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Healthcare Professional Newsletter |
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Topics of Public Health Interest
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Update on Ebola Virus Disease (Sudan ebolavirus) Outbreak in Central Uganda
- The Centers for Disease Control and Prevention (CDC) issued this Health Alert Network (HAN) Health Update as a follow-up to a HAN Health Advisory (Outbreak of Ebola virus disease (Sudan ebolavirus) in Central Uganda) issued on October 6, 2022. This Health Update serves to inform public health departments, public health laboratories, and clinicians in the United States about the ongoing outbreak of Ebola virus disease (EVD) in Uganda caused by Sudan virus (species Sudan ebolavirus). No suspect or confirmed EVD cases related to this outbreak have been reported in the United States (U.S.) or other countries outside of Uganda to date. However, as a precaution because of increasing cases in Uganda, CDC is communicating with public health departments, public health laboratories, and healthcare workers in the United States to provide an update and raise awareness of this outbreak and the potential for importation of cases.
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 COVID-19 Vaccine Updates
- Expiry dates of Moderna 10-dose vials products have been extended. Moderna has updated the Moderna Vial Expiration Checker: https://modernacovid19global.com/vial-lookup?#vialLookUpTool
- Single-Dose Vials of Pfizer Bivalent Booster (Ages 12 years and older) are now available to request in VaxMaX.
- Providers can request to receive 50, 100, or 150 vials
- Single dose vials are intended for providers with consistently low or irregular patient traffic
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Winter Holiday Vaccine Deliver Schedule - providers should request inventory during the 12/8 - 12/12 ordering window to support administrations through the remainder of 2022. Vaccine requested after 12/12 will likely be delivered between 12/27 - 12/29 or after 1/2/2023.
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Pfizer - anticipated holiday delivery schedule
- December 22. - Normal Deliveries
- December 23 through December 26 - No Deliveries
- December 27 through December 29 - Normal Deliveries
- December 30 through January 2 - No Deliveries
- January 3 - Normal Delivery Cadence Resumes
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McKesson - anticipated holiday delivery schedule
- December 22 - No Deliveries
- December 23 through December 26 - No Deliveries
- December 27 through December 29 - Normal Deliveries
- December 30 through January 2 - No Deliveries
- January 3 - Normal Delivery Cadence Resumes
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For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
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Upcoming Events
- COCA Call- Updates on Multisystem Inflammatory Syndrome in Children (MIS-C): Epidemiology, Case Definition, and Prevention.
- During this COCA Call, presenters will review MIS-C epidemiologic and clinical trends, provide a rationale and description of changes in criteria for the new CSTE/CDC MIS-C surveillance case definition compared with the 2020 CDC MIS-C case definition, and discuss information relating to MIS-C and COVID-19 vaccination.
- Date: December 8, 2022
- Time: 2:00 PM- 3:00 PM ET
- Webinar Link: WEBLINK
- Passcode: 510428
- Dial In #: 1-669-254-5252
Helpful Resources
- V-safe for COVID-19 — Reminder! V-safe, CDC’s after vaccination health checker, is available for enrollment after any dose of COVID-19 vaccine, including updated bivalent boosters. It takes just a few minutes to enroll and enter vaccine information and then v-safe will send participants personalized and confidential health check-ins via text messages to ask how they feel after vaccination. Participation in v-safe helps CDC gather important information and monitor any potential side effects in real time so scientists can quickly study them and determine if there is a safety concern with a particular vaccine. This information helps us communicate timely and transparent information about the safety of vaccines to public health officials, healthcare providers, and the public.
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V-safe for Mpox: V-safe now offers personalized health check-ins for those who received the mpox vaccine. Participants will need to enroll for v-safe mpox even if they previously enrolled and participated in v-safe for COVID-19, and they can participate in v-safe after their second dose of mpox vaccine, even if they did not participate after their first dose. Visit the new v-safe webpage at www.cdc.gov/vsafe.
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Pharmacy Newsletter: The Pharmacy Channel is starting a new bi-weekly newsletter, which will feature topics beyond COVID-19, including new vaccines or schedule changes, new drugs, Virginia and Federal pharmacy law updates, or more. Please complete this survey to subscribe!
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COVID-19 Therapeutics Update
Process and Logistics Updates
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Lagevrio Order Quantity Change in Health Partner Order Portal (HPoP)
- As of November 21, 2022, Lagevrio orders greater than 15 will no longer need to be in multiples of 15. The minimum order is still 15 patient courses; however, you may now order any number of courses above 15, such as 16 or 21 courses.
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HPoP Holiday Shipments and Deliveries
- COVID-19 Therapeutic product deliveries will NOT take place on:
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Monday, December 26, 2022 with normal shipping resuming on Tuesday, December 27, 2022.
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Monday, January 2, 2023 with normal shipping resuming on Tuesday, January 3, 2023.
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Therapeutic Shelf-Life Extensions and U.S. Government (USG) Product Return
- Many COVID-19 therapeutic products may have initial expiration dates approaching, but most of them have received extensions. Additionally, if you have a USG product to return please refer to the product return guidelines. Extensions and return guidelines can be verified on the COVID-19 Therapeutics website under “Summary of COVID-19 Therapeutics.”
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Coming Soon! On Site Destruction of Expired or Unauthorized USG Therapeutic Products
- Mid-December HPOP will enable reporting for all licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations. Therapeutics can be destroyed on site only if:
- Guidelines are followed on what therapeutic product can be destroyed
- It is expired product or unauthorized product that can no longer be stored
- Sites follow established protocols for destruction and attest in HPOP to following all regulations
- Quantities of any product destroyed are recorded in HPOP
- Important Note: No unexpired product that is currently authorized for use can be destroyed.
- The established manufacturer returns process for each product are still an option for sites who do not have an established method for proper destruction or otherwise prefer to go through the returns process.
- Returned product must also be recorded in HPOP
- This process is not yet enabled in HPOP. A news banner will appear in HPOP when it goes live.
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Paxlovid Access for Higher Social Vulnerability Index Areas
- In November, emails were sent out from Health and Human Services (HHS)/Administration for Strategic Preparedness and Response (ASPR) to extend provider sites a one-time distribution request of 20 courses of Paxlovid. This is a continued effort to increase oral antiviral dispensing in vulnerable areas with no previous dispensing. This is an extension of the enhanced distribution initiative that was previously launched by HHS/ASPR to pre-position Paxlovid at new sites, with a focus on areas of higher social vulnerability.
Clinical Updates
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FDA Announces Bebtelovimab is Not Currently Authorized in Any U.S. Region
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Nowcast data from the Centers for Disease Control and Prevention (CDC) published last week estimates that the combined proportion of COVID-19 cases caused by the Omicron BQ.1 and BQ.1.1 subvariants is above 57% nationally, and already above 50% in all individual regions but one, and data shows a sustained trend of increasing prevalence across all regions. Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time.
- The U.S. Government recommends all products be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the United States. Health care providers should use other approved or authorized products that are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, which include the following:
- Paxlovid/Paxlovid Renal
- Veklury (remdesivir)
- Lagevrio (molnupiravir)
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Evusheld Fact Sheet Update
- On November 18, 2022, the FDA updated the EVUSHELD Fact Sheet to include updated information on SARS-CoV-2 variants. This update only encompasses section 12.4, Microbiology. There is no change to important safety information nor dosage and administration. For more information, see Table 6 (in the EVUSHELD Fact Sheet linked above).
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CDC Develops COVID-19 Plan Guide for the Public
- The CDC developed a guide to assist individuals in putting together a COVID-19 plan so that all information needed is on hand if a person or member of their household becomes sick with COVID-19. The guide is:
- Downloadable and editable
- Can be shared with family, friends, and medical providers
- Includes additional information about COVID-19 prevention
- For more information and access, please visit the CDC Personal Plan and How to Protect Yourself and Others.
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The VDH COVID-19 Therapeutics Webinar and Open Forum is changing!
- We value your time and participation as healthcare providers. Therefore, our therapeutic webinar and open forum will now be combined into a single monthly presentation. We will still provide a therapeutic overview and updates, guest speakers, and an opportunity to ask questions and discuss barriers. Our next VDH Healthcare Provider COVID-19 Therapeutics Webinar with a guest speaker from Pfizer will be December 21, 2022 from 1:00-2:00 PM EST. Please stay tuned for registration details.
Resources and Tools
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Link to Sign Up for the Newsletter:
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Did a colleague share this newsletter with you, and you’d like to sign up to receive it directly? Do you know of a colleague that would benefit from receiving information on therapeutics from VDH? Click here to sign up!
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VDH Therapeutics Website for Healthcare Provider
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VDH Therapeutics Website for the Public
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VDH Healthcare Professionals and Healthcare Workers
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VDH Variants and Their Impacts
- With variants continuing to evolve and the potential impacts on available therapeutics, VDH developed a new resource to help providers stay up to date on what COVID-19 drugs are expected to be effective. The document is available here and on the VDH Health Professionals and Workers Website.
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 Mpox Updates
- VDH continues to address health inequities that contribute to the mpox vaccine disparities that the Commonwealth is experiencing in specific populations. The burden of disease continues to be disproportionately higher for our Black/African American and Latino populations, while the vaccination rate is disproportionately higher among our white population, thus creating vaccination disparity.
- To address this disparity, VDH is accepting applications for CDC’s Mpox Vaccine Equity Pilot, which provides vials of mpox vaccine at no cost for innovative, collaborative, and community-centered projects seeking to address vaccination disparities among one or more priority groups most affected by mpox. Territorial, local health departments, tribal governments, tribal organizations, and local non-governmental organizations in Virginia are encouraged to apply. Go to VDH’s Equity in Mpox webpage to learn more.
- Addressing health disparities is important for improving our nation's overall health and economic prosperity. To learn more about how to best communicate with your patients while eliminating barriers and stigma, visit CDC Reducing Stigma in Mpox Communication and Community Engagement Guidance.
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Medical Countermeasure Guide Update: An updated version of the Private Providers MCM Guide is available on the VDH Healthcare Professionals website, which includes a simplified list of vaccine eligibility requirements by removing the eligibility categories (PEP, Expanded PEP, and PrEP). Private providers are advised to make the appropriate updates to communications to the public.
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Patient-friendly mpox resources:
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Findings in the CDC Science Brief Detection and Transmission of Mpox Virus:
- It may be possible for transmission to occur prior to the onset of illness and viral shedding may continue after recovery of symptoms for an unknown period of time.
- It may be possible that infected persons who never experience illness may have painless lesions shedding virus in anatomical sites not readily visualized. However, no cases of transmission to date have been linked to exposure to an asymptomatic person either before or after infection.
- Updates surrounding vaccine guidance have been posted on the VDH Vaccine Guidance Webpage. A reminder that vaccination is strongly encouraged within the first 4–14 days after exposure, and that once mpox symptoms appear vaccination is not recommended.
- VDH adopted relaxed vaccination guidance as it pertains to subcutaneous versus intradermal administration methods. Providers may opt to administer JYNNEOS via subcutaneous method if preferred by the patient. This change will be reflected in the newest MCM Guide, expected to be published in December 2022. The following verbiage will be used on VDH resources:
- “During this outbreak, the alternative regimen (intradermal route) is preferred, but the JYNNEOS vaccine may be administered subcutaneously using the standard regimen (subcutaneous route). People of any age with a history of developing keloid scars and individuals younger than 18 years of age should receive the vaccine via the subcutaneous route. Patients with concerns about intradermal administration due to potential stigma or other personal reasons should be offered subcutaneous doses. CDC recommends that health care providers have both subcutaneous and intradermal vaccine administration options available on site so that those unable or unwilling to receive the intradermal regimen, can receive the subcutaneous regimen.”
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Mpox Provider Training
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Upcoming Mpox Webinars:Please feel free to share these links with other healthcare providers, all are welcome
- General Mpox Webinar (and covering other current public health topics) for the Virginia Nurses Association
- Thursday, December 8, 2022, 12 PM - 1 PM
- Register here
- General Mpox Webinar - presented by VDH
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Wednesday, December 14, 2022, 6 PM - 7 PM
- Register here
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