Apologies if the tweet has been posted, the archive is 3 weeks old but a search of the url didn't show anything, not that that meant it isn't buried somewhere.
Also this goes on for a bit [6k+/15k character limit], so there will be tl;dr's at the bottom but I would recommend at least reading the trial study portion in point 1.
So the title relates to this twitter events archive: https://archive.vn/pGPa1
According to health experts, there could be regular side effects expected after a vaccination, such as muscle aches. But similar to other types of vaccines, COVID-19 vaccines undergo trials and testing involving thousands of volunteers to make sure they are safe before being approved.
Now, being a scientist myself [mostly skilled in the ways of how to find things and make them dead] this article seems like an attempt to push the emerging CoViD vaccines and placate any fears being raised about how quickly it was pushed through various tests. All the while choosing to completely skip over the history behind vaccine/drug development that includes examples of when both trial studies and finished products have gone horribly wrong, as well as how long some other vaccines took to actually get to the distribution stage.
- Trial Studies: Theralizumab.
Disclaimer: I had a case study on this trial at one point to highlight how/if/when things go wrong which is the reason I remember it so much.
Developed in 2006 as an immunomodulatory drug it failed spectacularly during it's first in human study in March of 2006 when it almost killed every single person not given the placebo [6 out of 8].
Excerpts from the wiki page for it:
In its first human clinical trials, it caused catastrophic systemic organ failures in the subjects, despite being administered at a supposed sub-clinical dose of 0.1 mg per kg, some 500 times lower than the dose found safe in animals. Six volunteers were hospitalized on 13 March 2006, at least four of these suffering from multiple organ dysfunction.
The trial was a double-blind, randomized, placebo-controlled study, with two of the eight subjects receiving a placebo, and six receiving 1/500th of the highest dose used in previous experiments with cynomolgus macaques. All six of the trial subjects who received the drug were male, aged 19 to 34 (median 29.5); none had a notable medical history, and all were well in the 2 weeks before the trial. The drug was given by intravenous infusion, starting at 8am, with an interval of around 10 minutes between patients, and each infusion lasting from 3 to 6 minutes. Roughly fifty minutes after the first participant received his dose, he complained of a headache, and soon afterwards fever and pain. He took his shirt off, complaining that he felt like he was burning. Shortly after, the remaining participants who received the actual drug also became ill, vomiting and complaining of severe pain.
So to summarize;
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6 men between 19 and 34 were given a dose 1/500th of the highest dose previously used.
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They were given these doses at 10 minute intervals.
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50 minutes after receiving the dose patient 1 started showing symptoms of what was essentially similar to a cytokine storm.
Those of you counting will note this 50 minutes means all 6 who got the actual drug and not the placebo got the actual drug. Unlucky number 6 was just caught there.
Of the various side effects the 6 suffered: one volunteer lost his fingers and toes, one was described as looking like the "Elephant Man" because his head swelled so much, and all 6 likely suffered long term disruptions to their immune systems.
- "Finished Products: Thalidomide
I'm not actually going to go into this at all as there's so much info about Thalidomide because it's that widely known about. The point is that not only was it long after being finished and distributed that things went so badly, but the historic problems: deformities in newborns, were never going to be caught because the only way to have done so would have been to run trials on pregnant women.
Good luck with that one.
Anecdotal: The CoViD vaccine has some women considering whether to have children beforehand in case there are side effects that aren't learned of until far, far too late down the line.
- Development History: Ebola
This is more just to point out how long, and I do mean "long" it can take sometimes for vaccines to develop, however there are issues using it as an example I'll cover.
History blurb:
Ebola was first recorded in June 1976 in Sudan [as well as 1979 and 2004].
Later outbreaks over the following decades occurred in: Zaire [twice: 1976, 1995], Gabon [4 times: '94, '96, '96 again, '04], Uganda [3 times: '00, '07, '12], Republic of the Congo [4 times: '02, '03, '03, '05], Democratic Republic of the Congo [7 times: '07, '08, '12, '14, '18, '18, '20], and all over the fucking place in 2013: Major outbreaks: Liberia, Sierra Leone, Guinea, minor cases: Nigeria, Mail, USA, Senegal, Spain, UK, Italy - originating in Guinea.
The tl;dr of Ebola being: Don't go to central Africa.
Anyway, the vaccine only came out in 2019, around 43 years after the initial discovering.
Now one issue with any development project is financing which is generally affected by how important a project is. So while Ebola was kicking around between 1976 and 2013 it's probable the rest of the world really didn't give a shit because it was very much a central African virus with blips in other locations at the time that weren't even human cases [mostly macaques]. Until 2013 that is when it was more widespread and possibly scared enough people into deciding to actually fund a vaccine for it.
So while it took 43 years from start to "finish" it may have "only" taken 6. Still a lot longer than any of the CoViD vaccines have had since the initial outbreaks aren't even 18 months old themselves.
tl;dr's
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Theralizumab: Drug testing can go "catastrophic"ally wrong.
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Thalidomide: Just because a product is finished doesn't mean shit can't go wrong.
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Drug development: Sometimes problems need to hit home to actually get done but they still take a long time, even taking into consideration advances in medical research and science.
The actual tl;dr: "Vaccines can have side effects, but they are expected and not dangerous"
Vaccines can have side effects
Yes.
but they are expected
No.
and not dangerous
Also no.
I don't have time to give this a complete readthrough now, but Dengvaxia is another one to look at. Another coronavirus - Dengue Fever vaccine, 20 years in development and it still killed people as an inconvenient side effect.
specifically Filipino children that hadn't been exposed to dengue before recieving the vaccine, had severe (fatal) reactions when later exposed.
Dengue is an interesting one among the Flaviviridae and arboviruses/zoonoses in general.
4 serotypes of the virus, any can give you the disease, contracting any will not give you immunity to itself or the others and are in fact more likely to kill you if you are unlucky enough to contract it a second time.
I need to check an old ppt I gave years ago for the exact numbers but roughly first time infection effects are:
90% are asymmetric
9% ish show flu like symptoms
1% have actual severe symptoms that will probably be diagnosed as Dengue or at least "not the flu"
I'm aware those are the engagement ratio numbers so I may be mixing things up a bit, will correct as needed when I can access the slides I have the info on.
So those 90% are fucked if they get it a second time because they didn't even know they had it the first time. Second group at least might have an idea, and the third group will hopefully gtfo from areas of infection.
I am not a scientist but one thing I keep asking myself:
With how they pushed through the vaccine/s haven't they lost all credibility when it comes to future regulations? As in: On what grounds would they deny Pfizer's next drug when it's obviously possible and extremely safe (just ask all the politicians) to invent, produce and test a drug in under a year? How will they justify the obligation for years of trials when they obviously aren't needed to produce a safe drug.
Octogenarian dies from respiratory infection, "every life matters! stop killing grandma!" Octogenarian dies from respiratory infection vaccine, "well, you know, these things happen."
Not going to see truly "long-term" effects in the elderly. And you can't tell if it affects reproduction in them, either.
Two problems with the ebola comparison:
One, most people who get COVID-19 recover from COVID-19, which proves humans are pretty good at producing countermeasures against COVID-19. If you can find something other than COVID-19 that induces the production of those same countermeasures, you've got your vaccine. Ebola on the other hand has a mortality rate of up to 90%. Even a vaccine a thousand times less dangerous than the Ebola its emulating would kill millions of Africans, so it's a harder task.
Two, as you say, Ebola only affects shithole countries. Remember when some idiot brought it to the United States and nothing happened? Eradicating Ebola would be nice, but the world isn't throwing everything at making that their number one priority.
And what stopped the last Ebola outbreak was a mutated strain that was asymptomatic. When the symptom is you bleed to death, a asymptomatic mutation is self-correcting
That's always a fun one to discuss regarding parasitoid-host interaction. Many parasites don't want to kill the host, at least not immediately, for a range of benefits:
Resources
Heat - from mammals, birds, etc
Increased reproduction dispersal - flight from birds for example
Lancet Flukes for example go through a cycle of cows, snails, and ants. They only "kill" the ants however and through behavioral modification rather than direct symptoms.
Cow craps out eggs, snails eat eggs, snail secrete now born flukes as cysts in mucus, ants consume mucus for water and take up cysts, flukes cause ants to climb grass at night, to avoid desiccation, to get eaten by cows, go into reproduction mode and churn out hundreds of eggs to continue the cycle.
Cows being very large mammals are the definitive host where the flukes reproduce due to the above mentioned reasons: warm blooded so a massive heat source, large intake of resources, and relatively speaking greater mobility than the other two hosts; although as both of those would be near the cows anyway that's less important here. So above all else the flukes wouldn't ever want to cause too much damage to cows as it would inevitably kill the flukes as well.
For a virus like Ebola mutating from lethal to asymptomatic that's not necessarily a good thing. Yes people stop dying, but the virus doesn't either as the hosts keep going. If it then mutates again? Well you run the risk of a massive carrier population that's been playing host to the asymptomatic mutation for years.
https://www.bitchute.com/video/QHeF0XM__O4/ A bit of a long one (1:48), but a good one from Michelle Malkin about the issues of the MRNA vaccine tests (from Dec11). Summary:
A combined total of 73,000 participants for both vaccine trials (Pfizer/BioNTech, and Moderna). This includes the control groups. Less than 200 tested positive, which means less than 200 people tested for whether the vaccine actually works.
The British Medical Journal stated there would need to be 5-10 times the number of participants, or 5-10 times the amount of time in the trial for statistical significance. Additionally, that the trial was "not designed to detect reduction in hospital admissions, use of intensive care, or deaths, nor are the vaccines being studied to determine whether they can interrupt transmission of the virus."
Studies are supposed to be blind. There was a facebook group for the Pfizer trial, where participants shared what they think the vaccine vial looked like. This included a photo of it. Participants were attempting to confirm whether they recieved the vaccine, because if not, they were going to join the Moderna trial.
Pregnant (or potentially pregnant) women were not allowed to participate. Birth control was required for the length of the trial. This was an issue because some, such as the previous head of pfizer research stated that the spike protein the vaccine targets is similar to the spike protein in the placenta. If the immune system confused or targeted this as well, it would make women infertile.
There is also a possibility those vaccinated may suffer an elevated immune response when exposed to the virus (or one similar). This has been the case in some prior vaccines (such as for dengue). The lack of sufficient testing didn't determine whether this would occur for this vaccine.
You can use https://wonder.cdc.gov/vaers.html to find reports of adverse events from one of the covid vaccines.
This video: https://odysee.com/@HighImpactFlixMain:2/VAERS:9 shows how the process to get to the relevant information. He also states in the video that "doctors have historically reported less than 1% of adverse reactions of other vaccines on this very reporting system." He doesn't mention where he read this from, or that he's sure it's accurate however.
Making an effective vaccine for humans with such varied genetics is rather like optimising a PC game to run on many different kinds of hardware. For most people it'll run fine, but there will be certain edge cases where a combination of factors causes the game to crash (or the immune system, in the case of a vaccine).
Just remember, if you want unbiased peer review of their test results, or more significant testing across a wider range of subjects, you're anti-Science.
Which is why Polish government is making sure only people that ended up with at least 2 week long hospitalization can expect any sort of compensation (if they survive) and amount awarded bureaucratically is non-negotiable and not a subject to a fair trial.
Generous!
In Canada and the USA, there's a law stating you get NOTHING! GOOD DAY SIR! Because it is a medicine administered in a "State of emergency" type deal, they're immune to negligence suits, harm suits, and malpractice suits. Strictly speaking, they could give you an embolism from an air-filled syringe, and you'd just be SoL by some readings of the rules.