Public Policy Updates

Today, the Centers for Disease Control and Prevention (CDC) issued a statement about a recently detected preliminary signal for stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 bivalent mRNA vaccine. To date, they have not seen an association or increased risk of stroke from vaccines in these databases. The totality of the … Continued

The CDC joined the government of Uganda and global public health community in marking the end of the Ebola outbreak in Uganda, 42 days after the last reported case. Read the CDC announcement.

The U.S. Department of Health and Human Services has extended the COVID-19 Public Health Emergency (PHE) for another 90 days, effective January 11, 2023. Read the HHS announcement.

SARS-CoV-2 Omicron variant XBB.1.5 now accounts for 28 percent of the virus circulating in the U.S. The FDA is closely monitoring this subvariant because it is similar to other subvariants against which Evusheld is not effective. Evusheld is currently the only option for pre-exposure prophylaxis of COVID-19 and is authorized under Emergency Use Authorization (EUA) for use … Continued

A joint CDC/FDA investigation has identified seven linked cases of sepsis after transfusion from bacterially contaminated platelet blood products since 2018. The cases occurred in multiple states and genetic testing of isolates by the CDC found with high probability that the organisms were related and had a potential common source. Read the FDA safety alert and … Continued

Both CDC and FDA note that a negative COVID-19 test does not rule out the possibility that a person may have an infection that is not yet detectable. Therefore, both agencies recommend retesting for people who have symptoms or may have been exposed to COVID-19. The FDA has developed a guide to understanding at-home OTC … Continued

The FDA is providing additional information about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 200 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The two recent issues are: Read the FDA safety communication.

Honeywell Personal Protective Equipment has issued a Mandatory Stop Use Notice of the PAPR Cartridges PA7DEHE and PA7OVAGHE produced prior to November 2022. The company has identified a quality issue with these cartridges that could cause possible exposure to carbon and other substances, creating a potential safety issue for the user. Read the Honeywell Safety … Continued

A new U.S. Government Accountability Office (GAO) analysis of CDC and CMS data found that transmission of COVID-19 in the community surrounding a nursing home, known as community spread, had the strongest association with the duration of an outbreak. In the analysis of six nursing homes in four states, the GAO identified a range of … Continued