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Author: Rishi Sharma

Dosing of Moderna COVID-19 Vaccine (2023-2024 Formula)

Dosing of Moderna COVID-19 Vaccine (2023-2024 Formula)

FDA released important information to ensure correct administration of the Moderna COVID-19 vaccine (2023-2024 formula) for individuals 6 months through 11 years.  

The announcement states that providers who administer Moderna COVID-19 vaccine (2023-2024 formula) to individuals ages 6 months through 11 years should ensure that the correct volume of the vaccine (0.25 mL) is withdrawn from the vial and administered to the patient. 

Providers should discard the vial and excess volume after extracting a single 0.25mL dose. Excess volume should not be used to administer an additional dose. Additionally, never combine partial doses from multiple vials to make one dose for a patient.

FDA shared this information after learning some providers may not recognize that the single dose vial of Moderna COVID-19 vaccine (2023-2024 formula) contains more than 0.25 mL of the vaccine and may be withdrawing the entire contents of the vial to administer. FDA has not identified any safety risks associated with administration of the higher dose in individuals 6 months through 11 years of age, and no serious adverse events related to this issue have been identified.  

For additional information, see the FDA announcement, updated Moderna fact sheet, and the vaccine administration resources listed at the end of this email.

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

Supply Updates and Borrowing VFC Doses

Supply Updates and Borrowing VFC Doses

The nirsevimab supply shortage continues to evolve and is not expected to resolve soon. Review this CDC advisory with updates about nirsevimab supply and recommendations to prioritize the use of the limited supply of this product.

With these limitations, the Immunization Program wants to remind providers that borrowing of VFC vaccine should be extremely limited. The goal of the Vaccines for Children (VFC) program is to vaccinate VFC eligible children. Given this landscape, please be aware of the following:

  •  It is neither practical nor feasible for the Philadelphia VFC program to allow borrowing during these times of supply constraints.
  • While there are supply constraints for nirsevimab, VFC supply stock should remain prioritized for VFC eligible children. 
  • If you have questions about borrowing, you can email victor.obeck@phila.gov. To borrow vaccine, you must first reach out to victor.obeck@phila.gov to request a borrowing form. Private vaccine borrowed without approval may not be replaced.

These constraints do not apply to COVID-19 vaccine. Please ensure that you have COVID-19 vaccine on hand for your VFC-eligible, private, and CHIP-insured patients. If your site still needs to access COVID-19 vaccine privately, you can reach out to our local pharmaceutical representatives listed below:

Novavax: Rich Aceto – raceto@novavax.com
Pfizer: Brian Bengston – brian.bengston@pfizer.com
Moderna: Lynne Timby – lynne.timby@modernatx.com

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. 
Read the blog post!

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.

COVID-19 Vaccine Commercialization

COVID-19 Vaccine Commercialization

Tuesday, September 12, 2023, marked the beginning of COVID-19 commercialization. Here are some important changes to be aware of in this new period of COVID-19 vaccination:  

  1. The Department of Public Health’s COVID-19 program has formally ended.  
  1. Bivalent COVID-19 vaccines are no longer authorized for use.  
  1. The Advisory Committee on Immunization Practices (ACIP) approved the use of updated (monovalent) COVID-19 vaccines. 
  1. 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). 
  1. 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.  
  1. 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. 

The new COVID-19 vaccine 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.   

Providers can place COVID-19 vaccine orders for VFC eligible patients and/or the Bridge Access Program eligible patients through the PhilaVax immunization information systems (IIS). A step-by-step ordering guide is available to assist with this. 

Recommendations for COVID-19 Vaccine 

  • 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. 

Available Products 

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 

Additional Resources 

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

Purchase Vaccine for Privately Insured Patients 

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

Guidance for Patients Regarding Vaccine Availability 

Patients are having some initial difficulty finding updated COVID-19 vaccine, especially pediatric doses. This is due to delays in shipping from manufacturers. The Health Department published recommendations for Philadelphians seeking updated COVID-19 vaccine doses. Read the recommendations here and consider sharing them with your patients. 

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.