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COVID-19: CDC Gives Preference to mRNA Vaccines; CMS Vaccine Rule Revived

World Health Organization (WHO) officials in a Dec. 14 press briefing named the omicron SARS-CoV-2 variant the fastest-spreading variant.

“Omicron is spreading at a rate we have not seen with any previous variant,” said WHO Director-General Tedros Adhanom Ghebreyesus, PhD. “We’re concerned that people are dismissing omicron as mild. Surely we have learned by now that we underestimate this virus at our peril. Even if omicron does cause less severe disease, the sheer number of cases could once again overwhelm unprepared health systems.”

Preliminary data from the South Africa COVID-19 Modeling Consortium show the omicron variant of the virus is spreading at twice the rate of the delta variant.

CDC Committee Recommends mRNA Vaccines

The Centers for Disease Control and Prevention (CDC) endorsed its Advisory Committee on Immunization Practices’ (ACIP’s) recommendation to give clinical preference to messenger ribonucleic acid (mRNA) vaccines over the Janssen COVID-19 vaccine, which uses an adenovirus vector.

ACIP cited concerns about thrombosis with thrombocytopenia syndrome (TTS), a condition that causes blood clots and low platelet count. TTS has been seen in 1 in 100,000 women age 30–49 who received the vaccine, and the condition has a fatality rate of 15 percent. ACIP previously recommended a pause in Janssen vaccine administration in April and rescinded the pause two weeks later.

Meeting discussion focused on the risks and benefits of continuing to use the vaccine, as well as the populations to which the vaccine is offered, which include people experiencing homelessness, homebound people, incarcerated individuals, migrant or seasonal workers, rural populations, college students, those at higher risk of COVID-19, educators, and long-term care facility residents — groups that may have lower health literacy compared with the population as a whole.

The Food and Drug Administration (FDA) on Dec. 14 revised the fact sheet for the Janssen COVID-19 vaccine to include a contraindication to the administration of the vaccine to individuals with a history of TTS following the Janssen COVID-19 vaccine or any other adenovirus-vectored COVID-19 vaccine. The fact sheet also includes updated information about the risk of TTS following vaccination.

Distribution Paused on COVID-19 Test That Fails to Detect Omicron Variant

Meridian Bioscience Inc. has paused distribution of its Revogene SARS-CoV-2 test. Because the test is a single-target test that detects a portion of the N-gene where deletions occur with the omicron variant, the test is not expected to detect the SARS-CoV-2 omicron variant.

Meridian has not yet distributed this test and does not intend to distribute this test, within or outside the United States, until this issue is resolved.

CMS Vaccine Rule Revived in 25 States

A Dec. 15 decision by the U.S. Court of Appeals for the Fifth Circuit has limited the scope of a previous injunction that blocked the Centers for Medicare & Medicaid Services’ (CMS’) COVID-19 vaccine mandate for health care workers nationwide.

The appeals court upheld the Louisiana district court’s preliminary injunction, which was challenged by the Biden administration and applies to facilities in 14 plaintiff states:

  • Arizona;
  • Alabama;
  • Georgia;
  • Idaho;
  • Indiana;
  • Kentucky;
  • Louisiana;
  • Montana;
  • Mississippi;
  • Ohio;
  • Oklahoma;
  • South Carolina;
  • Utah; and
  • West Virginia.

However, the court also granted a stay on the injunction’s application to other jurisdictions, noting that, “This vaccine rule is an issue of great significance currently being litigated throughout the country. Its ultimate resolution will benefit from ‘the airing of competing views’ in our sister circuits.”

Ten other states already are subject to the Missouri district court preliminary injunction upheld by the U.S. Court of Appeals for the Eighth Circuit:

  • Alaska;
  • Arkansas;
  • Iowa;
  • Kansas;
  • Missouri;
  • Nebraska;
  • New Hampshire;
  • North Dakota;
  • South Dakota; and
  • Wyoming.

Further, the Texas district court reactivated the state’s challenge to the CMS vaccine mandate and entered a preliminary injunction enjoining the CMS mandate for facilities in Texas.

The results of these decisions split the nation, with 25 states subject to the CMS vaccine rule and 25 exempt.

President Joe Biden on Dec. 16 filed an emergency application in the Supreme Court to reinstate the mandate nationwide, arguing in part that the emergence of the omicron variant and expected spike in COVID-19 cases during the winter underscores the urgent need for the CMS rule.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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