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COVID-19 Vaccine

Use the Most Recent COVID-19 Vaccine EUA

Use the Most Recent COVID-19 Vaccine EUA

Dear COVID-19 Vaccine Providers,

Please make sure your site is using the most up to date Emergency Use Authorization (EUA) for COVID-19 vaccine. Check the FDA website weekly for updates for each COVID-19 vaccine brand. The bullets below list the most recent information on the EUAs for each COVID-19 vaccine brand.

Pfizer-BioNTech (Comirnaty) | FDA page (last update 9/22)

  • August 23, 2021 – The FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
  • Continues to be available under EUA, including for individuals 12 years of age and older, for the administration of a third dose in certain immunocompromised people, and for a single booster dose in people:
    • 65 and older
    • 18 through 64 at high risk of severe COVID-19; and
    • 18 through 64 whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Moderna | FDA page (last update 9/27)

  • December 18, 2020 – The U.S. Food and Drug Administration issued an EUA for Moderna.
  • June 25, 2021 – Tue FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.
  • August 12, 2021 – The FDA amended the Moderna COVID-19 Vaccine EUA to allow for an additional dose to be given to certain immunocompromised individuals.
  • The EUA allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Janssen COVID-19 Vaccine | FDA page (last update 8/27)

  • February 27, 2021 – The U.S. Food and Drug Administration issued an EUA for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • April 23, 2021 – The FDA amended the EUA to include information about a very rare and serious type of blood clot in people who receive the vaccine.
  • The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

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

COVID-19 Reporting Requirements

COVID-19 Vaccine Reporting Requirements

As COVID-19 Vaccine providers move towards offering boosters and additional doses, we want to ensure that all vaccination data is being captured and reported to the Philadelphia Department of Public Health (PDPH).
Providers must meet the two daily reporting requirements: reporting administered doses to PhilaVax IIS and reporting their dose inventory to VaccineFinder.

1. Providers are required to report doses administered within 24 hours of dose administration to the IIS.

  • If you are a flat file reporter, your excel spreadsheet should be uploaded to via your SFTP account daily.
  • HL7 reporters should ensure that vaccination data is being captured within your Electronic Health Record (EHR) system.
  • Please do not violate HIPAA regulations by sending patient and/or administration data via email to PDPH and/or the Philavax@phila.gov inbox.
  • Providers that are not actively reporting doses administered to the IIS will not be able to place future orders for COVID-19 vaccines.
  • If you are have having trouble uploading your data via your SFTP account or require additional assistance, please email vaccines@phila.gov.
2. Providers are expected to report doses on-hand in their inventory every 24 hours to VaccineFinder.
  • Providers should be reporting to Vaccine Finder daily including weekends and holidays.
  • Provider should report to Vaccine Finder even if they have zero inventory.
  • Providers that are not actively reporting doses on-hand to Vaccine Finder will not be able to place future orders for COVID-19 vaccines.
  • If you are having trouble with your Vaccine Finder account, please email covidproviders@phila.gov.
Thank you for keeping Philadelphia safe and healthy. If you have any additional questions, please email vaccines@phila.gov.

Pfizer Vaccine Boosters Now Approved!

Pfizer Vaccine Boosters Now Approved!

The CDC is now recommending that certain people who have been vaccinated by the Pfizer COVID-19 vaccine receive a booster dose. The Philadelphia Department of Public Health (PDPH) asks all COVID-19 Vaccine Providers to immediately begin administering booster doses to all eligible people.

Eligibility

The CDC recommends COVID-19 vaccine boosters should be provided at least 6 months after completing the Pfizer COVID-19 vaccine primary series (first 2 doses of Pfizer-BioNTech) to people aged:

  • 65+
  • 18+ AND residing in long-term care settings
  • 50-64 AND with underlying medical conditions

A COVID-19 vaccine booster may also be provided at least 6 months after completing the Pfizer COVID-19 vaccine primary series (first 2 doses of Pfizer-BioNTech) to people aged:

  • 18-49 years with underlying medical conditions that put them at increased risk
  • People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting

Note: Booster doses are not authorized for anyone under the age of 18, regardless of medical condition or occupation. Additionally, Moderna and Janssen boosters have not yet been approved. Providers are expected to adhere to their signed CDC provider agreement and the EUAs when administering COVID-19 vaccines and should avoid off-label administration/use.

Ordering Boosters

Booster doses can be ordered the same way all COVID-19 vaccine is ordered – either through PhilaVax or the Monday.com ordering form. There is no need to differentiate it from other orders.

Please use your current Pfizer COVID-19 vaccine inventory for booster doses and first/second doses before ordering additional vaccine.

If you have any questions, please email vaccines@phila.gov.

Partner to Hold Vaccine Clinics!

Partner to Hold Vaccine Clinics!

Dear COVID-19 Vaccine Providers,

With COVID-19 vaccine boosters anticipated in the near future, PDPH expects an uptick in community organizations requesting vaccine at events.

If you have not signed up already and are interested in being partnered with a community organization to provide them COVID-19 vaccine at events, please sign up using the link below.

Thank you to all providers that are currently signed-up to be matched with Philadelphia-based organizations who are seeking COVID-19 vaccine for their community members. If you have already filled out the survey, there is no need to fill it out again.

Fill Out Our Vaccine Provider Capacity Survey!

In the event that PDPH has an organization seeking a vaccine provider, you will be contacted by PDPH to confirm your interest in partnering to hold the clinic before any contact information is shared. Thank you for keeping Philadelphia safe and healthy. If you have any questions, please email vaccines@phila.gov.

Temporary Change to Vaccine Ordering Deadline

Temporary Change to Vaccine Ordering Deadline

Dear COVID-19 Vaccine Providers,

Next week, the deadline to order any COVID-19 vaccine will be Tuesday September 28, 2021 at 5:00PM. This is a one-time change. Please complete your order(s) by this date.

Please remember that a closed reconciliation and temperature log must be submitted with each vaccine order.

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

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.