Public Policy Updates

6/7/22 — The FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19.  Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this … Continued

5/25/22 — The FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use.

5/25/22 — The FDA issued warning letters to Santhigram Kerala Ayurvedic Co. of U.S., Inc.  and to Ayuryoga, Inc. for selling unapproved products with fraudulent claims to treat multiple diseases, including COVID-19. 

5/25/22 — The FDA revised the scope of authorization for Evusheld’s EUA to include new information on hypersensitivity reactions and the risk of cross-hypersensitivity with COVID-19 vaccines and related clinical recommendations. Clinicians should consider consulting an allergist-immunologist prior to administering Evusheld to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to a COVID-19 vaccine.  

5/24/22 — Following FDA’s revised EUA to include booster shots of the Pfizer-BioNTech COVID-19 vaccine to children five years of age and older, the CDC strengthened its COVID-19 recommendation to include a booster shot for this age group five months after their initial Pfizer vaccination series. Read the CDC announcement.

5/24/22 — The CDC issued a Health Alert Network (HAN) Health Advisory to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 rebound.” Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease. Paxlovid treatment … Continued

AHRQ Technical Brief APIC comments AHRQ Technical Brief, April 22, 2022

5/17/22 — The CDC and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) are holding virtual listening sessions on the proposed revision to hospital and critical access hospital Conditions of Participation (CoP) on hospital data reporting provisions for COVID-19 after the conclusion of the current public health emergency (PHE), as well as … Continued

5/17/22 — In anticipation of a COVID-19 vaccine for the under-5 population, CDC has updated the Pediatric Operational Planning Guide. Read the updated COVID-19 Vaccination for Children page on the CDC website. Access a direct link to the PDF of the guide.