COVID-19 Vaccine Providers Newsletter 05.25.2022

CDC:

  • Updated: Use of COVID-19 Vaccines in the United States: Interim Clinical Considerations - Recent changes include:
    • New guidance for use of a Pfizer-BioNTech COVID-19 Vaccine booster dose in children aged 5–11 years
      • CDC now recommends that children ages 5 through 11 years should receive a booster vaccine 5 months after their primary Pfizer-BioNTech vaccination series.
      • Children aged 5 to 11 years who are moderately or severely immunocompromised should receive one booster dose at least 3 months after the third primary dose, for a total of 4 doses.
      • Up-to-date: People aged 5 years and older are up to date with their COVID-19 vaccines when they have received all doses in the primary series and all booster doses recommended for them, when eligible.
    • Updated guidance that the following people should receive a second COVID-19 booster dose:
      • People aged 12 years and older who are moderately or severely immunocompromised
      • People ages 50 years and older
    • Updated guidance for people who are moderately or severely immunocompromised and are treated with B-cell-depleting therapies
    • Clarification of COVID-19 vaccination guidance for multisystem inflammatory syndrome in children (MIS-C) and adults (MIS-A)
    • Updated guidance for primary series vaccination after SARS-CoV-2 infection
      • People who recently had SARS-CoV-2 infection may consider delaying a primary series dose or their first or second COVID-19 vaccine booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic).
  • Updated: Public Health Science Agenda for COVID-19 - CDC recently updated the Public Health Science Agenda for COVID-19. CDC developed 15 priority public health science questions around eight thematic topic areas for the science agenda. They include 1) Health equity 2) Vaccines 3) Variants 4) Prevention strategies 5) Testing 6) Treatment 7) Natural history, transmission, breakthrough infections, and reinfection and 8) Post-COVID conditions and other health impacts.

Two priority questions were added in March 2022 to address research gaps in evaluating equitable access to treatments for COVID-19 and the effectiveness of COVID-19 treatments in improving outcomes from COVID-19, post-COVID conditions, and other conditions unrelated to COVID-19. These questions relate to the broad scope of CDC’s scientific work, both in the United States and globally. They are also related to the ongoing work in the broader scientific community, such as other government agencies, academics, and the private sector.

  • Updated: the Pediatric Operational Planning Guide, which can also be located on the COVID-19 Vaccination for Children webpage.
  • Isolation and Quarantine in Early Care and Education (ECE) Programs - CDC's quick guides to isolation and quarantine of children in early care and education programs. VDH child care guidance also allows for facilities to use Test to Stay as an alternative to quarantine for children aged 2 years and older and staff who are either not eligible for COVID-19 vaccines or not up to date on their COVID-19 vaccines.
  • New: On May 24, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to provide an update on the potential for recurrence of COVID-19 or “COVID-19 rebound.”
    • Paxlovid continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease. Paxlovid treatment helps prevent hospitalization and death due to COVID-19. COVID-19 rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative.
  • New:  Monkeypox.  On Tuesday, May 24, 2022, CDC held a one-hour Clinician Outreach and Communication Activity (COCA) webinar titled “What Clinicians Need to Know About Monkeypox in the United States and Other Countries.”  The COCA Call presents information about what clinicians need to know about monkeypox including guidance about the typical clinical presentation, treatment options, pre-and post-exposure prophylaxis, and reporting to public health authorities.  The webinar recording is available on CDC's website.  Clinicians, public health professionals, and all others can sign up to receive information about upcoming COCA Calls and other CDC information here.

 

FDA

  • Update: On May 23, the U.S. Food and Drug Administration (FDA) revised the dates of the upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings due to new data from sponsors and expected submissions of emergency use authorization (EUA) requests. The new dates are as follows:
    • June 14 will be the new meeting date for the FDA and its advisory committee of external experts to discuss Moderna’s EUA request for 6 years through 17 years of age.
    • June 15 will be the new meeting date for the Moderna EUA request for 6 months through 5 years of age and Pfizer-BioNTech EUA request for 6 months through 4 years of age, based on expected completion of an EUA submission.
  • Updated: Know Your Treatment Options for COVID-19 - The FDA published the refreshed consumer update webpage with the latest information on COVID-19 therapies. The FDA has approved two drug treatments (Veklury and Olumiant) for COVID-19 and has authorized others for use during this public health emergency.

WHO:

  • WHO validates 11th vaccine for COVID-19 - the World Health Organization (WHO) issued an emergency use listing (EUL) for CONVIDECIA, a vaccine manufactured by CanSino Biologics, China, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2. WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines as a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
    • CONVIDECIA was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan, programmatic suitability and a manufacturing site inspection conducted by WHO. The Technical Advisory Group for Emergency Use Listing, convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19 and that the benefits of the vaccine far outweigh risks.

Memorial Day Holiday Ordering and Shipping Schedule

  • In anticipation of Memorial Day, please review the ordering and shipping information below. Please 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 below prior to 9:00 pm ET Tuesday, May 24th.
    • McKesson Specialty (Moderna and Janssen)
    • Pfizer Customer Service
    • 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 websitewhich includes reference guides and tutorial videos.

Best Practice Spotlight

Upcoming Events


  • HEP Connects Webinar Highlights Rural Preparedness Considerations - CDC’s next PHEP Connects webinar, “The Rural Context and Public Health Emergencies,” is scheduled from 1 p.m. to 2 p.m. EDT on Wednesday, June 8. Diane Hall, CDC’s rural health lead, and Alana Knudson, director of the National Opinion Research Center (NORC) Walsh Center for Rural Health Analysis, will discuss rural considerations in emergency planning and preparedness. This webinar will also include an overview of CDC’s work in rural health, COVID-19 resources that benefit state, tribal, local, and territorial health departments, and a discussion of a rural preparedness toolkit currently in development. Participant information to follow.

Helpful Resources

HHS

  • New Surgeon General Advisory Sounds Alarm on Health Worker Burnout and Resignation - Health workers, including physicians, nurses, community and public health workers, nurse aides, among others, have long faced systemic challenges in the healthcare system even before the COVID-19 pandemic, leading to crisis levels of burnout. The pandemic further exacerbated burnout for health workers, with many risking and sacrificing their own lives in the service of others while responding to this public health crisis. The Surgeon General’s Advisory Addressing Health Worker Burnout lays out recommendations that the whole-of-society can take to address the factors underpinning burnout, improve health worker well-being, and strengthen the nation’s public health infrastructure.

VDH

  • Updated General FAQs - Added a new question to the 'Schools, Workplaces & Community Locations' section, under 'Community Questions and Concerns' subsection. Question is about how public health recommendations apply to private organizations or businesses.
  • Updated Travelers page - Edits made to overall page content. Removed some content, including the tables and redirected to CDC travel pages. Retained VDH International Traveler monitoring information.

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