Virginia Department of Health, Office of Communications

Measles case detected in Kentucky at large gathering

Virginia Department of Health, Office of Communications sent this bulletin at 03/01/2023 01:16 PM EST

March 1, 2023

Healthcare Professionals Newsletter

Welcome to the Healthcare Professionals Newsletter, a monthly combined effort of the former Therapeutics Updates and COVID-19 Vaccine Provider Updates.

Topics of Public Health Interest

Updates to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the U.S.

On January 31, 2023, the Panel on Treatment of HIV in Pregnancy and Prevention of Perinatal Transmission published updated Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal Transmission in the United States.

Changes include updates to recommendations on infant feeding for individuals with HIV

Due to the potential of HIV transmission in human milk, previous clinical guidelines in the United States did not recommend breastfeeding for individuals with HIV in the United States.

The updated guidelines note that:

People with HIV (PWH) who are considering conception, are pregnant, or in the postpartum period should receive evidence-based counseling to support decision making about infant feeding.
The risk of HIV transmission while breastfeeding is less than 1% (but not zero) for PWH on antiretroviral therapy (ART) with sustained undetectable viral load through pregnancy and postpartum.
Clinicians should support the choices of people with HIV to breastfeed (if they are virally suppressed) or to formula/replacement feed.
It is inappropriate to engage Child Protective Services (CPS) or similar services in response to infant feeding choices of PWH.
HIV testing is recommended as a standard of care for all sexually active people and should be a routine component of pregnancy care.

An overview including additional information of the revisions is now described on the NIH clinical information website in What’s New in the Guidelines. If you have questions or would like additional information, please contact Safere Diawara, Clinical Quality Coordinator for the VA Ryan White Program Part B at Safere.Diawara@vdh.virginia.gov or 804-864-8021.

Measles case detected in Kentucky at large religious gathering

For your awareness, the Kentucky Department for Public Health has confirmed measles in an unvaccinated individual who, while infectious, attended a large spiritual revival gathering on February 17 and 18 at Asbury University in Wilmore, Kentucky. An estimated 20,000 people are thought to have attended the gathering on the days that the measles exposures occurred. Travel to Kentucky should be considered when evaluating a suspect measles case.

Are you signed up for HAN alerts?

That’s the CDC’s Health Alert Network. On February 24, 2023, a HAN alert was issued for the Increase in Extensively Drug-Resistant Shigellosis in the United States. Sign up for these notifications on the CDC HAN email updates page.

COVID-19 Vaccine Updates

No UPS return labels from McKesson Specialty Health COVID shipments

Please note, effective February 14, 2023, providers will no longer receive UPS return labels for any size of frozen shipping containers from McKesson Specialty Health COVID shipments.

Recipients are asked to dispose of any frozen shipping containers and packing materials as you would any other waste. Providers are encouraged to recycle the cardboard components of their frozen shipping containers through their local recycling program. A flyer about this change will be included in vaccine shipments for the next few weeks to help inform providers about this change.

If you have any questions, please contact McKesson COVID Customer Care, Monday through Friday, 8 a.m. to 8 p.m. at (833) 343-2703; or email COVIDVaccineSupport@McKesson.com.

Johnson & Johnson's Janssen COVID-19 Vaccine

As of February 22, 2023, the supply of Johnson & Johnson's (J&J)/Janssen COVID-19 vaccine (NDC# 59676-0580-15) is depleted and no longer available for ordering.

Providers with unexpired J&J/Janssen COVID-19 vaccines should continue reporting inventory to Vaccine Finder/Vaccines.gov. As a matter of best practice, providers should use the manufacturer's online tool to check expiry dates.

U.S. to End Covid Public Health Emergency in May

On January 30, 2023, the White House announced that both the COVID-19 national emergency and public health emergency (PHE) will end on May 11, 2023.

The revocation of the COVID-19 PHE will not affect the emergency use authorizations (EUAs) currently issued for COVID-19 vaccines or therapeutics. Supply and distribution of federally stocked products with an EUA will continue without interruption.

The U.S. Department of Health and Human Services (HHS) created a fact sheet of what will and will not be impacted by the end of the COVID-19 PHE.

COVID-19 Vaccine Reminders

Please encourage your patients to stay up-to-date with CDC vaccination guidelines (see CDC Interim Clinical Considerations).

Primary vaccination series

For the primary series, three monovalent COVID-19 vaccines are recommended: Moderna, Novavax, and Pfizer-BioNTech.
Bivalent mRNA vaccines are not authorized at this time for primary series doses with the following exception: children aged 6 months through 4 years who receive 2 primary series doses of a monovalent Pfizer-BioNTech vaccine should receive a bivalent Pfizer-BioNTech vaccine as their third primary series dose.
Vaccine products made by the same manufacturer should be used for all doses of the primary series (see Interchangeability of COVID-19 vaccine products).

Booster vaccination

Individuals aged 6 months and older are recommended to receive one bivalent mRNA booster dose 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 through 4 years who receive 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., monovalent or bivalent) was administered for the 3rd 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 in people aged 18 years and older who completed any FDA-approved or FDA-authorized monovalent primary series, have not received any previous booster dose(s), and are unable (i.e., contraindicated or not available) or unwilling to receive an mRNA vaccine and would otherwise not receive a booster dose.

COVID-19 Vaccine Ordering

For questions about VaxMax and its functionality, please visit the VaxMax Help website, which includes reference guides and tutorial videos.

COVID-19 Therapeutics Updates

Process and Logistics Updates

Updated Therapeutics Clinical Implementation Guide

ASPR has released an updated clinical implementation guide for use by providers. This is a comprehensive review of available outpatient COVID-19 therapeutics to treat eligible patients with mild-to-moderate symptoms of COVID-19. The document also describes processes for obtaining and reporting COVID-19 therapeutics.

Shelf-Life Extension for Sotrovimab

On February 15, 2023, the FDA authorized a shelf-life extension from 24 months to 30 months for the GlaxoSmithKline monoclonal antibody sotrovimab. Due to the prevalence of variants circulating within the United States that are not susceptible to sotrovimab, it is not currently authorized in any U.S. region.

HHS: Therapeutics Locator Tool to Include Outpatient Veklury (remdesivir) Providers

HHS is requesting healthcare partners who order Veklury (remdesivir) for outpatient use to support improved public awareness and product access. Some patients with COVID-19 will not be able to take Paxlovid and Veklury is the preferred second-choice medication according to the National Institutes of Health COVID-19 Treatment Panel. This initiative will provide visibility of Veklury outpatient infusion sites in the locator tool to assist in matching patients at high risk of severe COVID-19 with this medication. To opt in to this initiative, infusion sites must provide their information on the provider opt-in webpage.

Clinical News

FDA: EUA Revisions for both Paxlovid and Lagevrio; EVUSHELD update

On February 1, 2023, the FDA revised the EUAs for both Paxlovid and Lagevrio to no longer require positive results of direct SARS-CoV-2 viral testing. The scope of authorization now requires, in addition to other requirements, that adults and pediatric patients (aged 12 years of age or older, weighing at least 40 kg) have a current diagnosis of mild-to-moderate COVID-19.

In uncommon instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. Their health care provider may determine that treatment is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the product’s authorization are met.

Based on the CDC Nowcast from February 25, 2023, the percentage of circulating SARS-CoV-2 variants that are resistant to the drug EVUSHELD continues to be more than 90%. As a result, EVUSHELD (a combination of the monoclonal antibodies tixagevimab and cilgavimab used for pre-exposure prophylaxis against COVID-19) continues to be deauthorized by FDA.

Resources and Tools

VDH Therapeutics Website for Healthcare Providers

Check out the VDH Therapeutics webpage! There are a variety of resources and tools for providers. Reach out to COVID19Therapeutics@vdh.virginia.gov for questions, comments, or feedback on information you’d like to see. Details on the U.S. Government (USG) Therapeutic Reporting Cadence in HPoP [all doses administered and current inventory on-hand two times each week (every Monday and Thursday)] can also be found at the Health Partner Order Portal (HPoP) Job Aid.

VDH Therapeutics Website for the Public

The general public can access information about COVID-19 therapeutics at VDH Protect Your Health: Available COVID-19 Treatments.

VDH Variants and Their Impacts

With variants continuing to evolve and the potential impacts on available therapeutics, VDH continues to update a resource to help providers stay up to date on what COVID-19 drugs are expected to be effective.

Other Resource Links:

Treatment of Mpox: Information for Virginia Healthcare Providers

COVID-19 Therapeutics Decision Aid (ASPR)

Find where to access therapeutics at the Administration for Strategic Preparedness & Response page.

Best Practices

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers.

Mpox Updates

End of Public Health Emergency

On December 2, 2022, HHS announced that the Public Health Emergency (PHE) declaration for mpox, which expired on January 31, 2023, will not be renewed. As a result, VDH has rescinded the Mpox Statewide Standing Order authorizing the dispensing and administration of the mpox vaccine for certain healthcare professionals. For mpox vaccinating sites, the following CDC standing orders may be used after January 31, 2023:

PHE expiration does not affect the EUA for JYNNEOS and this vaccine can continue to be administered to people under the age of 18 through the subcutaneous route and to adults through the intradermal route. Providers may continue to order JYNNEOS as needed through VaxMax and monthly reporting requirements will continue to be required for all JYNNEOS vaccine providers.

Mpox Vaccine Eligibility

On February 17, 2023, VDH simplified its mpox vaccination eligibility criteria to align directly with CDC recommendations.

Virginia COVID-19 Information Center
1-877-VAX-IN-VA | 1-877-829-4682 | Mon-Fri 8am-5pm

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