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WEBSITE OF THE STATE OF SOUTH DAKOTA DEPARTMENT OF HEALTH
Joan Adam, Secretary of Health

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COVID-19 Vaccine Information

for healthcare providers

NOTE: Please check this web page twice weekly for updated material.

Provider Enrollment Instructions

Vaccinator TrainingStorage & Handling TrainingVaccine Data Entry Training Vaccine Coordinator Training

VIEW HEALTHCARE PROVIDER WEBINARS & SLIDES FOR UPDATES, CHARTS, HIGHLIGHTS, ETC.

Updates for Vaccine Providers

FALL BIVALENT BOOSTERS UPDATE

On Oct. 12, 2022, CDC Director Dr. Rochelle Walensky released a statement and signed a decision memo recommending updated bivalent COVID-19 boosters for children five years and older. This expands on CDC's recommendation issued Sept. 1 for updated COVID-19 boosters for people ages 12 and older and clears the way for the boosters to be administered to children.

New updated booster options include the Pfizer-BioNTech bivalent COVID-19 booster for children ages 5 through 11 years old, and the Moderna bivalent COVID-19 booster for children and adolescents ages 6 through 17 years old. The updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the mRNA COVID-19 vaccine composition, increasing protection against the currently circulating variants.

As with the bivalent boosters for the 12 years and up age group - with this EUA, monovalent mRNA COVID-19 vaccines are NO LONGER authorized for use as boosters in people ages 5 years and older. Providers who do not yet have the pediatric bivalent boosters in stock must reschedule existing appointments for monovalent Pfizer-BioNTech or Moderna boosters in people 5 years and older for when locations have the bivalent COVID-19 vaccines available. Monovalent mRNA COVID-19 vaccines remain authorized for primary vaccine series in people 5 years and older.

Any monovalent mRNA COVID-19 vaccine booster administered to people ages 5 years and older after FDA’s authorization of bivalent boosters must be reported as a vaccine administration error to VAERS. In this situation, organizations or providers may submit a single, aggregate VAERS report describing the error, how it happened, and how many people were affected. If any vaccine recipient developed an adverse event, an individual VAERS report should also be submitted.

VACCINE INTERCHANGEABILITY AND COADMINISTRATION

CDC recommends that everyone ages 6 months and older stay up to date with COVID-19 vaccination. You are up to date if you have completed a primary series and received the most recent booster dose recommended for you by CDC. Vaccines are safe and highly effective at protecting people from serious illness and remain the best way to protect from severe COVID-19 hospitalization and death. Either mRNA vaccine can be used if it has been authorized for their age group.

Providers should offer influenza and COVID-19 vaccines at the same visit, if the person is eligible. With both influenza and SARS-CoV-2 circulating, getting both vaccines is important for prevention of severe disease, hospitalization, and death. Getting both vaccines at the same visit increases the chance that a person will be up to date with their vaccinations.

ORDERING

Ordering is available now via SDIIS for the new pediatric bivalents as well as the bivalents for the 12 years and older age group. The bivalents have the same storage and handling parameters as the original vaccine products.

Pfizer-BioNTech bivalent COVID-19 vaccine for children aged 5-11 years and older:

  • Vial with an orange cap similar to the existing Pfizer-BioNTech product for this age group, but with a label that identifies it as a bivalent booster

  • Packaged in 10-dose vials in cartons of 10 vials each (100 doses total)

  • Requires diluent (note: providers will not be able to opt out of receiving ancillary kits, see below)

  • Once punctured, each vial must be used within 12 hours

  • Minimum order quantity of 100 doses

Moderna bivalent COVID-19 vaccine:

  • The same vial (dark blue cap, gray border) and presentation for Moderna is expected to be used for all authorized age groups (people aged 6 years and older), but volume and dosage expected to differ by age:

    • Adolescents aged 12-17 years: same volume and dosage as for adults aged 18 years and older

    • Children aged 6-11 years: half the volume and dosage as for adults aged 18 years and older (drawn from the same vial). i.e., one vial yields double the number of doses when used for 6-11-year-olds as when used for people aged 12 years and older

  • Packaged in 5-dose vials in cartons of 10 vials each (50 doses total)

  • Does not require diluent

  • Once punctured, each vial must be used within 12 hours

  • Minimum order quantity of 100 doses

Ancillary supplies will be provided, including a variety of 1-inch and 1.5-inch needles and syringes. Orders of bivalent Moderna COVID-19 vaccine for children aged 6-11 years will be sent with two ancillary kits per minimum dose order to accommodate double the number of doses provided in each vial. An ancillary opt-out continues to be available for all non-diluent (non-Pfizer) kits.

List of Expiry Look-up Pages  

You may also refer to the CDC Operational Guidance on Identification, Reporting and Disposal of COVID-19 Vaccine.

Resources, educational opportunities

 

CDC COCA Calls

Sept. 8 - 2022-2023 Influenza Vaccination Recommendations and Guidance on Coadministration with COVID-19 Vaccines

Sept. 13 - Recommendations for Bivalent COVID-19 Booster Doses in People Ages 12 Years and Older


Updated Guidance: Interim Clinical Considerations for Use of COVID-19 Vaccines

CDC has updated its guidance for COVID-19 vaccination, including:

  • Guidance for primary series vaccination using Novavax COVID-19 Vaccine in adults ages 18 years and older
  • Updated guidance on COVID-19 vaccination and myocarditis and pericarditis

To view all updates, please visit CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States.


ACIP Recommends Moderna and Pfizer COVID-19 Vaccines for Young Children

The Advisory Committee on Immunization Practices (ACIP) voted unanimously (12-0) on June 18, 2022 to recommend the Moderna and Pfizer COVID-19 vaccines for young children.

  • A two-dose Moderna COVID-19 vaccine series (25ug) is recommended for children ages 6 months – 5 years, under the EUA issued by FDA

    Two doses of 25ug Moderna COVID-19 vaccine, 28 days apart
  • A three-dose Pfizer-BioNTech COVID-19 vaccine series (3ug each) is recommended for children ages 6 month – 4 years, under the EUA issued by FDA

    Three doses of 3ug Pfizer-BioNTech COVID-19 vaccine, 21 days and at least 8 weeks apart  

The Committee expressed strong support for the vaccination recommendation, stating that vaccination shows clear benefit in preventing hospitalization and death.

More details on the approval of both vaccines are available here.


Adult Ancillary Kit Opt-out

  • J&J opt-out is available

  • Moderna opt-out is available

  • Pfizer ADULT opt-out is now available

If you wish to not receive ancillary kits, please indicate this in the notes section of the order screen in SDIIS.



Updated information:

Pfizer-BioNTech COVID-19 Vaccine

Pfizer-BioNTech Resources:


Vaccine Inventory Reminders

Cartons and vials of Pfizer-BioNTech COVID-19 PURPLE Cap vaccine with labeled expiration dates of October 2021 through November 2022 may now be used beyond the printed date. The new updated expiry dates can be found HERE. These vaccines may remain in use until the updated expiration date providing approved storage conditions have been maintained.

We appreciate your efforts to reduce the Pfizer PURPLE Cap vaccine inventory in the field, which continues to decline. Please continue to use Pfizer PURPLE Cap before ordering the Pfizer Tris GRAY Cap. Remember to keep your inventory of the purple and gray cap vials separate to avoid any confusion. Purple cap vials require diluent while gray cap vials do not.


PFIZER WEBINARS FOR HEALTHCARE PROVIDERS
COVID-19 Vaccine Medical Updates and Immunization Site Training


Contact Information: https://www.pfizer.com/contact

Moderna COVID-19 Vaccine Moderna COVID-19 Vaccine Janssen COVID-19 Vaccine

Janssen Website

Shelf Life Extension for the Johnson & Johnson's Janssen COVID-19 Vaccine

The Food & Drug Administration announced the approval of a shelf life extension for the Johnson & Johnson's Janssen COVID-19 vaccine for an additional three months. The shelf life of this vaccine has been updated from 6 months to 9 months. This decision is based on data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 9 months when refrigerated at temperatures of 36° – 46° Fahrenheit (2°– 8° Celsius).

This shelf life extension applies to all inventory dated to expire on March 7, 2022 or later. Vaccine dated prior to March 7, 2022 should be disposed of according to state and local regulation and reported as waste according to your COVID-19 provider agreement. Vaccine providers should visit the Janssen COVID-19 Vaccine Expiry Checker webpage to confirm the expiration dates. This shelf life extension applies to refrigerated vials of J&J/Janssen COVID-19 vaccine that have been held in accordance with the manufacturer's storage conditions.

COVID-19 vaccines that are authorized under an EUA do not have fixed expiration dates, and expiration dates may be extended as we get more stability data. Always check the manufacturer's website to obtain the most up-to-date expiration dates for the COVID-19 vaccines you have on hand.

Janssen Resources:

Contact Information:

VaccineFinder (VF)

As of May 1, 2022, providers must report COVID-19 vaccine supply levels at least WEEKLY by close of business on Fridays. All other provisions regarding data remain unchanged.

Resources:

  • Provider Resources
    • Guides on account creation, inventory reporting, and setting your location to display to the public.

  • Vaccines.gov Reporting
    • Additional information for providers, including check lists for public display on vaccinefinder.org

Contact Information:

VAERS - Vaccine Adverse Event Reporting System

VAERS Website - Healthcare providers are required by law to report to VAERS

Contact VAERS at:

  • Phone: 800-822-7967 | Fax: 877-721-0366 | E-mail: info@vaers.org   

  • For non-urgent concerns, email covid19vaxsafety@cdc.gov. For emergencies relating to COVID-19 vaccine safety, call CDC Emergency Operations Center at (770) 488-7100.

 
V-Safe

v-safe website - CDC is requesting that healthcare providers give patients a v-safe information sheet at the time of vaccination and encourage them to enroll and fill out the surveys when prompted to do so.

Contact Information: Call 800-232-4636 | TTY 888-232-6348 | Open 24 hours, 7 days a week

General Vaccine Guidance and Resources

Pregnancy & Breastfeeding Vaccination Guidance

Pediatric Vaccination Guidance

Vaccination Clinic Guidance

Long-Term Care Facility Guidance

Storage and Handling Guidance

Post-Vaccination Guidance

Fact Sheets & Communication Resources

South Dakota Vaccination Plan

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