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Author: Immunization Program Comminucations Coordinator

Pfizer-BioNTech Vaccine Gets Approval & Expiration Extension

Pfizer-BioNTech Vaccine Gets Approval & Expiration Extension

The Pfizer-BioNTech vaccine has been granted official Food and Drug Administration (FDA) approval! The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. Although the full approval is only for individuals 16 years of age and older, Comirnaty can still be given to individuals 12 through 15 under the existing EUA. The Comirnaty vaccine is still contracted under the federal government and will not be distributed commercially at this time. Providers are expected to continue following the CDC Provider Agreement terms set forth at the time of enrollment with PDPH.

In addition to the FDA’s full approval, an amendment to the EUA for the Comirnaty vaccine has been made to extend the expiration dates from 6 to 9 months.

Cartons and vials of Pfizer-BioNTech’s Comirnaty vaccine may remain in use for 3 months beyond the printed date as long as authorized storage conditions (-90°C to -60°C or -130°F to -76°F) have been maintained. Frozen vials stored at -25°C to -15°C and refrigerated vials stored at 2°C to 8°C are NOT eligible for extension.

See the below chart for guidance:

Printed Expiry Date Updated Expiry Date
August 2021 November 2021
September 2021 December 2021
October 2021 January 2022
November 2021 February 2022
December 2021 March 2022
January 2022 April 2022
February 2022 May 2022

The extended expiration date is effective immediately for all currently available batches that have not yet expired. Please note: Expiration dates extension does NOT apply to vials dated July 2021 and earlier

Currently available vaccine will not have an updated NCD. Please refer to the
current EUA Fact Sheet for information by clicking the button below. And additional information on Comirnaty’s storage and handling may be found at: Administration Overview for Pfizer-BioNTech COVID-19 Vaccine.

If you have questions about the extended expiration or the storage requirements of Comirnaty vaccine, please contact us at vaccines@phila.gov.

Thank you working to keep Philadelphia safe and healthy. Together we can stop COVID-19!

Vaccine Formulary Updates and Ordering Directions

Vaccine Formulary Updates and Ordering Directions

COVID-19 vaccine ordering will remain dynamic over the next few weeks as new configurations (anticipated in late October) become available, phase out, and product lines are reintroduced. We continue to have a healthy supply of all vaccine and we hope to keep you as informed as possible regarding the shifts in vaccine configurations.

Although vaccinations have been expanded for immunocompromised individuals, we want to encourage all sites to use what you have on hand to meet these needs given the large volumes of inventory in the field. We want you to use vaccine to the best of your ability. We continue to be cautiously optimistic that the Pfizer vaccine, currently held at ultra-low temp conditions, will receive an extension. You should consider these possible extensions prior to placing orders for additional Pfizer vaccine.

Please review the following upcoming changes below.

COVID-19 Vaccine Ordering Tips!

  • Use the COVID-19 vaccine you have in your inventory before ordering more.
  • Only order vaccine that you can reasonably administer.
  • Administer, report, and assess your vaccine needs.
  • Order again – as needed!

Vaccine Configurations to be Phased Out this Week!

Pfizer 450 for ages 12+

  • 450-pack Pfizer configuration comes to an end this week.
  • Any site ordering more than one 450-pack this week should order an 1170 pack instead.
  • We anticipate new smaller package configurations will be available in October. Stay tuned for more details!

Returning and Ongoing Vaccine Configurations

Pfizer 1170 returning August 18th

  • Pfizer 1170-pack will be re-introduced on Aug 18th.
  • Ancillary kits:
    • Ancillary kits for this packaging are configured with 80% 1” needles that may be used for pediatric patients.
    • Some of the needles in the adult kit are 1.5” long and should not be used to vaccinate pediatric patients (see Vaccine Administration: Needle Gauge and Length (cdc.gov)).
    • Providers may need to acquire additional 1” needles to supplement the adult ancillary kit if needed.
  • Orders submitted with a pediatric order intention will error out.

Moderna 100 – Temporary Only returning for a limited time only on August 19th at 12pm Eastern

  • Limited supply of 4.5 million doses
  • Moderna 100-pack will be re-introduced on Aug 19th.
  • All due to expire in Nov/Dec 2021

Moderna 140

  • Ages 18+ (awaiting EUA expansion for adolescents to activate PED ancillary)

J&J/Janssen 100 estimated return in September

  • Maximum orders of 100 doses
  • 6-month shelf life

Dry Ice Will Not be Provided for Pfizer Vaccine

Given the updated storage capability for Pfizer vaccine (2-8C for 30d) and based on the availability of dry ice locally for sites that need it, dry ice recharges will not be provided to support the 450 or 1170 packs:

  • If you intend to use the Pfizer thermal shipping container for temporary ULT storage, you must have a plan in place for replenishing the dry ice every five days.
  • Locations utilizing the shipping container for storage must activate the data monitoring system (via email from Controlant)

If you have any questions about ordering please contact us at vaccines@phila.gov. Thank you for helping keep Philadelphia safe and healthy!

Formulary Updates

Vaccine Formulary Updates and Ordering Directions

COVID-19 vaccine ordering will remain dynamic over the next few weeks as new configurations (anticipated in late October) become available, phase out, and product lines are reintroduced. We continue to have a healthy supply of all vaccine and we hope to keep you as informed as possible regarding the shifts in vaccine configurations.  
 
Although vaccinations have been expanded for immunocompromised individuals, we want to encourage all sites to use what you have on hand to meet these needs given the large volumes of inventory in the field. We want you to use vaccine to the best of your ability. We continue to be cautiously optimistic that the Pfizer vaccine, currently held at ultra-low temp conditions, will receive an extension. You should consider these possible extensions prior to placing orders for additional Pfizer vaccine.
 

COVID-19 Vaccine Ordering Tips! 

· Use the COVID-19 vaccine you have in your inventory before ordering more.
· Only order vaccine that you can reasonably administer.
· Administer, report, and assess your vaccine needs .
· Order again, as needed! 

Vaccine Configurations to be Phased Out this Week!

Pfizer 450 for ages 12+

  • 450-pack Pfizer configuration comes to an end this week.
  • Any site ordering more than one 450-pack this week should order an 1170 pack instead.
  • We anticipate new smaller package configurations will be available in October. Stay tuned for more details!

Returning and Ongoing Vaccine Configurations 

Pfizer 1170 returning August 18th

  • Pfizer 1170-pack will be re-introduced on Aug 18th.
  • Ancillary kits: 
  • Ancillary kits for this packaging are configured with 80% 1” needles that may be used for pediatric patients.
  • Some of the needles in the adult kit are 1.5” long and should not be used to vaccinate pediatric patients (see Vaccine Administration: Needle Gauge and Length (cdc.gov)). 
  • Providers may need to acquire additional 1” needles to supplement the adult ancillary kit if needed.
  • Orders submitted with a pediatric order intention will error out.
 

Moderna 100 – Temporary Only returning for a limited time only August 19th at 12pm Eastern

  • Limited supply of 4.5 million doses
  • Moderna 100-pack will be re-introduced on Aug 19th.
  • All due to expire in Nov/Dec 2021

Moderna 140 

  • Ages 18+ (awaiting EUA expansion for adolescents to activate PED ancillary)

J&J/Janssen 100 estimated return September

  • Maximum orders of 100 doses
  • 6-month shelf life

Note: Dry Ice Will Not be Provided for Pfizer Vaccine

Given the updated storage capability for Pfizer vaccine (2-8C for 30d) and based on the availability of dry ice locally for sites that need it, dry ice recharges will not be provided to support the 450 or 1170 packs:

  • If you intend to use the Pfizer thermal shipping container for temporary ULT storage, you must have a plan in place for replenishing the dry ice every five days.
  • Locations utilizing the shipping container for storage must activate the data monitoring system (via email from Controlant)

If you have any questions about ordering please contact us at vaccines@phila.gov. Thank you for helping keep Philadelphia safe and healthy!

Pediatric Flu Vaccine is Available to Order!

Pediatric Flu Vaccine is Available to Order!

A supply of FluLaval pre-filled syringes for your VFC patients is now available for ordering!

Please note, all flu vaccine from the 2020-2021 season must be accounted for before you can order flu for the 2021-2022 season. Guidance on accounting for remaining doses can be found at this notice here. And more information on how to Order VFC/VFAAR flu vaccine can be found at this notice here.

We will send out additional emails and update the flu page as more presentations of flu become available.

Have questions?
Contact Christine Wilson at 215.685.6728 or christine.wilson@phila.gov, or Charma Miller at 215.685.6667 or charma.miller@phila.gov for assistance.

Avoiding Administration Errors: Scheduling Errors

Avoiding Administration Errors: Scheduling Errors

Dear Immunization Provider,

The Immunization Program thanks you for your critical role of ensuring children in Philadelphia receive up-to-date immunizations prior to the school year!

To help you in your immunization efforts we have assembled some tips for avoiding one of the most common vaccine administration errors: scheduling errors!

What are Administration Errors?

Administration errors due to scheduling occur when vaccines are given too early – either before the appropriate minimum age or before the recommended interval for a particular vaccine.

Unfortunately, early doses are not valid. Minimum ages and dosing intervals have been studied for efficacy and safety. Administering vaccines out of this range may not generate an adequate immune response, leading to vulnerability to disease, side effects, or harm to the provider’s relationship with the patient/parent. It is in everyone’s best interest to avoid administration errors!

Exception: There is a 4-day grace period before the minimum interval or age, although this should not be used when scheduling visits. This does not apply to the 28-day interval between two live injectable vaccines (e.g. MMR, Varicella) or Flumist if not administered simultaneously, or intervals between the rabies vaccine.

Common Scheduling Errors

Here are some of the most common scheduling errors found when reviewing immunization histories and scheduling immunization appointments:

  • Administering the 1st dose of MMR, varicella, or hepatitis A vaccine before 12 months of age
  • Giving the 4th dose of DTap before age 12 months (or less than 6 months after the 3rd dose)
  • Not administering a dose of IPV after 4 years of age (at least 6 months after previous dose)
  • Finishing the hepatitis B series before 24 weeks of age
  • Administering any vaccine (except hepatitis B) before age 6 weeks
  • Giving the 2nd dose of MenACWY vaccine before age 16 years for a healthy adolescent
  • Inadequate spacing for the hepatitis A, hepatitis B, IPV and HPV series
  • Using the incorrect needle size
  • Injecting vaccine at the incorrect injection site
  • Confusing Tdap (Tetanus, Diphtheria, Pertussis) and DTap (Diphtheria, Tetanus, Pertussis) vaccines

Tips from the Immunization Program

Here is a list of tips to find past administration errors and avoid them going forward:

  • Keep an immunization schedule handy for clinical and office staff!
  • When scheduling well-child visits, ensure a child will have reached the appropriate age (e.g., will be at least 12 months on the date of their 1-year well-child visit).
  • Review the patient’s immunization record, by searching the PhilaVax IIS or by obtaining the patient’s vaccination records by contacting their previous healthcare provider.
  • Use the tools in PhilaVax to understand what is indicated for the patient.
    • A red exclamation mark means that a dose is not valid.
    • Click “Recommend” below a patient’s record to see when vaccines are recommended.

Did you know? You can update your PhilaVax settings so recommended vaccines display at the top of your screen when reviewing patient records. Follow the steps below and reference the screenshots to do it yourself!

  1. Click your username in the upper right-hand corner (see screenshot 1)
  2. Under “User Defaults,” click “Display Today’s Recommendations” (see screenshot 2)
  3. Click “Update” to save the change (see screenshot 2)
screenshot 1
screenshot 1
screenshot 2
screenshot 2

 

What do I do if an Administration Error Happens?

  • Check for guidance from the Advisory Committee for Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC)
  • Make a report to the Vaccine Adverse Events Reporting System (VAERS)
    • Recommended if a dose administration error occurs (required for a COVID-19 vaccine under Emergency Use Authorization)
    • Required if an adverse event occurs

Have questions about vaccine scheduling or the PhilaVax software? The Philadelphia Immunization Program is here to help! You can email us at vaccines@phila.gov for assistance.

Resources & References

Check Your COVID-19 Vaccine Expiration Dates

Check Your COVID-19 Vaccine Expiration Dates

Several lots of Pfizer, Moderna, and J&J COVID-19 vaccine product have their expiration dates in June and July. Please be mindful of when your COVID-19 vaccine expires!

Remember, always check the product’s expiration dates prior to administering. For Pfizer and Moderna, immediately remove and properly dispose of expired doses as medical waste in order to avoid administration of expired doses. Expired Janssen/J&J doses can be quarantined at this time pending stability studies (DO NOT USE these expired loses in the interim).

Waste is required to be reported to The Philadelphia Department of Public Health (PDPH) via the following form: COVID-19 Vaccine Wastage Adjustments

Pfizer

Expiration Dates are on the vials and can also be found in PhilaVax with the shipment information.

Please note: Pfizer has been approved for storage at standard refrigerator temperatures for 1 month (i.e., 31 days). Prior to being placed in the refrigerator, Pfizer can also be kept at standard freezer temperatures for 2 weeks.

Moderna

Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA)

Please note: Vials can be used for up to 12 hours after being punctured.

J&J

Janssen COVID-19 Vaccine Product Quality Checker

Please note: The FDA has authorized an extension of the Jassen/J&J vaccine’s shelf life from 3 months to 4.5 months.

Quick Reference Guide

Please refer to the COVID-19 Vaccine Quick Reference Guide for Healthcare Professionals to see a storage/handling, administration, and general comparison of the three COVID-19 vaccines. This guide is extremely useful and can be printed for posting at provider locations.

MenQuadfi (MenACYW-TT), a New Meningococcal Vaccine, is Now Available for VFC

MenQuadfi (MenACYW-TT), a New Meningococcal Vaccine, is Now Available for VFC

To download a PDF version of this PDF, click here!

In 2020, the Food and Drug Administration licensed an additional meningococcal serogroups A, C, W, and Y (MenACWY) – MenQuadfi
(MenACYW-TT), from Sanofi Pasteur Inc.

MenQuadfi is now available for providers enrolled in the Vaccines for Children (VFC) program. This advisory includes an overview
of important information about MenQuadfi.

MenQuadfi is licensed for use in individuals 2 years and older in the United States.

Recommendations For Use

Eligible Groups for Receipt of VFC Supplies of MenQuadfi

VFC supplies of MenQuadfi may be given to VFC-eligible children aged 2 years through 18 years.

Licensed Dosing Schedule

MenQuadfi is for intramuscular use only.

MenQuadfi is approved for routine vaccination of children and teens, age 11 through 18 years: a single dose at age 11 or 12 years with a booster dose at age 16 years.

MenQuadfi may also be used for children at increased risk who are age 2 years and older (the primary dosing schedule and booster dose interval varies by age and indication):

  • People with functional or anatomic asplenia
  • People who have persistent complement component deficiency (an immune system disorder) or who take a complement inhibitor (eculizumab [Soliris] or ravulizumab [Ultomiris])
  • People who have HIV infection
  • People who are at risk during an outbreak caused by a vaccine serogroup
  • People age 2 months and older who reside in or travel to certain countries in sub-Saharan Africa as well as to other countries for which meningococcal vaccine is recommended (e.g., travel to Mecca, Saudi Arabia, for the annual Hajj)
  • Microbiologists who work with meningococcus bacterial isolates in a laboratory
  • First-year college students living in residence halls who are unvaccinated or undervaccinated; these students should receive a dose if they have not had a dose since turning 16 or if it has been more than 5 years since their previous dose

These recommendations are summarized in Table 3 of the recommendations published by ACIP in MMWR in 2020: www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf.

The Advisory Committee on Immunization Practices (ACIP) recommends that whenever feasible, the same manufacturer’s brand should be used to complete the series. However, if the previous brand is unavailable or unknown, any brand may be used to complete the series. Do not defer immunization solely to wait for a specific meningococcal vaccine brand to be available. From age 2 years and up the MenACWY vaccines are interchangeable.

Storage

  • MenQuadfi should be stored at 2º to 8ºC (36º to 46ºF). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after the expiration date shown on the label.

How MenQuadfi is supplied

  • MenQuadfi is supplied in a single-dose vial in packages of 5 vials (NDC No. 49281-0590-05). The dosage for MenQuadfi is 0.5 mL. MenQuadfi does not contain a preservative. The vial stopper for this product is not made with natural latex rubber.

Ordering and Billing

MenQuadfi is available for ordering through the PhilaVax IIS as of today, June 8, 2021. Please contact Christine Wilson (Christine.Wilson@phila.gov) or Charma Miller (Charma.Miller@phila.gov) to add MenQuadfi to your next order. Please note, your practice must choose a single product to order for each antigen. We recommend that sites that are part of a system, or are affiliated, use the same vaccine presentations across sites to ensure continuity of care and help prevent administration errors.

  • CVX code: 203
  • CPT code: 90619

Resources

Vaxelis (DTaP-IPV-Hib-HepB), a Hexavalent Vaccine, is Now Available for VFC

Vaxelis (DTaP-IPV-Hib-HepB), a Hexavalent Vaccine, is Now Available for VFC

To download a PDF version of this notice, click here!

Vaxelis is now available for providers enrolled in the Vaccines for Children (VFC) program. This advisory includes an overview of important information about Vaxelis.

Vaxelis is a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib, PRP-OMP), and hepatitis B (HepB) (recombinant) vaccine. In 2018, FDA licensed Vaxelis for use in children age 6 weeks through 4 years: it is indicated as a 3-dose series for infants at ages 2, 4, and 6 months. ACIP voted to add Vaxelis to the Vaccines for Children (VFC) Program in 2019. Vaxelis became commercially available in the United States in 2021.

Recommendations For Use

Eligible Groups for Receipt of VFC Supplies of Vaxelis

VFC supplies of Vaxelis may be given to VFC-eligible children from 6 weeks through 4 years of age (prior to the 5th birthday).

Licensed Dosing Schedule

Vaxelis is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. Vaxelis is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). Vaxelis is indicated for use in infants at ages 2, 4, and 6 months.

Recommended minimum ages for administration of Vaxelis (DTaP-IPV-Hib-HepB) vaccine and intervals between doses — United States, 2020*

Age/Interval
Minimum age for any dose 6 weeks
Minimum interval between doses 1 and 2 4 weeks
Minimum age for dose 2 10 weeks
Minimum interval between doses 2 and 3 4 weeks
Minimum age for dose 3 24 weeks†
Maximum age for any dose 4 years, 364 days (do not administer on or after the fifth birthday)

† If the third dose of DTaP-IPV-Hib-HepB is given before age 24 weeks, an additional dose of hepatitis B vaccine should be given at
age ≥24 weeks to complete the hepatitis B series.

*DTaP-IPV-Hib-HepB can be used for children aged <5 years requiring a catch-up schedule. However, vaccine doses should not be
administered at intervals less than the minimum intervals indicated in this table.

For guidance on transitioning to Vaxelis and how it fits into the immunization schedule, visit: https://www.vaxelistransition.com.

The Advisory Committee on Immunization Practices (ACIP) recommends that whenever feasible, the same manufacturer’s brand should be used to complete the series. However, if the previous brand is unavailable or unknown, any brand may be used to complete the series. Do not defer immunization solely to wait for a specific brand to be available.

Storage

Vaxelis should be stored at 2º to 8ºC (36º to 46ºF). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after the expiration date shown on the label.

How Vaxelis is supplied

Vaxelis is supplied in a single-dose vial in packages of 10 vials (NDC no. 49281-0590-05). The dosage for Vaxelis is 0.5 mL. Vaxelis does not contain a preservative. The vial stopper, syringe plunger stopper, and syringe tip cap are not made with natural rubber latex.

Administration

Just before use, shake the vial or syringe until a uniform, white, cloudy suspension results.

Inspect the vial or syringe for particulate matter and discoloration prior to administration. If either of these conditions exist, the product should not be administered.

Administer a single 0.5 mL dose of Vaxelis intramuscularly. In infants younger than 1 year, the anterolateral aspect of the thigh is the preferred site of injection. The vaccine should not be injected into the gluteal area.

Vaxelis should not be combined through reconstitution or mixed with any other vaccine. Discard unused portion. Vaxelis is for intramuscular use only.

Precautions and Contraindications

Do not administer Vaxelis to anyone with a history of severe allergic reaction to a previous dose of Vaxelis, any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.

Do not administer Vaxelis to anyone with a history of encephalopathy within 7 days of a pertussis containing vaccine with no other identifiable cause.

Do not administer Vaxelis to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

Ordering and Billing

Vaxelis is available for ordering through the PhilaVax IIS as of today, June 8, 2021. Please contact Jillian Brown (Jillian.Brown@phila.gov) to begin the process of transitioning to Vaxelis at your site. Please note, your practice must choose a single type of combination vaccine to use as part of the primary series. We recommend that sites that are part of a system or are affiliated use the same vaccine presentations across sites to ensure continuity of care and help prevent administration errors.

  • CVX code: 146
  • CPT code: 90697

Resources

Vaccine Information Statements (VIS):

CDC Morbidity and Mortality Weekly Report (MMWR): https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6905a5-H.pdf.

For guidance on transitioning to Vaxelis and how it fits into the immunization schedule, visit: https://www.vaxelistransition.com.

Product insert for Vaxelis includes additional vaccine information, found at: https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf.

Additional information on vaccines and vaccine preventable diseases can be found at: http://www.cdc.gov/vaccines/