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originally posted by: SlapMonkey
a reply to: Klassified
That is a good letter, BUT it needs to be updated, as the Cominarty vaccine is no longer considered "experimental," and this letter claims that all of the vaccines are experimental. Of course, there's a low supply of Cominarty, and I have read that the FDA/CDC is allowing Pfizer to use their vaccines produced under the EUA as a replacement for Cominarty. Legally, they are different vaccines, and therefore if the supply says "Pfizer/BioNtech" instead of "Cominarty," you are still able to refuse the jab per federal law, even if Pfizer has one that has been FDA-approved.
And that assumes that the mandate is based on the recent FDA full approval. If not, and it's just one of those tyrannical companies that doesn't care about your health and is giving an ultimatum to get an experimental shot or be fired, then that's a different ballgame. Hopefully most employers aren't that heartless and unconcerned with the right to personal choices.
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This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part.
The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate:
As a 2-dose (separated by 21 days) schedule;
At various different dose levels in Phase 1;
As a booster;
In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]).
The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg.
Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study.
In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity.
The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg.
To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 43998 participants
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : May 2, 2023
Estimated Study Completion Date : May 2, 2023