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Pfizer Vaccine for Pediatric Providers

Pfizer Vaccine for Pediatric Providers

UPDATE: Please refer to the PDPH Emergency Order Concerning COVID-19 Vaccine Information Statements 5/14 for guidance.

On May 10, the US Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to adolescents ages 12-15 years. Yesterday, May 12, the CDC Director adopted the CDC’s Advisory Commitee on Immunization Practices’ (ACIP) recommendation that endorsed the safety and effectiveness of Pfizer-BioNTech COVID-19 vaccine in this population. Providers may begin vaccinating 12–15-year-old patients today. This advisory contains important information regarding administering Pfizer COVID-19 Vaccine to adolescents and teenagers.

If your site has not already enrolled as a COVID-19 Vaccine Provider, you can enroll now to make sure your adolescent patients can get vaccinated!

Click here to enroll in our COVID-19 Vaccine Program!

Ordering Partial Trays of Pfizer & Adolescent Vaccination Updates

Please use this guide to order a partial tray of Pfizer.

For the week of 5/10, orders must be received by noon on Friday, 5/14. Going forward, orders must be submitted by 5 pm on Wednesday.

Only use this process to order if you’re been directed to during your COVID vaccine enrollment process.

Offering COVID-19 Vaccine

There is no longer a residency requirement for COVID-19 vaccinations. You are free to vaccinate individuals who live outside of Philadelphia city limits going forward.

PDPH does not require COVID-19 Vaccine providers to offer vaccinations to the greater public unless a site is specifically interested in vaccinating more than their patients.

If your site is interested in offering the vaccine at an off-site location, offering the vaccine to the whole family, or have questions about offering the vaccine in your community, email vaccines@phila.gov so that we can connect you with the right Philadelphia Immunization Program team member.

Co-administration

Per the ACIP meeting on 5/12, COVID-19 vaccines may be administered without regard to timing. This includes simultaneous administration of other vaccines on the same day, as well as co-administration within 14 days. We will forward the MMWR documenting this decision once its is published.

Consent

The patient or their parent and guardian must have had the opportunity to have his/her questions answered satisfactorily before the immunization is given. Written consent for immunization is not required. Implicit consent is acknowledged by the presentation for vaccination of an adolescent with their parent or guardian. There is no Vaccine Information Sheet (VIS) for this vaccine. The FACT SHEET FOR RECIPIENTS AND CAREGIVERS about the Emergency Use Authorization (EUA) Pfizer-BioNTECH COVID-19 Vaccine to Prevent Coronavirus must be shared with the intended vaccine recipient or their parent or guardian prior to immunization.

Currently in Philadelphia, individuals 16 -18 years of age may authorize his or her own immunization with the Pfizer vaccine under the EUA, without the approval or consent of another person. At this time, individuals 12 to 15 years of age must have a parent’s implicit consent for vaccination under an EUA.

Click here to download PDPH’s Emergency Order Concerning COVID-19 Vaccine Information Statements. To view the original regulations, please go to Section 4, part b of the Regulations Governing the Immunization and Treatment of Newborns, Children and Adolescents document found here.

Wastage

As COVID-19 vaccine supply becomes more available and appointments become more sporadic, PDPH is asking providers to ensure vaccination for all eligible patients, even if it means leaving some doses unused or wasted.

Right now, it is critical that providers prioritize vaccinating eligible persons who are willing to be vaccinated over wasting vaccine. Providers should vaccinate any eligible persons who wish to receive vaccine at their clinic location, even if it means puncturing a multi-dose vial and potentially wasting doses. PDPH understands that some, or all remaining doses in the vial may need to be wasted to vaccinate a person.

Please download our Vaccine Wastage Guide here. You can find additional information on vaccine wastage guidance by reading this detailed Vaccine Wastage Advisory.

Pfizer Resources

Thank you for keeping Philadelphia safe and healthy.

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

Providers Can Now Vaccinate Non-Philadelphia Residents

Providers Can Now Vaccinate Non-Philadelphia Residents

During this phase of the COVID-19 vaccine rollout, vaccine supply has become more available. There is no longer a residency requirement for COVID-19 vaccinations. This will allow providers to vaccinate people who live outside of Philadelphia city limits going forward.

As vaccine appointments have become more sporadic, we hope that this change helps your site vaccinate as many patients as possible, and lessens vaccine wastage.

Thank you for keeping Philadelphia safe and healthy.

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

Enroll as a COVID-19 Vaccine Provider!

Enroll as a COVID-19 Vaccine Provider!

Providers that are able to report to the PhilaVax IIS and store COVID-19 vaccines are able to pursue enrollment as a COVID-19 vaccine provider with PDPH.

The Philadelphia Department of Public Health (PDPH) encourages all eligible providers to enroll within the COVID-19 vaccine program and assist in the effort to vaccine Philadelphia against COVID-19.

How Do I Enroll?

PDPH has created a comprehensive 8 page Provider Guide to help aid new and prospective COVID-19 Providers with the provider enrollment process.

Click here to download the Provider Guide!

The Comprehensive Provider Guide to the Enrollment Process covers:

  • Who can be a provider?
  • How do you become a provider?
  • How long does it take to enroll and start vaccinating?
  • Enrollment tips
  • Reporting guidelines
  • Storage and Handling requirements
  • Philavax and Ordering inquiries

There is also a FAQ section at the end which covers questions related to enrollment, reporting, ordering/PhilaVax, and storage and handling. If you have specific questions about a topic, the Provider Guide has specific emails listed for who to contact.

Once you have reviewed the guide, you can start filling out our COVID-19 Vaccine Provider Enrollment Form.

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

Thank you for keeping Philadelphia safe and healthy from COVID-19!

Enroll Your Site as a COVID-19 Vaccine Provider!

Enroll Your Site as a COVID-19 Vaccine Provider!

Pfizer/BioNTech asked the Food and Drug Administration (FDA) on April 9th to expand the emergency approval of their COVID-19 vaccine to include its use in adolescents ages 12 to 15.

Enroll to make sure that adolescents can access COVID-19 vaccine when its available to them!  

How Do I Enroll?

To enroll as a COVID provider your site must be able to:

  • Be able to vaccinate at least 50 patients, 12 years of age and up, over a 2-week period
  • Report COVID-19 vaccination electronically within 24-hours of administration
  • Store the vaccine in monitored fridge and freezer storage units that are compliant with CDC Immunization requirements

(If your site is a VFC provider, you already meet the storage and handling and temperature reporting requirements to be a COVID-19 vaccine provider.)

To help you enroll in our COVID-19 Vaccine Provider program, we have created a Provider Agreement Guide which walks you step-by-step through the Enrollment Form. Please review the Provider Agreement Guide in its entirety before filling out the agreement form and survey. Once you have reviewed the guide, you can start filling out our Enrollment Form.

Enroll In Our COVID-19 Vaccine Program!

Have questions about the enrollment process?

Attend one of our Town Halls for VFC Providers interested in enrolling as COVID-19 Providers:

Virtual Town Hall for VFC Providers interested in enrolling as COVID-19 Providers

Dates and times:
Tuesday 5/4 at 12PM
Wednesday 5/5 at 5PM
Tuesday 5/11 at 5PM
Wednesday 5/12 at 12PM

Gotomeeting Link: https://global.gotomeeting.com/join/926918173

Meeting ID: 926 918 173

Dial In: +1 (669) 224-3412

Thank you for your continued work to keep our city safe and healthy!
If you have any questions, please email vaccines@phila.gov.

PDPH Will No Longer Push 2nd Doses Automatically

PDPH Will No Longer Push 2nd Doses Automatically

Attention COVID-19 Providers,

PDPH will no longer push 2nd dose orders automatically to COVID-19 Vaccine providers. Providers are responsible for keeping track of when they need to place 2nd dose orders.

Starting next week, sites will place orders on Wednesday for both 1st and 2nd doses as needed. PDPH will continue to monitor inventory and reporting and may adjust orders as needed.

Thank you for keeping Philadelphia safe and healthy.

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

Moderna Vaccine EUA and National Drug Code (NDC) Amendments

Moderna Vaccine EUA and National Drug Code (NDC) Amendments

Attention COVID-19 Vaccine Providers, as of April 26, 2021, there have been recent amendments to both the Moderna COVID-19 Vaccine Emergency Use Authorization (EUA) and the issuance of a new National Drug Code (NDC). These changes include:

  • Increase in the fill volume of the vaccine vials
  • New labeling for the existing vial and the upcoming larger volume vial
  • Modifications to storage and handling temperatures

PDPH is planning to transition from both NDCs in early May to a single NDC for the larger volume vial by the end of May. Some changes to note are:

Ancillary Kits: The new ancillary kits will support administration of 140 doses of vaccine and will be optimized to extract 14 doses per vial.
Wastage: Partners and jurisdictions may see an increase in reported wastage. We know there is always waste with vaccine administration and that an increase in wastage could cause concern for leaders. We recommend jurisdictions communicate with their stakeholders about these metric changes. Please reference the Wastage Reporting Table for reminders on when to report wastage. Note: An unextracted 15th dose from the larger volume Moderna vial does NOT result in reportable waste.

Please review and download the following resources to learn more about the Moderna EUA amendments:

Thank you for keeping Philadelphia safe and healthy from COVID-19. If you have any questions, please email vaccines@phila.gov.

J&J COVID-19 Vaccine Pause Lifted by FDA

J&J COVID-19 Vaccine Pause Lifted by FDA

Attention COVID-19 Vaccine Providers:

On Friday April 23, the CDC and FDA lifted the pause in the use of Johnson & Johnson’s Janssen COVID-19 vaccine after completing a review of reports of adverse events. Today, the following operational guidance will allow for the return of J&J vaccine to distribution and administration. The J&J/Janssen vaccine may be administered now.

Health care providers administering the vaccine and vaccine recipients or caregivers should review the following documents:

Both documents have been revised to include information about the risk of this syndrome that has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

Please refer to these additional resources for more information:

Thank you for keeping Philadelphia safe and healthy from COVID-19. If you have any questions, please email vaccines@phila.gov.

Make Your Provider Page Public with VaccineFinder!

Make Your Provider Page Public with VaccineFinder!

Dear Immunization Partner,

The Philadelphia Department of Public Health (PDPH) and the CDC are requesting that you make your provider page in VaccineFinder public. VaccineFinder is the portal that you’re using to log your COVID-19 vaccine inventory every 24 hours and can be found here: https://covid.locating.health/

Making your provider page public will allow fellow Philadelphians to search for vaccine clinics near them and therefore make it easier for them to be vaccinated. Your public-facing page will not display inventory information (i.e., number of doses on hand). PDPH has created a training video, linked below, to help you complete this process if you need:

Click here to watch the VaccineFinder Training Video

Please include any information regarding registrations for vaccinations, including a phone number or scheduling link, if possible, on your display page so that members of the public can more easily schedule appointments. As distribution and eligibility expands, it is important to promote vaccine opportunities that are currently available. If your site has the capacity to accept walk-ins, please also include this information on your VaccineFinder page as we hope to continue improving accessibility to vaccinations across the city.

We understand that making your VaccineFinder page public, posting your registration information, and allowing walk-in appointments may raise concerns. If you or your site are concerned, feel free to reach out to a contact at PDPH or email vaccines@phila.gov and they will connect you with a PDPH staff member to help you address your concerns.

Thank you for all the hard work you are doing to vaccinate Philadelphians!

CDC and FDA Call for Pause of Use for Johnson & Johnson COVID-19 Vaccine

CDC and FDA Call for Pause of Use for Johnson & Johnson COVID-19 Vaccine

Attention all COVID-19 Vaccine Providers: The CDC and FDA have called for a pause of use for the Johnson & Johnson COVID-19 Vaccine. Please read the joint CDC and FDA statement below:

Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine

The following statement is attributed to Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.

 

Thank you for all you do to keep Philadelphia safe and healthy from COVID-19.

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

DDL Switch Out Delay

DDL Switch Out Delay

Dear VFC Provider:

Your DLL(s) may need to be re-calibrated. Under routine guidelines, the Philadelphia Department of Public Health (PDPH) would replace your old DDL(s) with a newly calibrated DDL(s). However, we are currently unable to replace DDLs due to manufacturing difficulties caused by the COVID-19 pandemic.

Recognizing this, the CDC has released updated guidance regarding the use of DDLs. The CDC is allowing the use of DDLs for up to 2 years from the expired calibration date. After consulting with the DDL manufacturers and DDL experts, the CDC is confident that DDLs that have recently reached the 2 years post-expired calibration date would still operate with the accuracy to suffice the CDC required parameters for storage and handling.

This allowance is applicable to PDPH provided DDLs.

PDPH is committed to always preserving the viability of vaccines. As soon as the shortages in the DDL market improve, PDPH will move forward with the usual biannual swap out. We’ll contact you when the newly recalibrated DDLs are mailed out to your site.

Until then, please let us know if your DDL displays a low battery symbol (pictured below) or is experiencing any other issues by emailing us at TempCheck@phila.gov or calling us at 215-685-6424.

 

Thank you for patience and understanding as we grow the Philadelphia vaccine distribution network.

Please feel free to contact us with any questions or concerns.

Sincerely,

The Immunization Storage & Handling Team