There were human trials, but they skipped Longitudinal trials (long term effects) and they also didn't do challenge responses (exposing those people with the vaccine to COVID in a controlled manner), correct?
I find it fascinating how we submit batteries of tests to code as software engineers. Yet when it comes to our own health as a species, the rigor suddenly falls.
It'd be fine back when Jenner created the first vaccine over 185 years ago. There were no ethics boards back then. A lot of people died from snake oil treatments too.
It's not lack of rigor, it's ethics. We don't want to intentionally expose people to something that might kill them. Instead, we perform a trial on a large group and allow them to naturally avoid or be exposed to the virus as they will. Then, with full mathematical and statistical rigor (the best kind of rigor) we determine whether the vaccine has a demonstrated benefit.
We test code. We don't do destructive code tests in production.
Normal vaccine trials is like normal software testing. Challenge testing is like running dangerous tests in production. Its faster at detecting a problem than normal tests, but ultimately not needed and can blow up badly. The argument for doing it during covid is that time was of the essence and its faster than normal testing procedures. Instead we opted for the safer slower normal testing procedure.
They didn't just decide to "skip" long term effect studies. Long term effects can be studied only over a long term. No one wants to wait five or more years with the world in disarray.
Do longitudinal studies ever happen before a vaccine is released? Every longitudinal study I can find uses data from after a vaccine has been released to the general public. Stage 4 studies happen after the vaccine is in use by the general public.
“Even after the vaccine is approved and licensed, regulatory agencies stay involved, continuing to monitor production; inspecting manufacturing facilities; and testing vaccines for potency, safety and purity.
The FDA also monitors adverse events that may occur related to receiving the vaccine, including through its Vaccine Adverse Event Reporting System and Phase 4 clinical trials—optional studies pharmaceutical companies may be required to perform after a vaccine is licensed to continue to monitor safety and effectiveness.” [0]
How long were the trials? I recall a famous drug that was given in the 70s and it produced birth malformations. Took years for doctors to realize the cause and ban its use in pregnant women. Is there a possibility of unforeseen consequences from using RNA? What if someone has for XYZ reason more reverse transcriptase than usual? Will his-her DNA be altered?
Of course there's a possibility. The problem with long-term effects is that if a problem takes 70 years to show up, then by definition we won't know about it for 70 years.
This applies not just to any drug you take, but also to the ingredients in the food you eat and the particles in the air we breath. We've come to such realizations before, and we will again.
But we also know for sure that COVID-19 is killing people right now.
The risk of long term effects is actually very small - almost insignificant. Long term effects tend to be an issue for drugs that are taken over the long term. With a vaccine that is only taken twice, the vaccine itself and its direct byproducts (ie the spike proteins) are only in the body for a limited period. After that it's only the immune response that remains. There's no realistic mechanism for a previously unseen effect to show up from it years down the line.
There is a small possibility that there could be detrimental effects to a fetus, which is why the vaccines are not currently recommended for pregnant women. It's not expected that there would be a negative effect; it just hasn't yet been tested. (Fortunately pregnancy is not a chronic condition, so people can still be vaccinated after giving birth.)
I'm not an expert myself, but I've done a lot of reading. I don't have a specific source at hand, but this is the consensus I've gotten from any interviews of vaccinologists or epidemiologists I've read or heard. Essentially that any side effects from vaccinations show up within a few weeks—that there just isn't a mechanism for them to appear years down the line if they haven't already been seen sooner, for the reason I described.
Now again it is possible that side effects could still be discovered in patients with complicating factors that weren't represented in the trials (like pregnancy or other known or unknown pre-existing conditions). Or just because the effects were too rare to show up significantly in the trials. But again these would be expected to show up quickly as widespread vaccination begins, as did the few severe allergic reactions that have occurred.
Of course as with anything, especially as charged an issue as vaccines, if one goes looking for it one can find plenty of purported evidence that long-term side-effects (by which I mean here side effects that don't show up until long after the vaccine is taken) are possible or even common. But the expert consensus based on the totality of evidence appears to be that this is not a serious concern.
The main difference is that the way the mRNA vaccine works is much better understood. Maybe better understood,on a molecular level, than many other medications.
My wife and I are trying to conceive and it's such a tough call whether or not she should get vaccinated. I try to read everything, even though I know the answer is "nobody knows." While we wait for more evidence we'll continue to quarantine and stay safe. We're hoping there's a bit more evidence by the time the vaccine is available to us.
I wish you weren’t downvoted, this is a valid, rational, and interesting question devoid of any kind of message or blanket statement like “all vaccines cause autism” or what have you.
There were also all the issues with the 1970s Swine Flu vaccine that turned out to not even be all that effective. 60 Minutes did a piece on it, and it's getting more and more difficult to search for on YouTube:
> it's getting more and more difficult to search for on YouTube
Just to be clear, since this sounds conspiratorial - it is most likely difficult to search because 60 minutes is a copyrighted show and they have an official YT channel but only carries segments of their episodes. So, I suspect it is quite difficult to find any full episode.
Could be, but several months ago it was very easy to find and now it's buried further and further down. Considering everything YouTube and Twitter have been doing over the past few months to control the narrative, it's also equally likely they're intentionally burying it.
I assume you're referring to the very slight increase in cases of GBS in people who had that particular swine flu vaccine? It's interesting to note that the CDC says that having the flu is more likely to cause GBS than getting the vaccine. Both of those risks are extremely slight.
Two U.S. pharmaceutical giants, Pfizer and Moderna, are in the final phase of coronavirus vaccine development, and Oxford University is expected to start large-scale human trials of its vaccine in the U.S. this month.
The initial numbers look awesome: Pfizer: 8/18,198 vaccine, 162/18,325 placebo; Moderna: 5/13,934 vaccine, 90/13,883 placebo for 7 and 14 days respectively after the second dose.
