The US Food and Drug Administration (FDA) announced late Thursday, August 12, 2021, that the Pfizer and Moderna mRNA vaccines are now emergency use authorized to include a third “booster” shot only for immunocompromised individuals, such as individuals with solid organ transplants taking immunosuppressant drugs, to be given at least 28 days after the second shot.  The FDA does clarify the booster shots are not emergency use authorized for other fully vaccinated individuals at this time.  Also, this does not apply to the single-dose Johnson & Johnson vaccine.

Non-grandfathered health plans, whether insured or self-funded, must provide no-cost coverage of the third “booster” shot for immunocompromised individuals within 15 business days.  During the public health emergency declaration, this no-cost coverage must be available in- or out-of-network.  Once the public health emergency ends, cost-sharing can be applied out-of-network only if there is adequate in-network access to the vaccine.  At this time, the federal government has been paying for all vaccines, so the only costs charged have been for administration of the vaccine.

Public health officials have high hopes that Pfizer’s vaccine developed in partnership with BioNTech will receive full approval from the FDA within the next few weeks.  Moderna filed its request for full approval June 1 but is still submitting data.  Johnson & Johnson has not submitted a request for full approval yet.

It is also expected that full approval will be followed by more vaccine mandates.  So far, the federal government is mandating employees and contractors either be vaccinated or submit to weekly testing paid for by the employer.  Some entities such as hospitals, universities, airlines, and some municipalities have already begun full vaccine mandates (with legally required reasonable accommodations) prior to full FDA approval.  Justice Amy Coney Barrett of the US Supreme Court on Thursday rejected an appeal from students of Indiana University without offering an explanation or referring the matter to the full court for review, allowing the university to move forward with its vaccine mandate.

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.

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