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COVID-19 Vaccine

CDC Clinician Outreach and Communication Activity (COCA) Call on 9/9/2021

CDC Clinician Outreach and Communication Activity (COCA) Call on 9/9/2021

The Centers for Disease Control and Prevention (CDC) has announced a Clinician Outreach and Communication Activity (COCA) Call.

When: September 9th at 2pm EDT.

Topic: 2021-2022 Influenza Vaccination Recommendations and Guidance on Coadministration with COVID-19 Vaccines

Meeting link: https://www.zoomgov.com/j/1610456908?pwd=cFI3YzIvMWZzOFE4bmEwakswaUZsdz09#success

Webinar ID: 161 045 6908

Passcode: 220280

Click here to join the CDC Coca Call!

During this COCA Call, presenters will provide updates on the Advisory Committee on Immunization Practices (ACIP) recommendations for the 2021-2022 influenza vaccination season and guidance for coadministration of influenza and COVID-19 vaccines.

There will be a web on-demand version of the call available after the live event.

Please click here to access additional COCA calls and other training from CDC, the World Health Organization, and other training providers.

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

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!

Moderna 10-Dose Vials Discontinued

Moderna 10-Dose Vials Discontinued

COVID-19 Vaccine Providers,

Effective Wednesday, July 28 at 4pm ET you will no longer be able to order vials of Moderna 10-dose. All supplies in the warehouses have been depleted and no additional Moderna 10 vials will be manufactured.

PhilaVax ordering for Moderna 10 will be turned off and only Moderna 14-dose vials will be available moving forward.

Any orders placed and approved this week by Wednesday at 5pm will be for the Moderna 14-dose vials. Orders were converted from the 10-dose packaging to the 14-dose packaging as a result of the discontinuation. Ancillary kits should also reflect the 14-dose vials.

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

J&J/Janssen COVID-19 Vaccine Expiration Extension

J&J/Janssen COVID-19 Vaccine Expiration Extension

Dear COVID-19 Providers,

On July 29th, the Food & Drug Administration authorized an extension of the shelf life for Johnson & Johnson’s Janssen COVID-19 vaccine from 4.5 months to 6 months (an additional 45 days).

Click here to read the extension authorization!

The decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 6 months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

Providers should visit https://vaxcheck.jnj/ to confirm the latest expiration dates of vaccine, including those currently available for administration throughout the U.S. This extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer’s storage conditions.

COVID-19 vaccines that are authorized under an EUA do not have fixed expiration dates, and their expiration dates can be extended as we get more stability data. Always be sure to check the manufacturer’s website to obtain the most up-to-date expiration dates for COVID-19 vaccines you have on hand.

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

Reminder: Check the Expiration Date on Your COVID-19 Vaccine!

Reminder: Check the Expiration Date on Your COVID-19 Vaccine!

COVID-19 Vaccine Providers, please make sure you are checking the expiration dates of your COVID-19 Vaccine and using vials with sooner expiration dates first.

If you are approaching vaccine Beyond Use Dates or Expiration Dates, please try to utilize these doses at your site. You can also reach out to us if you are interested in returning vaccine prior to its expiration. We may be able to arrange pickup depending on the amount and expiration date.

We can work together to ensure that wastage is avoided when possible and that we are efficiently utilizing vaccine supply at provider sites.

Here’s how to find the expiration date of the different COVID-19 Vaccine Brands:

Pfizer: Vials stored in an utlracold storage unit can be used until the last day of the month printed on the tray and each vial.

  • Sites are able to order a partial trays/smaller allocations of Pfizer using this form.
  • Orders are due by Wednesday at 5pm along with a reconciliation and a temperature log.
  • Pfizer deliveries from PDPH will arrive frozen on Tuesday or Wednesday.
    • The frozen vaccine can be placed in a standard freezer for two weeks and will have a two week BUD sticker on it. At the end of two weeks, the vaccines can be moved to the fridge for an additional 31 days. You will need to write a new BUD sticker (with the 31 day BUD) once the vaccine is moved to the fridge.

Moderna: The expiration date for doses stored in the freezer can be acquired on the Moderna website by entering the lot number that is printed on the box:

Janssen: The expiration date can be determined three ways:

  • Scan the QR code on the outer carton
  • Call 1-800-565-4008
  • Visit vaxcheck.jnj

We may also be able to transfer unopened vials of Pfizer and Moderna that have been moved to refrigerated temperatures and are nearing their beyond use date (BUD).

To inquire about transferring expiring doses, please email vaccines@phila.gov with “transfer” in the subject.

J&J (Janssen) COVID-19 Vaccine Stability Update

J&J (Janssen) COVID-19 Vaccine Stability Update

J&J/Janssen has determined that at proper refrigerated storage conditions, the vaccine appears to be very stable across all the lots tested. The company is cautiously optimistic that 6 months total refrigerated storage will be authorized.

The company is hoping to have an extension of the expiration for refrigerated storage of the vaccine to 6 months by early August. PDPH will communicate any updates regarding J&J expiration dates once additional guidance is available.

We ask that you do the following:

  • Continue to use the inventory you have to prevent loss of vaccine
  • Quarantine expired doses as new stability data may become available in the near future
  • Reach out to the health department for J&J ordering in order to optimize vaccine use. Sites are still unable to place orders for J&J directly into PhilaVax at this time.

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

COVID-19 Vaccine Ordering Deadline

COVID-19 Vaccine Ordering Deadline 

The Philadelphia Department of Public Health (PDPH) Immunization Program would like to remind COVID-19 providers that the deadline to order COVID-19 vaccine is Wednesday at 5pm for orders placed both through Philavax and Monday.com. Orders placed after the deadline will not be processed.

Vaccine orders are delivered on the following Tuesday or Wednesday; please plan accordingly for upcoming clinics.

Quick Steps to Order:

Going forward, the Immunization Program will not process any orders that do not have a closed reconciliation and submitted temperatures by Wednesday at 5PM.

If you have questions, please reach out to vaccines@phila.gov.

Did Your Patient Receive a COVID-19 Vaccination Outside the United States?

Did Your Patient Receive a COVID-19 Vaccination Outside the United States?

Have questions? The “People vaccinated outside the United States” section of the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines provides guidance on different scenarios.

Talk to your patient and gather the initial information:

  1. Which COVID-19 vaccine did the patient receive?
  2. Is the COVID-19 vaccine authorized by the United States Food and Drug Administration (FDA) or listed for emergency use by the World Health Organization (WHO)?
  3. Did your patient complete a full series of this COVID-19 vaccine (e.g. receive both doses if two doses are recommended)?

Guidelines as of 7/15/21:

US FDA-authorized COVID-19 vaccines:

  • Pfizer-BioNTech (Comirnaty, Tozinameran; mRNA nucleoside modified) – 2 doses
  • Moderna (Spikevax; mRNA nucleoside modified) – 2 doses
  • Johnson & Johnson / Janssen (Ad26.COV2-S recombinant) – 1 dose

COVID-19 vaccines listed for emergency use by the WHO:

  • US FDA-authorized vaccines above
  • AstraZeneca-Oxford (Covishield, Vaxzevria; ChAdOx1-S recombinant) – 2 doses
  • Sinopharm (Vero Cell inactivated) – 2 doses
  • Sinovac (Vero Cell inactivated) – 2 doses

See the table below for a summary of recommendations for patients who received a COVID-19 vaccination outside of the US:

Resources:

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