CDC:

• UPDATED: CDC Recommends Booster Dose for Children Aged 5 to 11 Years and Strengthens Recommendation for Second Booster
  • On May 19, the Advisory Committee on Immunization Practices (ACIP) met to discuss whether to recommend a single booster dose of the Pfizer-BioNTech (Pfizer) COVID-19 vaccine for children aged 5–11 years. The CDC Director endorsed the updated ACIP recommendations.
  • They met because on May 17, 2022 the U.S. Food and Drug Administration (FDA) authorized a single booster dose of the Pfizer vaccine for this age group to be given at least 5 months after completing the primary series.
    • FDA updated the Pfizer Fact Sheets for healthcare providers, vaccine recipients, and caregivers.
    • Vaccine providers in Virginia may immediately begin administering a single Pfizer booster dose for children aged 5–11 years based on the updated CDC recommendation.
    • The Pfizer vaccine with the orange cap is formulated for children aged 5–11 years and should be used for this single booster dose. Other formulations of the Pfizer vaccine with the gray or purple cap for adolescents or adults should not be used.
    • When updated, providers can reference the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States
    • Please continue to encourage parents and guardians to enroll their children in v-safe.
  • In addition, CDC strengthened its recommendation that those 12 years and older who are immunocompromised and those 50 years and older should receive a second booster dose at least 4 months after their first.

• NEW: Updated Pediatric COVID-19 Operational Guide. The updated Pediatric COVID-19 Operational Planning Guide includes details about the anticipated Pfizer-BioNTech vaccine for children aged 6 months through 4 years and the Moderna vaccine for children aged 6 months through 5 years. This guide is intended to inform planning for all current COVID-19 vaccine programs for children in these age groups, should either or both vaccines receive FDA Emergency Use Authorization (EUA) and CDC recommendation. The planning guide includes an overview of the differences in the Pfizer-BioNTech vaccine for adults/adolescents, the vaccine for children ages 5 through 11 years, and the vaccine for children 6 months through 4 years. A document detailing the characteristics of the Moderna vaccine for children aged 6 months through 5 years is being developed. The planning guide will be updated regularly as CDC learns more about the pediatric COVID-19 vaccines. Additional information is available at COVID-19 Vaccination for Children.

 

FDA:

• FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV - The EUA authorizes at-home sample collection with testing performed in a laboratory. FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infection consistent with COVID-19. This product is the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test authorized by FDA and allows an individual to self-collect a nasal swab sample at home and then send that sample to Labcorp for testing.
• MedWatch -  Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA- Woodside Acquisitions is recalling these tests because they were distributed to U.S. customers without authorization, clearance, or approval from the FDA. Woodside Acquisitions did not provide the FDA with adequate validation data to show that the performance of these tests is accurate, and there is a risk of potential false negative, false positive, or misinterpretation of results

Memorial Day Holiday Ordering and Shipping Schedule

• In anticipation of Memorial Day, please acquaint yourself with the ordering and shipping information below. You are encouraged to use the information below to submit orders early in the week before the holiday (Monday, May 23rd or Tuesday, May 24th) if you need vaccine for clinics over the weekend.
  • Deliveries will occur as scheduled on Friday, May 27th. If you wish to hold orders on Friday, please contact McKesson or Pfizer via the emails provided below prior to 9:00 pm ET Tuesday, May 24th.
    • McKesson Specialty (Moderna and Janssen)
      • COVIDVaccineSupport@McKesson.com
    • Pfizer Customer Service
      • cvgovernment@pfizer.com
  • Pfizer-BioNTech Vaccines
    • No vaccine deliveries on Monday, May 30 (Memorial Day).
  • Moderna and J&J/Janssen Distributed Vaccines
    • No vaccine deliveries on Monday, May 30, or Tuesday, May 31 (you may receive ancillary kits on Tuesday for orders arriving on June 1).
• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

The CDC Interim Clinical Considerations for the Use of COVID-19 Vaccines references Vaccine Recommendations and Guidelines of the ACIP, which states for adults, the deltoid muscle is recommended for routine intramuscular (IM) vaccinations. However, the anterolateral thigh can also be used. The CDC Interim Clinical Considerations also directly states that it is acceptable to administer a COVID-19 vaccine intramuscularly into the anterolateral thigh of an adult, if the deltoid muscle is not acceptable or available (Table C of CDC Clinical Considerations). The COVID-19 Vaccine Standing Order is based on guidance from CDC/ACIP, therefore the anterolateral thigh can be an acceptable alternative site for IM administration of the vaccine . Prior to administration, the vaccinator should be trained on giving IM injections into the anterolateral thigh. 

• Needle length and injection site selection is based on age, sex, and weight. Visit the CDC Vaccine website for more guidance.
• Informational Videos:
  • Intramuscular (IM) Injection: Sites
  • Intramuscular (IM) Injection: Supplies for Children
  • Intramuscular (IM) Injection: Supplies for Adults
    • Vastus Lateralis Intramuscular Injection
• Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

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VDH External Web Updates

• (New, 5/12/22) Child Care & Day Camps: Added the Spanish translation for VDH's COVID-19 Interim Guidance for Child Care Facility Collaboration with the Local Health Department that was last updated on March 11, 2022.
• (Updated, 5/11/22) Demographics dashboard: Revisions involved adding rates for age groups, race/ethnicity, and sex, the ability to select more than one district, and the ability to compare between selections.
• (Updated, 5/11/22) Social Gatherings and Events: Revisions involved general language updates and adding external link icons to non-VDH links.