COVID-19 Vaccine Provider Weekly News Digest - Aug. 26, 2022

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COVID-19 Vaccine Provider Weekly News Digest

August 26, 2022
71st Edition


Labor Day 2022 Holiday Ordering and Shipping Schedule

NO ORDERS WILL BE DELIVERED MONDAY, SEPTEMBER 5, 2022 – LABOR DAY

McKesson Specialty (Moderna & Novavax) will not deliver vaccine orders on Tuesday, September 6, 2022.

Pfizer-BioNTech COVID-19 Vaccines:

  • Pfizer will not be processing orders over the holiday weekend.
  • Orders placed by 9:00 a.m. ET Thursday, Sept. 1 will be delivered Tuesday, Sept. 6.

Moderna & Novavax COVID-19 Vaccines:

  • McKesson Specialty will not be processing orders over the holiday weekend or on Tuesday, Sept. 6, 2022.
  • McKesson Specialty customer service is reaching out to awardee and partner ordering points of contact to determine if order holds are requested.

For any questions, contact the VacShipments Team at (833) 832-7068 (Option 2) or email COVID19VacShipments@dshs.Texas.gov

The table below summarizes when COVID-19 vaccine will or will not be delivered over the holiday.

labor day delivery chart

Pre-Ordering: Fall Bivalent COVID-19 Vaccine Booster

In anticipation of the potential Emergency Use Authorizations (EUAs) by the Food and Drug Administration of new bivalent COVID-19 vaccine boosters, Texas Department of State Health Services (DSHS) is requesting all providers place a pre-order for these new COVID-19 vaccines in the Vaccine Allocation and Ordering System (VAOS) for both Pfizer and Moderna products.

Wave 2 pre-ordering will be from August 24 through August 30, 2022.

COVID-19 vaccine orders will begin shipping only after the issuance of the EUAs which is unknown at this time. DSHS will provide a shipping update once EUAs are issued.

Bivalent COVID-19 Vaccine Booster:

  • The new vaccine will contain the current COVID-19 vaccine plus an Omicron BA.4/5 variant specific vaccine in equal parts (bivalent).
  • Both Pfizer and Moderna have developed a COVID-19 bivalent vaccine booster that are available for pre-ordering.
  • The bivalent COVID-19 vaccines will likely be authorized as a single dose.
  • Additional clinical considerations will follow once the CDC makes its recommendations:
    •  Pfizer bivalent COVID-19 vaccine booster is expected (pending EUA) for individuals >12 years.
    • Moderna bivalent COVID-19 vaccine booster is expected (pending EUA) for individuals >18 years.
  • The new bivalent COVID-19 vaccine booster will have the same storage and handling requirements as the current vaccine products from the respective manufacturers.
  • Pfizer bivalent COVID-19 vaccine booster will be available in 6-doses per vial with a minimum order quantity of 300 doses.
  • Moderna bivalent COVID-19 vaccine booster will be available as 5-doses per vial, with a minimum order quantity of 100 doses.
  • Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. An ancillary opt-out continues to be available for all non-diluent kits.

FDA Authorized! EUA of Novavax COVID-19 Vaccine for 12-17 Years of Age

The FDA expanded the emergency use authorization of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.

The COVID-19 vaccine is authorized for emergency use as a two-dose primary series. The two doses are given three weeks apart.

Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.

For more information see the resources below:


Add Your Organization to Vaccine Finder

Vaccines.gov helps people find the latest information on COVID-19 vaccine availability at certain providers and pharmacies.

To add your organization to vaccines.gov: email COVID19VacEnroll@dshs.texas.gov or call (877) 835-7750. Include your provider pin.

For each location, Vaccines.gov displays:

  • Types of COVID-19 vaccines available
  • Website or phone number to take the next step to get vaccinated
  • Hours of operation

Reminder: Small Dose Ordering Update

For all small dose orders a notification email will be sent on Thursdays to providers requesting temperature preference. Responses are required by 12:00pm CT the following day.

*Note that cold chain vaccine temperatures are recorded in Celsius not Fahrenheit.

For questions, reach out to the VacShipments team at (833) 832-7068 (Option 2) or email at COVID19VacShipments@dshs.Texas.gov.


Reminder: Make Sure to Verify COVID-19 Vaccine Expiration Dates

Providers should regularly check inventory for expired COVID-19 vaccines and immediately remove expired inventory. If you are not sure, quarantine your COVID-19 vaccine to ensure that it has been verified.

Expired COVID-19 vaccines should be reported as waste only after expiration has been confirmed by the manufacturer.

To obtain the current expiration status of your COVID-19 vaccines, utilize the appropriate manufacturer Vaccine Expiration Date Lookup Tool, as expiration reports in VAOS may not reflect current expiration. Providers can access manufacturer expiry tools below:


Reminder: COVID-19 Vaccination Outside the United States

If an individual received COVID-19 vaccines outside the United States, whether they are up to date depends on which COVID-19 vaccine (and how many doses) they received:

  • FDA authorized and/or approved vaccines: Do not repeat the series; follow the guidance by CDC.
  • WHO authorized and/or approved vaccines: Do not repeat series; administer a booster if eligible, complete the series with mRNA vaccine, or administer second booster if eligible.
  • Mixed FDA and WHO authorized and/or approved vaccines: Do not repeat the series, administer booster or second booster, if eligible.
  • Not FDA or WHO authorized and/or approved vaccines: Start an FDA series 28 days following last vaccine administration.

For more information, visit Interim Clinical Considerations for Use of COVID-19 Vaccines


Reminder: What to Do When a Vaccination Card Is Full?

As a reminder, the ancillary kits that accompany every COVID-19 vaccine order include Vaccination Record Cards for every dose. If a vaccination card is full, the CDC recommends that a second card be completed, and the two cards stapled together. Patients should bring both cards to future vaccination appointments for verification of vaccination history.

When a Vaccination Record Card is Full:

  1. Complete a new card for the patient
  2. Staple both cards together
  3. Encourage the patient to photograph both cards in case they become separated
  4. Bring both cards to future vaccination appointments

For more information, visit Your CDC COVID-19 Vaccination Record and Vaccination Card | CDC.


Reminder: Expiring! Pfizer Purple Cap COVID-19 Vaccine Disposal

Most of the distributed Pfizer PURPLE Cap COVID-19 vaccine has expired, but small amounts of inventory remain on shelves. Providers are encouraged to transition to the Pfizer GREY Cap COVID-19 vaccine product by August 31, 2022, and to dispose of all expired PURPLE Cap COVID-19 vaccines.

To confirm expiry dates for Pfizer COVID-19 vaccine, providers can visit this webpage.


Reminder: Expiring! Johnson and Johnson/Janssen COVID-19 Vaccine Disposal

A large quantity of J&J COVID-19 vaccine is expiring in August 2022. Providers can check expiration dates at Janssen COVID-19 Vaccine Expiry Checker. Again, providers should dispose of all expired COVID-19 vaccine.


Provider Tip! Regulatory Terminology for COVID-19 Vaccines

Emergency Use Authorization (EUA): Mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the U.S. Food and Drug Administration (FDA) can make a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval.

FDA Approved: FDA-approved vaccines have undergone the agency’s standard process for reviewing the quality, safety and effectiveness of medical products included in a manufacturer’s submission of a Biologics License Application (BLA)—a comprehensive document that addresses specific requirements.

Emergency Use Instructions (EUI): Provision of the 2013 Pandemic and All-Hazards Preparedness Reauthorization Act which gives CDC legal authority to create and issue EUI to permit emergency use of FDA-approved medical products. The EUI consist of Fact Sheets to inform healthcare providers and recipients about approved, licensed, or cleared conditions of use, and may provide information about emergency use of FDA-approved medical products that is not included in or differs in some way from the information provided in the FDA-approved labeling (package insert).

For more information, visit Clinical Guidance for COVID-19 Vaccination | CDC.


Webinar dates

Texas Vaccine Providers Weekly Webinars

Join the Texas Vaccine Providers Webinars for the latest updates and Live Q&A discussion.

Tuesdays at 12:00 p.m. CST

  • The next webinar is on September 6th at 12 p.m. CST – Register here.

Review highlights, recordings, and slide presentations of past webinars by visiting the COVID-19 Vaccine Providers Webinars page.

 

Training/Job Aids

Access trainings, VAOS job aids, and other relevant information by visiting the COVID-19 Vaccine Management Resources page.

For a full catalog of the current VAOS job aids, please visit the VAOS Training Catalog.

EUAs COVID-19 Vaccines

Pfizer Purple Cap (12+):

EUA Fact Sheet for Healthcare Providers

EUA Fact Sheet for Recipients and Caregivers

Pfizer Gray Cap (12+):

EUA Fact Sheet for Healthcare Providers

EUA Fact Sheet for Recipients and Caregivers

Pfizer Pediatric:

EUA Fact Sheet for Healthcare Providers

EUA Fact Sheet for Recipients and Caregivers

Moderna:

EUA Fact Sheet for Healthcare Providers

EUA Fact Sheet for Recipients and Caregivers

J&J/Janssen:

EUA Fact Sheet for Healthcare Providers

EUA Fact Sheet for Recipients and Caregivers

Novavax:

EUA Fact Sheet for Healthcare Providers

EUA Fact Sheet for Recipients and Caregivers