In phase 3, safety has been established, but monitoring continues.
No, this is incorrect.
At least that's what the CDC says (
https://www.cdc.gov/vaccines/basics/test-approve.html):
"In Phase III, the vaccine is given to thousands of people and tested for efficacy
and safety."
Or GSK (
https://ca.gsk.com/en-ca/research/trials-in-people/clinical-trial-phases/)
"The principle objectives in Phase III are to:
-
demonstrate the safety and effectiveness of the new medicine or vaccine in the typical patient likely to use it
- confirm effective dosing levels
-
identify side effects or reasons why the treatment should not be given to people with the condition in question (known as ‘contraindications’)
- build knowledge of the benefits of the medicine or vaccine and compare them with any risks
compare results against any currently achieved by existing treatments"
Or wikipedia:
https://en.wikipedia.org/wiki/Vaccine_trial#Phase_III"Phase III trials continue to monitor toxicity, immunogenicity, and SAEs on a much larger scale.
The vaccine must be shown to be safe and effective in natural disease conditions before being submitted for approval and then general production."
etc.
Evaluation of safety continues to be an important part of Phase III trials. It has
not been established when the (limited) phase II trials are complete.
This has been developed and gone through trials and approval faster than any vaccine before in history. You are claiming that mRNA vaccines are safe in humans based upon theory. Before this month, no mRNA vaccine has ever been approved for use in humans.
My concern is related to the above facts. I work in QA. "Unprecedented speed", "never before tested", "reduced testing rigor", "extremely high development pressure", and "should be fine in theory" all raise warning flags for me.
Many mRNA vaccines have been developed over the past 15 years or so. They have uniformly been incredibly safe.
mRNA vaccines are safe in humans based upon theory based on many trials that have gone to phase III.
Limited trials have been completed - and that's great! We're not depending entirely on theory. A large scale roll-out of this type of vaccine has never been done before though.
As we've already determined, phase II testing is limited in scope does not determine safety of a vaccine. To date no mRNA vaccine has received the widespread distribution to prove it's safety.
This doesn't mean that it's unsafe. It's great news that we have a history of mRNA vaccines being used in trials - this reduced risk of long term complications. But safety is absolutely not proven at this point, and risk does exist on this front. To claim otherwise is dishonest.
No mRNA vaccine has ever been approved for use in humans, because they have not demonstrated statistically significant efficacy in phase 3 trials, not because they were unsafe for humans.
My argument wasn't that mRNA vaccines are unsafe . . . it was that we don't really know much about their safety to be rolling this out to every human being on Earth. We
think that they're safe, and all signs seem to be good so far.
"Unprecendented speed" is probably true, but doesn't mean much. "Never before tested" is not true, mRNA vaccines have been in development and testing for almost 20 years. "Reduced testing rigor" is just not true. "Extremely high developmental pressure" is very true.
I'm not sure how the argument that 'Unprecedented speed' doesn't mean much can be made. The shortest ever development speed of a vaccine prior to this was about three years. That means that for the Mumps vaccine we had
some long term data regarding the safety of the vaccine.
Never before tested is true when considering scale.
This vaccine has been developed from start to finish in well under a year. That means that testing rigor has been reduced from the normal multi-year process which gives some longer term data on effects.
The mRNA is just the vehicle into the cells. The cells pick it up and will try to produce some antigens from the mRNA strand, then the mRNA strand gets "discarded" and basically denatures and is urinated out the body. The antigens are then "presented" to our immune cells and hopefully they produce an antibody response. There is no drug, no neurotransmitters, no heavy metals, nothing that should last in our body more than a few days.
This statement is made by drawing inferences from current theory rather than real world testing. That is exactly the thalidomide mistake. Scientists working theory at the time was that no drug taken by a pregnant woman could pass across the placental barrier and harm the developing fetus. We found out that the theory didn't always hold - to great cost. Theory is good - testing is better.
I believe that everyone involved in developing this vaccine is doing everything they can to ensure it's safety. Risk for this vaccine is likely to be higher than one developed using the normal processes and under normal conditions. The significance of this added risk is not currently known - and it very well could amount nothing at all. That is my fervent hope.
I also appreciate everyone's input in this conversation. I'm learning more about this vaccine and have been encouraged by much of what I've seen.