The agency's rationale for inaction appears to undermine its own repeated warnings against treating COVID with ivermectin, an antiviral with a long safety record that few if any Americans are confirmed to have used unsafely in the COVID context.
COVID vaccine labels will remain largely unchanged, even as ongoing research provides further evidence of the poor performance of the two-strain bivalents, whose uptake has plateaued at 1 in 6 Americans, against evolving Omicron subvariants.
The Coalition Advocating for Adequately Labeled Medicines filed the FDA petition in January, asking for several new labeling requirements for licensed and emergency use vaccines made by Pfizer and Moderna.
The petition cites false statements on infection and transmission by federal officials as well as arbitrary herd immunity thresholds invoked by Pfizer, Moderna and the FDA to induce vaccination.
Pfizer's label should note the FDA authorized a new formulation with a different "Buffer" without clinical studies, and that its phase III trials showed waning efficacy two months after the second dose and that data haven't been reported for pregnant women since their study ended in July.
The FDA granted one request - to revise Pfizer's bivalent label with updated clinical data - while denying the others as not required by regulation or necessary for "Safe and effective use."
The timing of the response is "Curious" because the FDA has revoked the monovalent mRNA vaccines' authorization, leaving only emergency-use-authorized bivalents, she said, asking: "And where is the emergency?"
No comments:
Post a Comment