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posted ago by CarmenOfSandiego ago by CarmenOfSandiego +52 / -0

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.

  1. 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;

  • 6 men between 19 and 34 were given a dose 1/500th of the highest dose previously used.

  • They were given these doses at 10 minute intervals.

  • 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.

  1. "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.

  1. 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

  • Theralizumab: Drug testing can go "catastrophic"ally wrong.

  • Thalidomide: Just because a product is finished doesn't mean shit can't go wrong.

  • 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.