arts-based and digital knowledge translation initiatives to reduce stigma, improve social inclusion and quality of care for them.

“The predominant assumption is people living with dementia don’t have the capacity to be creative,” says Dr. Kontos, who is also a professor in the Dalla Lana School of Public Health at the University of Toronto. “However, we know through extensive research that dance…powerfully supports people living with dementia to be creative and to flourish.

“And flourishing should be a goal that we all have.”

Dr. Kontos co-produced in 2023 Dancer Not Dementia, a short documentary film. It captured the power of a dance program for seniors – Sharing Dance Older Adults (SDOA) – to challenge the stigma associated with dementia, support social inclusion and enrich lives. It’s told through the eyes of residents and staff at Alexis Lodge Dementia Care Residence and Cedarhurst Dementia Care Home in Toronto.

SDOA was jointly developed by Canada’s National Ballet School (NBS) and Baycrest Centre in 2013 for older adults with a range of physical and cognitive abilities, including dementia.

Typically, dance programs in dementia care settings are provided as a therapeutic intervention for older adults. However, SDOA’s goal is to provide a creative outlet for participants and opportunities for social interaction with other people living with dementia, staff and loved ones.

Now, Dr. Kontos will look to incorporate traditions from marginalized communities into SDOA through a $750,000 Canadian Institutes of Health Research (CIHR) Institute of Aging Implementation Science Team Grant. Dr. Rachel Bar, Director of Research and Health at NBS is co-principal applicant for the grant.

This CIHR funding supports projects that evaluate the effectiveness of existing programs, services and models of care that show promise for those impacted by cognitive impairment and dementia. An important focus is improving equitable and inclusive access to care and support.

The three-year grant to Drs. Kontos and Bar will support SDOA efforts to partner with organizations in Black, Chinese and South Asian communities to integrate their cultural practices into its programming.

Training dancers from these communities to teach the adapted program is central to these partnerships.

“People living with dementia from marginalized communities rarely have their traditions honoured with art and leisure programming,” says Dr. Kontos.

“It’s important to align dance programs with the cultural traditions of these communities. Otherwise, the music and movements wouldn’t reflect the experiences of ethno-culturally diverse populations, and the programs wouldn’t be inclusive.

“We wouldn’t be supporting their capacity to be creative or to be in relationships with others through dance. We would be falling short.”

SDOA has already partnered with Alexis Lodge, Alzheimer Society of Canada, Baycrest, NBS, Indus Community Services, Social Planning Council of Ottawa, and Yee Hong for this initiative.

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CDC: Heat may have contributed to four human cases of bird flu in Colorado

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Credit: Alexas Fotos from Pexels

Heat probably played a role in at least four cases of bird flu in poultry workers confirmed by U.S. health officials Sunday—the first cases in poultry workers in two years.

Sweltering temperatures in Colorado rose to at least 104 degrees, which is suspected to have contributed to the human cases, according to Dr. Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention. The barns where poultry workers were culling chickens were “no doubt even hotter,” Shah said during a press conference on the most recent outbreak of bird flu in humans.

The new cases bring the U.S. total to at least nine cases since the first human case of the current outbreak was detected in 2022, also in a Colorado poultry worker. Eight of the nine were reported this year.

The workers were separating chickens that were going to be killed to stop the spread of the virus. The fans may also have contributed to the human infections because, while helping to keep the environment cooler, they “also spread things like feathers around which are known to carry the virus,” Shah added.

The large and strong fans also make it difficult for protective goggles and face masks to stay in place, he said.

About 60 workers at the poultry farm showed symptoms of illness and were tested for bird flu. Four tested positive for bird flu and one additional presumptive case is awaiting confirmation.

The illnesses were relatively mild, with symptoms including conjunctivitis and common respiratory infection symptoms like fever, chills, coughing, and runny nose, according to the CDC. None were hospitalized, officials said. The other U.S. cases have also been mild.

Officials said they are bracing for more cases.

The CDC says the risk to the general public remains low and the health agency is not recommending livestock workers be vaccinated against bird flu given the “mild symptoms noted thus far,” Shah said.

An initial analysis of virus samples from an infected poultry worker does not show any changes in the virus that would make it easier to spread among people and there is no evidence of person-to-person spread in the U.S.

“It’s important to note that this assessment is based on what we know today and may change,” Shah said. “CDC is constantly looking for key changes that may alter our risk assessment of the virus, such as the severity of illness that it causes, the ease with which it can transmit to humans or changes to its genetic fingerprint.”

At the request of Colorado’s officials, the CDC sent a 10-person team to Colorado to help the state manage the bird flu outbreak in humans and poultry. The team included epidemiologists, veterinarians, clinicians and industrial hygienists.

Shah also noted it was a bilingual team. Overall in the U.S., it is estimated about half of farm workers are Latino.

An analysis of the virus from an infected worker indicates that the infections at the chicken farm are “largely the same” as the strain detected in dairy herds in Colorado and other states, according to Shah. But an investigation is ongoing to determine exactly how the outbreak is spreading between wild birds, chicken and cattle.

Since 2022, a highly contagious strain of bird flu has spread across the U.S. at an unprecedented rate.

Georgia’s powerhouse poultry industry, which produces more broiler chickens than any other in the country, has mostly dodged the kinds of major outbreaks that have resulted in the deaths of more 90 million birds in commercial and backyard poultry flocks in the U.S.

About 1.8 million chickens will be killed at the Colorado poultry farm after these latest bird flu cases were detected.

In late 2023, ducks at a commercial breeding farm in Sumter County, Georgia, tested positive for H5N1. This year, in March, the virus made a jump to a mammal species that surprised many scientists: cows.

With a significant dairy industry, plus even larger beef and poultry interests, the potential arrival of the virus here threatens Georgia’s economy and the health of residents.

As of Monday, the H5N1 virus has been confirmed in 158 dairy herds in 13 states, according U.S. Agriculture Department.

So far in Georgia, there have been no bird flu cases in cattle, and there have been no human cases.

Since the unprecedented spread of H5N1 in poultry in 2022, the Georgia Department of Public Health has quietly monitored 132 people for signs of the virus, according to DPH spokeswoman Nancy Nydam. Those tracked were either first responders to one of the state’s few virus outbreaks in backyard and commercial poultry flocks or farmworkers where the infections occurred. Of those monitored, fewer than 10 people were tested for H5N1 and none came back positive.

Since the virus was discovered in cattle, a small number of first responders from Georgia who went to other states to help with investigations—fewer than 15—have also been monitored for signs of illness.

Federal officials said Tuesday they still believe they can eliminate the bird flu virus from , even as the number of herds infected continues to grow. The latest state to recently report infected dairy cattle was Oklahoma. North Carolina is the only state adjacent to Georgia to report an infected dairy herd.

Eric Deeble, acting senior adviser for the H5N1 response at the USDA, said investigations show the is spreading among cattle through cattle moved from one herd to another and the shared use of milking equipment. It can be contained through enhanced biosecurity measures such as thoroughly cleaning milking “parlors” and equipment, separating sick cows, and having dairy workers wear protective equipment.

Deeble also noted USDA scientists are also working with partners to develop a cattle-specific H5N1 vaccine—a process requires many steps and will take time.

The USDA is also exploring the possibility of developing a poultry vaccine as the number of cases soar, and outbreaks lead to the slaughter of millions of farmed birds. But USDA and industry stakeholders point to challenges that would hinder a vaccination program.

The biggest sticking point is around trade.

Mike Giles, president of the Georgia Poultry Federation, said mass vaccination would be impractical for several reasons, including the fact that the industry would lose its lucrative export market: The United States and many of its trade partners restrict the import of products or eggs from countries affected by the highly pathogenic strain or flocks that have been vaccinated against it.

“(Bird flu) has been, from an animal health standpoint, our top concern,” Giles said. “The challenge, and I think the industry has responded to it well, has been maintaining the state of preparedness and urgency and focus on biosecurity, and I think that has been accomplished.”

2024 The Atlanta Journal-Constitution. Distributed by Tribune Content Agency, LLC.

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Here is the new guidance for RSV vaccines

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Health officials recently changed the guidelines for respiratory syncytial virus vaccines. Here’s what Canadians need to know about the guidance and the virus itself.

New guidance on vaccines

As of July 12, the National Advisory Committee on Immunization (NACI) now recommends RSV vaccines for individuals who are 75 years old and older, especially those who have a greater risk of developing severe RSV.

Based on current evidence and expert opinion, NACI said in a news release, it also strongly recommends vaccines for those aged 60 and older who live in nursing homes and other chronic care facilities.

What is RSV?

RSV is a common contagious virus that often causes bronchiolitis, a lung infection, and pneumonia.

Infants face the highest risk of developing severe RSV disease, however, this risk also increases with age and with certain medical conditions, according to the Public Health Agency of Canada (PHAC). It can lead to serious complications for older people, including hospitalization and death.

What are the symptoms?

RSV typically causes mild, cold-like symptoms that usually begin two to eight days after exposure to the virus, according to PHAC.

Those with RSV may experience a runny nose, coughing, sneezing, wheezing, fever and less appetite and energy. Infants may be irritable, have trouble breathing and have less appetite and energy.

What is the treatment?

RSV infections are usually mild and last about one to two weeks. If you are infected, health officials recommend you stay home and limit contact with others.

They also recommend lots of rest and drinking plenty of fluids. Take over-the-counter products, such as acetaminophen or ibuprofen, if you have a fever. Seek immediate care or go to the hospital if you’re having trouble breathing or become dehydrated, PHAC adds.

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