Last week, Pfizer submitted an Authorization Request to Modify the Formula used in their COVID-19 Vaccine.
Vaccine formulation
Authorization is being requested for a modified formulation of the Pfizer‑BioNTech COVID-19 Vaccine. Each dose of this formulation contains 10 μg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple dose vials.
To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID-19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) buffer instead of the phosphate-buffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride. The packaged vials for the new formulation are stored frozen at -90°C to - 60°C. The frozen vials may be thawed and stored at refrigerator at 2°C to 8°C for up to 10 weeks.
There is a lot to unpack in just swapping out an ingredient in this as well as the new storage temperatures moving to -90°C to - 60°C, remembering that in the early days of the vaccine roll-outs there were certain logistics challenges to delivering vials that needed to be kept at -60 until the day of use and then of course the number of batches that were discarded because they seemingly stale dated on the day thawed.
There were some clinics and pharmacies allowing customers to cut ahead in the queues if they had appointment no-shows or if they had extra batches. This was a big thing in the early days of the vaccines.
Since then, we’ve seen some confusion surrounding these procedures, including:
Residents of First Nation in Ontario given expired Pfizer vaccine for nearly a month
This apparently wasn’t a big issue, even though they weren’t able to contact everybody that received one of these expired doses to confirm health, they did absolutely know that these people would not be considered fully vaccinated by the expired doses:
Since then individuals who have received expired doses have been contacted or attempted to be contacted.
The expired doses do not pose any health risks to those who have taken them but according to the ISC they have been informed that anyone who was given an expired dose will need to be revaccinated.
When it comes to vaccine status those who were given the expired shots are not considered fully vaccinated.
So, when it now comes to -90 storage, I would suspect that further issues may be involved but the new secret sauce will actually store thawed for up to 10 weeks.
It would almost make you wonder why Pfizer wouldn’t have started off with tromethamine as a buffering agent to begin with.
Well, I did a little digging into this buffering/preservative agent and came across some pretty interesting information.
Tris - An organic amine proton acceptor. It is used in the synthesis of surface-active agents and pharmaceuticals; as an emulsifying agent for cosmetic creams and lotions, mineral oil and paraffin wax emulsions, as a biological buffer, and used as an alkalizer.
Tromethamine is not only just like a squeeze of lime into your guacamole to keep it from browning, it “makes blood and urine more alkaline or less acidic. It is used to treat metabolic acidosis, a condition where the body produces too much acid or when the kidneys are not removing enough acid from the body”.
Sounds a lot more involved than the phosphate-buffered salt water used in the previous mix, kind of makes you wonder if this amine proton acceptor is “Safer” for 5-11 year olds and why it’s only being applied for in a briefing document specific to this age range?
Real Answer…I don’t know.
If I was a parent, I’d want to know why my child would be getting this buffering agent, knowing that it actually mucks with body chemistry in an age group that has almost a perfect survival rating with COVID.
As I was reading through the information on TRIS, I came across it’s “Best Taken” application being listed as:
It is given as an infusion into a vein over a period of time.
Why?
This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
It “MAY” cause tissue damage if it leaks outside of the vein.
You may see where I’m going here…given that this is being introduced into children as a part of a Intramuscular Injection - COVID-19 Vaccination, not an Intravenous Injection meaning it actually never hits the vein so it won’t be leaking out to cause tissue damage; It gets injected right into the tissue, where it CAN cause DAMAGE.
And if you’ve been through any vaccination, you know that these are not an injection “given over a period of time”, they are stabbed in and squeezed out of a syringe - maybe a little less dramatically than my simple description but all the same.
As for other side effects, they range from:
Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Fever.
Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
Trouble breathing, slow breathing, or shallow breathing.
Shortness of breath, a big weight gain, or swelling in the arms or legs.
While I am sure that people at the FDA have certain measures in place, it was only one day after submitting this briefing document that the FDA approved vaccinations in children from the ages of 5-11 under Emergency Use Authorization with a unanimous vote of 17-0.
An FDA adviser said we need to give kids vaccines to fully understand their safety.
Uh huh.
While you may question the FDA decision based on what actual emergency children in the 5-11 age group are in, your issue will now be with this vaccine rolling out as a part of the mandatory vaccination and passport programs. What will this mean for their childcare, schooling, travel and social outings?
Seems to be a fair sized risk for the privilege of dine-in Happy Meals.
Thank you for keeping me informed!