COVID-19 Vaccine Providers Newsletter 09.24.2021

  • On Friday, September 17, 2021, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) discussed the topic of Pfizer-BioNTech COVID-19 Vaccine booster doses in an open session. The committee members expressed support for booster doses for certain high-risk populations, including older adults, those at high risk for severe illness, or those at high risk of exposure who received the Pfizer vaccine. The recommended timing for a booster is at least 6 months after their second dose. The Moderna and Johnson and Johnson/Janssen (J&J) vaccines were not discussed at the meeting. Following this meeting, FDA authorized Pfizer-BioNTech booster doses for certain populations. More information is available here.
  • CDC Statement on ACIP Booster Recommendations - CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings. CDC recommends:
    • people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
    • people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
    • people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
    • people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
  • Covid Vaccine Providers are required to provide vaccines in accordance with the CDC Recommendations. With the CDC interim recommendations announced, providers would be in compliance to administer booster Pfizer vaccines to these populations. CDC will be providing further clinical considerations in an upcoming Morbidity and Mortality Weekly Report in the coming days. VDH will be issuing guidance to providers soon to assist in implementing the new recommendations
  • On September 13, 2021, the U.S. Department of Health and Human Services (HHS) changed the way that monoclonal antibodies purchased by the federal government (Bamlanivimab and Etesevimab ["Bam/Ete"] and REGEN-COV) are ordered and distributed in the U.S. Effective September 13, 2021, HHS will allot each state a specific number of Bam/Ete and REGEN-COV doses per week. Sites administering monoclonal antibodies must place their order with the Virginia Department of Health (VDH). In turn, VDH will place the order on behalf of the administration site with AmerisourceBergen, the medication distributor. Depending on the state's allocation of monoclonal antibodies for that week, some orders may need to be reduced to meet the available supply.
    • On Monday, September 20, 2021, VDH sent an email to all monoclonal antibody administration sites with information about how to order their needed supply of medication for the week of September 20, 2021. That email contained detailed instructions about how to order monoclonal antibodies. The cutoff time for orders this week was Tuesday, September 21, 2021 at 1 PM. Another email will be sent with instructions about how to order monoclonal antibodies for the week of September 27, 2021. If you are not currently receiving VDH's emails about ordering monoclonal antibodies and want to, please email mabs_requests@vdh.virginia.gov and indicate you would like to be added to the email distribution list. Currently, VDH is using a REDCap survey form for administration sites to complete. In the future, VDH plans to transition to the VaxMaX system, which was used for vaccine ordering, for monoclonal antibody ordering. If you have general questions, please email mabs_requests@vdh.virginia.gov. Please allow up to 48 hours for a response because the volume of emails is currently very heavy . VDH thanks you for your cooperation and patience as we work through this new ordering and allocation process.
  • New: CDC to Invest $2.1 Billion to Protect Patients and Healthcare Workers from COVID-19 and Future Infectious Diseases - On Friday, September 17, 2021, CDC  announced a $2.1 billion investment from the American Rescue Plan to strengthen infection prevention and control in the United States. A bulk of the funds, $1.25 billion, will go to 64 state, local, and territorial health departments over the next three years for various efforts, including expanding data monitoring and launching a first-of-its-kind program to train healthcare workers on infection prevention and control. Initial awards totaling $885 million will be made in October 2021 to jurisdictional health departments.
    • Strengthening state capacity to prevent, detect, and contain infectious disease threats across healthcare settings
    • Laboratory capacity for healthcare
    • Project Firstline
    • National Healthcare Safety Network (NHSN)
    • Antibiotic Stewardship
    • CDC will use the majority of the initial funding in October, $500 million, to support state-based nursing home and long-term care strike teams.
    • $385 million will be awarded in October 2021 to go to state, local, and territorial health departments to strengthen five critical areas:
  • All individuals with COVID-19 vaccinations reported to the Virginia Immunization Information System (VIIS) will have an automatically generated QR code that can be scanned to verify their COVID-19 vaccination record. The new functionality can be found at the existing COVID-19 Vaccination Record Portal. Individuals will be able to save their record to their computer or mobile device and use it at locations that accept COVID-19 Vaccination Records with QR Codes. Social media shareables and flyers have been  added to the Communications Hub to use in your community. The COVID-19 Vaccination FAQ page  has FAQs about the COVID-19 Vaccination Record with QR Code as well.
  • The VDH COVID-19 Vaccine Pharmacy Team has a new email to better support our pharmacy providers and long-term care facilities (LTCFs). Please email COVIDpharmacysupport@vdh.virginia.gov for COVID-19 vaccine questions or concerns related to pharmacies or LTCFs.
  • CDC reported the eighth and ninth U.S. human infections with influenza viruses that usually spread in pigs and not people occurring during the 2020-2021 influenza season. Each patient fully recovered from their illness, and no person-to-person spread was identified with any of these patients. These types of infections occur in people rarely, and usually in the context of contact with pigs, but are concerning because of their pandemic potential. These infections also serve as a reminder of the importance of following CDC’s recommended precautions for people to take when around swine.
  • UPDATED:  Science Brief: Background Rationale and Evidence for Public Health Recommendations for Fully Vaccinated People
    • Data were added indicating that COVID-19 vaccination remains highly effective against COVID-19 hospitalization and death caused by the Delta variant of SARS-CoV-2.
    • Data were added from studies published since the last update that further characterize reduced COVID-19 vaccine effectiveness against asymptomatic and mild symptomatic infections with the Delta variant of SARS-CoV-2.
    • Data were added from studies published since the last update that suggest decreased vaccine effectiveness against SARS-CoV-2 infection, symptomatic disease, and hospitalization in several groups of immunocompromised persons and the potential benefit of a third dose of COVID-19 vaccine in immunocompromised populations.
    • Data were added summarizing several small studies of heterologous COVID-19 vaccination series (i.e mixed schedules), which found that a dose of adenovirus vector vaccine followed by a dose of mRNA vaccine elicits antibody responses at least as high as two doses of mRNA vaccine.
    • Data were added from recent studies examining the duration of protection conferred by COVID-19 vaccination.
    • Data were added from recent studies describing clinical outcomes and transmissibility of SARS-CoV-2 infections in fully vaccinated persons.
  • Vaccination FAQs
    • NEW: New section- Vaccination: Records (COVID-19 Vaccination Record with QR Code); CMS testing requirements; LTCF: booster doses
    • UPDATED: vaccine effectiveness (VE) with Delta variant studies; breakthrough cases; estimated timeline - vaccine for younger children, with FDA statement; pregnant woman - additional dose; limitations of VAERS data; Antibody-Dependent Enhancement concern; DOLI standard; status of booster dose.
  • Continued Guidance on Vaccine Ordering- Over the past few weeks, we have seen an increase in provider ordering in anticipation of the pending decision on Boosters, which has raised our overall inventory levels across the State. We understand the decision to do so, and we still feel that we are at overall healthy levels. However, we do want to reiterate a few things to ensure that we continue to be good stewards of the vaccine available:
    • Use what you currently have on hand and only reorder what you need based on your current administration rates and inventory levels
    • For J&J, we are still seeing very small relative administration rates across the State; ensure that you are only ordering what you need to avoid the risk of waste. Direct ordering has resumed, so you can order more when you need it
    • Ensure that you are updating your VaccineFinder inventory balance so there's transparency into where vaccine is currently residing, for both VDH and for individuals looking to receive a dose
    • There is no need to stockpile. Vaccine is readily available and the processes are in place to submit regular orders as needed
  • For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Best Practice Spotlight

  • Providers Required to Report All Immunizations to Virginia Immunization Information System Starting January 2022Pursuant to Chapter 211 of the 2021 Special Session I, as of January 1, 2022, any health care provider, as defined in §32.1-127.1:03, in the Commonwealth that administers immunizations shall report such patient immunization information to the Virginia Immunization Information System (VIIS) pursuant to §32.1-46.01. If you are not already actively submitting immunization administration data to VIIS or unsure if you are, please contact our team as soon as possible. Please reach out VIISInfo@vdh.virginia.gov and a VIIS Trainer will contact you.
  • Check out our complete list of COVID-19 Vaccination Clinic Best Practices and our Lightning Learnings: Best Practices for Busy Providers!

 

Upcoming Events


  • The COCA Call will be Tuesday September 28 from 2:00 pm- 3:00 pm and will give clinicians an overview of the Pfizer-BioNTech COVID-19 booster vaccination. Clinicians will learn about the vaccine booster recommendations, safety of booster dose, and clinical guidance for using the Pfizer-BioNTech COVID-19 booster vaccine.
  • Join the Virginia Department of Health for a webinar on "COVID-19 Boosters and New Therapies: What’s New, What’s True" on October 6, 2021 from 6 p.m. to 7 p.m. This one-hour webinar has been approved for Continuing Medical Education (CME) credit / Continuing Education (CE) credit for physicians, nurses, and pharmacists. The webinar is free and open to all healthcare professionals and all healthcare staff.  Please share details with colleagues and members of your professional organizations.
  • Training Webinars on Pfizer-BioNTech COVID-19 Vaccine - Pfizer will be hosting a series of training sessions to review information and answer questions about the Pfizer-BioNTech COVID-19 Vaccine. Please click on the links below to join the sessions at the designated times. Each training below is the same content.
 

Helpful Resources

  • Updated: Facts About COVID-19 webpage (formerly known as Myths About COVID-19) -  Added information about Comirnaty vaccine being the same as the Pfizer vaccine. Updated information about ivermectin.
  • VDH Mask Page Updates
    • If fully vaccinated, you should wear a mask in indoor public spaces when community spread is substantial or high. (Added action button to check the level of community transmission.)
    • Clarified that masks should not be placed on a sleeping child.
    • Updated workplace section to reflect DOLI's recently revised Standard. In most workplaces, employees are currently required to wear a mask while indoors. Employers and employees must follow mask requirements provided in the Virginia Department of Labor and Industry (DOLI) Standard.
      • See DOLI's FAQ for additional information on the Standard.
    • Added action buttons to link to VDH signage toolkits.
  • EARLY RELEASE: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021 - Two 2-dose mRNA COVID-19 vaccines (from Pfizer-BioNTech and Moderna) and a 1-dose viral vector vaccine (from Janssen [Johnson & Johnson]) are currently used in the United States. Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%). Although these real-world data suggest some variation in levels of protection by vaccine, all FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization.
  • New: Counterfeit or fake vaccination cards should be reported to the HHS Office of the Inspector at 1-800-HHS-TIPS or www.oig.hhs.gov and the FBI at tips.fbi.gov.

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