­Weekly Vaccine Digest 05/17/2024 Los Angeles County Department of Public Health

County of Los Angeles, California sent this bulletin at 05/17/2024 02:34 PM PDT

­Weekly Vaccine Digest 05/17/2024

Los Angeles County Department of Public Health

Dear Colleagues and Partners!

Below are the LACDPH weekly vaccine administration and order updates, upcoming webinars, and newsworthy events. Attached you will find a pdf version of this document. Additionally, attached are the slides and links presented during Wednesday's LAC DPH Biweekly Office Hours. To view past CDPH recordings, slides and other important information on the VFC, VFA, BAP and LHD 317 programs please visit https://eziz.org/.

If this message was forwarded to you, and would like to be added to our listserv, please contact our COVID-19 Provider Vaccine Call Center at covidvaccinereq@ph.lacounty.gov

 

Table of Contents

·      Page 1-3: May is Hepatitis Awareness Month, VFC COVID-19 Vaccine Supply, COVID-19: FDA VRBPAC Meeting Postponed, Increase in Invasive Serogroup Y Meningococcal Disease in the U.S. (3/28/24 CDC Health Advisory) and suggested dosing, Storage & Handling Penbraya

·      Page 4-6: ADULT VACCINES VISITS (AVVs), BAP: COVID Vaccine Supply Update, PEMGARDA (pemivibart) Emergency Use Authorization (EUA) Updates, Long-Term Care Facility Partner Updates on COVID-19: PEMGARDA™ (Pemivibart), Immunizations, and Test Orders, Long-Term Care Facility Partner Updates on COVID-19: PEMGARDA™ (Pemivibart), Immunizations, and Test Orders

·      Page 7-9:  VFA Processing and Shipment, , Upcoming Webinars, LACDPH & CDPH Provider Office Hours Link

 

REMINDER: Memorial Day is Monday, May 27. If your site will be closed, please set a temporary closure on your myCAvax accounts during holiday closures at your sites. This will ensure that CDPH can exclude any necessary orders from processing to avoid shipping incidents. If you need assistance with adding or updating a temporary closure, contact the CDPH Provider Call Center ProviderCallCenter@cdph.ca.gov 833-502-1245

May is Hepatitis Awareness Month

The month of May is designated as Hepatitis Awareness Month in the United States, and May 19th is Hepatitis Testing Day. During May, CDC and our public health partners work to shed light on the impact of these hidden epidemics by raising awareness of viral hepatitis while encouraging testing and vaccination.

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For more information:

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COVID-19: FDA VRBPAC Meeting Postponed

  • Now, June 5, 2024: the FDA Vaccines and Related Biologic Products Advisory

Committee (VRBPAC) will meet to discuss and make recommendations on the

selection of strain(s) to be included in the 2024-2025 Formula for COVID-19

vaccines.

  • This new date will allow for additional time to obtain surveillance data and other

information so VRBPAC will have more up-to-date information when discussing and

making recommendations. FDA does not anticipate that the date change will impact

COVID-19 vaccine availability for the Fall.

  • June 26-28, 2024: CDC ACIP anticipated to review and vote on

recommendations for 2024-25 season

  • Late Summer – Fall: 2024-25 vaccine anticipated to be available for use

FDA VRBPAC Meeting Announcement (rescheduled 6/5/24)

ACIP Meeting 2/28/24: COVID-19 vaccine policy and next steps (cdc.gov)

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Increase in Invasive Serogroup Y Meningococcal Disease in the U.S. (3/28/24 CDC Health Advisory) and suggested dosing

Healthcare providers should:

1) Have a heightened suspicion for meningococcal disease, particularly among populations disproportionately affected: ages 30-60y, Black/African American, people living with HIV.

 2) Be aware that patients may present without symptoms typical of meningitis, and

3) Ensure that all people recommended for meningococcal vaccination, including people with HIV, are up to date for meningococcal vaccines.

  • Incidence rates of meningococcal disease have declined in the United States since the 1990s and remain low
  • Incidence decreased during the COVID-19 pandemic and is returning to pre-pandemic levels in California and the US
  • The proportion of serogroup Y cases is also increasing in California, but the increase is general (no disproportionately affected groups observed so far in California)

Pentavalent Meningococcal Vaccine (MenACWY-MenB) Penbraya Available

  • Suggested routine dosing:
    • Dose 1 (11-12 yrs)= Menveo (MenACWY-CRM) or MenQuadfi (MenACWY-TT)
    • Dose 2 (16-18 yrs) = Penbraya (MenACWY-TT/MenB-FHbp)
    • Dose 3 (16-18 yrs, ≥6 months after dose 2) = Trumenba (MenB-FHbp)

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Storage & Handling Penbraya

PENBRAYA

  • PENBRAYA is supplied in a kit that includes:
    • a vial of Lyophilized MenACWY Component (NDC 0069-0271-01)
    • a prefilled syringe containing MenB Component (NDC 0069-0332-01)
    • a vial adapter
    • The Lyophilized MenACWY Component is reconstituted with the MenB component toform a single dose of PENBRAYATM
    • A single dose after reconstitution is approximately 0.5 mL
    • PENBRAYA is supplied in cartons of 1, 5, and 10 kits.

Storage:

  • Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton.
  • During storage, the white solids and clear liquid component may become separated in the prefilled MenB syringe
    • Store the carton horizontally to minimize the time necessary to resuspend the MenB Component.
    •   Do not freeze. Discard if the carton has been frozen.

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Penbraya: Ordering through the VFC Program

  • Both PENBRAYA (MenACWY-MenB) presentations will be available for ordering from VFC starting this week:
  • Single-dose vial; 1-pack, NDC: 00069-0600-01
  • Single-dose vial; 5-pack, NDC: 00069-0600-05
  • If a VFC provider decides to order PENBRAYA , Trumenba would be needed for additional MenB dose(s) when MenACWY isn’t indicated.
  • If a VFC provider plans on switching to Trumenba from another MenB vaccine product because they will be using PENBRAYA , submit the “Provider Request Form to Update Vaccine Brand Products Administered”

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Vaccines for Children (VFC) Coming Soon to myCAvax!

VFC vaccine ordering, and other related VFC activities will go live in myCAvax on Monday, June 10, 2024.

With this transition, myVFCVaccines will no longer serve as your home for ordering VFC vaccine, submitting returns and transfers, and other VFC Program-related activities. In preparation for the move to myCAvax, we ask that all VFC providers make sure Key Practice Staff changes which occurred after your practice completed the 2024 VFC Recertification are reported to VFC. Additionally, verify data logger information is updated in MyVFCvaccines. If any data logger has an expired Certificate of Calibration, update that as soon as possible to prevent any distributions to vaccine ordering. 

The last day to submit a new VFC vaccine order in MyVFCvaccines is Friday, May 24, 2024. If your routine vaccine order is due on or shortly after this date, please consider submitting your order before this cutoff date to prevent any disruptions to your vaccination services. 

 Once live, VFC providers will be able to easily:

  • Report shipping incidents electronically
  • Access practice dashboards
  • View support resources in the Knowledge Center
  • Read important broadcast messages from CDPH upon logging in to myCAvax
  • Centralize many state-funded vaccine programs in one platform

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ADULT VACCINES VISITS (AVVs)

  • CORE DATA ELEMENTS IN EHR/EMR
  • Eligibility (317)
  • Race/ethnicity
  • Date of administration
  • Vaccine manufacturer
  • Vaccine lot number
  • Name and title of the person who administered the vaccine
  • Address of the facility where the permanent record will reside
  • Vaccine information statement (VIS)
  • Date printed on the VIS
  • Date the VIS was given to the patient or parent/guardian

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BAP: COVID Vaccine Supply Update

As manufacturers prepare for the 2024-2025 season, BAP Program product availability is expected as follows:

  • Novavax: Latest 2023-2024 expiry is Friday, May 31, 2024. This product is no longer available for ordering.
  • Pfizer: 12yo+ (refrigerated/never frozen) - latest 2023-2024 expiry is Saturday, August 31, 2024. Pfizer estimates supply will run out as soon as late May / early June.
  • Moderna: Latest 2023-2024 expiry for 12yo+ vaccines is late September or better. Moderna indicates supply sufficient to meet demand between now and when 2024-2025 vaccine is available.

 

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PEMGARDA (pemivibart) Emergency Use Authorization (EUA) Updates

PEMGARDA (pemivibart) is a recombinant monoclonal antibody that has not been approved, but has been authorized by the Food and Drug Administration (FDA) under an EUA for the pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg):

  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS CoV-2 and
  • Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate response to COVID-19 vaccination.

Here is what providers need to know:

  • Initial dose: 4500 mg administered as a single IV infusion over a minimum of 60 minutes.
  • Repeat dose: As above. Repeat dosing can be given every 3 months.
  • Contraindicated in individuals with previous severe hypersensitivity reactions (anaphylaxis) to any component of PEMGARDA.
    • For individuals with a severe hypersensitivity reaction to a COVID-19 vaccine, consult with an allergist/immunologist.
  • Please track all serious adverse events and medication errors: 

For more information:

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Long-Term Care Facility Partner Updates on COVID-19: PEMGARDA™ (Pemivibart), Immunizations, and Test Orders

 

  1. New monoclonal antibody: On March 22, 2024, Invivyd’s PEMGARDA™(pemivibart) monoclonal antibody received Emergency Use Authorization (EUA) for the pre-exposure prophylaxis (PrEP) of COVID-19 in adults and certain adolescents who are not currently infected with or have had recent exposure to SARS-CoV-2 and who have moderate to severe immune compromise and are unlikely to mount an adequate immune response to COVID-19 vaccination. It is important to note that PReP with PEMGARDA™ is NOT a substitute for vaccination. For more information including the EUA and Healthcare Provider Fact Sheet, please refer to the PEMGARDA™ website. PEMGARDA™ is currently available to order from specialty distributors. Please contact the Invivyd Medical Information Department at 1-800-890-3385 or emailmedinfo@invivyd.comfor more information.     

  

  1. 2023-2024 COVID-19 vaccine recommendations:Previous communicationshighlighted the CDC recommendations to protect against severe  disease: Everyone 6 months and older is recommended for a first dose. People 65 years and older are now recommended for a second dose at least 4 months after the first dose. 

  

  1. Test orders: Until June 30, 2024, Local Health Departments (LHDs), Skilled Nursing Facilities (SNFs), Elder Care, and Long-Term Care Facilities (LTCFs) are able to request both at-home tests and CLIA-waived professional antigen tests from CDPH.  

  

At home tests (anticipated expiration dates from 11/2024 - early 2025): 

  • All counties other than Los Angeles: Order at-home tests from CDPH using the At-Home Test Order Form. At-home tests should be prioritized for populations who are uninsured, underinsured, or have poor access to medical care or who are high risk for severe disease.  
  • Los Angeles County organizations can access at-home testing resources through LA County Department of Public Health by visiting LA County At-Home Testing Resources. 

Professional CLIA-waived tests (expiration dates of July 2024). Facilities requesting CLIA-waived tests must have a valid CLIA waiver and State Laboratory License to be eligible. Order CLIA-waived tests from CDPH using the Professional CLIA-Waived Test Order Form. 

 

  1. Outbreaks:If your facility is experiencing an outbreak, please contact your Local Health Department (LHD).  

 

More resources are also available on the Long-Term Care Facilities (LTCFs) page. 

 

Additional resources:

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VFA Vaccine Processing and Shipment

 

  • VFA sites should allow for up to 2 weeks after order submission for review, processing, and shipment of the order.
  • If vaccine inventory or accountability corrections are needed prior to order approval, VFA Program staff will notify the clinic’s Vaccine Coordinator. Please respond as soon as possible to prevent delays in order approval. Orders needing correction will be held in queue until requested corrections are resolved or orders will expire after 2 weeks of pending corrections.
  • Delivery windows are dependent on provider’s days/hours of operation. Update hours in myCAvax for any holiday or temporary closures.
  • Watch for emails regarding order confirmations, advance shipment notices of vaccine, and temperature monitoring alerts. McKesson does not ship on Fridays and no deliveries are made on Mondays.
  • Orders may ship out sooner than anticipated 'orders shipped' by dates and may arrive earlier than the ‘Estimated Delivery’ dates.

 

For more information please see the VFA Ordering Letter.

 

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UPCOMING WEBINARS

  • CDPH Infection Prevention Webinar
    • Wednesday, May 29 f from 3:00 – 4:00 pm
    • Register here
  • AIM Webinar
    • Friday, May 31, 2024 from 11:00 pm -12:00 pm
    • Register here
  • Creating Accessible Public Health Communications
  • CDPH Infection Prevention Webinar from 3:00 – 4:00 pm
    • When: 4th Wednesday of the month
    • Register here
  • California Immunization Coalition Annual Summit
    • Location: The Safe Credit Union Convention Center in Sacramento, CA - June 5-6, 2024 Registration Link

Slides and recordings from previous CDPH webinars and Office Hours can be found here. _____________________________________________________________________________

LACDPH & CDPH Provider Office Hours Link

LA County Department of Public Health Provider Immunization Office Hours Information

  • Every other Wednesday from 9am-10am – May 22, 2024

To request meeting slides or be added to our Office Hours listserv, please email covidvaccinereq@ph.lacounty.gov

Microsoft Teams meeting

Join on your computer or mobile app

Click here to join the meeting

Or call in (audio only)

+1 323-776-6996,,350547595#   United States, Los Angeles

Phone Conference ID: 350 547 595#

 

California Department of Public Health Provider Office Hours Registration Link

  • NOTE: The next Provider Office Hours will be held next Friday May 31 from 9am-10:30am.
  • Complete one-time registration here.
  • Meeting recordings and slides can be found here.

 

Providers should add staff names to the Provider Listserv to receive weekly emails and updates. To be added, please email blanca.corona@cdph.ca.gov