New mRNA Flu Shots Miss This Season and Reach Only Canadians Over 50
Health Canada has authorized Moderna’s mRNA flu vaccine and a combined flu and COVID-19 shot for adults 50 and older, but neither will reach pharmacies this season. Canada’s advisory committee still recommends the non-mRNA flu shot.
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Canada Becomes First to Authorize Moderna’s mRNA Flu and Flu-COVID Shots
Canadians will not be able to get Moderna’s newly authorized mRNA flu vaccines this winter. Health Canada cleared the company’s flu vaccine, mFLUSIVA, and its flu and COVID-19 combination, mCOFLU, on Thursday 5 November, for adults aged 50 and older. Moderna told the Canadian Press that neither will reach pharmacies in time for this respiratory virus season.
The approval is real, and Moderna says Canada is the first country to authorize both vaccines. But it changes little for the people who face the most risk from flu right now.
What stays the same this winter
Canada’s National Advisory Committee on Immunization still recommends the non-mRNA flu shot that is available this year for everyone aged six months and older. Adults 65 and older are advised to take a higher-dose version, because aging immune systems often need a bigger boost. The committee also strongly advises COVID-19 vaccination for everyone 65 and over and for residents of long-term care, retirement homes and assisted living. Moderna and Pfizer both have mRNA COVID-19 vaccines available in Canada this year.
Nothing in the authorization changes those recommendations. The sources do not report a price, a purchasing decision by any province, or a recommendation from the committee for the new vaccines. Until those arrive, the new products are authorized but not on offer.
A narrow label, a hard road to approval
Both vaccines are cleared only for adults 50 and older. Younger adults and children are outside the label, even though the committee advises flu vaccination from six months.
| 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.
The US route was bumpy. The Food and Drug Administration first said it would refuse to consider Moderna’s application, then reversed about a week later after talks led to an amended filing. The dispute centred on a 40,000-person trial that found the vaccine more effective in adults 50 and older than one of the standard flu shots. CBS News reported that the agency’s vaccine director, Vinay Prasad, faulted the trial for leaving out another brand specifically recommended for people 65 and older.
The gap for older adults
That objection matters because the over-65s are a large part of the age group the label covers. Moderna’s revised application sought full approval for adults 50 to 64 and accelerated approval for those 65 and older. The company also agreed to run an additional study of the vaccine in older adults. Accelerated approval means the evidence for that group is still to come.
For readers over 65 in Canada, then, the shot that is authorized is not the one health officials recommend, and the evidence base for their age group is the part Moderna still owes. The side effects mentioned by CBS medical correspondent Céline Gounder were pain at the injection site, fatigue and headache. The older-adult study Moderna agreed to run is not complete.
The combination shot has its own open question. 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. The sources describe the authorization of the combination but not the trial results behind it, so we cannot say how its protection compares with taking the two separate shots.
Questions the sources leave open
Several basic questions have no published answer in the sources we reviewed. None gives a price for either vaccine or says whether any province plans to buy them. None reports how many doses Moderna could supply in Canada, or whether the company will seek approval for younger adults. The authorization is a regulatory step, not an offer to the public.
In practice, a 70-year-old in Canada this winter is advised to take the higher-dose conventional flu shot and, under the committee’s advice, a COVID-19 vaccine. A 55-year-old is advised to take the standard flu shot. The new vaccines change neither piece of advice until the committee says otherwise.
What would change it
Provinces need a recommendation before they buy. That depends on the advisory committee, which has said nothing on these vaccines in the material we reviewed, and on a price nobody has published. The manufacturing argument is real. Gounder told CBS that egg-based production would take 18 months to cover a quarter of the world’s population in a pandemic, and she said mRNA could do it much more quickly. That benefit belongs to a future emergency, though, not to this season.
The practical dates are short. In the United States the timing is less clear. 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. The vaccines will not be in pharmacies this winter, so the earliest a Canadian over 50 could be offered one is next flu season. Until then the recommended shot is the conventional one, and the extra study of older adults is the piece of evidence still outstanding.






