FDA Approval
- 2 distinct letters
- Pfizer
- BioNTech
- Authorization is for BioNTech.
- Initiated only when product becomes available.
- Pfizer still under EUA (has legal immunity).
- Dr. Robert Malone: Suggest you hold off for BioNTech
- Will not have liability protection the same as the Pfizer product
- BioNTech FDA Authorization was rushed without following precedent.
- This is “conditional” approval only (based on remaining studies).
- External advisory committee has been bypassed.
- Public comment has been bypassed.
- FDA says it has “no concerns”.
- Malone:
- FDA does not have safety and efficacy concerns.
- Efficacy data cites only original COVID virus strains, not Delta, or other strains.
- FDA/CDC hiding data.
- Child Vaccinations
- Risk of COVID in pediatric cohert is basically non-existent.
- Pfizer
- Not for < 16 yrs old.
- BioNTech is authorized for ≥ 16 yrs old only.
- The conditional FDA approval may be used to get Emergency Use Authorization for < 16 yrs old.
- They will disregard studies (that are negative).
- The conditional FDA approval may be used to get Emergency Use Authorization for < 16 yrs old.
- No data on safety of pregnancy.
- Some studies still to be accomplished 2023-2024.
- Malone: Thinks this authorization is to give the government and corporations cover for vaccine mandates.
- They did this because they knew it violates bioethics.
- They are invalidating VAERS (and the 20 other different databases) by saying it is inadequate.
- This authorization is for a vaccine that is not available.
- There are 2 separate letters for 2 vaccines.
- Pfizer is under EUA and is under liability shield.
- BioNTech product (Comernity) is NOT YET AVAILABLE.
- Has no liability waiver.
- There are 2 separate letters for 2 vaccines.