The Food and Drug Administration (FDA) on July 16 granted Pfizer Inc. and BioNTech SE Priority Review designation for the Biologics License Application (BLA) for their COVID-19 mRNA vaccine. The companies submitted their BLA in May 2021, and the FDA’s goal decision date is January 2022.
U.S. Surgeon General Issues Health Misinformation Advisory
U.S. Surgeon General Vivek Murthy, MD, on July 15 issued the Biden administration’s first Surgeon General’s Advisory, which warns the American public about the threat of health misinformation about COVID-19.
The advisory defines misinformation as “information that is false, inaccurate, or misleading according to the best available evidence at the time.” Misinformation includes disinformation, which is spread intentionally for a malicious purpose.
The advisory urges health care professionals and organizations to engage proactively with patients and the public, use technology platforms to share accurate health information with the public, and partner with community groups to prevent and confront health misinformation. The advisory recommends using personalized, localized, and easy-to-understand approaches to combat misinformation.
The advisory also includes recommendations for individuals, educators, journalists, technology platforms, researchers, funders, and governments.
CDC and Office of Minority Health Launch Minority Health Social Vulnerability Index
The Centers for Disease Control and Prevention (CDC) and Office of Minority Health (OMH) created the Minority Health Social Vulnerability Index (SVI), including databases and a dashboard, to help health care professionals plan targeted and equitable COVID-19 testing, vaccine, and treatment efforts.
The Minority Health SVI builds on the original CDC SVI, launched in 2011 to help emergency response planners and public health officials target communities most likely to need support in a public health emergency by adding additional social factors associated with COVID-19 outcomes. These factors include:
- socioeconomic status;
- household composition and disability;
- minority status and language, including statistics for specific race and ethnicity categories and languages;
- housing type and transportation;
- health care infrastructure and access; and
- medical vulnerability.
FDA Updates Janssen COVID-19 Fact Sheet
FDA on July 8 revised its fact sheet for health care providers administering the Janssen COVID-19 vaccine. This update includes new guidance for vaccine storage before the first puncture of the vaccine vial, considerations about thrombosis with thrombocytopenia following vaccination, and warnings of an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.