Comment on Donald Trump tells court he had no duty to ‘support’ the US Constitution
sj_zero 11 months agoThere are typically 3-4 phases of testing for vaccines.
Phase 1: Small groups of people (20 to 100) receive the trial vaccine. This phase gathers information on the vaccine’s safety, identifies side effects, and studies how well the vaccine works to cause an immune response.
Phase 2: The clinical trial expands to hundreds (100-300) of trial participants who have characteristics (such as age and physical health) similar to those for whom the vaccine is intended.
Phase 3: The vaccine is given to thousands of people and tested for efficacy and safety.
Phase 4 (if applicable): Ongoing studies after approval, designed to monitor the effectiveness of the approved vaccine and detect any side effects not identified in the clinical trial.
The Emergency Authorization from the FDA allows the use of unapproved drugs in the case of emergencies. the 4 vaccines to be used starting in late 2020 before Phase 1/2 trials were complete for Moderna and before Phase 3 trials were complete for Pfizer/Biontech, Astrazeneca, and Johnson&Johnson.
Phase 3 trials would be completed in late 2022, by which time many covid restrictions and mandates were already dropped and a majority of many populations had already been vaccinated by the time the normal required testing was completed.
https://www.gao.gov/assets/gao-21-319.pdf (Figure 8)
https://www.fda.gov/media/144636/download
I can't argue against the idea that we were in a situation where we needed something fast so decisive action needed to be taken, but we can see some of the effects of the fast tracking. First, the AstraZeneca vaccine (which I don't think was accepted under the Emergency Authorization in the US) was found to have a higher risk of blood clots than the others (Phase 3 testing of that particular vaccine lasted until early 2023) so was restricted for use in places like England and Canada where it was accepted for use. As well, because testing was fast tracked, politicians were out there making false claims about the effectiveness of the vaccines. If the vaccines were really as highly effective as touted, then covid should have gone extinct in populations that were fully vaccinated, but that didn't happen (and the counterpoint to that was that the virus mutated and so the vaccine wasn't for those viruses, but it doesn't particularly matter -- if it doesn't prevent covid it doesn't prevent covid). As well, because of the limited data set due to fast tracked testing, it wasn't known until later that boosters would be required to maintain efficacy after a certain point.
In the United States, the Johnson&Johnson vaccine was first accepted under the emergency use authorization, but later had its use restricted, and then later fully revoked as it became obvious there were potential issues with blood clots:
https://www.cnn.com/2022/05/05/health/fda-johnson-johnson-vaccine-eua/index.html
https://www.cnn.com/2023/05/15/health/johnson-johnson-covid-vaccine-end/index.html
https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html
The US government and the CDC was recommending that pregnant women get the vaccine in April of 2021, over a year before phase 3 testing was completed. That really set off alarm bells for me because typically pregnant women are excluded from medical trials because of the ethical implications of potentially harming a baby in the womb. Thalidomide is a famous example where a drug was approved (not in America but in many other jurisdictions -- For her role in preventing the approval of thalidomide in the U.S., President John F. Kennedy presented Frances Kelsey with the highest award for civilian federal workers, the Distinguished Federal Civilian Service medal.) and it turned out to have unexpected side-effects on unborn children. Given all this, that was a potential risk and I think a lot of pregnant women didn't have the facts required to make a good decision.
https://www.youtube.com/watch?v=kbdoXen3AR8
https://www.reuters.com/article/us-health-coronavirus-vaccines-pregnancy-idUSKCN24W1NZ
At the end of the day, while COVID vaccine skeptics predicted absolutely genocidal consequences for rushing the development of the vaccines, the reality is that the risks paid off. There are some side effects from the vaccines no doubt, but overall we were able to get society back on track significantly before the standard testing regime was completed. The only thing for me is that the government was not being honest to the people about the fact that it was a risk. In my case, I took the vaccine knowing there was a risk because I had a duty to my family to keep my workplace going so I could continue to support them, but some people took it without being properly informed as to the potential risks or the fact that the vaccines were operating under an emergency authorization and testing was not completed.
FooBarrington@lemmy.world 11 months ago
Thank you for the links. I understand your point, though I still question which parts of which phase were skipped - there is a big difference between “XYZ wasn’t done” and “XYZ was in the process of being done, and preliminary results were analysed”, which seems to be the case for the trial phases.
sj_zero 11 months ago
By definition, anything allowed by an emergency authorization isn't fully approved. Whether you define testing that won't be completed for another 2 years as "skipped" or just "not complete" is irrelevant -- it's still an untested experimental drug or it wouldn't require an emergency authorization.
The one thing skipped is the progressive nature of the testing. Typically, phase 1 justifies phase 2 testing, and phase 2 justifies phase 3 testing. Under project Warp speed, this progression was largely bypassed so that different phases of testing could overlap.
Phase 3 testing wasn't even remotely close to being done by the time of the emergency use authorization. Phase 1 and 2 testing was only just done by the time of the emergency use authorization. The testing wasn't done yet, and wouldn't be complete for years. It wouldn't be done until after the pandemic was declared over. It doesn't matter if it was skipped or not, it wasn't completed.
The fact that two of the four major vaccines ended up being pulled off the market because they were unsafe should be definitive proof of my point. The testing wasn't done, and so these potential risks weren't caught during testing, and so dangerous products were put out to market, and after it was discovered those products had their emergency use authorization rescinded.