How many of those vaccines had a shortened testing and approval process like the Covid vaccines?
No vaccine in human history prior to COVID has had the scrutiny and close study with the best knowledge that we have placed onto COVID vaccines.
The testing was NOT rushed. Shortening is not rushing or unsafe. Why is that?
1. The parts of the testing that were cut out were not safety oriented, they were testing regimes that pharma usually does to see if the vaccine is likely to work well enough to pour in more money. In this case the gov said "here is some $ so you don't have to worry about the $."
2. The reason things went fast is most vaccine test regimes are longer than would otherwise be required because it takes that long to reach primary endpoints in the study (ie enough of the study group gets infected), and as it turns out during a pandemic, that doesn't take as long.
Vaccine hesitant folks have this idea that in the 1950s or 1960s we were doing so much more testing with vaccines that we didn't do here. Vaccine hesitant folks also usually assume we had as much understanding then as we do now, but we didn't. We knew so much less back then, had far less diagnostic capability to work up cases and AE, didn't look at things like asymptomatic infection and transmission in Phase III data, and Phase IV (we are in IV) was not technologically enabled by VAERS and VSAFE.
The RARE Adverse Effects (AE) we are now finding are NOT because the testing timeframe of safety studies was too short. It wasn't. These rare AEs are short term onset (days to weeks) which is what virtually every vaccine AE ever has ever been (and when we see delayed AE from vaccine they are related to the short term AE). The reason we are finding rare AE now is that nobody does a Phase III trial with 1 million participants needed to see a rare AE with certainty. The COVID vaccine Phase III trials were huge with 30K or 60K participants!
Now we have given 10s or 100s of millions of doses of each vaccine in the US. So we are finding AE that are occurring in the 1 in 100K or 1 in 1M ranges of AE.
Why is that enough? Because if you are trying to make a vaccine, you are making it for something that is dangerous enough that you power your Phase III to detect rates of serious AE several order of magnitude lower than the risk of the disease the vaccine targets.
You could literally kill 1 in 10K vaccine recipients and still have the vaccine be a very good idea against a disease that kills more than 1 in 100. We would have seen that signal in Phase III. Happily, it appears the vaccines kill less than 1 in 1M. Your chances of being struck by lightening are higher. (I'm going outside, how about you?)
You're right, but are we going to ignore the cumulative risks as more and more are discovered? Each individual issue with the vaccines so far has had a very low risk associated with it, but we're ignoring the fact that quantity has a quality of its own. Or do we keep dismissing each individual issue as a minor low risk problem until it's too late?
Too late for what???? Nobody dismisses that individual bad outcomes are bad for those individuals. This is risk versus benefit!
Let me tell you the quality of the quantity of cumulative rare AE discovered: SUPER LOW compared to the vaccine's benefit.
We are discovering things that happen to around 1 in 100K people
or fewer. So if we discover 20 of those rare AE, then you might have enough things happening that it would have been a safety signal in the Phase III data.
And if you did discover 20 of them, would that be enough to say "vaccine bad?" Nope. Why not? Here's why:
1. The overall risk from COVID is much much higher than than for the rare AEs being identified, even in populations at lower risk for COVID complications.
2. The specific vaccine AEs identified are also caused by COVID at a rate many (many!) times higher than the vaccine (such as myocarditis, blood clots, and GBS). Myocardial complications occur in more than 1 in 100 COVID cases. The number one cause of myocarditis is viral infection, and the same for GBS.
3. COVID is pandemic and likely to become endemic.
Vaccines are never zero risk. We do stop giving them though when the risk outweighs the benefits. When have we seen that?
1. Smallpox!
That vaccine gave people myocarditis, even killed people. But Smallpox was horrible. We eradicated it (except for some samples at CDC Atlanta and Biopreparat Kolstovo (and whoever the Soviets slipped it to?). So, we stopped giving Smallpox vaccine to the public because the benefit was zero and the risk remained.
2. Polio!
Polio is horrible. We have riskier Oral Attenuated Vaccine OAV that works better and longer but with higher AE, and we Inactivated (injected) Polio Vaccine IPV with lower AE. In countries where Polio is endemic or importation risk is high, they give OAV because the benefit is worth the risk. In countries where Polio is eradicated (USA) and importation risk is low, we give IPV.
