CNN via WMUR (Archived): Pfizer seeks FDA authorization for updated COVID-19 booster.
Pfizer and BioNTech have submitted their application to the U.S. Food and Drug Administration for emergency use authorization of their bivalent COVID-19 vaccine for use in people age 12 and older, the companies said in a statement on Monday.
This updated formulation will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5, and would be administered as a 30 microgram dose.
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Pre-clinical data demonstrated that the new BA.4/5 bivalent vaccine "generated a strong neutralizing antibody response against omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain," according to the companies. They said a clinical study is expected to start this month.
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White House COVID-19 Response Coordinator Dr. Ashish Jha said recently the updated boosters should be available to the public early- to mid-September, but it is ultimately up to the FDA as to when the shot will get the greenlight.
"...generated a strong neutralizing antibody response against omicron
BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type
strain[.]" Gosh! It's New and Improved!
"The data says...The data demonstrates..." That vinyl or CD has been playing the same song for the past two and a half years. Someone put some AC/DC on.
Does anyone believe the FDA won't authorize Coof Booster Number Five? C'mon. There's money to be made! It's Pharmabusiness, Baby!
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