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Nirsevimab (Beyfortus) and COVID-19 Updates

Nirsevimab (Beyfortus) and COVID-19 Updates

Nirsevimab

Due to high demand and limited supply cited by the CDC, nirsevimab (Beyfortus) ordering through VFC has been put on hold as of October 17, 2023. The CDC is working with Sanofi to secure a supply of this immunization within the next 2 – 3 weeks. 

We will provide an update when nirsevimab becomes available for ordering. Please continue to immunize eligible children with your current supply.

COVID-19

For children under 5, access to COVID-19 vaccine is currently limited as most pharmacies are not vaccinating this age group. As a provider enrolled in the Vaccines For Children (VFC) program, here’s how to ensure these kids get the vaccine they need:

  • Order COVID-19 vaccine through the VFC program
  • Borrow VFC doses of COVID-19 vaccine to immunize your privately and CHIP insured patients while you wait for COVID-19 supply from the manufacturers*

*To request a borrowing form and learn more about the guidelines of this limited-time option, contact our VFC coordinator at victor.obeck@phila.gov. We highly encourage continuing to offer COVID-19 vaccine at every opportunity. 

What does commercialization mean for VFC providers?

The Department of Public Health’s federal COVID-19 program has formally ended. COVID-19 vaccines are now part of the routine immunization schedule.

With the exception of certain specialty providers, all Vaccines for Children (VFC) providers are required to stock COVID-19 vaccine inventory for both privately/CHIP insured patients and VFC eligible patients.

Learn more in this blog post that consolidates recent COVID-19 vaccine updates and lists available COVID-19 products.

Resources

Nirsevimab:

Recommendations and ordering guidance
MMWR
FDA page
Package insert
Immunization Information Statement (use this instead of VIS!)
Product and ordering information (AAP)

COVID-19:

Pfizer 2023-24 COVID-19 Vaccine

Comirnaty 12+

2023-24 COVID Vaccine 5 yrs – 11 yrs

2023-24 COVID Vaccine 6 mo – 4 yrs

Moderna 2023-24 COVID-19 Vaccine

Spikevax 12+

2023-24 COVID Vaccine 6 mo – 11 yrs

Have other questions about nirsevimab, COVID-19, or VFC? Contact our VFC coordinator at victor.obeck@phila.gov.

2023-2024 Novavax Now Available to Order

2023-2024 Novavax Now Available to Order

Novavax COVID-19 vaccine, adjuvanted (2023-2024 formula) is now available to order. 2023-2024Novavax is authorized for individuals 12 years and older. 

This product package contains two multi dose vials each containing five doses. The NDC for this product is NDC # 80631-0105-02. 

It can be ordered through PhilaVax following the same steps used to order all other 2023-2024 COVID-19 vaccine products.  Vaccines for Children (VFC) and Bridge Access Program (BAP) providers can order Novavax for eligible patients. 

As a reminder, your practice can now: 

1) Order COVID-19 vaccine through the Vaccines for Children (VFC) program

2) Order COVID-19 vaccine for privately insured adults, and 

3) Enroll in the Bridge Access Program (BAP) to procure COVID-19 vaccine for uninsured or underinsured adults. BAP vaccines can only be used for uninsured and underinsured patients aged 18 and up. 

When possible, VFC providers should vaccinate eligible 18-year-olds with VFC vaccine before using BAP vaccine. 

This new blog post highlights important changes in this new period of COVID-19 vaccination, including:

  • The Department of Public Health’s COVID-19 program has formally ended.
  • Bivalent COVID-19 vaccines are no longer authorized for use.
  • The Advisory Committee on Immunization Practices (ACIP) approved the use of updated (monovalent) COVID-19 vaccines.
  • Providers can order the updated COVID-19 vaccine for privately insured patients by directly contacting the manufacturers for each product (see below for more information). 
  • With the exception of certain specialty providers, all Vaccines for Children (VFC) providers are required to stock COVID-19 vaccine inventory for both privately/CHIP insured patients and VFC eligible patients.  
  • Philadelphia vaccine providers are encouraged to enroll in the Bridge Access Program to provide updated COVID-19 vaccines for uninsured or underinsured adults 18 years and older. 

If you have any questions about ordering COVID-19 vaccine, contact dphproviderhelp@phila.gov

Beyfortus (nirsevimab) Now Available Through VFC

Beyfortus (nirsevimab) Now Available Through VFC 

On July 17, 2023, FDA licensed AstraZeneca and Sanofi’s Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD).

On August 3, the ACIP voted unanimously to recommend nirsevimab for use in infants during the RSV season, which is October through March.

VFC Ordering 

Beyfortus (nirsevimab) (5 x 0.5mL syringes) and (5 x 1.0mL syringes) is available to order through the Vaccines for Children (VFC) program starting today, October 2, 2023.

VFC providers who see patients recommended to receive nirsevimab this season are required to include both dosages of nirsevimab in their next VFC order. VFC providers will need to provide nirsevimab for their privately and CHIP insured patients, as applicable.

Dosage and Administration

RSV comes in two dosages: 

  • 50 mg 
  • 100 mg 

Both dosages are administered as an intramuscular injection with a single-dose, pre-filled syringe, and should be ordered to properly administer by weight. 

Eligible Patients

  • Infants aged <8 months born during or entering their first RSV season
    • 1 dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5kg) 
  • Children aged 8-19 months who are at increased risk of severe RSV disease and entering their second RSV season
    • 200 mg nirsevimab, administered by two 100 mg syringes

Children at increased risk include those: 

  • with chronic lung disease resulting from premature birth who required medical support at any time during the six-month period before the start of their second RSV season
  • who are severely immune compromised
  • with cystic fibrosis who have severe lung disease or whose weight is less than the 10th percentile compared with other babies of the same length
  • who are American Indian and Alaska Native

Reporting 

All doses of nirsevimab administered in Philadelphia must be reported to PhilaVax. 

Storage and Handling

Store refrigerated between 36°F to 46°F (2°C to 8°C) through the expiration date.  

Nirsevimab may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours. After removal from the refrigerator, nirsevimab must be used within 8 hours or discarded.

Reporting Adverse Events

Nirsevimab is the first drug product to be included in the VFC program. If nirsevimab is administered: 

Additional resources:
MMWR
FDA page
Immunization Information Sheet for Patients
Package insert

If you have any questions, please email victor.obeck@phila.gov.

Additional Vaccines Available for VFC

Additional Vaccines Available for VFC

Flumist and the Moderna 2023-24 COVID-19 vaccine for 6 mo – 11 yrs are now available to order for your VFC eligible patients through PhilaVax.

Flumist
Eligibility: 2 – 18 years
Packaging: 10 0.2 mL, intranasal sprayers
CVX: 149
CPT: 90672
NDC: 66019-0310-10

View a step-by-step ordering guide

View more information on all flu vaccines available this season

Moderna COVID-19 Vaccine 6 mo – 11 yrs
Packaging: 10 0.25 mL vials
CVX: 311
CPT: 91321
NDC: 80777-0287-92

View a step-by-step ordering guide here.

View more information on all COVID-19 vaccines available this season

VFC and VFAAR Shipping Delays

VFC and VFAAR Shipping Delays

Our vaccine distribution center is currently working through an unanticipated backlog of VFC and VFAAR orders as a result of having relocated. Due to this please be aware that there are likely to be delays with some vaccine shipments.

For your September and October orders, add 1 to 2 weeks of additional vaccine, if you have space in your storage units. Please add a note to the comments section of the order indicating this intention.

As a reminder, you can order routine vaccines every 25 days (from the last approved order). Use the ordering formula cheat sheet to calculate how much vaccine to order. Continue to order flu vaccine as needed.

We’re here to help! Reach out to us with any questions at DPHProviderHelp@phila.gov.

COVID-19 Vaccine Available to Order Through VFC and the Bridge Access Program

COVID-19 Vaccine Available to Order Through VFC and the Bridge Access Program

On September 12, 2023, ACIP approved the use of updated COVID-19 vaccines. The new products are monovalent (single), Omicron variant XBB.1.5. Under the new recommendation, everyone over 6 months is eligible for an updated COVID-19 vaccine this fall.

This marks the start of commercialization. VFC sites are now required to stock COVID-19 vaccine, for both your privately/CHIP insured patients and your VFC eligible patients.

Recommendations

  • Everyone ages 5 years and older is recommended to receive 1 dose of a 2023-24 mRNA COVID-19 vaccine.
  • Children ages 6 months – 4 years should complete a multi-dose initial series (2 doses of Modera or 3 doses of Pfizer mRNA COVID-19 vaccine) with at least one dose of the 2023-24 COVID-19 vaccine.
  • People who are moderately or severely immunocompromised should complete a 3 dose initial series with at least one dose of the 2023-24 COVID-19 vaccine and may receive 1 or more additional 2023-24 COVID-19 vaccine doses.
  • Bivalent mRNA COVID-19 vaccines are no longer recommended.

Starting, today, Thursday September 14, sites are able to order COVID-19 vaccine for VFC and/or the Bridge Access Program through PhilaVax. View the step-by-step ordering guide.

Available Products

Additional resources

If your site needs assistance placing an order or has questions, please reach out to dphproviderhelp@phila.gov.

To procure vaccine on the private market, please contact your local sales representative:

Thank you for keeping Philadelphia safe and healthy. If you have any general questions, please email vaccines@phila.gov.

Pediatric Pneumococcal Vaccine Updates

Pediatric Pneumococcal Vaccine Updates

As a reminder, Prevnar 20 (PCV20, Pneumococcal 20-valent Conjugant Vaccine; NDC 00005-2000-10) is now available to order for your VFC eligible patients. Prevnar 13 (PCV13) is no longer available to order through the VFC program. Please read our previous advisory on these changes.

To transition from PCV13 to Vaxnuvance (PCV15) or PCV20, providers can either:

  • Continue to use any remaining Prevnar 13 vaccines still on-hand through the expiration date before transiting to PCV15 or PCV20.
  • Return remaining doses of PCV13 after receiving a supply of VFC PCV15 or PCV20. Providers who choose to return PCV13 doses before the expiration date will not be penalized. Instructions on how to return vaccine can be found here. If returning PCV13 before expiration, please indicate “other” for the return reason (see step 6 of the job aid).

If you have clinical questions about Prevnar, please review these resources:

We will continue to provide updates as we get clarification from the CDC.

In you have additional questions, email, Victor Obeck, VFC Coordinator, victor.obeck@phila.gov

New Vaccine Product Available for VFC/VFAAR

New Vaccine Product Available for VFC/VFAAR

A one-vial presentation of Menveo (MenACYW-135) is now available through the Philadelphia VFC & VFAAR programs. This presentation does not require reconstitution. The Prescribing Information now describes both presentations of Menveo: the current two-vial presentation and a new one-vial presentation. 

One-vial Presentation (NEW) 

  • NDC: 58160-0827-30 
  • For use in individuals 10 years through 55 years of age. 
  • The one-vial presentation contains Menveo in a single vial with a pink cap 
  • This presentation does not require reconstitution. 
  • Available to order for VFC and VFAAR. 

Two-vial Presentation

  • NDC: 58160-0955-09
  • For use in individuals with special medical conditions 2 months through 9 years of age going forward*
  • The two-vial presentation includes a vial with a gray cap containing the MenCYW-135 liquid conjugate component and a vial with an orange cap containing the MenA lyophilized conjugate component. The contents of the vials must be combined to form Menveo prior to administration. 
  • The two-vial presentation is no longer available through VFAAR. 
  • Providers with existing supply of the Menveo 2-vial presentation on hand may continue to administer the vaccine to indicated VFC-eligible patients aged 2 months – 18 years of age. Do not initiate returns of the Menveo 2-vial presentation until the vaccine expires. The Philadelphia VFC Program will not process returns of unexpired Menveo 2-vial vaccine.

*There is a limited supply of the two-vial presentation available through the VFC program. To ensure that vaccine is available for individuals 2 months of age through 9 years of age, plan to only use the two-vial presentation for individuals 2 months through 9 years of age. Order the one-vial presentation for individuals 10 years through 18 years of age. 

CPT/CVX Codes

The CPT and CVX code for the new presentation is the same as the old presentation:  

  • CPT: 90734 
  • CVX: 136

Resources

Sites using the two-vial presentation of Menveo you can now order the one vial presentation. Please make sure the Menveo, one-vial presentation, is added to your EHR before ordering. If you have any issues ordering, please reach out to our coordinators:

Thank you for keeping Philadelphia safe and healthy. If you have any questions, please email vaccines@phila.gov.

Please note, Menveo and Menquadfi are interchangeable. To change the formulation that your site orders, please complete the Change Request Form. Our team will review your request and reply with next steps. We recommend that sites that are part of a system or are affiliated use the same vaccine presentations across sites to ensure continuity of care and help prevent administration errors.

Private COVID-19 Vaccine Procurement 

Private COVID-19 Vaccine Procurement 

Commercialization of COVID-19 vaccines is occurring next week. VFC Providers are required to match vaccines on the private side. We have created an FAQ to assist providers through this transition. 

Take these steps now to plan which COVID-19 vaccines you will purchase privately: 

  1. Review the anticipated presentations of vaccine products.
  2. Decide which products you plan to carry for your pediatric population. You may need to order more than one product to vaccinate all the children you see who are between 6 months – 18 years of age. You do not need to order multiple products for the same age group. 
  3. Establish relationships with manufacturer(s) for the vaccine products you plan to offer.

Review anticipated presentations of products

Establish relationships with manufacturers

Reach out to these pharmaceutical representatives to prepare your practice to order private stock of COVID-19 vaccine:

Once we have more information about VFC COVID-19 vaccine ordering, we will release resources and trainings to provide further guidance in this process.

New Vaccine Product Available Through VFC: Prevnar 20

New Vaccine Product Available Through VFC: Prevnar 20

On June 27, 2023, the CDC approved Prevnar 20 (PCV20) for use in pediatric patients. Beginning September 6, 2023, this Prevnar 20 is available to order for your VFC eligible patients. The Prevnar 13 (PCV13) is no longer available to order through the VFC program.

Sites using Prevnar 13 can now order Prevnar 20. Please make sure Prevnar 20 is added to your EHR before ordering.

Please note, Vaxneuvance and Prevnar 20 are interchangeable. To change the formulation that your site orders, please complete the Change Request Form. Our team will review your request and reply with next steps. We recommend that sites that are part of a system or are affiliated use the same vaccine presentations across sites to ensure continuity of care and help prevent administration errors.

Prevnar 20

PCV20 is now available through the Vaccines Children (VFC) program.

    • CVX code: 216
    • CPT code: 90677
    • NDC number: 00005-2000-10

For more information on Prevnar 20, review the package insert.

Additional resources:

FDA Prevnar 20 page
Immunize.org’s Ask the Experts 
VIS

Thank you for keeping Philadelphia safe and healthy. If you have any questions, please email vaccines@phila.gov.