COVID-19 Vaccine Providers Newsletter 04.30.2021

On April 23, the Advisory Committee on Immunization Practices concluded that the benefits of resuming Johnson & Johnson/Janssen COVID-19 vaccination among persons aged 18 years and older outweighed the risks and reaffirmed its interim recommendation under FDA’s Emergency Use Authorization, which includes a new warning for rare clotting events among women aged 18–49 years.  With the FDA’s EUA revisions announced April 1, the Moderna vaccine will be available in two different vials by early May: the current maximum 11 dose vial and a new maximum 15 dose vial. The vial will remain the same size but will be filled to the higher volume.
  • A new National Drug Code (NDC) has been issued for the larger volume Moderna vial, which has been given a range of 13-15 doses in the EUA.
  • Moderna is planning to transition all manufacturing to the new vial in May. During this transition, providers may receive allocations that include quantities of both Moderna vaccine vials.
  • Ancillary kits will be reconfigured to extract a maximum of 14 doses per vial, plus a 5% surplus to account for damage or wastage.
  • The Moderna larger volume vial may contain 15 0.5 mL doses of vaccine. However, it will not always be possible to extract the 15th dose. This is based on the overfill in the vial and the type of syringes used to administer the vaccine. Therefore, vaccination providers should expect to withdraw 13-15 doses from each vial.
    • Each dose must contain 0.5 mL of vaccine.
    • When the amount of vaccine remaining in the vial is not a complete 0.5 mL dose, discard the vial and the residual vaccine regardless of the number of doses withdrawn. Do not save vials to combine residual vaccine from more than one vial to get a complete dose. An unextracted 15th dose (or 11th dose from the current vial) does NOT count as waste.
    • Vaccination sites should continue to reliably extract 10 doses from the current volume vial and plan to extract 14 doses from the new larger volume vial using the ancillary kit supplies provided.
  • The labels for the two Moderna vials differ by the placement of a blue field on the max 15 dose vial. Each is also clearly labeled with the maximum dosage.
  • For more information, please visit CDC’s Moderna COVID-19 vaccine web page.
All Virginia residents aged 16 years and older are eligible for a COVID-19 vaccine in the Commonwealth. 
  • VDH encourages providers to vaccinate individuals regardless of in-state or local residency.
  • In addition, providers should not require individuals to present identification or documentation with a Virginia address in order to be vaccinated.
The Americans with Disabilities Act (ADA) applies to all COVID-19 vaccination services Providers are responsible for properly maintaining COVID-19 vaccination medical records.
  • Providers must maintain the vaccine administration records for a minimum of six years following vaccination for people aged 18 years and older. For minors, records must be kept until the child reaches the age of 18 or becomes emancipated, with a minimum time for record retention of six years from the last patient encounter regardless of the age of the child. 
  • These records must be made available to any federal, state, local, or territorial public health department to the extent authorized by law.
As a reminder, please enter all vaccine requests for the upcoming week into VaxMaX by Mondays at 7 pm ET. 
  • Note: submitting a request for doses will not guarantee that the requested number of doses will automatically be approved and shipped.
  • For any questions about VaxMaX and its functionality, please visit the VaxMaX help website as a resource for reference guides and tutorial videos. 
  • As a reminder, VaxMaX should be used for vaccine management and distribution, redistributions, data tracking, and other reporting.

Best Practice Spotlight

For even easier access to the information included in CDC’s Guide for Community Partners, CDC released a short two-pager, COVID-19 Vaccine Equity: Best Practices for Community and Faith-Based Organizations

  • This resource provides an overview of strategies and interventions detailed in the Guide.
  • Specifically, it provides best practices and examples for information and materials to disseminate, methods and platforms to use, useful and accessible venues and locations to conduct outreach and vaccination sites, trusted and influential messengers to engage, and vaccination appointment and site logistics to consider.

Check out our complete list of COVID-19 Vaccination Clinic Best Practices here.

Helpful Resources

Refer to the Summary of Legal Authorities for Pharmacists to Administer COVID-19 Vaccine for a concise summary of existing and additional legal authority (e.g., Standing Order issued by Health Commissioner on April 27, 2021) for pharmacists to administer and bill/receive reimbursement for the administration for COVID-19 vaccine. 

CDC released updated interim guidance for fully vaccinated people, including the following. Please share these guidelines with your practice and patients as appropriate:

  1. Guiding principles for fully vaccinated people are now provided.
  2. Underscores that immunocompromised people need to consult their healthcare provider about these recommendations, even if fully vaccinated.
  3. Fully vaccinated people no longer need to wear a mask outdoors, except in certain crowded settings and venues.
  4. Clarification that fully vaccinated workers no longer need to be restricted from work following an exposure as long as they are asymptomatic.
  5. Fully vaccinated residents of non-healthcare congregate settings no longer need to quarantine following a known exposure.
  6. Fully vaccinated asymptomatic people without an exposure may be exempted from routine screening testing, if feasible.

As part of a shared commitment to President Biden's National Strategy - PDF and Executive Order to ensure an equitable COVID-19 response, the Office for Civil Rights (OCR), the Administration for Community Living (ACL), and the Office of the Assistant Secretary for Planning and Evaluation (ASPE) at the U.S. Department of Health and Human Services (HHS) have published several new resources to help states, vaccination providers, and others leading COVID-19 response activities improve access to vaccines for people with disabilities and older adults. These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them – to ensure accessibility. See links to highlighted resources below:

  • New guidance outlining legal standards under the federal civil rights laws prohibiting disability discrimination and providing concrete examples of the application of the legal standards in the context of COVID-19 vaccine programs and how to implement them.
  • Fact sheet setting out specific steps that those involved in the planning and distribution of vaccines to combat the COVID-19 pandemic may wish to consider to promote compliance with disability rights laws and provide access to vaccination programs for people with disabilities. 
  • Administration for Community Living (ACL) strategies and best practices for helping people with disabilities and older adults access COVID-19 vaccines. 
  • HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) issue brief on the prevalence and characteristics of older adults who are normally unable to leave home unassisted and for whom leaving the house would take considerable and taxing effort.
  • Earlier COVID-19 guidance from HHS Office for Civil Rights (OCR) addressing civil rights protections prohibiting discrimination on the basis of race, color, national origin, and civil rights of persons with limited English proficiency.

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