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Healthcare Professionals Newsletter
Welcome to the Healthcare Professionals Newsletter, a monthly combined effort of the former Therapeutics Updates and COVID-19 Vaccine Provider Updates.
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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 will end on May 11, 2023.
The revocation of the COVID-19 public health emergency will not affect the emergency use authorizations (EUAs) issued for COVID-19 vaccines or therapeutics. Supply and distribution of EUA products will not be impacted, and the federal government has stated that they will continue to disburse the supply that they have in stock.
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Harmonization of Vaccine Strain Composition of COVID-19 Primary Series and Boosters
On January 26, 2023, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss harmonizing the strain composition of all COVID-19 vaccines, simplifying immunization schedules, and establishing a process for vaccine strain selection and recommendations.
The Committee voted unanimously (21 Yes - 0 No) and “the Committee recommends harmonizing the vaccine strain composition of primary series and booster doses used in the U.S. to a single composition.”
Evidence supports the use of the same vaccine strain composition for primary and booster COVID-19 vaccinations. The Committee felt that this transition will simplify the COVID-19 vaccination regimen, contribute to easier vaccine deployment, and may improve vaccine coverage. The Committee also considered a simplified immunization schedule for future periodic COVID-19 vaccination campaigns, which could include a two-dose series for children and immunocompromised adults, and 1 dose for all other older children and adults.
More data is needed on dosage, dosing intervals, who should get the two-dose schedule, who should get a single dose, etc.
No change in vaccination recommendations at this time as VRBPAC will continue this discussion, specifically on the strain selection process, in June 2023.
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COVID-19 Vaccine Ordering
For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.
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COVID-19 Therapeutics Update
Process and Logistics Updates
New! Paxlovid Shelf-Life Extension
FDA authorized a shelf-life extension to 24 months for Paxlovid. Check all inventory for the extended expiration dates. Unopened cartons of Paxlovid (300 mg nirmatrelvir and 100 mg ritonavir; or 150 mg nirmatrelvir and 100 mg ritonavir), must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers.
For up-to-date information on expiration dates for all COVID-19 therapeutics, please visit: the Department of Health and Human Services (HHS) HHS/ASPR Important Updates and FDA Expiration Dating Extension. As a reminder, all monoclonal antibodies must be maintained under proper refrigerated temperatures, even if they are not currently authorized for use, since they may be authorized again in the future for use against new strains of SARS-CoV-2.
New COVID-19 Therapeutic Resources
AmerisourceBergen Transition to Cencora
On January 24th, 2023, together with Alliance Healthcare, AmerisourceBergen announced its intent to rebrand under the new name Cencora. The transition will occur over the course of 2023 and there are no immediate impacts to any commercial or COVID-19 distribution operations. For COVID-19 questions, continue to contact them at c19therapies@amerisourcebergen.com. Please visit cencora.com for more information.
Clinical News
Evusheld is Not Currently Authorized for Emergency Use in the U.S.
On January 26, 2023, the FDA announced that the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) has been revised and based on this revision, Evusheld is not currently authorized for use in any U.S. region at this time. CDC Nowcast data affirms that certain SARS-CoV-2 variants are projected to make up more than 90% of the variants currently circulating in the U.S. Since Evusheld is not expected to provide protection against COVID-19 if exposed to those variants, HHS and AstraZeneca have paused distribution of Evusheld until further notice.
Those who have used Evusheld still have options to increase their protection against serious consequences of COVID-19, like hospitalization and death. Details about these and other treatment options expected to retain activity against COVID-19 can be found on the FDA Emergency Use Authorization page.
Legislative Provision to Allow Part D Payment of EUA Oral Antivirals if Commercialized While Under EUA
H.R. 2617 was enacted to include EUA oral antivirals Paxlovid and Lagevrio as covered Part D drugs if these products are commercialized while still under EUA. Note: There is no change to the current payment structure. Prior to this change, a product available only under EUA would not have met statutory definition of a covered Part D drug. COVID-19 oral antivirals continue to be provided by HHS free of charge and no payment can be sought for U.S. Government (USG) procured medications. The Centers for Medicare and Medicaid Services is already able to cover fully approved oral antivirals under Part D.
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 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 here.
VDH Therapeutics Website for the Public
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.
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 Mpox Updates
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Mpox Public Health Emergency (PHE) Lifted: On December 2, 2022, the HHS announced that the PHE declaration for mpox expired on January 31, 2023, and will not be renewed. HHS continues to closely monitor mpox cases and encourages all at-risk individuals to get vaccinated.
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Mpox Testing is Encouraged to Identify Cases: While the number of new mpox cases is much lower than last summer, the ultimate public health goal is to be able to eradicate community mpox transmission within the United States. To help achieve this, healthcare providers are encouraged to test potential cases presenting with a new rash illness for mpox. Concurrent testing for other sexually transmitted infections might be indicated, based on clinical presentation. Testing allows for prompt identification of cases and allows for timely contact tracing efforts to interrupt chains of transmission.
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Mpox Vaccine Statewide Standing Order Revoked: With the mpox PHE declaration expiration, VDH is no longer able to maintain the Mpox Statewide Standing Order, which authorized the dispensing and administration of the mpox vaccine under the State Health Commissioner, Dr. Colin Greene. The standing order was revoked on January 31, 2023.
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Providers are encouraged to create their own standing order or utilize the CDC standing order templates (subcutaneous and intradermal) to authorize certain healthcare personnel to continue vaccinating high-risk individuals.
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Pharmacists may continue to order and administer the vaccine under their own NPI, based on the allowances of the PREP Act.
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Providers may continue to order JYNNEOS vaccine as needed through VaxMax and monthly reporting will continue to be required for all JYNNEOS vaccine providers.
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More information on mpox vaccination can be found in the Private Provider MCM Guide (updated 1/25/23).
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Additional resources:
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