FDA keeps moving the goalpost to benefit Pfizer NOT US Citizens!
👉11/19/21: FDA letter to Pfizer
fda.gov/media/150386/d…
👉2/3/21: FDA reissued letter of EUA authorization to allow flexibility on date of submission of reporting of vaccine administration errors by Pfizer.
How is this legal!
👉8/23/21: FDA clarified subsequent to FDA approval of COMIRNATY (COVID19 Vaccine) for 16 yrs & older, EUA would remain in place for Pfizer-BioNTech Vax.
👉Also authorized COMIRNATY (COVID-19 Vax)
😱which has full FDA APROVAL under this EUA for certain uses!
👉Having concluded revising Comirnaty EUA is appropriate to protect public health or safety FDA again reissuing 10/21/21 letter of authorization in entirety w/ revisions to amend EUA for COMIRNATY Vax & Pfizer-BioNTech Vax to authorize use as a single booster dose 18 yrs or older
😱OMG!
Page 3!
👉37,586 participants 16 years AND OLDER! How many were actually age 16 through 18? They only followed for 2 months!
👉36,523 participants 12 years AND OLDER! How many were actually 12 through 18? Followed for only 7 days!
5/10/21: Ongoing Phase 1/2/3 trial enrolled approx 46,000 participants.
👉including 2,260 age 12 through 15.
👉Trial participants randomized 1:1 to receive Pfizer-BioNTech COVID-19 Vaccine or saline control
(so ony 1,130 partipants age 12 through 15 actually received the vax!)
10/29/21: Authorization Pfizer-BioNTech COVID-19 Vax using Tris buffer for 5-11 yrs.
👉Ongoing Phase 1/2/3 trial enrolled 4,695 age 5-11 yrs.
👉3,109 received Pfizer-BioNTech COVID-19 Vax.
👉Approx 1,538 received saline control in Phase 2/3.
👉What did the 1,538 get in Phase 1?
10/29/21: Authorization of manufacturing change to include addtl formula of Pfizer-BioNTech Vax using Tris instead of PBS...FDA reviewed data on analytical comparability, which uses lab testing to demonstrate a change in product formulation is 👉not expected👈 to impact safety
Science!
11/19/21: Expanding eligible population for booster doses to 18 yrs & older FDA reviewed data provided 👉by sponsor👈& other data available to FDA including real world evidence👉suggesting👈decreased risk of myocarditis
following booster doses compared w/ 2nd doses...
More science!
Based on totality of scientific evidence available, FDA concludes a homologous or heterologous booster dose of Pfizer-BioNTech COVID-19 Vax
👉may be effective👈
and known & potential benefits of booster dose of Pfizer-BioNTech
👉outweigh known & potential risks👈
B. Based on totality of scientific evidence available to FDA, it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vax may be effective in preventing COVID-19...
C. There is no adequate, approved, and available alternative Pfizer-BioNTech COVID‑19 Vax to prevent COVID-19.
• Pfizer will supply Pfizer-BioNTech COVID‑19 Vax either directly or through authorized distributor(s) to emergency response stakeholders as directed by US government, including CDC &/or other designee, for use consistent w/ terms & conditions of this EUA;
Pfizer-BioNTech formulations that use Tris & PBS (each 0.3 mL dose containing 30 µg modRNA) described in detail under Product Description covered by this authorization will be administered by vax providers & used only to prevent COVID-19 in individuals 12 yrs or older.
Pfizer-BioNTech COVID-19 VaX that uses Tris (each 0.2 mL dose containing 10 µg modRNA), as described in more detail under Product DescriptioN covered by this authorization will be administered by vaX providers used only to prevent COVID-19 in individuals 5 through 11 yrs of age.
For use in individuals 12 yrs & older
Pfizer-BioNTech COVID-19 Vax that uses PBS buffer (supplied in multiple dose vials w/ purple caps) supplied as frozen suspension; each vial must be diluted w/ 1.8 mL sterile 0.9% Sodium Chloride Injection USP prior to use to form vaccine.
👇
For use in individuals 5 to 11 yrs
Pfizer-BioNTech COVID-19 Vax that uses Tris buffer & is supplied in multiple dose vials w/ orange caps is supplied as frozen suspension; each vial must be diluted w/ 1.3 mL of sterile 0.9% Sodium Chloride Injection USP prior to use to form vax
E. Pfizer Inc may request changes to this authorization, including to authorized Fact Sheets for the vax. Any request for changes to this EUA must be submitted to Office of Vaccines Research & Review (OVRR)/Center for Biologics Evaluation
& Research (CBER).
Look at 23!
F. Pfizer will report to Vaccine Adverse Event Reporting System VAERS
• Serious adverse events (irrespective of attribution to vax)
• Cases of Multisystem Inflammatory Syndrome in children & adults
• Cases of COVID-19 that result in hospitalization or death reported to Pfizer
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