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Latest News

Pre-Exposure Prophylaxis with Evusheld

September 16, 2022

What You Need To Know

  • In addition to following the recommended COVID-19 vaccination schedule, tixagevimab/cilgavimab (Evusheld), a combination of two monoclonal antibodies, should be administered to people who are moderately or severely immunocompromised every 6 months for pre-exposure prophylaxis to supplement vaccine protection. Per the product EUA, Evusheld can be given at least 2 weeks after COVID-19 vaccine. People may initiate Evusheld at any time after this interval, including between doses in the primary series and between any primary and booster doses.
  • This medication can provide protection for those not expected to mount an adequate immune response following vaccination, including those who are immunocompromised due to a medical condition or immunosuppressive medication, or for those individuals for whom COVID-19 vaccination is not recommended due to a history of severe adverse reaction to COVID-19 vaccination.
  • Evusheld is administered by intramuscular injection by a healthcare provider at an office or healthcare facility.
  • Current locations of EVUSHELD distribution can be found here.

The current treatment guidelines [5.4 MB, 456 pages] on the use of Evusheld as pre-exposure prophylaxis:

  • Tixagevimab 300 mg plus cilgavimab 300 mg (Evusheld) administered as two 3-mL intramuscular (IM) injections for adults and adolescents (aged ≥12 years and weighing ≥40 kg) who do not have SARS-CoV-2 infection, who have not been recently exposed to an individual with SARS-CoV-2 infection AND who:
    • Are moderately to severely immunocompromised or
    • Are not able to be fully vaccinated with any available COVID-19 vaccines due to history of severe adverse reactions
  • Tixagevimab plus cilgavimab should be repeated every 6 months.
  • Individuals who received tixagevimab 150 mg plus cilgavimab 150 mg should be given a second dose as soon as possible.
    • If the initial dose was administered ≤3 months prior, the second dose should be tixagevimab 150 mg plus cilgavimab 150 mg.
    • If the initial dose was administered >3 months prior, the second dose should be tixagevimab 300 mg plus cilgavimab 300 mg.
  • Individuals should be clinically monitored after injections and observed for at least 1 hour.
  • Evusheld is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to Evusheld.
  • There is not currently sufficient evidence to recommend either for or against the use of SARS-CoV-2 serologic testing to assess for immunity or guide clinical decisions about using Evusheld for pre-exposure prophylaxis. For more information, see NIH’s COVID-19 Treatment Guidelines.

Evusheld and timing with COVID-19 vaccination

  • Evusheld may be given at least 2 weeks after any COVID-19 vaccine.
  • After this interval, Evusheld may be initiated at any time between primary series and booster doses.
  • COVID-19 vaccines may be administered at any time after Evusheld administration.
  • Use of monoclonal antibodies is not a substitute for COVID-19 vaccination.

To learn more, please visit https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/pre-exposure-prophylaxis.html.

Ending COVID-19 Isolation

September 12, 2022
  • Updated guidance reflects new recommendations for isolation and precautions for people with COVID-19.
  • Removed Assessment for Duration of Isolation and Key Findings From Transmission Literature sections so page provides most current information.

Key Points

  • People who are infected but asymptomatic or people with mild COVID-19 should isolate through at least day 5 (day 0 is the day symptoms appeared or the date the specimen was collected for the positive test for people who are asymptomatic). They should wear a mask through day 10. A test-based strategy may be used to remove a mask sooner.
  • People with moderate or severe COVID-19 should isolate through at least day 10. Those with severe COVID-19 may remain infectious beyond 10 days and may need to extend isolation for up to 20 days.
  • People who are moderately or severely immunocompromised should isolate through at least day 20. Use of serial testing and consultation with an infectious disease specialist is recommended in these patients prior to ending isolation.

Recommendation for Ending Isolation

For people who are mildly ill with SARS-COV-2 infection and not moderately or severely immunocompromised:

  • Isolation can be discontinued at least 5 days after symptom onset (day 0 is the day symptoms appeared, and day 1 is the next full day thereafter) if fever has resolved for at least 24 hours (without taking fever-reducing medications) and other symptoms are improving.
  • Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation​.
  • high-quality mask should be worn around others at home and in public through day 10. A test-based strategy may be used to remove a mask sooner.
  • If symptoms recur or worsen, the isolation period should restart at day 0.
  • People who cannot wear a mask, including children < 2 years of age and people of any age with certain disabilities, should isolate for 10 days.
  • In certain high-risk congregate settings that have high risk of secondary transmission, CDC recommends a 10-day isolation period for residents.

For people who test positive, are asymptomatic (never develop symptoms) and not moderately or severely immunocompromised:

  • Isolation can be discontinued at least 5 days after the first positive viral test (day 0 is the date the specimen was collected for the positive test, and day 1 is the next full day thereafter).
  • high-quality mask should be worn around others at home and in public through day 10. A test-based strategy may be used to remove a mask sooner.
  • If a person develops symptoms within 10 days of testing positive, their 5-day isolation period should start over (day 0 changes to the first day of symptoms).
  • People who cannot wear a mask, including children < 2 years of age and people of any age with certain disabilities, should isolate for 10 days.
  • In certain high-risk congregate settings that have high risk of secondary transmission, CDC recommends a 10-day isolation period for residents.

For people who are moderately ill and not moderately or severely immunocompromised:

  • Isolation and precautions can be discontinued 10 days after symptom onset (day 0 is the day symptoms appeared, and day 1 is the next full day thereafter).

For people who are severely ill and not moderately or severely immunocompromised:

  • Isolation should continue for at least 10 days after symptom onset (day 0 is the day symptoms appeared, and day 1 is the next full day thereafter).
  • Some people with severe illness (e.g., requiring hospitalization, intensive care, or ventilation support) may remain infectious beyond 10 days. This may warrant extending the duration of isolation and precautions for up to 20 days after symptom onset (with day 0 being the day symptoms appeared) and after resolution of fever for at least 24 hours (without the taking fever-reducing medications) and improvement of other symptoms.
  • Serial testing prior to ending isolation can be considered in consultation with infectious disease experts.

For people who are moderately or severely immunocompromised (regardless of COVID-19 symptoms or severity):

  • Moderately or severely immunocompromised patients may remain infectious beyond 20 days. For these people, CDC recommends an isolation period of at least 20 days, and ending isolation in conjunction with serial testing and consultation with an infectious disease specialist to determine the appropriate duration of isolation and precautions.
  • The criteria for serial testing to end isolation are:
    • Results are negative from at least two consecutive respiratory specimens collected ≥ 24 hours apart (total of two negative specimens) tested using an antigen test or nucleic acid amplification test.
    • Also, if a moderately or severely immunocompromised patient with COVID-19 was symptomatic, there should be resolution of fever for at least 24 hours (without the taking fever-reducing medication) and improvement of other symptoms. Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation​.
    • Re-testing for SARS-CoV-2 infection is suggested if symptoms worsen or return after ending isolation and precautions.
  • If a patient has persistently positive nucleic acid amplification tests beyond 30 days, additional testing could include molecular studies (e.g., genomic sequencing) or viral culture, in consultation with an infectious disease specialist.
  • For the purposes of this guidance, moderate to severely immunocompromising conditions include, but might not be limited to, those defined in the interim clinical considerations for people with moderate to severe immunocompromise due to a medical condition or receipt of immunosuppressive medications or treatments.
    • Other factors, such as end-stage renal disease, likely pose a lower degree of immunocompromise, and there might not be a need to follow the recommendations for those with moderate to severe immunocompromise.
    • Ultimately, the degree of immunocompromise for the patient is determined by the treating provider, and preventive actions should be tailored to each patient and situation.

To learn more, please visit https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html.

CDC Recommends the First Updated COVID-19 Booster

September 2, 2022

Effective September 1st, 2022, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.

Updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading.

In the coming weeks, CDC also expects to recommend updated COVID-19 boosters for other pediatric groups, per the discussion and evaluation of the data by ACIP on Sept. 1, 2022. When data are available and FDA authorizes these other types of COVID-19 boosters, CDC will quickly move to help make them available in the United States.

The Food and Drug Administration’s (FDA) authorization of updated COVID-19 boosters, and CDC’s recommendation for use, are critical next steps forward in our country’s vaccination program—a program that has helped provide increased protection against COVID-19 disease and death.

The following is attributable to Dr. Walensky:

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”


U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

To learn more, please visit https://www.cdc.gov/media/releases/2022/s0901-covid-19-booster.html