@birb_k - KBirb
Quickest slide ever. VRBPAC meeting 10/22/2020, prep to launch injections. Steve Anderson, FDA/CBER Dir. of Biostatistics & Epidemiology. Screen cap of critical slide 16. Video clip starts at slide 15. Watch as he asks for slide 17, slide 16 flashes by. https://youtube.com/watch?v=1XTiL9rUpkg&t=9210s… 1/
@birb_k - KBirb
8 months later June 2021. Steve gives safety data update. This slide is shown. “Vaccine enhanced disease” missing. Then he says some Adverse Events of Special Interest (AESI’s) “obviously have now signaled,” but it did not appear to trigger any action. https://www.youtube.com/watch?v=70Xhn3K9SlQ&t=5817s 2/ https://t.co/dmSTQE9STi
@birb_k - KBirb
Note: The Oct 2020 flash-by slide 16 is included in the presentation ndocument uploaded to the VRBPAC event record. Link: https://www.fda.gov/media/143557/download 3/
@birb_k - KBirb
Nipah. Outbreak | Study | Vaccine. The unique combination of these 3 elements feels familiar, uncomfortable. A) OUTBREAK. Multiple outlets now reporting Nipah outbreak & isolation efforts in Kerala, India. Nipah has historically been low transmission and highly lethal. But… 1/
@birb_k - KBirb
Nipah. Outbreak | Study | Vaccine. B) STUDY. The NIH/NIAID funded a 3-year Cooperative Agreement program 2020-2022 on Nipah, while Fauci was in office. The awardee? Peter Daszak and EcoHealth Alliance. Was gain-of-function involved? (asking due to precedence) 2/ https://t.co/EBma02ygxi
@birb_k - KBirb
Nipah. Outbreak | Study | Vaccine. C) VACCINE. No Nipah vaccine has existed, but an mRNA candidate (of course) is in active Phase 1 trials. Who is doing the trial and has worldwide rights to the outcome? Moderna. Who funded the trial? NIH/NIAID (royalty?) History rhymes. 3/ https://t.co/LC7lFk24rB
@birb_k - KBirb
Will Nipah remain a deadly but low-transmission disease with localized, non-global consequences? Hopefully. But if a version manipulated for transmissibility leaked, that would be bad. In COVID context Fauci/NIAID had ties to EcoHealth & Moderna. Same apparently with Nipah. 4/ https://t.co/UOVmaYGJmw