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Pfizer “Tris Product” Shelf-Life Extension

Pfizer “Tris Product” Shelf-Life Extension

FDA has approved a shelf-life extension for the Pfizer Pediatric vaccine (orange cap, 5-11 years old, diluent required) and the soon-to-be available Adol/Adult Tris (gray cap, age 12+, no diluent). The expiration date for Pfizer orange and gray cap vaccine has now been extended to 9 months (while held at ULT, or ultra-low temperatures). This approval takes effect immediately. This extension applies to frozen, ultra-low temperature (ULT) inventories only.

Details about this extension may be found in the updated facts sheets, accessible here: Healthcare Providers for 5-11 years of age, orange cap (must dilute); Healthcare Providers for 12 years of age and older, gray cap (no dilution). The Fact Sheets for both orange and gray cap vials provided by the FDA now reads, “regardless of storage conditions, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.”

As you are aware, the date printed on the Pfizer Pediatric (orange cap) and Adult/Adolescent (gray cap, 12+, no diluent) vaccine vials indicate the manufacture date and NOT the expiration date. The updated expiry dates for both the orange and gray cap vials based on 9 months from the date of manufacture are provided below.

The QR code provided on the Pfizer Pediatric Vaccine carton provides a link to the EUA but does not provide information on expiration dates.

Please follow EUA recommendations for storage:

Pfizer Pediatric vaccine (orange cap, 5-11 years old, diluent required):
• If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
• Pfizer-BioNTech COVID-19 vaccine multiple dose vials with orange caps and labels with orange borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to dilution.
• After dilution, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution.

Adol/Adult Tris (gray cap, age 12+, no diluent) formulation:
• Frozen vials may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.
• Vials may be transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.

Regardless of storage condition, vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.

All Pfizer updated Fact Sheets may be found using the following links:

Pfizer-BioNTech Fact Sheets (English) and FAQs

Provider Fact Sheet: 5-11 years of age, orange cap (must dilute)

Provider Fact Sheet: 12 years of age and older, gray cap (no dilution)

Notice: Upcoming User Re-Enrollment

Notice: Upcoming User Re-Enrollment

Dear PhilaVax Users,

PDPH is currently preparing for annual user re-enrollment. In preparation for this enrollment, no new user accounts will be issued until January 3, 2022.

Users must complete the confidentiality agreement for the 2022 calendar year.

You can find the form at the button below when re-enrollment begins on January 3.

Pfizer 1170 (Purple Cap) Retirement and Transition Plan

Pfizer 1170 (Purple Cap) Retirement and Transition Plan

Pfizer vaccine 1170 (with the purple cap) is being retired and a new formulation of Pfizer vaccine for adults/adolescents will be available soon. The new formulation, Pfizer Tris Sucrose Adult formulation, has a gray cap and does not require diluent for mixing at administration sites.

View the Emergency Use Authorization.

Pfizer Tris Sucrose Adult Formulation

  • The vial packaging has a gray cap.
  • The vaccine does not contain preservative and is provided as a multiple dose vial.
  • Each vial must be thawed prior to administration.
  • DO NOT DILUTE prior to use.
  • DO NOT STORE in a standard freezer.
  • One vial contains 6 doses of 0.3 mL.
  • This formulation may be stored at 2-8C (36-46 F) for up to 10-weeks, and can be used on individuals 12 years of age and older.

Attend a Healthcare Provider Training

Dose Preparation and Use

  • Gray cap vaccine may be stored at room temperature (8C to 25C/46F to 77F) for a total of 12 hours prior to the first puncture.
  • After first puncture, the vial should be held between 2C and 25C/35F to 77F.
  • Vials should be discarded 12 hours after first puncture.
  • During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
  • Do not freeze thawed vials.

Storage and Expiration

The date of manufacture is printed on the vial, not the expiration date. Undiluted vials can be stored up to 9 months in an Ultra Low Temperature (ULT) Freezer -90°C to -60°C (-130°F to -76°F). Vaccines should not be used after 9 months from the date of manufacture printed on the vial and cartons.

Pfizer Tris (gray cap) will be available to order soon, but please use existing PBS formulations (purple cap packs) to the greatest extent possible prior to ordering Pfizer Tris (gray cap). Providers should ideally only carry one Pfizer adult formulation at a time. time.

If you have any questions, contact vaccines@phila.gov.

Updated CDC COVID-19 Vaccine Recommendation

Updated CDC COVID-19 Vaccine Recommendation

CDC Director Dr. Rochelle Walensky updated COVID-19 vaccine guidance to preferentially recommend that people receive either of the two-dose Pfizer or Moderna COVID-19 vaccines, instead of the single-dose Johnson & Johnson vaccine to protect against COVID. The update came in response to the risk of a potentially fatal blood clot side effect. When this side effect was first discovered identified in middle-aged women in April 2021, the federal government ordered a “pause” on administering the vaccine. After reviewing the data, the federal government found that the benefits of the vaccine outweighed the risk and “unpaused” administration of the vaccine.

The CDC’s Advisory Committee on Immunization Practices reviewed data collected since then and found the number of cases of the side effect was higher than expected though still extremely rare, affecting 54 people out of 14,000,000 doses administered through August, and was found in men as well as women. It was found that nine people in the United States died from the blood clotting side effect. None of those deaths were in Philadelphia. The new data prompted today’s update.

The Health Department released the following statement in response to the update:

“Today’s news about the Johnson & Johnson COVID-19 vaccine fortunately only applies to that vaccine, which is not related to the Moderna or Pfizer vaccines,” said Health Commissioner Dr. Cheryl Bettigole. “It’s important to remember that no one who experienced the blood clotting side effect did so more than four weeks after they got their Johnson & Johnson vaccine, so if it’s been longer than that, you should be okay. If you recently received a first dose of Johnson & Johnson vaccine within the last four weeks, seek immediate medical care if you experience certain symptoms.”

“The Johnson & Johnson vaccine works differently than either the Pfizer or Moderna vaccine, and this blood clotting side effect has not been seen in people who got those vaccines. I still strongly recommend that everyone who is eligible get every dose of COVID vaccine that they are eligible to receive as soon as possible. People who are younger than 60 should seek out either Pfizer or Moderna vaccine, rather than J&J.”

“Even with this new development, COVID vaccines are our best defense against severe COVID disease. They can reduce your risk of contracting and spreading COVID, and are much more likely to keep you from experiencing severe symptoms.”

The symptoms Dr. Bettigole recommended new recipients of the Johnson & Johnson vaccine look out for include:

  • Severe headache
  • Backache
  • New neurologic symptoms
  • Severe abdominal pain
  • Shortness of breath
  • Leg swelling
  • Tiny red spots on the skin (petechiae)
  • New or easy bruising

If you have any additional questions, contact vaccines@phila.gov.

Upcoming COVID-19 Vaccine Ordering Changes

Upcoming COVID-19 Vaccine Ordering Changes

Due to the holiday, COVID-19 vaccine orders are due on Mondays at 5pm for the next two weeks (the week of the 20th and the 27th). Please submit your upcoming orders by Monday at 5pm instead of Wednesday in order for them to be processed.

For assistance with submitting your order, email:

Provider Education Coordinator
DPHProviderhelp@phila.gov

Vaccine Order Specialist
Christine Wilson
Christine.Wilson@phila.gov

Vaccine Order Specialist
Charma Miller
Charma.Miller@phila.gov

Pediatric COVID-19 Vaccine Expiration Dates

Pediatric COVID-19 Vaccine Expiration Dates

Please check your pediatric (orange cap) COVID-19 vaccine’s expiration date to avoid administering expired vaccines.

How to determine vaccine expiration:

  • The pediatric COVID-19 vaccine (orange cap) does not have an expiration date printed on the vial. Vaccines expire 6 months after the manufacture date which is printed on the vial.
  • Vaccines placed in the refrigerator for storage expire 10 weeks after they are placed in the unit or on the expiration date, whichever comes first.
  • Always check that your 10-week Beyond Use Date (BUD) is before the expiration date.

Use this diagram to check the expiration date:

  • Please note, many sites have vaccines that will expire at the end of January.
  • Based on the diagram above, vaccines manufactured in August 2021 expire at the end of the day on January 31, 2022.

Work with your team to plan how these doses will be used prior to expiration.

What to do when vaccines are expired:

  • Vials that are not used by their expiration date must be discarded and reported as wastage using this form.

If you have any questions, please email vaccines@phila.gov. Thank you for keeping Philadelphia safe and healthy.

Holiday Vaccine Ordering Changes

Holiday Vaccine Ordering Changes

If you need vaccine for clinics scheduled on the holiday weekend:

  • Submit orders early, preferably the week of December 13, in anticipation of the limited holiday work hours.
  • The last day to order partial deliveries of vaccine is December 15. There will be no partial vaccine deliveries on the week of December 27.
  • Note the holiday delivery schedules below. Vaccine deliveries will not occur between December 24 and December 27. Vaccine deliveries will also not occur between December 31 and January 3.

Christmas Holiday Delivery Schedule

New Year’s Holiday Delivery Schedule

For assistance with submitting your order, email:

Provider Education Coordinator
DPHProviderhelp@phila.gov

Vaccine Order Specialist
Christine Wilson
Christine.Wilson@phila.gov

Vaccine Order Specialist
Charma Miller
Charma.Miller@phila.gov

COVID-19 Booster Recommendations Extended to 16- and 17-year-olds

COVID-19 Booster Recommendations Extended to 16- and 17-year-olds

The following is attributable to CDC Director, Dr. Rochelle Walensky:

“Today, CDC is strengthening its booster recommendations and encouraging everyone 16 and older to receive a booster shot. Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants. We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”

At this time, only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for adolescents aged 16 and 17. More information will be available on CDC’s website soon.

Emergency Use Authorization

A new emergency use authorization (EUA) was released on 12/9/21 for the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY. Pfizer vaccine supplied in a multiple dose vial with a purple cap is authorized for use to provide:

  • a 2-dose primary series to individuals 12 years of age and older;
  • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise;
  • a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY; and
  • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.

Emergency Use Authorization Guidance

Emergency Use Authorization Guidance

When vaccinating your patients for COVID-19, it is mandatory to provide the individual with a copy of the FDA’s emergency use authorization (EUA) with each and every dose administered. Please ensure you are regularly checking for updated versions.

View the FDA’s EUA guidance pages:

If you have additional questions, please email COVIDvax@phila.gov.

Handling Open Vials of COVID-19 Vaccine

Handling Open Vials of COVID-19 Vaccine

It’s important that vaccine is stored properly before it is administered to protect its viability and ensure that your patients get the protection that they need. COVID-19 vaccine products do not contain any preservative and expire hours after the vial is first punctured.

Use the table to make sure that the COVID vaccine at your site is stored at the right temperature for the right amount of time after it has been punctured. If storing at room temperature, ensure that the temperature is in range, between 9°C and 25°C (47°F and 77°F). Doses not used within this time must be discarded, whether they are still in the vial or have been pre-drawn in a syringe. More information on when it is appropriate to pre-draw doses and how to keep track of pre-drawn doses is included below.

Pre-drawing Doses

It is best practice when administering COVID-19 vaccine to draw up the dose immediately before giving the vaccine.However, in some circumstances, such as mass vaccination events when multi-dose vials are used, it may be more practical to prefill syringes. Pre-drawn COVID-19 vaccine syringes prepared for administration must be labeled with the following legible identifying information to prevent errors:
  • Name and amount of vaccine
  • The expiration date, Beyond Use Date (BUD) and BUD time
  • The time the vaccine must be discard (see the table above)
  • Lot number
  • Initials of preparer

Syringes should be kept out of direct sunlight.

Have questions about storing your COVID vaccine?
Email TempCheck@phila.gov.
View the wastage guide.