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Weekly Vaccine Digest 09/22

County of Los Angeles, California sent this bulletin at 09/22/2023 03:22 PM PDT

Weekly Vaccine Digest 9/22

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 to this email you will find a pdf version of this digest and the links shared during this week’s CDPH Office Hours and the LA DPH Commercialized COVID-19 Vaccine Ordering Guidance. To view the CDPH recording and slides please visit https://eziz.org/covid/education/. Bridge Access Program COVID vaccine inventory supply remains extremely limited. Please order small quantities and you can order on a weekly basis. Orders will be reduced or rejected based on our available inventory.

If you received this email 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: Updated COVID-19 Vaccine

·Page 3: Upcoming Calls/Webinars

·Page 3-4: Storage & Handling

·Page 5-6: COVID-19 Vaccine Access

·Page 6: Bridge Access Program Retail Pharmacies

·Page 7-8: What’s New in Release 43

· Page 8-9: COVID-19 Vaccination Program Closeout, LAHAN

· Page 10: LA DPH & CDPH Provider Office Hours information

2023-2024 Updated COVID-19 Vaccine

2023-24 Updated COVID-19 Vaccine Recommendation
- Everyone 6 months and older should get an updated 2023-2024 COVID-19 vaccine.
- Updated formulation contains XBB.1.5 (Omicron subvariant) and are a better match for currently circulating COVID-19 strains.
- Vaccination remains the best protection against COVID-19-related hospitalization and death. Vaccination can also reduce the chance of suffering the effects of Long COVID.
- Updated Novavax 2023-2024 formulation is under FDA review. Original Novavax vaccine is still authorized.
- Bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
- CDC Press Release 9/12/23 can be found here.
- FDA Press Release 9/11/23 can be found here.
General Clinical Recommendations
- Ages 6 months through 4 years
  - Unvaccinated: 2 doses of updated Moderna COVID-19 vaccine or 3 doses of updated Pfizer-BioNTech COVID-19 vaccine
  - Previously vaccinated: 1 or 2 doses of updated mRNA vaccine depending on number of previous doses
- Ages 5 years and older
  - Receive 1 dose of updated (2023–2024 Formula) mRNA COVID-19 vaccine, regardless of previous vaccination history
  - No additional doses recommended for people 65+ at this time
- Pediatric age transition: age-appropriate vaccine product and dosage recommended on day of vaccination, except for children who receive the Pfizer-BioNTech COVID-19 Vaccine and transition from age 4 years to 5 years during the 3-dose vaccination series (see Transitioning from a younger to older age group)
Clinical Recommendations for People who are Immunocompromised
- Persons with moderate or severe immunocompromise
  - Unvaccinated: People 6 months of age and older are recommended to receive 3 homologous doses of either updated Pfizer-BioNTech or Moderna COVID-19 vaccine
  - Previously vaccinated: 1 or 2 doses of updated mRNA vaccine depending on number of previous doses
  - May receive 1 or more additional updated mRNA COVID-19 vaccine doses, at least 2 months after their last COVID-19 dose
  - Description of moderate and severe immunocompromising and treatments can be found in the CDC clinical considerations linked below.
Vaccine Interchangeability
- Homologous doses:
  - Children 6 months-4 years and immunocompromised individuals 6 months and older should receive all vaccine doses in their initial series from the same manufacturer
  - Mix-and-match allowed for:
    - People 5 years of age and older who have received 1 or more doses of an mRNA vaccine (or 1+ doses of Novavax/Janssen for 12+).
    - IC people 5 years of age and older who have received 3 or more doses of an mRNA vaccine (or 1+ doses of Novavax/Janssen for 12+).
    - A different age-appropriate COVID-19 vaccine may be administered if: same vaccine not available, previous dose unknown, person would otherwise not complete the vaccination series, or person starts but unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication.
Vaccine Coadministration
- In accordance with General Best Practice Guidelines for Immunization, routine administration of all age-appropriate doses of vaccines simultaneously (coadministration) is recommended for children, adolescents, and adults if there are no contraindications at the time of the healthcare visit.
- Providers may simultaneously administer COVID-19, influenza, and respiratory syncytial virus (RSV) vaccines to eligible patients.
Vaccination After COVID-19 Infection
- COVID-19 vaccination is recommended for everyone ages 6 months and older, regardless of a history of symptomatic or asymptomatic SARS-CoV-2 infection, including people with prolonged post-COVID-19 symptoms.
- People with known current SARS-CoV-2 infection should defer any COVID-19 vaccination at least until recovery from the acute illness (if symptoms were present) and criteria to discontinue isolation have been met.
- People who recently had SARS-CoV-2 infection may consider delaying a COVID-19 vaccine dose by 3 months from symptom onset or positive test (if infection was asymptomatic).
Updated Resources
- CDC Materials
  - Interim Clinical Considerations for Use of COVID-19 Vaccines in the United States
  - Stay Up to Date with COVID-19 Vaccines
- Vaccine Timing Guide can be found here.
- Vaccine Product Guide can be found here.
- Other COVID-19 Vaccine Resources on EZIZ can be found here.

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Upcoming Calls/Webinars/Resources

CDC ACIP Meeting: Maternal RSV Vaccine
- Today: Friday September 22^nd, 2023, 7AM PST, webcast link to join can be found here.
COVID-19 Crucial Conversations: Talking with Patients about the Updated COVID-19 Vaccine
- Wednesday September 27^th, 2023, 12PM-1PM, PST, registration link can be found here.
CDC Clinical Guidance for Use of Products to Prevent RSV Disease in Infants
- Wednesday September 27^th, 2023, webinar information can be found here.
Current Issues in Immunizations Webinar: CDC clinical guidance for Use of Products to Prevent RSV Disease in Infants
- Wednesday September 27^th, 2023, webinar information can be found here.
Addressing vaccine anxiety resources can be found here.
Sign up for the CDPH Office of Communications Newsletter here.
CDPH archived communications can be found here.
CDC COVID-19 Vaccination Requirements and Support can be found here.

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Storage and Handling

Spikevax and Moderna

Presentations
- Spikevax, Ages 12+
  - Single dose vials. 0.5 mL injection volume.
  - Prefilled Syringes, 0.5 mL injection volume.
- Moderna COVID-19 Vaccine, Ages 6 months - 11years
  - Single dose vials. 0.25 mL injection volume.
Minimum Order
- 10 doses (Note: minimum order may be larger if purchasing through a wholesaler, e.g., + 60 doses)
Storage (vials and prefilled syringes)
- Long-term frozen storage or (9 to 12 months from date of manufacture)
- Refrigerated storage for up to 30 days BUD
- Normal room temperature for up to 24 hours
Offering returns? Yes

Novavax (Coming Soon)

Presentation
- Ages 12+: 5 dose multi-dose vials. 0.5mL injection volume.
Minimum Order
- 10 doses, 2 vials
Storage
- Refrigerated expiry 9 months from date of manufacture
Offering returns? Yes, up to 100% for opened and unopened vials

Pfizer and Comirnaty

Presentations
- Pfizer COVID-19 Vaccine, 6 months – 4 years: Requires diluent (1.1 mL normal saline). 3 dose multi- dose vials. Yellow cap. 0.3 mL injection volume.
- Pfizer COVID-19 Vaccine, 5 years – 11 years: No diluent required. Single dose vials. Blue cap. 0.3 mL injection volume.
- Comirnaty,12 years+: No diluent required. Single dose vials. Gray cap. 0.3 mL injection volume.
Minimum Order
- 6 months – 4 years: 30 doses
- 5 years – 11 years: 10 doses (government supplied vaccine), 100 doses private purchase
- 12 years+: 10 doses (government supplied vaccine), 100 doses private purchase
Storage
- Long-term storage at ultracold temperatures, if vaccine was received at ultracold temperatures expiry (12 to 18 months from date of manufacture)
- Short-term storage (10 weeks) at refrigerated temperatures (most wholesalers have said they plan to ship this way)
Returns Offered? Yes

Links to EUA Fact Sheets and Package Inserts

Comirnaty, 12 years plus: Comirnaty Prescribing Information Highlights
Spikevax, 12 years plus: Spikevax Prescribing Information Highlights
Moderna, ages 6 month to 11 years: Moderna COVID-19 Vaccine (2023-2024) Fact Sheet EUA Highlights
Pfizer, ages 6 months to 11 years: Pfizer BioNTech EUA Fact Sheet Highlights

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COVID-19 Vaccine Access

COVID-19 Vaccines Transitioning to the VFC Program, what will change?

Vaccine availability for pediatric and adult populations to follow current models for non- COVID-19 vaccines upon COVID-19 Commercialization, post sunset of the USG COVID-19 Program.

Pediatric populations:
- Vaccines will be made available through the Vaccines for Children (VFC) Program for eligible children under 19 years of age.
- Vaccines for privately insured patients will be purchased following similar established mechanisms in healthcare for non-COVID-19 vaccines.
California’s Vaccine for Children (VFC) Program
- 55% of CA children under 19 years of age (6.1M) are eligible to receive VFC supplied vaccines
- CA’s program represents approximately 10% of the nation’s provider participation-with over 3,500 active provider sites throughout the state
- Distributes over 9M doses of pediatric vaccines annually
Pediatric COVID-19 Vaccine Ordering through VFC
- VFC COVID-19 Vaccine is now open for ordering
- VFC providers will order COVID-19 vaccine using the same order process they do for all other routine vaccines on the VFC order form of your MyVFCVaccines
- VFC Providers do NOT need to enroll in myCAvax.
- A new section for COVID-19 vaccines has been added to VFC’s order Form.
- Products are grouped by Age to facilitate ordering.
- If you have issues placing your order through the VFC program, contact VFC directly
  - Phone: 1-877-243-8832 Fax: 1-877-329-9832
  - Business hours: Monday - Thursday: 9 am – 4:30 pm, Friday: 9 am – 4 pm
COVID-19 Vaccines Addition to VFC Program
- COVID-19 vaccine is already a routinely recommended ACIP vaccine, and has been officially voted into the VFC Program.
IMPORTANT: CDPH Vaccine and Clinic Eligibility Guidelines based on Funding Source can be found

Vaccine availability for pediatric and adult populations to follow current models for non-COVID-19 vaccines upon COVID-19 Commercialization, post sunset of the USG COVID-19 Program.

This week, the initial round of BAP orders were processed. As expected with the limited supply, provider requests exceeded our initial allocation, so orders were processed on a first come, first served basis. Providers who ordered both products only had their Moderna request approved. Additionally, large requests were reduced due to supply limitations. As we await a new allocation, providers should keep the following in mind when ordering:

Order a 1–2-week supply of COVID-19 vaccine and re-order as necessary as you assess patient demand and while supplies last.
Moderna and Pfizer are interchangeable products, which should minimize ordering of both products per provider.
Adult populations:
- Limited vaccine supply has been made available through the CA Bridge Access Program (BAP) for uninsured/under insured adults.
- Bridge Access Program for Retail Pharmacies will also support adult uninsured/underinsured vaccination
- Vaccines for insured adults will be private supply, obtained via established processes, like non-COVID vaccines.
- An overview of CDC’s Bridge Access Program can be found here.
- BAP provider operations manual
- BAP order cadence calendar
- Eligibility guidelines by funding source

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Bridge Access Program Retail Pharmacies

CVS administering doses within both their storefronts and Minute clinics.
Walgreens administering doses in both their storefronts and plans for off-site events targeting areas of low access & low uptake.
eTrueNorth (eTN) is a pharmacy aggregator that subcontracts with smaller pharmacies – Intended to reach lower-access areas without other coverage within the Bridge Access Program.
- Additional subcontract negotiations between eTN and possible additional participating pharmacies are ongoing.
- eTN is currently not enrolling other major chains, for now: Riteaid, Walmart, Kroger, Albertsons...

People with Medicare and Medi-Cal will also have access to COVID-19 vaccines at no cost

COVID-19 vaccines covered under Medicare Part B without cost-sharing
Inflation Reduction Act, passed in August 2022, includes key provisions:
- Eliminates cost-sharing for all ACIP-recommended vaccines under Medi-Cal and Medicare Part D/equivalent plans
- Guarantees that nearly 50 million Medicare beneficiaries and more than 80 million Medicaid beneficiaries will have access to all vaccines recommended by ACIP without cost-sharing
All formulations of COVID-19 vaccine have been added to Medi-Cal's Contract Drug List.
- Magellan (third-party adjudicator): Currently updating files: new NDC's
- Hoping to process normally as early as next week.
Enrolling Bridge Access Program: joinetruenoth.com

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What’s New in Release 43?

My Turn

Clinic Managers and Vaccine Administrators will be able to:
- Add multiple funding sources to a single vaccine inventory
- Select / update funding source on the Walk-in, IIS Edit, Inline / Bulk Upload, and Vaccine Administration flows
- Select vaccine supply for publicly or privately funded vaccines on clinic setup and clinic vaccine supply pages
- View / download new reports that include vaccine funding source and patient insurance information for billing purposes
- Add privately purchased vaccines to the clinic inventory
Set Supply Source Funding During Clinic Creation
- Clinic Managers must identify the funding source for their vaccine supply using the two new sections in the Clinic Creation flow, ‘Publicly Funded’ and ‘Privately Funded.’
- Publicly funded vaccines are purchased and distributed by government health agencies to be administered to eligible individuals without charging the patient or any insurance plans for the cost of the vaccine.
- Privately funded vaccines are purchased by health care organizations and medical providers to be administered to individuals with commercial / private insurance (includes Medicare and Medi-Cal for adults) so that insurance companies reimburse for the costs associated with purchasing and administering the vaccine.

myCAvax

Updating Novavax Vaccine Inventory and Supply
- Starting in myCAvax R43, Novavax vaccine will be available as publicly funded and privately funded supplies. Clinic Managers will need to add both supplies to their clinics to serve all patients.
- Additionally, Clinic Managers will need to update the funding source on their existing Novavax vaccine inventories to reflect accurate funding for data quality.
Providers will:
- Shipment Incident
  - See updated fields on the ‘New Shipment Incident’ pop-up window
- Provider Community Site
  - See an updated landing page displaying program tiles based on the Provider’s program enrollment permissions
  - See the ‘Program Selected’ dropdown on multiple pages based on the Provider’s program enrollment permissions
  - See orders on the ‘Vaccine Orders’ page based on the program selected from the ‘Program Selected’ dropdown
  - See the COVID-19 or SGF ‘Shipment Incidents’ page based on the program selected from the ‘Program Selected’ dropdown
  - See the COVID-19 or SGF ‘Dashboard’ page based on the program selected from the ‘Program Selected’ dropdown
  - No longer see the ‘Open Transfer Orders’ pop-up window on the landing page
- Vaccine Ordering – Provider
  - See the COVID-19 or SGF ‘Vaccine Order Request’ page based on the program selected from the ‘Program Selected’ dropdown
  - Be able to place vaccine order requests for SGF flu vaccine on the ‘State General Fund - Vaccine Order Request’ page
  - Receive email notifications when their vaccine order request has been rejected or progressed to ‘Fulfillment Pending’
  - Receive a reminder email for an expiring COVID-19 or Outbreak draft order four days after the order creation date
  - Have their draft orders deleted seven days after the order creation date; they will also receive a confirmation email for the same
  - Be directed to the appropriate ‘Vaccine Order Request’ page when they click the ‘Submit Order’ button on a draft order
- Location Account
  - Have their location account’s sub-status updated to ‘On-Hold’ and the ‘Reason for On-Hold’ field updated with the ‘Provider Account Changes’ value when the shipping address fields are updated.

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CA COVID-19 Vaccination Program Close-out

What to Do with Bivalent Pfizer & Moderna Products
- Quarantine deauthorized mRNA products to prevent administration errors!
- Report vaccine products as “Waste” in myCAvax and use “Other” to add comment “deauthorized”!
- Already marked inactive? Inactive locations can now report as of 9/12/23!
- Dispose of vaccines following practice protocols; vaccines may be disposed of in a pharmaceutical waste container, or a comingled pharmaceutical/Sharps waste container.
- Waste Reporting Deadline: Saturday, September 30, 2023, by 11:59PM

NOTE: Continue to administer Novavax until the product is deauthorized!

What to do with old ancillary supplies?
- Check if ancillary supplies are expired.
- If supplies are expired, dispose of them according to your clinic's waste management policies.
- If supplies are not expired, you can use them for other clinical activities, give them to other providers, or dispose of them.
- Do not send them out of the country!
- Shred old CDC COVID-19 vaccination cards.
- If you should need additional ancillary supplies, reach out to The TPR.
Deauthorized COVID-19 Vaccine Inventory Checklist
- Remove deauthorized products immediately to prevent administration errors.
- For deauthorized bivalent products: Report as “Waste” and use “Other” to add comment “deauthorized"; dispose of products following practice protocols (may be disposed of in a pharmaceutical waste container, or a comingled pharmaceutical/Sharps container).
- For nonviable updated COVID-19 vaccine: Report as “Waste” and return to McKesson; label as “nonviable vaccine”.
- CDPH Inventory checklist can be found here.

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Los Angeles Health Action Network

Please see the Los Angeles Health Alert Network Advisory regarding the 2023–2024 formulation of the COVID-19 vaccine (attached).

Tuesday 9/12/23, the FDA deauthorized the 2022-23 mRNA bivalent Moderna and Pfizer-BioNTech mRNA COVID-19 vaccines for use in the United States. This means the vaccine should no longer be administered and should be discarded as medical waste. As you await delivery of your updated vaccine supply, please ensure the following:

Cancel any vaccine clinics you have scheduled until the 2023-2024 COVID-19 vaccine is available.
Dispose of any remaining doses of 2022-23 bivalent Moderna and Pfizer-BioNTech mRNA COVID-19 vaccine in pharmaceutical waste containers or comingled pharmaceutical/sharps waste containers. Follow local regulations and practice protocols for the disposal of regulated medical waste
Document any vaccine identified for disposal as 'wasted' in myCAvax.
If you have administered any of the 2022-2023 mRNA bivalent Moderna and Pfizer BioNTech mRNA COVID-19 vaccines since Tuesday, 09/12/2023, doses need to be reported in the Vaccine Adverse Event Reporting System (VAERS) Vaccine Adverse Event Reporting System (VAERS) (hhs.gov).
Resume vaccinations with the updated 2023-2024 COVID-19 once supply received.

For more information, please contact the LA DPH Provider Vaccine Call Center at covidvaccinereq@ph.lacounty.gov or 833-505-0761

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LACDPH & CDPH Provider Office Hours Link

LA County Department of Public Health Provider Immunization Office Hours Information

Every other Wednesday from 9am-10am - Next meeting: 09/27/23
- NOTE: Effective 2/01/23 the Office Hours will be held on a biweekly basis
This meeting amended to discuss COVID, Mpox, Flu and RSV vaccines. The meeting link will remain the same.
MS Teams meeting link below; please create a recurring calendar invite with this link.
To request meeting slides, 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

Every Friday 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

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