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1/13 Misleading headline, & I'm not surprised @Timcast ran with it. While I enjoy his content, he should know better. Here's why, from an industry expert, this is simply a clickbait non-story, but also why I won't be receiving the vaccine myself. https://twitter.com/Timcast/status/1337043496230932483
2/13 I've outlined pharma development in the past, but simply put most of the side effects of compounds happen in very small portions of the trial population. These are even rarer in the general population, IF the compound held to a high standard of scientific integrity.
3/13 I use this eg. frequently:
If I'm on Investigational Product (IP) for heart burn & report in my patient diary (or at a site visit) that 14hrs after a dose I had explosive diarrhea, this is marked as an Adverse Event (AE), & later a potential side effect - but...
If I'm on Investigational Product (IP) for heart burn & report in my patient diary (or at a site visit) that 14hrs after a dose I had explosive diarrhea, this is marked as an Adverse Event (AE), & later a potential side effect - but...
4/13 this is indiscriminate of the 5 Taco Bell burritos you had 6hrs post dose, 8hrs pre Hershey's squirts. Generally, an AE like this isn't worth the energy to dig in to find association w/ behavior - sites conduct dozens of studies simultaneously & lack bandwidth.
5/13 But Bell's Palsy is different. We don't know for sure what causes it, and in this instance the incidence is consistent w/ what we'd expect in the general population. We actively look at risks preemptively for things like this during the protocol development phase.
6/13 It's not just with vaccines, either, but with any injection requirement. Many studies require participants (we don't say subjects or patients) to self inject/dose a single use syringe up to 3Xweekly for 4 weeks between clinic visits.
7/13 Back to Bell's Palsy - it's the sudden onset of unilateral temporary paralysis of facial muscles resulting from seventh cranial nerve dysfunction, which generally resolves itself. It is a rarely observed outcome of vaccination (in this case there were 40K+ participants)
8/13 with no significant deviation from what the general pop. We also have to consider the age of the participants, & undisclosed neuro diagnosis: as we age we experience a degree of neurodegeneration & demyelination of nerves. Dafuq is demyelination?
9/13 Demyelination is the condition in which the protective, conductive sheath of nerves (myelin) is damaged & lost. It results in slowing or stopping of nerve impulses, causing neurological problems. It's prominent in neuro disorders, like MS. Age is important here b/c
10/13 the older you get the more the innate immune system changes, making it more difficult for remyelination to take place. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3896619/
11/13 We pivot back to BP. While Pfizer articles's misleading, the below case study is inconclusive (not just b/c of a 2 person sampling & reliance on >20 incidence out of 850K vaccinations). Side effects like this are not CAUSED by vaccines, only exposed. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928079/
12/13 I won't take the vaccine for 3 reasons, despite being involved in the industry:
1) I'm a healthy adult w/ great nutrition, exercise frequency, & robust immune system.
2) The side effects are worse or equal to Covid.
3) The virus will mutate further, just like the flu.
1) I'm a healthy adult w/ great nutrition, exercise frequency, & robust immune system.
2) The side effects are worse or equal to Covid.
3) The virus will mutate further, just like the flu.
13/13 W/ very low virulence at this point, we'll see CoV-2 become just like H1N1 & the common flu. A new vaccine will likely need to be developed/tailored for subsequent years, meaning it will join the up to 40% of common cold cases being the result of Coronaviruses.
