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DoorlessCarp🐭's avatar

Unredacted safety summary for BNT162c2.

TL;DR: I can see why they discontinued it at the time and tried to redact. I read that they advise not administering near a nerve, but the deal breaker is that 2 of the 12 (young) participants had severe local reactions, even at the lower dose.

They also reported poor immunogenicity in rats and NHPs, non human primates.

IMOH this should never have progressed beyond rodent studies.

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6.1.1.2.4 BNT162c2 - Summary of safety

BNT162c2 has been tested at doses of 0.1, 0.3, and 1 μg. Minimal reactogenicity was reported with any local reactions (chiefly pain) being mild or moderate and present in 4, 7, and 11 subjects in each dose cohort respectively. Systemic reactions showed little dose dependency overall with 7, 7, and 8 subjects reporting any systemic reaction by respective dose cohort.

2 subjects each in the 0.3 and 1.0 μg cohorts reported severe local reactions. All reported events were self-limiting or simply managed. No SAEs were reported and no subjects have withdrawn due to an AE. At the time of preparation of this summary, the overall assessment of safety data following dosing with BNT162c2 has not changed.

...7.2 Posology and method of administration

The BNT162 vaccines are intended for IM administration in the upper arm (deltoid muscle) using two doses 21 day apart (P/B regimen). For BNT162c2, optionally a single dose regimen is also under investigation. The vaccine should not be injected into areas where there may be a major nerve trunk

https://www.google.co.uk/url?sa=t&source=web&rct=j&opi=89978449&url=https://phmpt.org/wp-content/uploads/2023/10/19736_S0369-dsur-22apr2020-21apr2021.pdf&ved=2ahUKEwjShJDqgNKIAxUfVUEAHbVRFzMQFnoECCEQAQ&usg=AOvVaw0TZp0EVu4C-dQ80t1oZ0l_

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Robert Meldrum's avatar

Also, note that none of these studies identify what is in the “placebo” shot. In many prior vaccine studies, the new vaccine was tested against a “placebo” which was an already-approved vaccine. Not a placebo at all! The number of AE’s with the COVID vaccine placebos indicate that the placebos were not inert but in fact had something in them that also caused AE’s. There is speculation that the “placebos” may have been LNP’s with no mRNA: hardly inert. The Pharma companies refuse to identify what was used in their studies. Trust the science???

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