- Sep 19, 2020
- 8,345
- 9,724
- 2,138
Astonishing to me.
The EUA says the new shots are approved because of data from the old shots, and the expectations are similar.
New shot is supposed to work against Omicron XBB.1.5 variant.
Here is the EUA....
"Letter of Authorization (Reissued) The September 11, 2023 authorization of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age is based on: 1) effectiveness of the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) in individuals 6 months of age and older, 2) immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months through 4 years of age, and 3) safety data previously reviewed. FDA’s review of previously submitted safety data with Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), Pfizer and BioNTech’s bivalent vaccine (Original and Omicron BA.1) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and postmarketing safety data from Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), and Pfizer-BioNTech COVID-19 Vaccine, Bivalent did not identify specific safety concerns that would preclude issuance of an EUA. The safety data accrued with the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), bivalent vaccine (Original and Omicron BA.1), and Pfizer‑BioNTech COVID-19 Vaccine, Bivalent are relevant to Pfizer-BioNTech COVID‑19 Vaccine (2023‑2024 Formula) because these vaccines are manufactured using the same process. Based on the totality of the scientific evidence available, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine (2023-2024 Formula) may be effective in individuals 6 months through 11 years of age for the prevention of COVID-19 when administered in accordance with the dosing regimen and schedule as outlined in Section II. Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of the Pfizer-BioNTech COVID‑19 Vaccine (2023-2024 Formula) outweigh the known and potential risks of the vaccine for the prevention of COVID-19 in individuals 6 months through 11 years of age when administered according to the authorized dosing regimen and schedule."
www.newsweek.com
The Bivalent vaccine was also approved without any data.
www.nbcnews.com
VAERS reports 251 Bivalent-associated deaths as of today. I am sure the actual numbers are much higher. I reported my father's-in-law death to VAERS because no one else was going to do it.
The EUA says the new shots are approved because of data from the old shots, and the expectations are similar.
New shot is supposed to work against Omicron XBB.1.5 variant.
Here is the EUA....
"Letter of Authorization (Reissued) The September 11, 2023 authorization of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age is based on: 1) effectiveness of the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) in individuals 6 months of age and older, 2) immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months through 4 years of age, and 3) safety data previously reviewed. FDA’s review of previously submitted safety data with Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), Pfizer and BioNTech’s bivalent vaccine (Original and Omicron BA.1) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, and postmarketing safety data from Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), and Pfizer-BioNTech COVID-19 Vaccine, Bivalent did not identify specific safety concerns that would preclude issuance of an EUA. The safety data accrued with the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent), bivalent vaccine (Original and Omicron BA.1), and Pfizer‑BioNTech COVID-19 Vaccine, Bivalent are relevant to Pfizer-BioNTech COVID‑19 Vaccine (2023‑2024 Formula) because these vaccines are manufactured using the same process. Based on the totality of the scientific evidence available, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine (2023-2024 Formula) may be effective in individuals 6 months through 11 years of age for the prevention of COVID-19 when administered in accordance with the dosing regimen and schedule as outlined in Section II. Additionally, FDA determined it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of the Pfizer-BioNTech COVID‑19 Vaccine (2023-2024 Formula) outweigh the known and potential risks of the vaccine for the prevention of COVID-19 in individuals 6 months through 11 years of age when administered according to the authorized dosing regimen and schedule."
Was new COVID vaccine booster tested on only 8 mice? What we know
Some medical experts have expressed more hesitancy on new COVID boosters based not on safety but efficacy due to clinical trials not conducted on humans.
www.newsweek.com
The Bivalent vaccine was also approved without any data.
New Covid boosters, which target BA.5, haven't yet been tested in people. How well will they work?
The lack of human data means officials likely won’t know how much better the new shots are — if at all — until the fall booster campaign is well underway.
www.nbcnews.com
VAERS reports 251 Bivalent-associated deaths as of today. I am sure the actual numbers are much higher. I reported my father's-in-law death to VAERS because no one else was going to do it.
