While some employers are beginning to mandate COVID vaccination for their workers, the FDA has provided the following information on EUA vaccinations:
“Although informed consent as generally required under FDA regulations is not required for administration or use of an EUA product, section 564 does provide EUA conditions to ensure that recipients are informed about the MCM they receive under an EUA. For an unapproved product (section 564(e)(1)(A)(ii)) and for an unapproved use of an approved product (section 564(e)(2)(A)), the statute requires that FDA ensure that recipients are informed to the extent practicable given the applicable circumstances: That FDA has authorized emergency use of the product; Of the significant known and potential benefits and risks associated with the emergency use of the product, and of the extent to which such benefits and risks are unknown; That they have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product; and of any available alternatives to the product and of the risks and benefits of available alternatives. Therefore, FDA recommends that a request for an EUA include a “Fact Sheet” for recipients that includes essential information about the product. “ This statement references 21 CFR 50 (accessible at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50)
You can find more information in our fact sheet below:
NJCVC Covid workplace 1-25-2021.docx (2)