‌

Weekly Vaccine Digest 9/15

County of Los Angeles, California sent this bulletin at 09/15/2023 04:37 PM PDT

Weekly Vaccine Digest 9/15

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/slides shared during this week’s LA DPH & CDPH Office Hours. To view the CDPH recording and slides please visit https://eziz.org/assets/docs/COVID19/9.15.23_CDPHProviderWebinar.pdf

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 1-2: COVID-19 Program Close-out

· Page 2-3: Updated COVID-19 Vaccine

· Page 3: Upcoming Calls/Webinars, Storage & Handling Basics

· Page 4-5: Commercialized Vaccines

· Page 5-9: COVID-19 Vaccine Access

· Page 9-10: COVID-19 Vaccine Access: Pharmacy

· Page 10-12: Pharmacy Therapeutic Updates

· Page 12-13: CDPH Resources, LA DPH & CDPH Provider Office Hours information

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

euerhafjka

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”.

_____________________________________________________________________________________

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.
- COVID-19 vaccines are safe and hundreds of millions of people have safely received a COVID-19 vaccine in the U.S.
- Bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
CDC Proposed 2023-2024 mRNA COVID-19 Vaccine Recommendations
- Everyone ages 5 years and older is recommended to receive 1 dose of a 2023–2024 mRNA COVID- 19 vaccine
- Children ages 6 months–4 years should complete a multi-dose initial series (2 doses of Moderna or 3 doses of Pfizer-BioNTech mRNA COVID-19 vaccine) with at least one dose of the 2023–2024 COVID-19 vaccine
- People who are moderately or severely immunocompromised should complete a 3- dose initial series with at least one dose of the 2023–2024 COVID-19 vaccine and may receive 1 or more additional 2023–2024 COVID-19 vaccine doses
- Novavax:
  - The original Novavax COVID-19 vaccine remains authorized for use as a 2-dose primary series and can be given as a booster dose in limited situations.
  - Authorizations or approvals for 2023 -2024 Novavax COVID19 vaccine will be determined by FDA, with CDC recommendations to follow.
Updated FDA materials: Pfizer and Moderna
FDA Resources for Fall Respiratory Illness season can be found here.
Protect yourself from COVID-19, Flu and RSV
- CDC Respiratory Viruses page can be found here.
- CDC recommends that everyone 6 months and older stay up to date on COVID-19 vaccines and receive a seasonal flu vaccine.
- If you are 60 years and older, talk to your healthcare provider to see if RSV vaccination is right for you.
- CDC also recommends nirsevimab for all infants younger than 8 months who are born during or entering their first RSV season, as well as older babies 8 to 19 months old including AIAN children.

______________________________________________________________________________

Upcoming Calls/Webinars/Resources

CDC COCA Call: Preparing for the Upcoming Respiratory Virus Season: Recommendations for Influenza, COVID-19, and RSV Vaccines for Older Adults
- Tuesday September 19^th, 2023, 11AM-12PM, PST, zoom link to join the call can be found here.
CDC ACIP Meeting: Maternal RSV Vaccine
- Friday September 22^nd, 2023, 7AM PST, webcast link to join can be found here.
- Agenda not yet posted
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.

_____________________________________________________________________________________

Storage and Handling Basics

COVID-19 Storage and Handling basics have not changed
Please see, https://eziz.org/vaccine-storage/
The webpage listed above addresses:
- Types and grades of refrigerators and freezers
- Acceptable and unacceptable units
- Digital Data Loggers & temperature monitoring
- Vaccine management

_____________________________________________________________________________________

Commercialized Vaccines

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

_____________________________________________________________________________________

COVID-19 Vaccine Access

COVID-19 Vaccine Transition to Commercialization

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 anticipated to be available the week of 9/18/2023.
- 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.

43423423

Anticipated COVID-19 Vaccine Products in VFC

All COVID-19 Products will be Offered to California VFC Providers for Ordering, as they become available & Supply Permits

Vaccine Group

Vaccine Name

Min Order Qty

NDC

COVID (6 months - 4 years)^

(Pfizer) 3 Dose Vial – 30 doses/10 Vials Per Box

30 Doses

59267-4315-02

COVID (6 months - 11 years)^

(Moderna) Single Dose Vials - 10 Per Box*

10 Doses

80777-0287-92

COVID (5 years - 11 years)^

(Pfizer) Single Dose Vials - 10 Per Box

10 Doses

59267-4331-02

COVID (12 years - 18 years)

Comirnaty (Pfizer) Single Dose Vials - 10 Per Box

Novavax 5 Dose Vial – 10 doses/2 Vials Per Box*

Spikevax (Moderna) Single Dose Vials - 10 Per Box

10 Doses

00069-2362-10

80631-0105-02

80777-0102-95

NOTE:

*Not yet available through VFC. Moderna’s pediatric presentation for children 6m-11y and Novavax’s presentation for children will be available for ordering at a future date.

^ Products approved for emergency use (under EUA)

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.
- It is expected that ordering and availability for this vaccine, via routine VFC Program ordering processes, will occur upon FDA approval of an updated monovalent COVID-19 vaccine, ACIP vote, CDC recommendation, AND available vaccine supply (Allocations).

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.

Adult populations:
- Anticipate limited vaccine supply will be 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.

Background on the Bridge Access Program (BAP)

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) announced the HHS Bridge Access Program (BAP) for COVID-19 Vaccines and Treatments. BAP is a temporary measure created to prevent loss of access to free COVID-19 vaccines and treatment for uninsured and underinsured aged 19 years and older. The program will begin September 2023 and will end on December 31, 2024.

Topic	Bridge Access Program Quick Facts
Storing Vaccine	• Similar to previous products.
Fees	• Vaccine is provided free of charge. No administration fee for BAP
Supply and Anticipated Products	• Limited allocations of Pfizer, Moderna, and Novavax.
Program Timeline	• Bridge Access Program will end in December 2024
Eligible Clinic Types	• Public Health Clinics, FQHCs, RHC, Tribal Clinics, Indian Health, and other Designated facilities by Public Health Departments

Anticipated COVID-19 Vaccine Products in CA’s BAP

ijlkjl

NOTE: Novavax vaccine is not yet available through BAP and will be available for ordering at a future date.

Federal contracts have been modified to allow a sooner delivery of the 2023-2024 COVID-19 vaccines within public health infrastructure for children and adults.

Updated CDC Vaccine contract information has been posted, and for adult populations, current products are included in the list.

_____________________________________________________________________________________

COVID-19 Vaccine Access: Pharmacy

Where Will Vaccines Be Available for Pharmacies Through the Bridge Access Program?

Select pharmacies will ensure access to no cost COVID-19 vaccines using their extensive footprints and community partnerships.
Vaccines will be donated by manufacturers to pharmacies (via product reimbursement), and administration costs will be covered by CDC.

Bridge Access Program for Retail Pharmacies

CVS plans to administer doses within both their storefronts and Minute clinics.
Walgreens plans to administer doses in both their storefronts and at off-site events targeting areas of low access & low uptake.
eTrueNorth 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 eTrueNorth and possible additional participating pharmacies are ongoing.
Pharmacies are required to identify if they are a BAP participant on vaccines.gov.
- As of this morning, vaccines.gov was being updated.
Enrolling Bridge Access Program: joinetruenoth.com

Pharmacy Commercial Product Arriving

Pharmacies are expected to have commercial COVID-19 vaccine soon.
- Expected to be roll into pharmacies as early as yesterday and through the weekend.
Some pharmacies have appointments available as early as Monday.
BAP Pharmacies will be able to provide COVID-19 vaccine to insured patients and uninsured patients with the same supply.
- Some BAP systems are in place, however, may not be active yet. Patient must check with pharmacy if they are taking BAP patients.
As of this morning, vaccines.gov was not yet updated.

jjm,n

_____________________________________________________________________________________

Pharmacy COVID-19 Therapeutics Updates

AB-1341 Update: Passed

On the governor's desk awaiting signature
- Urgency clause – bill would go into effect immediately after signed.
- Governor must sign or veto by 10/14/2023
Highlights of the bill
- PharmacistmayfurnishCOVID-19oraltherapeuticsfollowingapositivetestforSARS-CoV-2
  - NOTE: positive test is not required for other prescribers.
- Pharmacist shall utilize relevant and appropriate evidence-based clinical guidelines published by the FDA in providing these patient care services.
  - Note: No off-label prescribing allowed for pharmacists.
- Pharmacist must notify the patient’s primary care provider.
  - If patient does not have a PCP pharmacist must make a patient record and retain.
- “COVID-19 oral therapeutics” means drugs that are approved or authorized by the FDA for the treatment of COVID-19 and administered orally. This covers FDA approved & EUA oral antivirals.
  - NOTE: Lagevrio EUA states LAGEVRIO may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which LAGEVRIO belongs (i.e., antiinfectives). Pharmacists are not authorized prescribers of Lagevrio.

Paxlovid Commercialization Update

All of the EUA product that Pfizer has produced has been purchased by the federal government and Pfizer has fulfilled and delivered all the government's orders.
According to Pfizer, it's their understanding that the federal government will not purchase any of the FDA approved Paxlovid.
Expected that all FDA approved Paxlovid will be only available commercially.
The earliest Paxlovid will be available commercially will be prior to the end of this year. The latest Paxlovid will be available commercially will be mid-summer 2024.
BAP for therapeutics?
- For Paxlovid, Pfizer states that once fed supply is exhausted, patients must enroll into Pfizer's Patient Assistance Program for Paxlovid at no cost for the uninsured.
- For Lagevrio, more information forthcoming from Merck.

EUA & FDA Approved NDCs

Paxlovid prescribing information | Pfizer.com

Shelf-Life Extensions for COVID-19 Oral Antiviral Therapeutics

The Administration for Strategic Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) announced the authorization of a shelf- life extension to 24 months for Paxlovid, and 30-36 months for Lagevrio.
Be sure to check all inventory for the extended expiration dates.
Do not destroy or dispose of any Paxlovid or Lagevrio that has not expired. It is the property of the federal government.

Shelf-Life Extension for Lagevrio (hhs.gov)

Shelf-Life Extension for Specific Lots of Paxlovid | HHS/ASPR

______________________________________________________________________________

CDPH Resources

Updated Flu, COVID-19, RSV Job Aids

Pediatric/Adult Influenza Vaccine Guide (IMM-859)
VFC Flu Usage Log (IMM-1053)
Block Timing Schedule (IMM-395) | Spanish

Provider Resources

COVID-19 Clinical Talking Points for Providers (IMM-1431)
VFC Flu Vaccine Page (EZIZ)

Promotional Materials

Who needs a flu vaccine? poster (IMM-782)
Flu & Respiratory Disease Materials (EZIZ)

Vaccine Communication Toolkits

Don’t Wait Vaccinate Toolkit (CDPH)
Fight Flu. Get Vaccinated Toolkit (CDPH)
Don’t Wait Vaccinate Flu Toolkit (CIC)

NOTE: Provider resources found on eziz.org/covid are migrating to eziz.org

COVID-19 Vaccine Timing guide can be found here.
COVID-19 Vaccine Product Guide can be found here.
COVID-19 Vaccine Access and Ordering 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 - 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

Update your subscriptions, modify your password or email address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by County of Los Angeles.