FDA

• FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Boosters
  • On August 31, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 Vaccines to authorize bivalent formulations of the vaccines for use as a single-booster dose at least two months following primary or booster vaccination.
  • On September 1,2022, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) reviewed information about Pfizer’s and Moderna’s COVID-19 updated bivalent vaccines. They recommended that both be placed into general public use.
  • The Pfizer and Moderna bivalent COVID-19 vaccines contain components from the original SARS-CoV-2 virus and spike protein components from the Omicron BA.4 and BA.5 subvariants. These new booster vaccines are referred to as “updated boosters.”
  • Following ACIP’s meeting,  the CDC endorsed ACIP’s recommendations for the use of updated COVID-19 bivalent boosters. Pfizer-BioNTech’s bivalent booster is authorized for people aged 12 years and older and Moderna’s updated booster for people aged 18 years and older.
  • Per the updated EUAs, Pfizer’s and Moderna’s monovalent mRNA COVID-19 vaccines are no longer authorized for use as boosters in people ages 12 years and older.
  • The bivalent booster recommendation replaces previous booster recommendations for people aged 12 years and older. As a result, all existing appointments for monovalent Pfizer-BioNTech or Moderna boosters in people 12 years of age and older should be rescheduled for a date and time when locations have the bivalent booster vaccine available.
  • At this time, there are no changes to COVID-19 vaccination schedules for children ages 6 months through 11 years

• Novavax COVID-19 for Adolescents: Updated Recommendations
  • On August 22, 2022, CDC Director Dr. Walensky signed a decision memo that Novavax’s COVID-19 vaccine be used as another primary series option for adolescents aged 12 through 17 years. This recommendation follows FDA’s emergency use authorization of the Novavax vaccine for this age group.
  • Novavax’s COVID-19 vaccine, which is available now, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adolescents. Having multiple types of vaccines offers more options and flexibility for the public, jurisdictions, and vaccine providers.
  • CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines has been updated with new guidance regarding adolescents and Novavax COVID-19 vaccine.

• Moderna (Spikevax) COVID-19 Vaccine Available for Ordering
  • The Moderna (Spikevax) COVID-19 vaccine received FDA approval in January 2022, for administration to people ages 18 years and older. Similar to Comirnaty, Spikevax is licensed through the Biologics License Applications (BLA) process.
  • The FDA-authorized Moderna COVID-19 vaccine for individuals ages 18 years and older will now be marketed as Spikevax. Ordering for Spikevax began in August 2022.
  • The FDA-approved Spikevax and the EUA Moderna COVID-19 vaccine for people ages 12 years and older have the same formulation and can be used interchangeably

Significant Changes to CDC Guidance or Materials

• (Updated) Interim Clinical Considerations for use of COVID-19 Vaccines. CDC has updated its vaccination recommendations to include:
  • New booster recommendation for people aged 12 years and older to receive 1 bivalent mRNA booster after completion of a monovalent primary series; it replaces all prior booster recommendations for this age group.
    • Recommendations for use of a bivalent Moderna booster dose in people ages 18 years and older
    • Recommendations for use of a bivalent Pfizer-BioNTech booster dose in people aged 12 years and older
  • Updated guidance for observation periods following COVID-19 vaccination
  • Updated guidance on COVID-19 vaccination and Multi-system Inflammatory Syndrome in children (MIS-C) and adults (MIS-A)

VDH

• Revised COVID-19 Vaccine Standing Order which was updated on September 2, 2022
• VDH COVID-19 websites have now been updated to reflect current CDC guidance. VDH policy leaves masking as a personal choice in most circumstances; exceptions are high-risk settings, including healthcare delivery, and as part of an isolation protocol, where masking is still recommended.
• VDH Interim Guidance for COVID-19 Prevention for Students, Teachers, and Staff in Child Care, K-12 Schools, and Day Camp Settings

• Notable revisions to the updated Virginia guidance include:
  • Updated testing guidance for persons who test positive for COVID-19 and are unable or choose not to wear a mask through day 10. Recommendations to either isolate for 10 full days (including children under age 2) or use the CDC's test-based strategy that includes two negative tests 48 hours apart.
  • Updated testing guidance for persons who have had recent or suspected exposure to an infected person. Guidance for exposed persons is no longer based on vaccination status. Persons who have had recent exposure may consider testing for COVID-19 ≥5 days after exposure (or sooner, if they are symptomatic), regardless of their vaccination status. “Test to Stay” is no longer routinely recommended. Schools that choose to implement Test to Stay programs can contact VDH for more information on available testing resources and/or guidance.

• 2022-2023 Communicable Disease Reference Chart for School and Child Care Facility Personnel 
  • Major changes include the following: Now applies to both K-12 schools and child care and includes COVID-19 and Monkeypox

• Bivalent COVID-19 vaccine ordering is expected to be available in VaxMax as soon as 9/8/2022. At that time, providers will be able to request bivalent booster doses through the normal COVID-19 order process.
• Expiry Lookup Tools
  • Pfizer: https://lotexpiry.cvdvaccine.com
  • Moderna: https://eua.modernatx.com/covid19vaccine-eua/providers/vial-lookup
  • Novavax: https://us.novavaxcovidvaccine.com/hcp
  • Johnson and Johnson/Janssen: https://vaxcheck.jnj/

• For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

• Monkeypox Webinars- These webinars will cover an overview of the current monkeypox situation, epidemiology of the virus, risk assessment/communication, infection prevention and control, testing, collaboration with public health officials, and medical countermeasure strategies, including an in depth overview of the JYNNOES vaccine and TPOXX therapeutic. There will also be an allotted time for questions.
  • Note: both sessions will present the same information/content.
  • Session 1: Friday September 9th at 12pm (noon) Registration Link -  https://us06web.zoom.us/webinar/register/WN_BCwWS11RQTSOMdI_9p2IrQ
  • Session 2: Tuesday, September 13th at 7pm Registration Link -  https://us06web.zoom.us/webinar/register/WN_3Zj_8VqpTOGpPIhKSI0paw

Refer to Previously posted resources