Previously authorized monovalent and bivalent COVID-19 products have been deauthorized since September 12, 2023 and should have been removed from your inventory. If any patients were vaccinated with deauthorized products after September 12, they should be re-vaccinated with one of the 2023 – 2024 products.
Additionally, if you are interested in providing COVID-19 vaccine to underinsured and uninsured adults and have not yet enrolled in the Bridge Access Program, please reach out to Bridge Coordinator, nyandra.mcfadden@phila.gov to begin enrollment.
Mpox vaccine deliveries will be paused during the week of Thanksgiving, November 20-24, 2023.
Ordering will remain open this week until Wednesday, November 15 by 5:00 PM. The last delivery for mpox vaccine will be on Thursday, November 16.
Remember to submit your temperatures to tempcheck@phila.gov and complete a reconciliation of vaccine on hand for your order to be approved.
Click the button below to submit your order request for mpox vaccine.
Deliveries for mpox vaccine will resume on the week of November 27. If you have any questions, please contact Marguerite Horton at marguerite.horton@phila.gov.
Due to the unprecedented demand for nirsevimab, supply of this product is extremely limited through both the Vaccines for Children (VFC) program and the private market. Below is an update on available supply and tips on how to prioritize use of available doses. This a rapidly evolving situation. The information in this advisory reflects the most up-to-date information available to our program at this time. Updates released after this advisory will supersede this communication.
VFC Supply
The CDC has set up an allocation system to distribute the supply of VFC doses still available from their distribution centers. At this time, no 100 mg doses have been allocated to Philadelphia. A limited number of 50 mg doses will be available later in November and December.
The current VFC supply shipped and allotted to Philadelphia will not cover all eligible infants. Infants face the highest risk of RSV-related hospitalization in the first 5 months of life, especially in the first month.
To facilitate more equitable access to these products for eligible infants when they are most at risk, our program will implementing the following:
Redistribution of shipped doses. Given the supply of these products, our program will be redistributing doses that were shipped to sites last month in line with the current CDC recommendations. We will be reaching out to specific sites during the week of November 13, 2023 to coordinate picking up and delivering doses. We are basing the amounts moved on sites’ reported VFC-eligible population younger than 1 year of age, the amount of product received, and the subsequent usage.
Prioritization of birthing hospitals. To protect eligible infants when they are at highest risk for hospitalization, we will be prioritizing distribution of the 50 mg doses to birthing hospitals.
Private Supply
Per this press release from 11/6/23, Sanofi is contacting providers about distribution plans for doses available through the private market. New orders for the 100 mg dose are no longer being accepted, as the demand exceeded the available supply for the season. Distribution of the 50 mg doses in the private market is being managed to fulfill existing orders and provide equitable access to remaining doses. Please reach out to your Sanofi representative for more information.
Protecting infants from RSV this season
Given the limited availability of nirsevimab this season, consider these measures to protect infants:
Schedule outpatient appointments for unimmunized infants 0-2 months born during RSV season before they are > 5kg and no longer eligible for the 50 mg dose
Our program understands that this has been a challenging roll out. The Philadelphia VFC program was not aware of supply issues when fulfilling initial provider orders. We appreciate your understanding as our program works to more equitably distribute doses throughout the city as we navigate the national supply limitations. Sanofi and the CDC are working to address the issues that affected distribution this season to better prepare for the 2024 – 2025 season.
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.
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:
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?
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.
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.
The City of Philadelphia will be closed on Monday, October 9th in observance of Indigenous Peoples’ Day. Mpox orders are due by 5pm on Tuesday, October 10th during this week. Deliveries will continue as normal.
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:
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:
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.
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.
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.
