HHS and the FDA should be leading the world in health care policy, not being over one year behind the curve.
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The Food and Drug Administration last month announced the availability of new Covid-19 vaccines directed to the latest variants in circulation but failed to disclose that the vaccines have not been established as safe and effective. Given the ongoing controversies about prior Covid mRNA vaccines during the pandemic, the FDA should do the work to assure the American people that the well-established standards for vaccine approval are applied to these novel mRNA technologies.
TheFDAcouldreleasethelatestCovidshotswithoutprovingsafetyandefficacybecausetheyremainunderthe“emergencyuseauthorization”(EUA)category.AccordingtotheFDA,“The‘maybeeffective’standardforEUAsprovidesforalowerlevelofevidencethanthe‘effectiveness’standardthatFDAusesforproductapprovals.”TheFDAhasthisauthorityonlybecausethesecretaryofhealthandhumanservicesdeterminedonFeb.4,2020,thattherewasapublichealthemergencythatinvolvedthevirusthatcausesCovid-19,andthisdeterminationhasremainedinplace
