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Moderna COVID-19 Vaccine Shelf-Life Extension

Moderna COVID-19 Vaccine Shelf-Life Extension

The FDA has approved Moderna’s request for a 3-month shelf-life extension (SLE) of all Moderna COVID-19 vaccines for under 6 years old. The relevant lot numbers are listed in the table below. 

Moderna has updated their web-based Vial Expiration Checker tool to reflect the extension of the four lot numbers below. Only the lot numbers below are included in this SLE approval. 

We encourage you to record these updates for management of your inventory and continue weekly monitoring of all COVID-19 vaccine expiration dates using the manufacturers’ online expiry checking tools:   

Moderna Vial Expiration Checker

Pfizer-BioNTech COVID-19 Vaccine Expiry Checker 

Novavax Expiry Date Checker 

Back-to-School Immunization Resources

Back-to-School Immunization Resources

The PDPH Immunization Program and the School District of Philadelphia (SDP) want to remind you that now is the time to prepare your patients for back-to-school. Pennsylvania law requires all students (K-12) to be vaccinated while attending school. Students that do not have the required vaccines may be excluded from school until they receive the appropriate vaccines.   

Since the 2020 school year, national coverage with state-required vaccines among kindergarten students has continued to decline. To help you get your patients back on track with immunizations, schedule vaccination appointments now to get ahead of the back-to-school rush.  

We have created a series of short video trainings to support your practice. The videos cover topics including school immunization requirements, the ACIP child and adolescent immunizations schedule, information on specific vaccines, vaccine interval spacing, and Vaccine Adverse Event Reporting System (VAERS) reporting. 

Training Videos 

Click on the buttons below to view the training videos.

Training #1: School District Immunization Requirements & the Effects of the Pandemic  

Training #2: Child & Adolescent Immunization Schedule 

Training #3: Vaccine Interval Spacing 

Training #4: Review of Live Vaccines 
 
Training #5: DTaP or TdaP: Which One to Choose 
 
Training #6: Vaccine Adverse Event Reporting System (VAERS) Reporting 

COVID-19 Vaccine Commercialization

COVID-19 Vaccine Commercialization

COVID-19 vaccine will soon be available for purchase on the commercial market and will be available to order through the Vaccines for Children (VFC) Program. We have created an FAQ and will host town halls to help with this transition.

Commercialization of COVID-19 vaccines will transition vaccines previously purchased by the U.S. government to established pathways of procurement, distribution, and payment by both public and private payers. The Bridge Access Program will support providers to vaccinate uninsured and underinsured adults 19 years of age and older in Philadelphia county.

Commercialization of COVID-19 vaccine is expected to take place in August or September 2023, with the exact timeline still forthcoming. Click the button below to read the FAQ and learn more about COVID-19 vaccine commercialization.  

Read the FAQ

On Thursday, August 10, 2023, we will host 2 town halls to discuss COVID-19 vaccine commercialization and the Bridge Access Program. Register for the town hall that best fits your schedule below. 

Register for the 12pm town hall

Register for the 7pm town hall

Updated Moderna Expiration

Updated Moderna Expiration

All orders for COVID-19 vaccine must be placed by this Thursday, August 3.

As a reminder, this Thursday, August 3 is the last day to order COVID-19 vaccine. Sites should order enough vaccine to last through August and September. Moderna vaccine may arrive short dated, as an extension on the expiry date is expected. 

Be on the lookout for an email with the updated expiration dates. You can also check Moderna’s online expiry tool below.

Moderna Expiry Tool

Return Expired Doses of Flu Today!

Return Expired Doses of Flu Today!

All VFC/VFAAR influenza vaccine supplied by the Philadelphia Immunization Program during the 2022-2023 flu season has expired. Please account for unused VFC/VFAAR flu vaccine at your site using PhilaVax:

  • Process a return for the unopened vials online in the Vaccines Returns module. A job aid with step by step instructions can be found here.
  • Adjust out open vials of Flu. A job aid with step by step instructions can be found here.

Return your vaccine before August 15th

Please complete these steps by August 15, 2023 to avoid delays in processing your site’s 2023-24 flu season orders. If you have questions, contact DPHProviderHelp@phila.gov.

All communication about the availability of flu vaccine will be made via email and posted on the PDPH website. Keep an eye out for upcoming messages! If you need to add more people to our mailing list, please contact us at vaccines@phila.gov.

Thank you for helping to protect Philadelphians this past year! We look forward to working together to keep people safe from the flu next season.

Update to the Naloxone Stocking Requirement

Update to the Naloxone Stocking Requirement

To our pharmacy partners:

It has come to our attention that an agency with which we subcontract for educational activities related to the naloxone stocking requirement has been visiting some local pharmacies and behaving in a way that is not consistent with either our contract with them or our values, failing to present ID or a business card, demanding proof that naloxone is carried on site, and threatening fines. I want to apologize to any of you who have experienced these visits. While we do believe that the naloxone stocking requirement is an important component of our local harm reduction response, our intention had been to share information and technical assistance where appropriate, not to browbeat or threaten our pharmacy colleagues. We are pausing this program until we can meet with the vendor and discuss their approach.

In the meantime, if you have questions, either about the naloxone stocking requirement or about this incident, please don’t hesitate to reach out at Andrew.Best@phila.gov.

Thank you,

Dr. Cheryl Bettigole, Health Commissioner
Andrew Best, Director, Division of Substance Use Prevention and Harm Reduction 

Developments in RSV Biologics

Developments in RSV Biologics

Respiratory syncytial virus, or RSV, is a negative-sense, single-stranded RNA virus. It is a common respiratory virus that usually causes mild, cold-like symptoms. In most regions of the United States, RSV season starts in the fall and peaks in the winter.  

Although most people who develop RSV infection have mild illness, certain individuals are at risk for severe disease and death. It is estimated that between 60,000 and 160,000 older adults are hospitalized due to RSV, and between 6,000 and 10,000 older adults die due to RSV each year.  
 
Among children younger than 5 years, 58,000 to 80,000 are hospitalized each year due to RSV; and 100 to 300 die from it.  

Those at high risk for severe illness from RSV include: 

  • Premature infants 
  • Infants, especially those 6 months and younger 
  • Children younger than 2 years old with chronic lung disease or congenital heart disease 
  • Children with suppressed immune systems 
  • Children who have neuromuscular disorders, including those who have difficulty swallowing or clearing mucus secretions 
  • Older adults, especially those 65 years and older 
  • Adults with chronic lung or heart disease 
  • Adults with weakened immune systems 

Vaccine Developments 

In 2004, the U.S. Food and Drug Administration (FDA) approved Synagis (manufactured by Sobi) the first monoclonal antibody used to prevent severe disease caused by RSV in high-risk infants. It must be given monthly throughout the RSV season. 

In May 2023, FDA voted in support of approval for RSVpreF, Pfizer’s vaccine candidate to prevent severe disease caused by RSV in infants through vaccination of pregnant people. RSVpreF is currently under FDA review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV. The FDA’s decision on the potential approval of RSVpreF is expected in August 2023. 

Also in May, the FDA approved two RSV vaccines, Arexvy and Abrysvo, manufactured by GSK and Pfizer, respectively. FDA approved both vaccines for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.  

In June 2023, the ACIP voted to recommend Pfizer and GSK’s adult RSV vaccines for adults 60 and older using shared clinical decision making.  

In July 2023, FDA approved nirsevimab (AstraZeneca and Sanofi), a monoclonal antibody that will be used to protect newborns and infants born during or entering their first RSV season. In contrast to Synagis, it will only have to be given once in a season. Nirsevimab is the first passive immunization product to be considered for inclusion by the ACIP in the CDC immunization schedule as a vaccine-like seasonal immunization. The ACIP will meet to discuss recommendations for implementation and inclusion in the VFC program on August 3. 

Vaccine/Antibody Availability and Insurance Coverage 

RSV vaccines for older adults are expected to be available this fall.  
 
These vaccines will be covered by Medicare Part D, Medicaid, and Affordable Care Act-compliant insurance plans. It is not yet known whether Arexvy and Abryvo will be included in the Vaccines for Adults at Risk (VFAAR) program. 

CDC is assessing whether nirsevimab will be included in the Vaccines for Children (VFC) program, so its cost and availability is unknown at this time.  

Developments in RSV vaccines are ongoing. Updates to vaccine product availability and insurance coverage of available vaccines are expected in the coming months.  

Interested in the COVID-19 Bridge Program?

Interested in the COVID-19 Bridge Program?

The Immunization Program will soon be launching a new vaccine program called the Bridge Program. Read on for more information, and complete the interest form below by July 14th!

The Bridge Program is a COVID-19 vaccine program for uninsured and underinsured adults 19 years of age and older in Philadelphia county.

The program will only offer COVID-19 vaccines for uninsured and underinsured adults, 19 and older.

Sites that wish to enroll in the Bridge Program will need to complete an enrollment form. This includes sites that are already enrolled in the COVID-19 program.

Provider Eligibility

  • Providers already seeing or are willing to see uninsured or underinsured adults, 19 years of age and older.
  • Providers who want to offer COVID-19 vaccine to their eligible patients.
  • Providers that can estimate the number of uninsured or underinsured adults their site currently sees or will see. Note: This information will be required on the Bridge Program enrollment form. Sites will not be able to enroll without this information.

Who counts as uninsured or underinsured?

  • Adults not covered by any health insurance plan.   
  • Adults who have health insurance, but coverage does not include any vaccines.
  • Adults who have health insurance, but coverage does not include all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP).
  • Adults who have health insurance, but there is a fixed dollar limit or cap for vaccines.
Bridge Program Interest Form

The Immunization Program expects to launch the Bridge Program in early fall, with an exact launch date still forthcoming, but in alignment with commercialization of COVID-19 vaccine.

To gain a better understanding of the numbers of sites interested in participating in the Bridge Program, we ask you to complete the above survey by Friday, July 14, 2023.

Commercialization of COVID-19 Vaccine

Commercialization of COVID-19 Vaccine

COVID-19 vaccine will soon be available for purchase on the commercial market and will be available to order through the Vaccines for Children (VFC) Program. We do not have an exact date or timeline for commercialization, but we want to provide as much lead time as we can for our VFC providers about this upcoming change.

Commercialization of COVID-19 vaccines will transition vaccines previously purchased by the U.S. government to established pathways of procurement, distribution, and payment by both public and private payers.

What does this mean?

There will not be a separate COVID-19 Provider Program as currently exists.

  • All VFC providers will be required to maintain a supply of COVID-19 vaccine for the entire patient population they serve. As with other ACIP recommended vaccines, your practice will need to stock COVID-19 vaccine for both VFC eligible children and privately insured patients once commercialization occurs.

Why is this important?

  • COVID-19 vaccine is an ACIP-recommended vaccine and has been added to the CDC Child and Adolescent Immunization Schedule.
  • Your patients may not have access to COVID-19 vaccine elsewhere. Pharmacies are not authorized to vaccinate kids under 3 years of age, so your practice may be the only place your patients can get vaccinated.
  • A very low percentage (<20%) of kids 6 months – 4 years have been vaccinated against COVID-19 in Philadelphia, which means they may not be protected against severe disease and death from COVID-19.

Did you know?

  • You don’t need an ultra-low freezer to store COVID-19 vaccine! You can store COVID-19 vaccines in your regular storage units.
  • Providers should never turn down an opportunity to vaccinate for COVID-19 due to fears of vaccine wastage! We expect smaller packaging sizes of vaccine to be available this fall with commercialization.

Please be on the lookout for updated messages from the Immunization Program about commercialization throughout the summer. Have questions or concerns? Direct them to vaccines@phila.gov.

Updated COVID-19 Delivery Schedule

Updated COVID-19 Delivery Schedule

With commercialization of COVID-19 nearing, PDPH will be reducing our capacity to deliver partial orders of COVID-19, placed through the Monday.com order form below. In June, we will deliver orders the week of the 12th and the week of the 19th. Any orders placed later in June will not be delivered until July. In July and August, we will deliver partial orders during the 3rd full week of the month. Please see the below ordering schedule for reference.

Partial Order Form

As we move forward with this new delivery schedule, sites will need to order slightly more vaccine to have enough supply to last them up to a month between orders.

If you have questions regarding COVID-19 deliveries, please email covidproviders@phila.gov.