Pfizer and BioNTech have announced the start of a phase 1 clinical trial for a new mRNA vaccine that prevents both the flu and COVID-19. The new vaccine targets 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 on the virus) 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 this new vaccine and the phase 1 clinical trial.
Flu COVID-19 combination mRNA vaccine
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)
I could not find any information on where the clinical trials would be located, as the companies did not list any trial locations yet. This trial has not started recruiting yet, so once they do, we should have that information.
Pfizer’s qIRV mRNA seasonal flu vaccine is currently in a separate phase 3 clinical trial which is recruiting patients throughout the USA.
When will get this new vaccine?
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 the BNT162b2 part of the vaccine against COVID-19 is already approved or has Emergency Use Authorization (EUA) and the qIRV influenza vaccine is in phase 3 clinical trials, the combination vaccine should probably get approval before the 2024-25 flu season. And if everything goes right, it could be available for the 23-24 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.