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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. 
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.

PIC Conference Registration Open Now! 

PIC Conference Registration Open Now! 

Philadelphia Immunization Coalition Fall Conference

We are excited to invite you to join us for the 2023 Fall PIC Conference, at the College of Physicians in Philadelphia. Our speakers include Dr. Andrew Kroger and Dr. Paul Offit, among others to be announced.  Topics covered will include COVID, Infant and Maternal RSV, Community Panel, Hepatitis B, and PDPH Updates.

Check-in begins at 8:30am.

Tickets will be $40 and include breakfast, all day coffee, and a wonderful hot lunch. Continuing education credits will also be provided.

Register ASAP to reserve your spot and reach out with any questions to veronica.alvarez@phila.gov.

Location

The College of Physicians of Philadelphia
19 S 22nd St, Philadelphia, PA 19103
View on map

Date and Time

Oct 04, 2023 8:30am ET – Oct 04, 2023 3:30pm ET

Register

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Penn State College of Medicine and Philadelphia Immunization Coalition. Penn State College of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Penn State College of Medicine designates this live activity for a maximum of 4.5 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Annual Conference Agenda

8:30am-9am: Arrive for Registration and Breakfast

9am-9:40am
PDPH Updates
Amber Tirmal, MPH, PDPH

9:40am-10am
Hepatitis B Updates
Danica Kuncio, MPH, PDPH

10am-10:20am
Community Grantee Updates (Local Community Organizations)

10:20am-10:35am
Break/Exhibitors

10:35am-11:50 am
Influenza/RSV/COVID
Dr. Andrew Kroger, MD, MPH, CDC

12pm- 1pm
Lunch/Exhibitors

1pm-2:15pm
Maternal RSV
Dr. Paul Offit, MD, CHOP

2:15pm-2:30 pm
Break/Exhibitors

2:30pm-3:30pm
Panel: Challenges and Opportunities for Pediatric Vaccination
Charna Blake, BSN, RN
AHS Vaccine Coordinator

Andrea Bailer, MSN, CRNP
CHOP Care Network

Jennifer Rice
Esperanza Health Center, Inc.

Kendra B. McDow MD, MPH, FAAP
School District of Philadelphia

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.