Earlier today Governor Northam issued an executive order announcing that all state workers must be vaccinated for COVID, or face weekly tests, beginning September 1st. But is it legal or does it conflict with federal law?
Following the announcement Delegate Dave LaRock sent the following letter questioning the Governor’s authority to require all 122,000 state workers to be vaccinated.
Under federal law, each person has the right to refuse a vaccine with only an emergency use authorization. The FDA’s published Guidance document spells out how products that are under EUAs are to be administered:
[S]ection 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.
[FDA, “Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,” (January 2017) (emphasis added).]
Please respond to the following questions as soon as possible:
- Under what authority are you requiring an EUA product for all Executive Branch employees, when the EUA statute requires that recipients “…have the option to accept or refuse the EUA product….”?
- For those who refuse the EUA product, what testing will be required? Particularly, after December 31, 2021, when CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only. https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html
Delegate Dave LaRock
Virginia House of Delegates, 33rd District<<<