COVID-19 Vaccine Providers Newsletter 11.17.2021

  • Additional Guidance for School Districts on COVID-19 Vaccination Clinics for Children Aged 5–11 Years - As K–12 schools continue to play an essential role in COVID-19 prevention by ensuring their students have access to the vaccine, CDC has developed School-Located Vaccination Clinics: Best Practices for School Districts. This guide provides a roadmap for school district administrators to work directly with local health departments and other vaccine providers (e.g., pharmacies) to set up vaccination clinics in places that K–12 students and their parents know and trust.
  • Formulation and dosage error among children aged 511 years -  CDC has updated information on vaccine administration and errors in their Interim Clinical Considerations for Use of COVID-19 Vaccines  to address when a provider administers a 0.1 ml dose of the ≥12 years Pfizer-BioNTech formulation vaccine to a child 5–11 years of age. This dosage amount is not guaranteed to provide an adequate amount of vaccine to the child due to the low volume. The CDC recommends the following if this error occurs:
    • If 0.1 ml administered of the ≥12 years formulation (purple cap) /COMIRNATY, in general, do not repeat dose. However, based on clinical judgement (e.g., child received 2 doses of incorrect formulation), a repeat dose of Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) may be administered at an interval of 21 days after the dose given in error.
    • If >0.1 ml administered of ≥12 years formulation (purple cap) /COMIRNATY, resulting in a higher-than-authorized dose, do not repeat the dose.
    • If the dose given in error is the first dose, administer the second Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) dose 21 days later.
    • As a reminder, all vaccine administration errors should be reported to the Vaccine Adverse Event Reporting System (VAERS).
    • The revised guidance, with a CDC issued EUI, addresses people who received certain non-FDA approved or authorized vaccines outside of the United States or as part of a clinical trial.
    • In brief, people vaccinated outside the United States who received a vaccine authorized or recommended by FDA or emergency use listed (EUL) by WHO are considered fully vaccinated if they completed the primary series or a heterologous (mix and match) series with a combination of FDA-authorized, FDA-approved, or WHO-EUL vaccines. The updated recommendations are for an additional dose as part of the primary series (if the person is moderately or severely immunocompromised and aged 12 years or older) and a booster dose (if the person is aged 18 years or older and with either a high-risk condition or high-risk exposure) for people who received an WHO-EUL vaccine not approved or authorized by FDAas part of the primary series. However, they should specifically receive the FDA-approved Pfizer-BioNTech COVID-19 vaccine (30 µg formulation [purple cap]) as their additional or booster dose.
    • People vaccinated in clinical trials within or outside the United States who received an WHO-EUL vaccine or a vaccine for which a U.S. data and safety monitoring board or equivalent has independently confirmed efficacy are considered fully vaccinated. This includes the Novavax COVID-19 vaccine and the Moderna COVID-19 vaccine in children 6-17 year olds. These individuals are eligible for an additional dose and a booster dose if they meet other eligibility criteria. If they do not plan to receive the additional dose or booster dose through the clinical trial, they should be given the FDA-approved Pfizer-BioNTech COVID-19 vaccine (30 µg formulation [purple cap] as their additional or booster dose. Clinical trial participants who have questions about whether they should receive an additional dose or booster dose outside of a clinical trial are advised to speak with a healthcare provider.
  • U.S. Surgeon General Releases New Community Toolkit for Addressing Health MisinformationAs a new phase of the COVID-19 vaccination campaign begins for children ages 5 to 11 years old, U.S. Surgeon General Dr. Vivek Murthy released the Community Toolkit for Addressing Health Misinformation - PDF to help Americans navigate the serious threat of health misinformation, especially online. Earlier this year, Dr. Murthy issued the first Surgeon General’s Advisory of this administration warning people about the urgent threat of health misinformation and calling for a whole-of-society approach to address it. Resources in the Community Toolkit include:
    • A Health Misinformation Checklist to help evaluate the accuracy of health-related content;
    • Tips on how individuals can talk to loved ones about health misinformation;
    • An outline of common types of misinformation and disinformation tactics; and
    • Reflections and examples of times individuals may have encountered misinformation.
  • World Health Organization (WHO): On November 3, 2021, the Technical Advisory Group for Emergency Use Listing listed the Bharat Biotech BBV152 COVAXIN vaccine for emergency use in those 18 years and older to prevent COVID-19. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim policy recommendations for the use of the Bharat Biotech BBV152 COVAXIN vaccine. This article provides a summary of those interim recommendations. The background document is also available here.
  • The Vaccine (updates) Newsletter will not be sent next week because of Thanksgiving.
  • Pfizer 6 hour Label Correction
    • Labels on the Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) vials were printed in the months prior to amendment of the emergency use authorization (EUA) by the FDA. In anticipation of approval, the labels were printed, “Discard 6 hours after dilution.”  However, the FDA approved the vaccine for discarding 12 hours after dilution. This updated information is printed in the Health Care Provider Fact Sheet as follows:
    • “After dilution, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in this Fact Sheet supersedes the number of hours printed on vial labels and cartons.”
    • We anticipate the label will eventually be updated, but please be aware that ALL Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) should be discarded 12 hours after dilution. Please make sure providers and staff are aware of this change to the Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) label.
  • Pfizer-BioNTech COVID-19 Vaccine 5–11 years formulation (orange cap) Vaccine Ordering - The CDC has informed us that, due to the Thanksgiving holiday, a weekly allocation of the Pfizer 5–11 year formulation vaccine will not be issued for doses that would have been ordered to arrive the week of 11/29. Because of this, the next doses that providers can expect to receive will be during the request window that opens on 11/25 that will arrive during the week of 12/6.
  • Small Shipment Redistribution Program (SSRP)- Due to the holiday next week, the SRRP has a limited window to send all deliveries and will only process a limited number of requests. Because of this, we are asking that providers only place an SSRP request if it is absolutely necessary to meet the demand for your facility next week. Additionally, to meet the timeline and to ensure that all shipments that are processed arrive by Tuesday, 11/23, the request window for the SSRP shipments next week will close this Friday at 4pm. After that the provider request portal will not allow you to submit a request until Thursday 11/25 for shipment to occur the week of 11/30.
  • Monoclonal Antibody (mAB) Ordering- We have also been informed by AmerisourceBergen that mABs will not be shipped during the week of Thanksgiving. During this time we may still place orders, and they will be processed, but they will not be set to arrive until the following week.
  • For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Best Practice Spotlight

Upcoming Events

    • Pfizer Vaccines U.S. Medical Affairs continues to host daily Medical Updates & Immunization Site Training for All Providers with a Focus on Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine for Children 5 through 11 Years of Age. In addition to Medical Updates, sessions will focus on the Storage, Handling, & Administration for currently available vaccine presentations. These sessions will be updated to reflect new information and changes that evolve. Such updates will be identified at the start of each session and further explained during each presentation.
      •  November 17 at 12:00 pm
      • November 18 at 12:00 pm
      • November 19 at 12:00 pm
      • November 22 at 5:00 pm
      • November 23 at 5:00 pm
      • November 24 at 12:00 pm
  • CDC COCA Call: What Clinicians, Pharmacists, and Public Health Partners Need to Know about Antibiotic Prescribing and COVID-19 - CDC Clinician Outreach and Community Activity (COCA) will host a webinar Thursday, November 18 at 2:00 pm EST to discuss the impact of the COVID-19 pandemic on antibiotic prescribing and strategies for optimizing antibiotic prescribing. You can join the webinar here. Additional call information is available here
  • Conversation on the Moderna COVID-19 Vaccine Booster Dose | Important Information for Healthcare Providers - Join Moderna and Jerome Adams, MD, MPH, Lauren B Angelo, PharmD, MBA, Jaime E. Fergie, MD, and James Mansie, PhD, for a roundtable, ThursdayNovember 183:00 – 4:00 p.m. ET, to discuss the EUA for the Moderna COVID-19 Vaccine Booster Dose, the data that informed this authorization and recommendation, and the impact on clinical practice. Moderated by James A. Mansi, Ph.D., Moderna’s VP Medical Affairs – Americas. Please register at this link to attend.
  • Webinar: Protecting Health Worker Mental Health: A Call to Action - CDC’s National Institute for Occupational Safety and Health (NIOSH) will host a special virtual event on Thursday, November 18 at 2:30 pm EST with NIOSH Director Dr. John Howard, Surgeon General Dr. Vivek Murthy, and other national experts from labor and medicine on the mental health of the nation’s critical health workforce. Registration is available here; a recording of the webinar will be available on the NIOSH website at a later date.
  • CDC's Advisory Committee on Immunization Practices Meeting - Scheduled from November 19 from 12 to 3 pm. The agenda for the meeting is not available yet. FDA's Vaccine and Related Biological Products Advisory Committee is not anticipated to meet ahead of the ACIP meeting.
  • Monoclonal Antibody Update Evidence and Clinical Use
    • Tuesday December 7 @ 12:00 pm EST
    • To join: Webinar link
    • Meeting number (access code): 2631 111 4513
    • Password: fqVGvZMM255
    • Phone: +1-408-418-9388

Helpful Resources

Information about the COVID-19 vaccination program is changing frequently. This newsletter will offer regular updates to providers who have submitted an intent to vaccinate or signed the CDC provider agreement within Virginia.

VDH COVID-19 Vaccination Response: Healthcare Professionals Website