COVID-19 Vaccine Providers Newsletter 08.25.2021

Posted on by Daniel Harker
  • COVID-19 Vaccine Standing Order Updated by the Health Commissioner - Following the recent CDC recommendations for an additional dose of an mRNA COVID-19 vaccine for certain immunocompromised people (i.e. third dose), the Health Commissioner's standing order has been updated and is posted on the VDH website. This standing order will continue to apply to pharmacists, pharmacy technicians and pharmacy interns as in accordance with the federal PREP Act. The standing order will remain in effect as long as there is a federal COVID-19 public health emergency, which doesn't necessarily correlate to the duration of the PREP Act. 
  • Press Release: FDA Approves First COVID-19 Vaccine - On August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under an emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. Watch the recorded media call to discuss the first COVID-19 vaccine approval here.
    • CDC’s Advisory Committee on Immunization Practices (ACIP) will be discussing its updated recommendations for this vaccine on August 30, 2021.
  • CDC COVID-19 Vaccination Program Provider Agreements: Providers are responsible for adhering to all requirements outlined in the agreement. Specifically, providers must administer COVID-19 vaccines in accordance with all program requirements and recommendations of CDC, the Advisory Committee on Immunization Practices, and the U.S Food and Drug Administration (FDA). This applies to both EUA and FDA approved COVID-19 vaccines. Accordingly, use of these products outside of those that have been approved and authorized by FDA (often referred to as “off-label use”) is not recommended. It would violate the provider agreement and could expose providers to the following risks:
    • Administration of the product off label may not be covered under the PREP Act or the PREP Act declaration; therefore, providers may not have immunity from claims.
    • Individuals who receive an off-label dose may not be eligible for compensation under the Countermeasures Injury Compensation Program after a possible adverse event.
    • CDC has defined the scope of the CDC COVID-19 Vaccination Program in terms of how the USG-provided vaccines may be used in the program.  Providers giving off-label doses would be in violation of the CDC Program provider agreement potentially impacting their ability to remain a provider in the CDC program.
    • Administration fees may not be reimbursable by payers.
  • Interchangeability of FDA authorized and FDA approved COVID-19 Products: The FDA-approved Pfizer-BioNTech product COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under the EUA to administer the vaccination series for those seeking the approved vaccine. The Fact Sheet for Healthcare Providers Administering Vaccine and Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.  Providers should continue to use the vaccines in their supply.
  • Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots - HHS announced a plan to begin offering COVID-19 vaccine booster shots this fall. The booster dose would be given at least eight months after the initial vaccine dose.  The plan is subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence.
  • From the press release: "The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant...The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability."
  • Investigation of Long-Term Effects of Myocarditis after mRNA COVID-19 Vaccination - CDC is actively investigating reports of people developing myocarditis after mRNA vaccination. As part of these investigations, CDC is conducting surveys of patients (or their parents/guardians) and their healthcare providers to learn more about potential long-term effects. People who meet the case definition of myocarditis following mRNA COVID-19 vaccination may receive a letter in the mail or phone call from CDC if at least 90 days have passed since the myocarditis symptoms began. Providers may be asked to provide information about a patient’s treatment. VDH asks that eligible providers participate in this survey and that you encourage any of your eligible patients to participate so that CDC can learn more about this condition and understand any association between myocarditis and COVID-19 vaccination.
  • Vaccination FAQs - VDH’s vaccination FAQs were recently updated to include vaccine summary data, the State Health Commissioner’s Public Health Order requiring universal masking in all indoor settings in Virginia’s K-12 schools, and stronger recommendations for  COVID-19 vaccination during pregnancy. A new section, Booster Doses, was added in response to the plan for offering COVID-19 vaccine booster doses in the fall.
  • Pfizer-BioNTech Vaccine Expiration Extension
    • On August 23rd 2021, the FDA approved an amendment to the EUA for Pfizer-BioNTech extending the expiration dates of COVID-19 Vaccine from six to nine months. 
  • Updated expiry dates for vaccine maintained in ultra-cold storage are shown below.
    •  Printed Expiry Date /Updated Expiry Date
      • August 2021/November 2021
      • September 2021/December 2021
      • October 2021/January 2022
      • November 2021/February 2022
      • December 2021/March 2022
      • January 2022 /April 2022
      • February 2022/May 2022
  • The extended expiration date is effective immediately for all currently available batches that have not yet expired. NOTE:  Expiration dates extension does NOT apply to vials dated July 2021 and earlier.
  • No changes have been made to the vaccine itself to enable extension of expiry dating. This change is based on stability data generated on batches manufactured over the past nine months of COVID-19 vaccine development.
  • Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as authorized storage conditions between -90°C to -60°C (-130°F to -76°F) have been maintained. Please note: the ultra cold temperature range has been broadened to -90° C (-130°F). Frozen vials stored at -25°C to -15°C and refrigerated vials (2°C to 8°C) are NOT eligible for extension.
  • Currently available vaccine will not have an updated NCD. Please refer to the current EUA Fact Sheet for information.
  • Additional information on Pfizer storage and handling may be found at CDC’s  Administration Overview for Pfizer-BioNTech COVID-19 Vaccine.
  • Adherence to SSRP Ordering Procedures
    • Orders should be placed through SSRP to cover the expected demand for the COVID-19 dose’s shelf life. As a reminder, once the doses are received, they can be frozen (non-ultra-cold) for two weeks, then they can be moved to refrigerated conditions for an additional 31 days after that (total of six weeks or 45 days). The SSRP program was not intended to provide weekly shipments, so please abide by the guidance listed above. If full tray sizes can be sustained based on your practice’s throughput and storage capabilities, we ask that you do so.
  • Pfizer Order Quantity Changes – SSRP & Direct Shipments
    • Direct shipments of the Pfizer vaccine are returning to 1170 doses per tray. To help facilitate provider’s ordering of small shipments, VDH is going to move the  SSRP order quantities up to 60 vials (360 doses)
  • One Additional Note:
    • The SSRP program has limited capacity and the expansion to allow 60 vials in a single order is aimed at accommodating as many providers as possible. Due to the manual work required to fill orders, we ask that all providers initiate their questions via email at VaxMax help (vaxmax_help@vdh.virginia.gov).We do not have a phone line and ask that you only contact direct persons or VDH Pharmacy staff after reaching out to the VaxMax Help email address. If providers over-order or abuse the program, we will not be able to sustain the number of requests we receive and would have to limit the program to only specific / targeted providers, which we are hoping to not have to do.
  • Canceled Vaccine Unit Pharmacy Office Hours: August sessions have been canceled and will restart in September. The schedule is being finalized.
  • For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Best Practice Spotlight

  • FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 | FDA
    • On July 30, 2021, the FDA revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together). With this revision, FDA authorized REGEN-COV for emergency use as post-exposure prophylaxis (prevention),  for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus — only after exposure to the virus. Healthcare providers should review the FDA’s Fact Sheet for detailed information about the use of REGEN-COV for post-exposure prophylaxis.

Upcoming Events

  • August 24 – 26: 2021 National Conference on Health Communication, Marketing and Media Conference (NCHCMM) - NCHCMM is excited to welcome CDC Director Dr. Rochelle P. Walensky as a featured guest speaker. In this fireside chat discussion, Dr. Walensky provides her insights into the success and challenges of the nation’s pandemic response and what is likely ahead in the coming weeks and months. Plus, be sure to register to hear topics like: Learning the Basics of Launching Your Own Public Health Podcast, Communicating Public Health in a Time of Disinformation and Science Skepticism, The HEALing Communities Study Health Communication Campaigns: Lessons Learned from Rural and Urban Communities, How Right Now: Developing and Evaluating a National Communications Campaign, and  Health Equity Guiding Principles for Inclusive Communication – Making It Stick.
  • Friday, August 27, 2021 at 2:00 pm EDT: CSTE Webinar, "Back to School'' -  The CSTE Public Health Law Subcommittee will host a webinar Friday, August 27, at 2:00 pm EDT. This call will be an open discussion on the issue of back-to-school, quarantine and other school-related legal issues, including whether schools can require quarantine of infected students. Questions may be sent to Sunbal Virk at publichealthlaw@cste.org to have them asked anonymously. Call information is below:
  • Monday, August 30 –31, 2021 from 10:00 am-4:00 pm EDT: CDC's Advisory Committee on Immunization Practices is meeting to discuss its updated recommendation for the COMIRNATY/Pfizer-BioNTech's COVID-19 Vaccine following full approval granted by FDA. Additional COVID-19 vaccine doses, including booster doses, might also be discussed.
  • Tuesday, August 31, 2021 from 7:00-8:00 pm EDT: Virginia Chapter, AAP Back to School Town Hall - VDH is partnering with the VA Chapter of the AAP on a Back to School webinar to review school guidance from CDC, AAP, VDH, and VDOE; describe methods to encourage COVID-19 vaccination; understand challenges facing schools; outline COVID-19 considerations for sports; review of tools and updated for mental health; and explore further resources for outpatient practice. 
    • Register in advance for this meeting. After registering, you will receive a confirmation email containing information about joining the meeting.
 

Helpful Resources

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