- within Compliance and Consumer Protection topic(s)
- with readers working within the Healthcare industries
Seyfarth Synopsis: Today the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, to prevent COVID-19 disease in individuals 16 and older. This could be big news for those on the fence about getting vaccinated, and for employers contemplating their COVID-19 vaccine programs.
The Pfizer vaccine has been administered under Emergency Use Authorization for more than nine months, but now has been fully approved by the FDA. Some vaccine-hesitant individuals may now change their opinions about whether to get vaccinated based on the FDA's full approval of Comirnaty. And for employers refraining from mandating vaccination, reduced employee resistance to and improved employee confidence in a fully-vetted vaccine may remove one barrier to requiring vaccination.
Of course, how vaccines can best be deployed remains a shifting conversation, with the Biden Administration now pushing for boosters. Those who have been defined by federal, state, and local government requirements and guidance as "fully vaccinated" may no longer meet that definition should it change to require the proposed booster. The OSHA COVID-19 Healthcare Emergency Temporary Standard ("ETS") defines fully vaccinated as "two weeks or more following the final dose of a COVID-19 vaccine." But will the ETS definition be modified to require three doses? Which definition might carry over to any permanent COVID-19 or infectious disease standard promulgated by the Biden Administration? Employers will need to stay on top of these and other COVID-19 vaccine concerns as science and society continue to adjust to the ongoing pandemic.
Please refer to our analyses of other COVID-19 vaccine issues in prior blog entries, including: President Biden to Require Federal Workers, Contractors to Provide Vaccine Attestation or Mask, Distance, and Test Multiple Times Per Week, Employers Do Not Need To Record Adverse COVID-19 Vaccine Reactions on their OSHA Form 300 Log, and OSHA Issues Updated Protecting Workers Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace.
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