Policy Updates

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.

5/17/22 — The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to authorize the use of a single booster dose for individuals 5 to 11 years of age at least 5 months after completion of a primary series with the Pfizer vaccine. Read the FDA announcement.

5/13/22 — Fagron, Inc. is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli. Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. Exposure to contaminated product could lead to adverse events, which … Continued

5/16/22 — Woodside Acquisitions Inc. is recalling the Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit and the Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. Read the FDA recall notice.