CDC Weekly Update – Week of 8/08/2022

COVID-19 Resources                                                                     

• CDC streamlines COVID-19 guidance to help the public better protect themselves and understand their risk — COVID-19 continues to be a serious public health threat, but high levels of immunity and the availability of treatment and prevention tools have made medically significant illness, hospitalization, and death less likely. 

CDC is updating and streamlining existing COVID-19 community guidanceto help people better understand their risk, how to protect themselves and others, what actions to take if exposed to the virus that causes COVID-19, and what actions to take if they have symptoms or test positive for the virus. 

• Media statement – CDC streamlines COVID-19 guidance to help the public better protect themselves and understand their risk | CDC Online Newsroom | CDC
• Morbidity and Mortality Weekly Report – Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022 | MMWR (cdc.gov)

CDC is also updating setting-specific guidance including, healthcare and congregate settings at higher risk of transmission. These updates are forthcoming at which time more information will be shared. 

Additional COVID-19 Resources 

• Morbidity and Mortality Weekly Report (MMWR) — COVID-19 Self-Test Data: Challenges and Opportunities — United States, October 31, 2021–June 11, 2022 — Increased self-test use has likely contributed to underascertainment of COVID-19 cases, because unlike the requirements to report results of laboratory-based and health care provider–administered point-of-care COVID-19 tests, public health authorities do not require reporting of self-test results. However, self-test instructions include a recommendation that users report results to their health care provider so that they can receive additional testing and treatment if clinically indicated. In addition, multiple manufacturers of COVID-19 self-tests have developed websites or companion mobile applications for users to voluntarily report self-test result data. You can learn more here: Morbidity and Mortality Weekly Report

Monkeypox Virus 

• JYNNEOS Smallpox and Monkeypox Vaccine Storage and Handling Summary — JYNNEOS may be stored refrigerated between 2°C and 8°C (between 36°F and 46°F) for up to 8 weeks from thawing. This updated information has been provided by the vaccine manufacturer based on available supportive stability data. 

Please note that this Beyond Use Date (BUD) guidance differs from the package insert guidance, which states that the vaccine may be kept at 2°C to 8°C (36°F to 46°F) for 12 hours (Section 2.2 Preparation and Administration and 16.2 Storage Conditions). For more information, click here. 

• Updated Infection Prevention and Control of Monkeypox in Healthcare Settings — On August 11^th, CDC updated its Infection Prevention and Control of Monkeypox in Healthcare Settings guidance. Recommendations were added on how to monitor exposed patients and when they should be isolated as well as how to assess the risk of healthcare personnel (HCP) with monkeypox exposures, monitoring HCP and when to apply work restrictions.  

The risk assessment table for HCP was updated to reflect the following: 

• The entry addressing HCP wearing all recommended PPE was moved from the low/uncertain category in the table to the table’s preamble and now describes why self-monitoring remains recommended for these HCP.
• Changed intact skin contact with potentially infectious materials or surfaces from higher risk to intermediate risk.

Additional Monkeypox Resources 

• Morbidity and Mortality Weekly Report (MMWR) — Interim Guidance for Prevention and Treatment of Monkeypox in Persons with HIV Infection — United States, August 2022 — Available summary surveillance data from the European Union, England, and the United States indicate that among MSM patients with monkeypox for whom HIV status is known, 28%–51% have HIV infection. Treatment of monkeypox with tecovirimat as a first-line agent is available through CDC for compassionate use through an investigational drug protocol. No identified drug interactions would preclude coadministration of tecovirimat with antiretroviral therapy (ART) for HIV infection. You can learn more here: Morbidity and Mortality Weekly Report

• COCA Now: FDA Authorizes Emergency Use of Monkeypox JYNNEOS Vaccine — On August 9, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization. The EUA for the JYNNEOS vaccine allows healthcare providers to administer the vaccine by intradermal injection for individuals ages 18 years and older who are at high risk for monkeypox infection, which will results in an up to five-fold increase in the total number of doses available for use. The EUA also allows for use of the vaccine in individuals younger than 18 years old who are at high risk of monkeypox infection. In these individuals JYNNEOS is administered by subcutaneous injection. 

In addition, the Centers for Disease Control and Prevention (CDC) has released Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Monkeypox Outbreak that provides interim guidance for healthcare professionals and public health officials regarding use of JYNNEOS and ACAM2000 vaccines during the monkeypox outbreak that began in the United States on May 17, 2022. Considerations apply only to the use of vaccine products in the United States.

JYNNEOS vaccine is licensed as a series of two doses administered 28 days (4 weeks) apart. In the context of the current national Public Health Emergency (PHE), two dosing regimens may be used. 

The standard regimen involves a subcutaneous (Subcut) route of administration with an injection volume of 0.5mL. The standard regimen is the FDA-approved dosing regimen. Since August 9, 2022, the standard regimen has been authorized for people 18 years old under an Emergency Use Authorization. 

An alternative regimen may be used for people ages ≥18 years or older under an EUA beginning August 9, 2022. The authorized alternative regimen involves an intradermal (ID) route of administration with an injection volume of 0.1mL. This approach could increase the number of available JYNNEOS vaccine doses by up to five-fold. Results from a clinical study showed that the lower intradermal dose was similar to the standard subcutaneous dose (Frey SE et al, Vaccine, 2015; 33(39):5225-5234). 

For more information:

·       FDA Press Statement: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

·       Considerations for Monkeypox Vaccination | Monkeypox | Poxvirus | CDC 

HHS Press Statement: HHS Secretary Becerra issues 564 determination, paving way for emergency use authorization of monkeypox vaccines | HHS.gov

Healthcare Quality Resources

• Healthcare-associated infections prevention workshop — CDC and FDA have just announced the speakers list ahead of their co-sponsored public meeting on August 30, Drug Development Considerations for the Prevention of Healthcare-Associated Infections. 

Registered attendees will hear experts discuss research and development needs for products, such as decolonization tools, that could help prevent healthcare-associated infections (HAIs), including antimicrobial-resistant HAIs. Speakers will also discuss ideas for research study designs that could provide evidence on potential products, as well as clinical results that may be relevant to assessing their efficacy. 

Prevention therapeutics and agents that stop the spread of dangerous germs (pathogens) will be critical to the nation’s success against antimicrobial resistance. Register Here  

• Project Firstline Releases New Interactive Resources on Infection Control — Understanding the stress and time constraints of working in a healthcare setting, Project Firstline has created new infection control educational resources that are interactive, approachable, and easy to use on your own schedule. Healthcare workers can test their infection control knowledge in real time with a variety of interactive resources, including: 

• When Healthcare Tasks Take a Turn! – How well can you stop infections from spreading when dealing with the unexpected?
• What’s Wrong with This Picture? – Identify the infection risks in common healthcare settings to reduce the spread of germs.
• Interactive Infographic – Explore the healthcare environment to understand where germs live and how they spread.

• Free Johns Hopkins Bloomberg School of Public Health Course on Infectious Disease Modeling, “Infectious Disease Transmission Models for Decision Makers” — This course is targeted to anyone who makes decisions about public health policies and aims to make them informed consumers of infectious disease models. The course provides a broad overview of infectious disease transmission models, how to assess their usefulness, and how these models can be appropriately used to make decisions. Anyone with a basic background in public health and infectious diseases with an interest in learning more about infectious disease models will benefit from this course. The development of this training was funded by the Centers for Disease Control and Prevention’s Center for Forecasting and Outbreak Analytics.