Good newsCanada Becomes First to Authorize Moderna’s mRNA Flu and Flu-COVID Shots
Health Canada has authorized Moderna’s mRNA flu vaccine and a combined flu and COVID-19 shot for adults 50 and older, the first country to clear both. A 40,000-person trial found the flu shot more effective than a standard one.
Read the bad side of this story
New mRNA Flu Shots Miss This Season and Reach Only Canadians Over 50
For the first time, a regulator has cleared both of Moderna’s mRNA vaccines for influenza. Health Canada authorized the company’s flu vaccine, mFLUSIVA, and its combined flu and COVID-19 vaccine, mCOFLU, on Thursday 5 November. Both are approved for adults aged 50 and older. Moderna says Canada is the first country to authorize both.
The decision matters beyond Canada because it adds a second major regulator to an approval that was far from certain a few months ago. The flu shot is the first of its kind: no mRNA influenza vaccine had been cleared anywhere before the US Food and Drug Administration approved this one in August.
What was approved
The two products do different jobs. mFLUSIVA protects against seasonal influenza. mCOFLU combines that protection with a COVID-19 vaccine in one injection. In principle, an older adult could get a single shot instead of two. Moderna’s chief executive, Stéphane Bancel, said in the company’s statement that influenza and COVID-19 “continue to place a significant burden on public health, particularly among older adults”, as CIDRAP reported. Moderna told the Canadian Press that the combination was approved in Europe last April, and that the flu-only shot won US approval in August.
The evidence for the flu vaccine comes from a trial of about 40,000 people. According to CBS News, the trial found the new vaccine more effective in adults 50 and older than one of the standard flu shots now in use. That comparison is the reason regulators took the product seriously, and it is what the reviewers in the United States argued over.
| Vaccine | Canada | United States | Europe |
|---|---|---|---|
| mFLUSIVA (flu) | Authorized 5 Nov 2026, adults 50+ | Approved Aug 2026, adults 50+ | Not covered in our sources |
| mCOFLU (flu and COVID-19) | Authorized 5 Nov 2026, adults 50+ | Not covered in our sources | Approved April 2026, per Moderna |
Table: GoodBad. Data from Moderna’s statements as reported by CBC and CIDRAP, and CBS News.
Why the manufacturing matters
Messenger RNA vaccines work by giving the body’s cells instructions to make a harmless piece of the virus, which trains the immune system without using the whole pathogen. Most flu vaccines are still grown in chicken eggs, a slow process that forces the World Health Organization to pick the strains for the season months in advance. Because they are made from a genetic sequence rather than grown in eggs, they can be produced faster.
Céline Gounder, a medical correspondent for CBS News, gave the network a comparison. If a flu pandemic struck, she said, egg-based production would take 18 months to cover a quarter of the world’s population. She said an mRNA vaccine could do it much more quickly, and could be updated more efficiently each year. That is her estimate, not a regulatory finding, but it is the practical case for the technology.
Canadian specialists welcomed the earlier US decision. Dawn Bowdish, an immunologist at McMaster University, said in August that mRNA vaccines seem to protect older people, people with other illnesses and people with weakened immune systems.
What it means for readers
If you are over 50 and live in Canada, nothing changes this winter. Moderna told the Canadian Press the new vaccines will not reach pharmacies in time for this respiratory virus season. Canada’s National Advisory Committee on Immunization still recommends the non-mRNA flu shot available this year for everyone from six months of age. Adults 65 and older are advised to take a higher-dose version, because aging immune systems often need a bigger boost.
The authorization is the step that makes next year possible. In the United States, availability is less certain. CBS News said Moderna expects its flu shot to be available for the 2026-27 season, while CBC reported in August that the vaccine would likely reach Americans next year. Once a vaccine is authorized, provinces and the advisory committee can decide whether to buy it and who should get it. Neither the price nor a purchasing decision has been reported.
The US approval came with conditions that show how much scrutiny the product has had. The FDA first said it would refuse to consider Moderna’s application. About a week later it reversed course and let the vaccine proceed to review, after talks with the company led to a revised approach and an amended application. Moderna then asked for full approval for adults 50 to 64 and accelerated approval for those 65 and older, and agreed to run an additional study in older adults. The dispute centred on the 40,000-person trial. The FDA’s vaccine director, Vinay Prasad, faulted it for not including another brand specifically recommended for people 65 and older. Side effects mentioned by Gounder were pain at the injection site, fatigue and headache.
What to watch
Three things will decide how much this changes. The first is whether the advisory committee recommends the mRNA shots, and for whom. The second is price, which no source has yet given. The third is the extra study in older adults that Moderna agreed to run for the FDA. It should show how well the vaccine holds up in the group that gets the sickest from flu.
For now, the news is simple: a two-in-one vaccine and a faster-to-make flu vaccine have each cleared a national regulator. The next flu season is the earliest anyone in Canada could be offered either.
