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Healthcare Professionals Newsletter
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Remind Patients: Protect Yourself. Protect Your Plans.
November brings falling leaves, cooler temperatures and holiday gatherings. However, holiday season is also respiratory illness season. Respiratory illnesses like COVID-19, flu and RSV tend to rise as cooler temperatures bring people indoors and people gather for the holidays. Help your patients protect themselves, and their holiday plans, by reminding them to get their COVID-19 and flu vaccinations early. They can get them right now—and at the same time! Patients can visit www.vaccinate.virginia.gov to find out where to get their COVID-19 and flu shots.
In addition to getting vaccinated, prevention steps such as frequent handwashing, covering coughs and sneezes, and staying home when sick can help reduce the spread of respiratory viruses. VDH offers a toolkit of printable and digitally sharable materials that provide tips for healthy respiratory habits in an easy-to-read format. Feel free to use these materials in your offices and on your social media and remind patients for the holidays: Protect yourself. Protect your plans.
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Emerging Public Health Issues
 CDC Provides Options for Clinicians in Response to Limited Supply of Nirsevimab
On October 23, 2023, CDC issued a Health Alert Network (HAN) Health Advisory in response to a limited supply of nirsevimab, a monoclonal antibody product to protect infants and young children from lower respiratory tract infection caused by respiratory syncytial virus (RSV). For the 2023–2024 RSV season there are not sufficient 100mg dose prefilled syringes of nirsevimab to protect all eligible infants weighing ≥5 kg and supply of the 50mg dose prefilled syringes may also be limited. Below is a summary of CDC recommendations to protect infants from RSV during the shortage:
- Prioritize 100mg doses of nirsevimab for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease.
- Avoid using two 50mg doses for infants weighing ≥5 kilograms (≥11 pounds) to preserve supply of 50mg doses for infants weighing <5 kilograms (<11 pounds). Please note that some insurers may not cover the cost of two 50mg doses for an individual infant.
- Suspend using nirsevimab in palivizumab-eligible children aged 8–19 months during the current RSV season. These children should receive palivizumab per American Academy of Pediatrics recommendations.
- Continue to offer nirsevimab to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and who live in remote regions, where transporting children with severe RSV for medical care is more challenging or in areas with high rates of RSV among older infants and toddlers.
- Discuss nirsevimab supply issues when educating pregnant people about RSVpreF vaccine (Abrysvo) as RSV vaccination during pregnancy is effective and will reduce the number of infants needing nirsevimab during the RSV season.
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Respiratory Vaccine Updates
Vaccines for Children Program Release Addendums for Nirsevimab and COVID-19 Vaccines
On October 18, 2023, CDC’s Vaccines for Children Program (VFC) released 2 addendums to its 2023–2024 VFC Operations Guide for Nirsevimab and COVID-19 vaccines – allowing a flexible, time-limited ramp-up period to meet the private inventory requirements. During this time, VFC providers will not be required to meet the private inventory minimum requirements if they do not intend to vaccinate their private pay patients.
V-safe Now Available for Adult RSV Vaccine
Adults aged 60 years or older who received an RSV vaccine can now register for V-safe. V-safe is a vaccine safety monitoring system that allows individuals to easily and confidentially share how they feel after getting a vaccine. Please use these V-safe materials to encourage patients who received the RSV vaccine to sign up for V-safe.
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Respiratory Treatment Updates
COVID-19 Therapeutics Commercialization
The federal government continues the process of transitioning the distribution of COVID-19 therapeutics (Paxlovid and Lagevrio) to the commercial market. On October 20, 2023, the U.S. Administration for Strategic Preparedness and Response release a guide to prepare stakeholders for the transition process. It’s important to note that changes in the commercialization process may continue to occur.
For Paxlovid (nirmatrelvir with ritonavir, standard and reduced dose packaging), the product will be available for purchase through the usual commercial marketplace starting on November 1, 2023. However, please note there will be an overlap period during which medical providers can continue to obtain Paxlovid from the U.S. Government (USG) at no cost while the product is also available by commercial purchase. On November 27, 2023, the USG will stop automatic replenishment/distribution of Paxlovid to medical providers. Paxlovid will still be available from the federal government—medical providers will need to order it via the out-of-cycle request process using the Health Partner Order Portal (HPOP). The last date/time for medical providers to order Paxlovid from the USG will be December 15, 2023, at 3 p.m.
From December 1, 2023, through December 31, 2023, if medical providers have EXCESS USG-distributed, Emergency Use Authorization (EUA)-labeled Paxlovid, they are encouraged to return the product through the Pfizer returns process to facilitate a credit to the USG. Returned product must have an expiration date of December 2023 or later. For Paxlovid returns, visit Inmar, email rarequest@inmar.com, or call 800-967-5952.
Pfizer will have two programs in place to help patients with the cost of the medication. Starting approximately November 1, 2023, the Pfizer Co-pay Savings Program will be available for eligible commercially insured patients. On or about December 1, 2023, the Pfizer Patient Assistance Program will begin. This program, which runs through December 2024, will provide Paxlovid at no cost to patients who are uninsured or covered by federal insurance programs (such as Medicare or Medicaid). Medication will be dispensed at participating patient assistance program sites. More detailed information about both programs will be forthcoming. Currently, please see www.paxlovid.com for available information or call 877-C19-PACK (877-219-7225) toll-free.
For Lagevrio (molnupiravir), the product will be available for commercial purchase on November 1, 2023. Similar to the process with Paxlovid, there will be an overlap period during which time Lagevrio will be available from the USG at no cost and available for commercial purchase. Medical providers who wish to order Lagevrio from the USG can do so using the out-of-cycle request process through HPOP. The last date/time to order Lagevrio through the USG will be November 10, 2023, at 3 p.m. For patients needing financial assistance to obtain Lagevrio, Merck (the product’s manufacturer) is anticipated to start a Lagevrio patient assistance program in mid-November 2023. The program’s website is www.merckhelps.com or one can call 800-727-5400 toll-free. More detailed information about the Merck Patient Assistance Program is anticipated in mid-November 2023.
Please note that any Paxlovid (standard or reduced dose) or Lagevrio obtained from the USG must be dispensed at no cost to the patient. Medical providers continue to be responsible for reporting the use of USG-obtained Paxlovid and Lagevrio.
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Mpox Updates
CDC Advisory Panel Recommends Routine Mpox Vaccination for At-Risk Groups
On October 25, 2023, CDC’s Advisory Committee for Immunization Practices (ACIP) unanimously recommended routine use of the 2- dose JYNNEOS mpox vaccine in people aged 18 years and older who are at risk for mpox. Those at risk include:
- Gay, bisexual, and other men who have sex with men and transgender or nonbinary people who in the past 6 months meet one or more of the following criteria:
- A new diagnosis of one or more sexually transmitted disease
- More than one sex partner
- Sex at a commercial sex venue
- Sex linked to a large public event in a geographic region where mpox transmission is occurring
- Sexual partners of people who are at risk
- People who anticipate meeting one or more of the risk criteria in the future
The panel had previously recommended mpox vaccine for individuals at risk of mpox only during an outbreak. This is an interim recommendation that ACIP will revisit in 2–3 years and CDC has updated its immunization schedules based on this recommendation.
New VDH Mpox Resources
VDH has developed the following new mpox resources:
For providers providing sexual health or HIV care the Integrating Mpox into Sexual Health and HIV Care is a new, one-page reference for providers performing sexual health, STI testing, or HIV care to support the incorporation of mpox vaccination, testing, and treatment into routine sexual health and HIV clinical care.
For patients the What Vaccines Do You Need? resource is a new, one-page table in English and Spanish for patients who are at increased risk of mpox and other infections. It shares information about the mpox vaccine (JYNNEOS), as well as flu, COVID-19, and meningococcal vaccines that patients may also be eligible for. This resource can be shared with patients in a clinical setting, at a vaccine event, or other outreach setting.
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Other Updates
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Virginia Infection Prevention and Control Training Alliance (VIPTA)
The VIPTA website is a one-stop-shop for infection prevention & control, healthcare-associated infections, and antimicrobial stewardship events and resources.
Subscribe to the monthly VIPTA Bulletin to get the latest events, featured training resources, guidance & regulation updates, and peer success stories. Sign up to be a VIPTA Partner and check out our promotional toolkit to spread the word on this great resource.
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School Health: Addendum to the Child and Adolescent Immunization Schedule for IPV
CDC published the following addendum to the Child and Adolescent Immunization Schedule: Adolescents aged 18 years or older who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
The IPV Supplemental Guidance has been updated by VDH.
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Reminder: Patient Immunization Reporting
Any health care provider, as defined in § 32.1-127.1:03, in the Commonwealth that administers immunizations shall report such patient immunization information to the Virginia Immunization Information System (VIIS). For more information go to our webpage.
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Other News!
Hampton Veteran’s Hospital Becomes Comprehensive Harm Reduction Site
The Hampton VA is now Virginia’s 11th comprehensive harm reduction (CHR) site, offering services exclusively to veterans who use drugs. Additional information about CHR can be found on the CHR website.
Fredericksburg Health Department Offering PrEP Services
The Fredericksburg Health Department began offering PrEP services on October 16, 2023, bringing the number of sites across Virginia offering PrEP services to 32 and the number of health departments offering PrEP to 22. Additional details about the PrEP program, including locations, can be found on VDH’s PrEP page.
The Condom Distribution Program is Under New Management
The condom distribution program is now overseen by the Division of Disease Prevention hotline. All inquiries or requests should now be directed to Sarah Lannon at hiv-stdhotline@vdh.virginia.gov. To access the most up-to-date condom order forms, please visit the Division of Disease Prevention community partner webpage and navigate to condom distribution program.
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Resources and Tools
VDH Resources
COVID-19 Resources
Vaccine Resources
Therapeutics Resouces
Therapeutics ASPR Webpages
Mpox Resources
Recent Webinars
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