Health Canada approves RSV vaccine for maternal immunization

Health Canada has approved a new vaccine geared toward protecting two groups most severely affected by the respiratory syncytialvirus (RSV): newborns, who would receive antibodies through maternal immunization, and Canadians over 60.

Pfizer Canada's bivalent vaccine, calledAbrysvo,aims to prevent lower respiratory tract disease caused by the virus.

It is the first RSVvaccine in Canada approved for use in pregnancy to provideprotection for infants from birth to six months of age, and the second approved for seniors aged 60 and over.

The U.S. Food and Drug Administration approved the vaccine for thosesame two groups in 2023.

RSV is a common but highly contagious respiratory virus that typically causes cold-like symptoms. For more vulnerable populations including infants, older adults or those with respiratory or cardiac conditions RSVcan lead to more severe illness, such as bronchiolitisor pneumonia, and potential hospitalization.

A one-shot dose of the Pfizer vaccine given to pregnant individuals during the third trimester (from 32 through 36 weeks) would produce antibodies that pass from parent to theinfant. Immunization during pregnancy is already recommendedfor other diseases, includingCOVID-19, influenzaand pertussis.

For older adults, the dose is also a single shot.

Last August, Health Canada approved another RSV vaccine for seniorsfrom manufacturer GSK. In spring 2023, the agency approved an antibody drug called nirsevimab to help protect newborns and infants from severe illness from RSV.

RSVis a leading cause of hospitalization in infants and young children.

"The first time that an infant encounters RSV and they have no prior immunity to the virus at all,that's when the virus has the greatest chance of getting from the upper respiratory tract and down into the lungs," explained Dr. Jesse Papenburg, a pediatric infectious diseases specialist at the Montreal Children's Hospital.

"When they have a lung infection, it's difficult for them to have to deal with those secretions in the lungs. They may require help in terms of oxygen support, ventilatory supportor IV hydration because they're having such a hard time breathing that they wind up not even being able to drink."

The availability of a vaccine given during pregnancy, as well as an antibody drug that can be given to newborns and infants, potentially could "substantially reduce the burden of RSV in Canadian children," he noted.

Consideration of availability, accessibility

According to Health Canada, federal officials will now work with provincial and territorial counterparts to determine interest, potential demand and timelines ofintroducingthese products into RSV vaccination programs.

"We're looking at the winter of 2024-25. That's when I would expect to see one or both of these products being available for use in Canada," Papenburg said.

Key factors include availability nirsevimab, for example, was approved in Canada in 2023 but there was none available due to extremely high demand in the U.S., Papenburg said and whether the products will be accessible to every Canadian who wants them.

"I'm a big proponent of universal vaccination programs, but we still can't neglect the cost of these universal vaccination programs on our health-care system. So these economic analyses are important to help us better decide how to use our health-care dollars," he said.

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The introduction ofnew tools to fightRSVcan't come soon enough, according Dr. Fatima Kakkar, a pediatric infectious diseases specialist and clinician-researcher at Sainte-Justine University Health Center in Montreal.

"They should be absolutely widely available. I think the provincial committees have a job to sort of make the official recommendations and encourage people and set up the optimal timing," she said.

"We can't really delay one or two years."

A spokesperson for Pfizer Canada said the company isassessing the availability of its RSV vaccine, consulting with different stakeholders regarding cost andon how to bring it to Canadians "as quickly as possible."

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Health Canada has approved the first respiratory syncytial virus (RSV) vaccine for pregnancy to protect infants from birth to six months of age. Pfizer Canada's bivalent vaccine, Abrysvo, is the second approved for seniors over 60.