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FDA Authorized Pfizer and Moderna for all Adults

The FDA approved Pfizer and Moderna booster injections for all adult age groups last week. At the same time, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the Moderna vaccine booster for all adults. Pfizer has applied for an emergency use authorization (EUA) for its COVID-19 oral medication. The Infrastructure Investment and Jobs Act and the Executive Order implementing it were signed by Vice President Joe Biden. The FDA has amended its guidance for SARS-CoV-2 test manufacturers.

The President signed the Infrastructure Investment and Jobs Act (IIJA) and an Executive Order to simplify its implementation on November 15. During a public health emergency declared by the HHS secretary, the IIJA amends the Homeland Security Act of 2002 to allow the secretaries of Homeland Security, Health and Human Services (HHS), and Veterans Affairs to transfer personal protective equipment (PPE) and the medically necessary equipment to the national stockpile under a domestic production contract.

In general, the secretary of Homeland Security has the authority to transfer excess PPE or medically essential equipment possessed by the Department of Homeland Security to HHS on a reimbursable basis at the request of the HHS secretary (DHS). The DHS secretary must decide whether the proposed personal protective or medically essential equipment is surplus and certify that its transfer would not endanger the health or safety of DHS officers, employees, or contractors.

The “Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised)” was reissued by the FDA, and it pertains to diagnostic and serologic tests. At-home and point-of-care testing, high-volume lab-based molecular diagnostic tests, lab-based and point-of-care high-volume antibody tests, and tests financed by US government agencies are all eligible for EUA requests. All other varieties must follow the regular premarket procedures.

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