Pfizer and BioNTech applied Aug. 22 to the Food and Drug Administration for emergency use authorization of an omicron BA.4/BA.5–adapted bivalent COVID-19 booster vaccine for individuals ages 12 and older.
The bivalent vaccine targets not only the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus that causes COVID-19, but also the original SARS-CoV-2 variant. Pfizer says the new booster is available to ship immediately upon authorization.
BA.5 cases make up nearly 90 percent of all current COVID-19 cases, and many health leaders fear cases will continue to rise with possible fall and winter surges.
NHSN to Take over COVID-19 Hospital Tracking
The Centers for Disease Control and Prevention announced Aug. 16 that the National Healthcare Safety Network (NHSN) will take over COVID-19 hospital data collection from TeleTracking.
The move comes as TeleTracking’s contract with the Department of Health and Human Services (HHS) is set to expire Dec. 31. TeleTracking initially signed a contract with HHS’s Administration for Strategic Preparedness & Response in March 2020 and has been responsible for hospital COVID-19 data since.
NHSN also will host a series of webinars, starting Aug. 23, to provide facilities and health groups more information about the transition, including data submission guidance.
CMS Provides Roadmap as End of PHE Looms
The Centers for Medicare & Medicaid Services (CMS) released a roadmap Aug. 18 for states and the health care community to prepare for the eventual end of the COVID-19 public health emergency (PHE).
HHS Secretary Xavier Becerra has committed to giving 60 days’ notice before ending the PHE to avoid disruptions, including potential coverage losses.
The COVID-19 PHE declaration, which has been in place since Jan. 27, 2020, has facilitated the use of emergency authority waivers, regulations, enforcement discretion, and subregulatory guidance, among other flexible options for health care providers.
CMS encourages health care providers to prepare for the end of this flexibility upon the PHE’s expiration and to begin working to reestablish previous health and safety standards and billing practices.
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.