[atcon]

Disclaimer: this is not legal or medical advice, but an encouragement to read the research for yourself and accumulate an understanding of the issues for your decision making. If you know any good studies or criticisms, please add them.

Emergency Use Authorization (EUA) and Biologics License Application (BLA) description: https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the....

There are already lawsuits challenging EUA vaccine mandates. They’d be moot, though, after FDA approval, since the Supreme Court has upheld states’ vaccination mandates (cf. Jacobson v. Massachusetts)

Some issues around BLA/FDA approval: First, a BLA has some implications. It would likely force the FDA to revoke EUAs to all other candidates (one of the conditions for an EUA is that no other viable approved treatments exist. Some of the controversy around ivermectin and off label use is related to this condition). This would impede development of other treatments, current and future.

Second, the history of SARS-cov vaccines is promising, but incomplete. Many previous trials showed good progress (high antibody titre levels, etc.), but tended to fare poorly on later virus challenges. eg https://journals.plos.org/plosone/article?id=10.1371/journal...

Third, sometimes, side effects might not be sufficiently analyzed until well after authorization, eg “Dengvaxia”: a dengue fever (R0=65, CFR=20-30%) vaccine that was extensively used in the Philippines in 2017-8, but later showed evidence of increasing risk of disease severity on the uninfected and now carries that warning: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214489/ https://en.wikipedia.org/wiki/Dengue_vaccine

Hayes et al. outlines some of the issues particular to SARS. Again, VAED is a known pitfall: https://childrenshealthdefense.org/wp-content/uploads/Haynes...

Finally, Breslow (https://blog.petrieflom.law.harvard.edu/2021/02/18/employer-...) suggests mandates aren’t legal: previous CDC and FDA guidance have consistently advised against mandatory use of EUA vaccines, and courts would probably continue to defer to those agencies. In April 2020, Dr. Amanda Cohn, the executive secretary of the CDC’s Advisory Committee on Immunization Practices, reiterated that “under an EUA, vaccines are not allowed to be mandatory. Therefore, early in the vaccination phase individuals will have to be consented and cannot be mandated to be vaccinated” (page 56, https://www.cdc.gov/vaccines/acip/meetings/downloads/min-arc...) In addition, the EEOC June 28, 2021 update (https://www.eeoc.gov/wysk/what-you-should-know-about-covid-1...), Section K in particular, defers to CDC and FDA guidance on EUA vaccine use and practices.