The U.S. SARS-CoV-2 Interagency Group on Nov. 30 declared the new omicron variant of SARS-CO-V-2 a variant of concern. As of Dec. 6, 16 states reported at least one case of COVID-19 caused by the omicron variant.
While it is unknown whether the omicron variant is more infectious than previous variants, preliminary data from South Africa (where the variant originated) suggest mutations to the receptor-binding protein of the variant will confer increased infectivity. The delta variant remains the predominant variant in the United States.
President Joe Biden on Dec. 2 announced a nine-point plan to combat the omicron and delta variants by:
- recommending boosters for all adults, expanding pharmacy hours, launching a public education campaign, working with AARP to promote boosters to seniors, and urging private employers to offer paid time off to employees to get boosted;
- vaccinating more children by launching Federal Emergency Management Agency family vaccine clinics that allow multiple family members to be vaccinated at one appointment, requiring Medicaid to cover vaccine counseling for people up to age 21, reviewing school COVID-19 safety policies, and supporting the Food and Drug Administration’s review of vaccines for children younger than age five;
- expanding access to at-home COVID-19 tests by requiring insurance reimbursement for at-home tests and expanding community distribution of no-cost tests;
- strengthening predeparture testing requirements for international travel and extending to March 18 the mask requirement for airplanes, rail travel, and public transportation;
- urging businesses to establish vaccination and testing protocols;
- providing more than 60 COVID-19 emergency response team deployments to assist states this winter and allocating $20 million in American Rescue Plan Act funding to strengthen the Medical Reserve Corps;
- committing to allocate COVID-19 antiviral treatment pills, when available, to the hardest-hit communities;
- donating 1.2 billion vaccine doses globally, committing to donate 200 million more doses within the next 100 days, and building vaccine manufacturing capacity; and
- taking steps to provide updated vaccinations for new variants, if necessary.
CMS Will Not Enforce Vaccine Mandate Amid Legal Challenges
The Centers for Medicare & Medicaid Services (CMS) announced in a Dec. 4 memo to state survey agency directors that it will not enforce the new vaccine mandate rule in certified Medicare and Medicaid providers and suppliers, amid court-ordered injunctions.
The U.S. District Court for the Eastern District of Missouri and U.S. District Court for the Western District of Louisiana issued preliminary injunctions against the implementation and enforcement of the rule. Together, these injunctions cover all states, Washington, D.C., and the U.S. territories. CMS has appealed both decisions and filed motions for stays of these orders.
FDA Expands Authorization for COVID-19 Therapeutic
The Food and Drug Administration (FDA) on Dec. 3 revised its emergency use authorization to allow administration of COVID-19 monoclonal antibody treatments in certain younger pediatric individuals, including neonates, not covered under prior authorizations.
The emergency use of bamlanivimab and etesevimab was originally authorized to be administered together for the treatment of mild to moderate COVID-19 in certain adults and pediatric patients (12 years and older). However, based on new evidence, FDA concluded bamlanivimab and etesevimab administered together might be effective for use as post-exposure prophylaxis of COVID-19 in adults and younger pediatric individuals.
The Office of the Assistant Secretary for Preparedness and Response also released a Health Partner Ordering Portal (HPOP) FAQ for allocating and requesting COVID-19 therapeutic products. The HPOP will be used to order future products. For questions on the portal, email COVID19Therapeutics@hhs.gov.
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.