Administration Errors: RSV for Infants

On November 30, CDC alerted immunization programs that they have received reports of infants being mistakenly administered RSV vaccines intended for adults. Infants should only receive the RSV preventive antibody, nirsevimab (Beyfortus, Sanofi).

RSV vaccines (Arexvy by GSK and Abrysvo by Pfizer) are recommended only for adults and have not been evaluated for safety or effectiveness in infants or children. Practices that carry both adult RSV vaccine and pediatric RSV preventive antibody products should review their immunization administration safety procedures to ensure only the correct product is administered to recipients. This is an opportunity to re-educate and re-train staff on RSV immunization formulations and practices.

In the event that a vaccine administration involving RSV vaccine occurs, CDC encourages vaccinators to promptly report errors to the Vaccine Adverse Event Reporting System (VAERS). Also, inform parents of error so that these infants can receive the correct product and be monitored for adverse reactions. 

CDC Clinical Guidance (updated December 7, 2023)

Because there are no data on the efficacy/effectiveness of RSV vaccines in preventing RSV disease in this age group, the infant should receive nirsevimab if otherwise eligible based on maternal RSV vaccination status. There is no specific recommendation for a minimum interval between administration of incorrect RSV vaccine and nirsevimab. Some experts suggest:

• That it could be reasonable to consider waiting 48 to 72 hours before proceeding with nirsevimab administration. This time frame is when we would expect side effects to the RSV vaccine, such as fussiness, would be most likely.

• Consideration should be given to administering nirsevimab in the limb opposite to where the RSV vaccine was administered to avoid potential interaction or binding of RSV antibody and vaccine, thereby reducing the effectiveness of nirsevimab.

If further clinical guidance is needed, connect with our medical experts at vaccines@phila.gov or CDC experts at NIPINFO@cdc.gov.

Quality Improvement Opportunity for VFC Providers

The Immunization Quality Improvement for Providers (IQIP) Program is a CDC initiative to help providers implement strategies that support their immunization activities.

VFC-enrolled practices are chosen by the CDC for IQIP enrollment each year. However, starting this project year (July 1, 2023 to June 30, 2024), VFC-enrolled practices may self-enroll in IQIP.

Practices that do not have pediatric patients capitated to them (e.g., shelter sites, sexual health clinics, and birthing hospitals) are not eligible to participate.

Why self-enroll in IQIP?

IQIP helps practices meet their goals of efficient and effective vaccination processes to ensure timely and complete vaccine coverage for all children.

How can IQIP participation serve pediatric departments and physicians?

• IQIP efforts can be converted to group quality improvement (QI) projects, which can be eligible to fulfill the American Board of Pediatrics maintenance of certification (MOC) Part 4 requirements
• IQIP can help residency programs develop QI projects and educational opportunities
• Through IQIP, departments can meet national immunization quality metrics

What does IQIP offer?

Provider Quality Assurance (PQA) nurses through the Philadelphia Department of Health (PDPH) Immunization Program, in partnership with the CDC, offer guidance, practical recommendations, and technical support to practices aiming to increase their vaccination coverage rates.

The focus of IQIP is based on four CDC core strategies:

1. Facilitate patient return for vaccination
2. Leverage Immunization Information Systems (IIS) functionality to improve immunization practice.
3. Give a strong vaccine recommendation
4. Strengthen vaccination communications

Get in touch!

To enroll your practice in IQIP, contact your VFC Program PQA nurse Beth Smith at beth.smith@phila.gov, Dom Shannon at dom.shannon@phila.gov, or Jennifer Malins at jennifer.malins@phila.gov.

For more information on how IQIP can serve pediatric departments and physicians, please contact our newly onboarded Immunization Program Medical Specialist, Dr. Mayssa Abuali, at mayssa.abuali@phila.gov.

Learn more about IQIP!

Nirsevimab (Beyfortus) Updates

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
• Utilize Synagis for qualifying infants
• Vaccinate eligible pregnant people with Abrysvo

Additional strategies are outlined in this CDC health advisory from 10/23/23.

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. 

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

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: 

• alone, suspected adverse events are reported to MedWatch
• simultaneously with any vaccine, suspected adverse events are reported to the Vaccine Adverse Event Reporting System (VAERS); additional reporting to MedWatch not needed

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

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.