Pfizer-BioNTech and Moderna have individually announced the results of phase 1 clinical trials for new mRNA vaccines that prevent both the flu and COVID-19. These new vaccine candidates target these two severe respiratory diseases with one jab.
Although during the past three years we have focused on the COVID-19 pandemic, the seasonal flu is also a dangerous disease. During the 2019-2020 flu season, the last one before COVID-19 mitigation efforts reduced the risk of flu, 390,000 Americans were hospitalized from the flu. And over 25,000 died.
So, a new mRNA vaccine (with all of its advantages to tailor the vaccine to the key antigens that are on the virus surface) that combines both flu and COVID-19 can be an effective weapon against these two diseases. In a couple of years, if all goes well, we will be able to get a season flu-COVID-19 mRNA vaccine that has been manufactured for the season’s prevalent variants of both diseases.
Let’s take a look at what we know about these new vaccines and the phase 1 clinical trials.
Pfizer-BioNTech flu-COVID vaccines
The new vaccine candidate combines Pfizer’s quadrivalent modified mRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development, and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) vaccine.
The phase 1 clinical trial is a randomized, open-label study that will include 180 participants split into 6 arms of 30 individuals each. The arms include:
- qIRV + bivalent BNT162b2 (dose level combination 1)
- qIRV + bivalent BNT162b2 (dose level combination 2)
- qIRV + bivalent BNT162b2 (dose level combination 3)
- qIRV alone (dose level 1)
- qIRV alone (dose level 2)
- bivalent BNT162b2 (dose level 1) + QIV (quadrivalent influenza vaccine)
Pfizer’s qIRV mRNA seasonal flu vaccine is currently in a separate phase 3 clinical trial which is recruiting patients throughout the USA.
As of today, Pfizer-BioNTech has not announced any results of this study.
Moderna flu-COVID vaccines
Moderna has recently announced positive phase 1/2 clinical trial results for its mRNA-1083 combination flu and COVID-19 vaccine. The study compared the safety and effectiveness of the combination vaccine compared to a standard dose influenza vaccine and the Moderna COVID vaccine.
The company reported that the combination vaccine showed an immune response equivalent to current flu and COVID-19 vaccines.
The clinical study found that the rates of local and systemic adverse reactions in the combination vaccine group were similar to the COVID-19 vaccine group in the trial. The majority of the adverse reactions were grade 1 or 2 in severity (not very concerning). Grade 3 local or systemic reactions were reported in less than 4% of participants.
When will get these new vaccines?
I used to be really good at predicting when we would see FDA approval for new vaccines. I always assumed it would be around 5-10 years after the commencement of phase 1 clinical trials before we would get approval for the vaccine.
I was wrong, of course. The whole COVID-19 vaccine development timeline made it different.
Because vaccines for the prevention of COVID-19 are already approved or have Emergency Use Authorization (EUA), these combination vaccines from Moderna and Pfizer-BioNTech should probably get approval before the 2024-25 flu season. Again, I wish I could predict these regulatory timeframes better, but if both components of the vaccine have approval, it should be easy to get approval for the combination vaccine, unless something deleterious shows up when they combine the two.
I’m looking forward to this vaccine, and not because I love a new vaccine whatever it is. I want to get two shots with one jab, as opposed to this year when I had one shot in one arm and the other in my other arm.
Let’s see what happens. And I promise to keep you updated.
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!
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