Ordinarily, the Food and Drug Administration’s (FDA) approval of a drug is generally followed by the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommending that the public take it. In the case of the latest COVID-19 vaccine, this took only one day. In a September 11 press release, FDA reported on that day’s approvals for updated mRNA vaccines. Importantly the agency used an “Accelerated Approvals Program.” More specifically the agency issued an emergency use authorization for the under 12-year-old cohort, while granting formal approvals for all else under the Accelerated Approvals Program, based on a surrogate endpoint. This means they used an exception they have to rush when there are serious unmet needs—and they don’t have to have comprehensive clinical evidence.
Wiseman D, Gutschi, LM. Chase safety not variants: Advisory Committee on Immunization Practice September 12, 2023. XBB1.5 variant: likely rapid waning and escape by emerging variants will quickly render this vaccine obsolete with more risk than benefit. v2. Research Gate 2023 Sep 14. Epub http://doi.org/10.13140/RG.2.2.26411.62248
Autoimmune reactions triggered by C19 genetic vaccines
Honored to be part of this paper just published. Please retweet and download paper:
Honored to be part of this pape just published: Autoimmune inflammatory reactions triggered by the COVID-19 genetic vaccines in terminally differentiated tissueshttps://t.co/MgWyhaZIxe
— David Wiseman PhD, MRPharmS Smoking Syringe (@AdhesionsOrg) September 15, 2023