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Healthcare Professional Newsletter |
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COVID-19 Vaccine Updates
- Reminder: COVID-19 Bivalent Vaccines
- Bivalent vaccines are now available to children aged 6 months and older.
- Those who are eligible may receive one bivalent mRNA booster dose at least 2 months after completion of any FDA-approved or FDA-authorized primary series or previously received monovalent booster dose(s) with the following exception: children aged 6 months–4 years who completed a 3-dose Pfizer-BioNTech primary series are not authorized to receive a booster dose at this time regardless of which Pfizer-BioNTech vaccine (i.e., a monovalent or bivalent) was administered for the third primary series dose.
- Monovalent mRNA vaccines are no longer authorized as a booster dose.
- A monovalent Novavax booster dose (instead of a bivalent mRNA booster dose) may be used in limited situations.
- Patients and parents are encouraged to talk with their healthcare provider about their options, especially those aged 60 years and older.
- Note: Moderna and Pfizer-BioNTech bivalent vaccine vials look very similar to their monovalent counterparts. Please ensure staff are aware of how to differentiate between bivalent and monovalent vaccines.
- Additional resources:
- URGENT: New Initiative to Increase COVID-19 Vaccination among Older Adults in Long-term Care Settings
- The approaching winter months bring increasing cases of respiratory diseases, including COVID-19. Encouraging older adults, whether they live in the community or in a facility setting, to receive the updated (bivalent) COVID-19 boosters is important. The updated (bivalent) COVID-19 boosters are the best protection against COVID-19 variants causing illness right now.
- A recent CDC report showed that adults aged 65 years and older (especially 85 years and older) have the highest COVID-19-related mortality rates, which are highest among the unvaccinated.
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CDC data showed that COVID-19 case rates are higher among nursing home residents who have not received all recommended vaccine doses than those who are up to date.
- CMS-certified nursing homes are required to report resident and staff vaccination data to CDC’s National Healthcare Safety Network (NHSN) each week. More information related to this reporting can be found at: CDC Weekly HCP & Resident COVID-19 Vaccination
- Supporting Health Care Providers and LTC Facilities with Vaccine Assistance:
- Share this sample letter with LTCFs so they can share it with residents and their families.
- Support a strong and clear recommendation from the patient’s healthcare provider to increase the likelihood of a patient agreeing to be vaccinated.
- Stay up to date on the latest COVID-19 data in your state or county, using CDC’s COVID-19 Data Tracker.
- Long term care settings may request vaccination services through a VDH program called the Pharmacist-Led Community Engagement Program (PLCEP) by completing this survey. The PLCEP connects facilities with a pharmacist who can come on site to administer free COVID-19 vaccinations and provide COVID-19 education and information.
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 COVID-19 Vaccine Ordering Updates
- 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
- No upcoming events scheduled
Helpful Resources
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COVID-19 Therapeutics Update
Process and Logistics Updates
- Shelf-Life Extension for Evusheld
- On December 5, 2022, theS. Food and Drug Administration (FDA) authorized an additional extension to the shelf life from 18 months to 30 months for all lots of Evusheld (tixagevimab co-packaged with cilgavimab). As a result of this extension, there are currently no expired Evusheld lots and, therefore, no returns or on-site destruction of uncompromised product is allowable. This extension applies to all unopened vials of Evusheld (including lot AZ220049 that was previously noted as expired and has received an extension) that have been held in accordance with storage conditions detailed in the Fact Sheet For Healthcare Providers and Evusheld Letter of Authorization. Visit ASPR’s website to learn more and review the table with co-pack lot numbers, labeled co-pack expiration dates, and the extended co-pack expiration dates.
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Now Available in HPoP – On-Site Therapeutic Destruction
- For licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations, therapeutics can be destroyed on- Only expired or unauthorized product that can no longer be stored can be destroyed. Unexpired product this is currently authorized for use cannot be destroyed. Sites are to follow established protocols for destruction and attest in HPoP to following all regulations and report the quantities of any product destroyed. Please refer to under Provider Enrollment and Job Aids to view the “Job Aid: Navigating the Health Partner Order Portal (HPoP)”. The existing returns process for each product manufacturer is still an option for sites that do not have an established method for proper onsite destruction or prefer to go through the returns process. Please reference the table under Summary of COVID-19 Therapeutics on the VDH Therapeutics Website.
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FDA Labeling Supplement for Veklury (remdesivir) and How to Order
- On December 16, 2022, the FDA approved the following labeling supplement modifying the indication for Veklury (remdesivir): a positive result of a COVID-19 test is no longer required. Veklury is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are hospitalized or not hospitalized, have mild to moderate COVID-19; and are at high risk for progression to severe COVID-19, including hospitalization or death.
- To order Velkury, hospitals can place orders by calling any of these distributors directly:
- AmerisourceBergen Specialty Distribution: 800-746-6273
- Cardinal Specialty: 855-855-0708
- McKesson Plasma and Specialty: 877-625-2566
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Non-hospitals, which include infusion centers, long-term care facilities, skilled nursing facilities, dialysis care, outpatient clinics/medical practices, acute/urgent care centers, retail and specialty pharmacies that serve long-term care or skilled nursing facilities, can contact these two distributors:
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Walgreens Launching Home Delivery of Lagevrio (molnupiravir)
- As of December 22, 2022, Walgreens has expanded the oral antiviral free prescription home delivery service to include Lagevrio. Patients with a prescription for Lagevrio who live in a socially vulnerable community, based on the Centers for Disease Control and Prevention (CDC) Social Vulnerability Index, are now able to have their Lagevrio prescription filled and delivered to their home at no cost via com and the Walgreens app. More than 8,000 Walgreens locations are offering same day delivery services to anyone who lives within 15 miles of participating Walgreens locations. The majority of Americans have access to this program (about 92% of the population). This expansion may also include the addition of Paxlovid and more details will be available at a later date.
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Sharing Your at Home Test Result Makes Your Test Count
- The National Institutes of Health (NIH) has implemented a new initiative called Make My Test Count that helps public health agencies determine how fast the SARS-CoV-2 virus is spreading or where surges are happening. Individuals can easily and quickly notify the NIH of their positive or negative COVID-19 test results. Data from Make My Test Count can help public health agencies monitor the COVID-19 environment while keeping personal test results private and anonymous.
Clinical Updates
- HAN Issued: Omicron Sublineages and Monoclonal Antibody Efficacy
- On December 20, 2022, the CDC issued a Health Alert Network (HAN) Health Update to emphasize to healthcare providers, public health departments, and the public that the majority of Omicron sublineages circulating in the United States have reduced susceptibility to bebetelovimab (a monoclonal antibody) and Evusheld (a monoclonal antibody combination of cilgavimab and tixagevimab). Of note, antiviral therapeutics for the treatment of COVID-19, ritonavir-boosted nirmatrelvir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) currently retain activity against circulating Omicron sublineages. These widely available medications can prevent severe disease, hospitalization, and death, but have been underused. Read the entire alert here.
- FDA Suspends Emergency Use Authorization (EUA) for Bebtelovimab
- Because the majority of circulating SARS-CoV-2 viruses are resistant to the action of Bebtelovimab, on November 30, 2022, FDA suspended the EUA for the drug. As a result, Bebtelovimab is not currently for use in any U.S. region. Previously, Bebtelovimab was authorized for the treatment of COVID-19 in outpatients who met specific criteria. FDA’s statement provides more information.
- COVID-19 and Underlying Medical Conditions
- CDC has provided an evidence-based resource for healthcare professionals addressing Underlying Medical Conditions for COVID-19. Age remains the strongest risk factor for severe COVID-19 outcomes. The risk of severe outcomes increases markedly with increasing age. Based on data from the National Vital Statistics System (NVSS) at the National Center for Health Statistics (NCHS) (Risk for COVID-19 Infection, Hospitalization, and Death by Age Group), compared with people aged 18-29 years, the risk of death is:
- 25 times higher in those aged 50-64 years
- 60 times higher in those aged 65-74 years
- 140 times higher in those aged 75-84 years
- 340 times higher in those aged 85+ years
- Notably, these data include all deaths in the United States that occurred throughout the pandemic from February 2020 to July 1, 2022 and includes deaths among unvaccinated individuals.
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Evusheld Fact Sheet Update
- The Evusheld Fact Sheet was updated in December to reflect In-vitro neutralizing data for several Omicron subvariants. The section updated was the Microbiology (12.4) neutralizing data. Evusheld is unlikely to be active against Omicron BF.7, BA.2.75.2, BQ.1, BQ.1.1 and XBB, but retains neutralization activity against BJ.1. Refer to section 5.3 in the EVUSHELD Fact Sheet for further information on Risk for COVID-19 due to SARS-CoV-2 Viral Variants Not Neutralized by Evusheld or by phone at (833) 832-7068, Option 0. FDA continues to recommend Evusheld as an option for pre-exposure prophylaxis to prevent COVID-19. Breakthrough infections are possible and patients are advised to have a treatment plan in place and to seek timely medical attention if COVID-19 symptoms occur.
Resources and Tools
- VDH Therapeutics Website for Healthcare Providers
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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 this new resource to help providers stay up to date on what COVID-19 drugs are expected to be effective. Link to document here.
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 Mpox Updates
- General Mpox
- Monkeypox Name Change: The World Health Organization (WHO) announced it will adopt “mpox” in place of the “monkeypox” naming convention. CDC supports this change. Both names will be used simultaneously for one year while “monkeypox” is phased out. Mpox will become a preferred term, replacing monkeypox, after the one-year transition period. VDH is following this recommendation and updating its materials and webpages to reflect the change. More information can be found in the CDC "Dear Colleague Letter".
- Medical Countermeasure Guide Update: An updated version of the Private Providers MCM Guide is available on the VDH Healthcare Professionals website, which includes information on “mpox” terminology adoption guidance by CDC, V-safe and relaxed guidance on JYNNEOS route of administration.
- The mpox treatment web page was updated to include the TPOXX Information Sheet for Virginia Providers and Brincidofovir ordering information.
- Vaccination Guidance
- In an effort to administer the complete 2-dose mpox vaccine series, vaccinators are recommended to schedule patients for their second JYNNEOS vaccine dose at the time of the first dose administration. Healthcare providers should consider the following as best practices:
- Offer patients the opportunity to schedule their second dose at the time of first dose administration
- Allow patients to schedule the second dose well in advance of their due date, if not scheduled at the time of first dose administration
- If needed, follow-up and make an appointment with patients who are eligible for a second dose but have not received it.
- More information on mpox vaccination can be found in the Private Providers MCM Guide.
- Additional resources:
- Mpox Provider Training
- General Mpox Webinar (and covering other current public health topics) for the Virginia Nurses Association
- General Mpox Webinar presented by VDH and the Virginia Chapter of the American College of Physicians
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