Health Canada approves 1st RSV vaccine for people 60 and older

Health Canada has approved the first vaccine for respiratory syncytial virus (RSV) for adults age 60 and over, but it may only be available in "limited" quantities for this fall's respiratory virus season.

RSV is a common but highly contagious virus that appears like a common cold for most people. In more vulnerable populations, RSV can cause bronchiolitis — the inflammation of the small airways in the lung — or pneumonia, say experts. 

Health Canada approved manufacturer GSK's new vaccine called Arexvy on Friday. In an email to CBC News, the federal health body confirmed that it anticipates a limited supply of the vaccine will be available for the upcoming RSV season. 

This news comes after the U.S. Food and Drug Administration (FDA) gave their approval for the vaccine in May. 

"It will be a game changer in significantly preventing severe illness and death, especially amongst older Canadians," said Dr. Samir Sinha, the director of geriatrics at Sinai Health and University Health Network in Toronto. 

Doctors have been calling for an RSV vaccine for seniors because although the virus is common, people who are older are more likely to become severely ill and need hospitalization. 

"This has been decades long in the making," Dr. Isaac Bogoch, an infectious disease specialist with the University Health Network in Toronto, said of the vaccine's approval. 

"It's a very tough virus, it can have negative health impacts. It [can] lead to hospitalization, intensive care unit stays, even death,"  Bogoch added. "And it's wonderful to have a vaccine that … appears to significantly reduce the risk of severe lower respiratory tract disease." 

RSV not well-tracked in Canada: experts

It's unclear how many people 60 and older in Canada are hospitalized or die from the illness, as experts say it's not properly tracked.

According to Sinha, Canada isn't properly screening for RSV and the illness itself can be hard to detect — making the exact burden unclear. 

But he estimates that it can be similar to the rates of hospitalizations and death seen with influenza — if not worse as the virus can spread more rapidly and symptoms may take a few days to develop. 

In Canada, 12,200 people are hospitalized and 3,500 die from influenza annually. 

Vaccine offers more than 80% protection, says GSK

In a news release issued Friday, GSK said a randomized clinical trial showed the vaccine has an 82 per cent efficacy in preventing lower respiratory tract disease caused by RSV, compared to seniors who got a placebo.

The company said it also showed a 94 per cent efficacy in preventing the illness in seniors with underlying medical conditions.

"I think this vaccine will go a long way based on the results that are available … the vaccine appeared to be safe and appeared to provide very significant protection," said Bogoch. 

He added that if the infection spreads to the lower respiratory tract, it can make it hard for people to breathe so that they need "supplemental oxygen." This is when people typically end up in hospital. 

Sinha said RSV infections can also "trigger other problems in the body," like a bacterial or viral pneumonia. 

"So it's not necessarily that if you get RSV you're going to die of that infection, but what you might do is trigger other heart or other lung complications that then can actually cost you your life potentially," he said. 

National guidance for the shot expected in 2024

RSV season in Canada usually starts in the late fall and lasts until spring. 

Health Canada said the vaccine is a single dose injection, but it's unclear whether people will need to get the vaccine every year or a booster. 

St. Joseph's Healthcare Hamilton infectious disease physician Dr. Zain Chagla said available data suggests that people who get the vaccine will be protected for up to two years. 

But beyond that, he said further research is needed. 

"Hopefully this [vaccine] gets in before RSV season, but if an older adult accesses the vaccine afterwards, they still could get a couple years benefit," he said. 

In an email to CBC News, Health Canada said that guidance from the National Advisory Committee on Immunization (NACI) on the use of the vaccine is expected next year. 

It said that based on consultations with Canadian experts, NACI has "first prioritized (and is currently developing) advice for RSV products to protect infants before developing advice for older adults."

It added that it will be up to individual provinces and territories to decide if they will work Arexvy into their existing RSV programs — and if so, it will work with them individually. 

Experts like Sinha say they also hope the Canadian government considers covering the cost of the vaccine as that can often be a "barrier to access," especially in more vulnerable populations. 

Sinha said that as soon as the vaccine is made available, he'll be recommending that all his patients get the shot. 

What about kids? 

Last winter was an especially bad season of RSV in the country, specifically for young kids. 

In addition to seniors, infants are at a higher risk of getting very sick with RSV. 

There is no RSV vaccine for children, but there are two kinds of antibody injections that can be given to high-risk babies to help prevent serious illness.  

One of them, palivizumab, has often been given to babies who were born prematurely – but it needs to be injected about once a month during RSV season to stay effective. 

A new antibody drug – nirsevimab, also known by the brand name Beyfortus – was approved by Health Canada in April. Nirsevimab only requires one injection to protect babies during the RSV season. 

It's not yet known how widely it will be recommended for babies in Canada this fall.  

On Thursday, the Centers for Disease Control and Prevention (CDC) in the U.S. recommended that babies born just before or during the RSV season, as well as babies who are less than eight months old before the season starts, should get the nirsevimab shot. 

The CDC also recommended that the shot should be given to some eight to 19-month-old babies who are at higher risk of getting seriously ill from the virus.