The FDA has granted full approval to Moderna’s messenger RNA (mRNA) COVID19 shot, Spikevax™, for persons age 18 and older. There are now two approved shots, although BioNTech’s Comirnaty is not yet available in the U.S., notes the Association of American Physicians and Surgeons (AAPS).
The change in designation from Emergency Use Authorization (EUA) theoretically might affect liability, mandates, and use by airline pilots, states AAPS, but is unlikely to make much difference at present.
Manufacturers and users of COVID-19 “covered countermeasures” have “sweeping” immunity from legal claims under the Public Readiness and Emergency Preparedness Act (PREP Act). Individuals who die or suffer serious injuries directly caused by the administration of covered countermeasures may be eligible to receive compensation through the Countermeasures Injury Compensation Program, which is extremely limited, states AAPS. FDA approval apparently does not change this.
Receipt of products under an EUA is supposed to be completely voluntary under federal law. Attempts of vaccine resistors to assert this have been met with the reply that a threat of loss of livelihood does not constitute coercion, states AAPS.
FDA approval might legitimize mandates to forcibly vaccinate, AAPS suggests, noting that the U.S. Supreme Court’s decisions on the OSHA and CMS employee mandates did not reach the issue of a right to bodily integrity.
According to Federal Aviation Agency (FAA) rules, medical examiners are instructed to “not issue” medical certifications to pilots using products that the FDA “approved less than 12 months ago.” The rule is evidently flouted with respect to COVID-19 vaccinations, AAPS states, regardless of reports of sudden death or cardiac damage in association with COVID-19 vaccination.
“While the FDA is intended to provide a roadblock to premature use of products before long-term safety studies are complete, the rush to vaccinate against COVID-19 has apparently overridden this barrier,” states AAPS executive director Jane Orient, M.D. “Thus, while FDA approval might affect a company’s stock price, its effect on current vaccination practice, from a practical standpoint, is likely to be minimal.