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COVID-19: Guidance Updates, Authorization of Antiviral Pills

The Centers for Disease Control and Prevention (CDC) updated isolation and quarantine recommendations for the public. These recommendations do not apply to health care personnel and do not supersede state, local, tribal, or territorial laws, rules, and regulations.

According to the new guidance, people with COVID-19 should isolate for five days. If they are asymptomatic or their symptoms are resolving (without fever for 24 hours), they then should wear a mask around others for five additional days. People exposed to COVID-19 should test for SARS-CoV-2 at day five after exposure.

FDA Authorizes Boosters for Adolescents

The Food and Drug Administration (FDA) Jan. 3 amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. Changes include:

  • authorizing a booster dose for adolescents ages 12–15;
  • shortening the period between primary dose series completion and booster dose administration from six to five months; and
  • authorizing a third primary series dose, administered 28 days after the second dose, for children ages 5–11 who have undergone solid organ transplantation or who have a condition causing an equivalent level of immunocompromise.

The agency noted that peer-reviewed data show a booster dose of the Pfizer vaccine greatly improved antibody response to fight the omicron variant of SARS-CoV-2, which is now the dominant variant of concern in the United States. CDC’s Advisory Committee on Immunization Practices is scheduled to meet this week to review the new authorization.

CDC Health Advisory on Therapeutics and the Omicron Variant

Meanwhile, CDC issued a health advisory about the use of therapeutics to treat COVID-19 caused by the omicron variant. Because of mutations in the omicron variant’s spike protein — the part of the virus that plays a major role in penetrating host cells and initiating infection — frequently used monoclonal antibody combinations, such as bamlanivimab and estevimab or casirivimab and imdevimab, are ineffective against the variant.

The monoclonal antibody sotrovimab is effective against the omicron variant but is in limited supply. CDC urges health officials to prioritize use for nonhospitalized patients who have risk factors for progression to severe COVID-19, including:

  • unvaccinated patients;
  • individuals with clinical risk factors;
  • individuals ages 65 and older; and
  • individuals not expected to mount an adequate immune response due to immunocompromising conditions.

Studies show that remdesivir, a nucleoside analog drug administered intravenously to treat hospitalized COVID-19 patients, was effective against the omicron variant, but data is limited. Additionally, FDA authorized two oral antiviral drugs to treat mild to moderate COVID-19 in patients at high risk of developing severe disease.

FDA on Dec. 22 authorized Pfizer’s Paxlovid for adults and children ages 12 and older who weigh at least 40 kilograms (about 88 pounds) who test positive for COVID-19. Available by prescription only, Paxlovid should be taken within five days of system onset. The drug comprises two tablets of nirmatrelvir, which stops the virus from replicating, and one tablet of ritonavir, which slows the breakdown of nirmatrelvir in the body, taken twice a day for five days.

The agency on Dec. 23 also authorized Merck’s molnupiravir for adults age 18 and older who test positive for COVID-19 and for whom other treatment options are not accessible. This medication, available by prescription only, is taken every 12 hours for five days, beginning within five days of system onset. This medication is not authorized for children, as it may interfere with bone and cartilage growth.

Because Paxlovid reduced severe outcomes by 88 percent, compared to molnupiravir’s 30 percent reduction, CDC urges health care providers to prioritize Paxlovid for high-risk populations. Molnupiravir should not be used in patients who are pregnant or breastfeeding. Both antiviral pills are expected to be active against all variants of concern.

CDC also is monitoring the effectiveness of AstraZeneca’s EVUSHELD, a pre-exposure monoclonal antibody treatment authorized for high-risk patients, against the omicron variant.

FDA Authorizes At-Home Tests Through Accelerated Review Process

FDA authorized two at-home, over-the-counter COVID-19 tests through a new accelerated review process for tests with potential for large-scale manufacturing.

The Department of Health and Human Services (HHS) in October 2021 dedicated $70 million in American Rescue Plan Act funding to the Independent Test Assessment Program (ITAP). Through ITAP, experts from the National Institutes of Health’s (NIH’s) Rapid Acceleration of Diagnostics Technology (RADx) program work with CDC, FDA, and HHS specialists to study over-the-counter tests.

The newly authorized tests include a test manufactured by SD Biosensor and distributed by Roche and a test manufactured by Siemens.

CMS Issues Guidance on Vaccine Mandate Compliance

The Centers for Medicare & Medicaid Services (CMS) on Dec. 28 updated its guidance for compliance with its COVID-19 vaccine mandate for health care workers in the 25 states where the mandate is not enjoined. The agency’s new deadline for Phase 1 of the mandate, which requires partial vaccination, is Jan. 27; the deadline for full vaccination is now Feb. 28.

CMS provides general guidance and survey procedures, as well as specific information for hospitals to comply with the vaccination requirements.

In a December 2021 comment letter to CMS, America’s Essential Hospitals requested the agency provide additional time for health care facilities to comply with COVID-19 vaccine requirements.

The U.S. Supreme Court on Jan. 7 will hear oral arguments in the case regarding the mandate’s legality, along with arguments in the case challenging the Occupational Safety and Health Administration’s rule mandating vaccines or weekly testing for companies with 100 or more employees.

President Biden Announces New Resources for Hospital COVID-19 Response

President Joe Biden on Dec. 21 announced several administration initiatives to respond to COVID-19 during the surge in cases caused by the omicron variant.

These initiatives include several efforts to increase hospital capacity to respond to COVID-19, such as:

  • preparing 1,000 military service members to deploy to burdened hospitals in January and February;
  • deploying emergency response teams, with more than 100 clinical personnel, to Michigan, Indiana, Wisconsin, Arizona, New Hampshire, and Vermont;
  • pre-positioning personal protective equipment and ventilators from the Strategic National Stockpile to send to states in need;
  • expediting ventilator shipments to states in need; and
  • urging the Federal Emergency Management Agency (FEMA) to:
    • increase staffing for the National Response Coordination Center and FEMA regions;
    • continue to provide states funding to expand hospital capacity; and
    • ready ambulances and emergency medical teams to transport patients to open beds;

Additionally, Biden announced efforts to expand vaccination and testing, including by providing 500 million free rapid tests to Americans upon request.

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 communications manager at America's Essential Hospitals.

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