COVID-19 Novavax Vaccine Ordering Open
On July 13, 2022, Novavax’s COVID-19 vaccine received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a two-dose primary series to individuals 18 years of age and older. Subsequently, on July 19, 2022, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) made recommendations that Novavax’s COVID-19 vaccine be used as another primary series option for adults ages 18 years and older. The CDC Director, Rochelle P. Walensky, MD, MPH, endorsed ACIP’s recommendations for the Novavax COVID-19 vaccine.
Novavax’s COVID-19 vaccine is now available for open ordering through the Vaccine Allocation & Ordering System (VAOS).
- The Novavax COIVD-19 vaccine is a protein-subunit vaccine. It is authorized for 18 years and older 2-dose primary series, administered 21 days apart.
- Maximum benefit from the vaccine is 2 weeks following the second dose.
- The Novavax COVID-19 vaccine should be stored in standard refrigerator conditions between 36-46° F (2-8° C).
-
Do NOT freeze this vaccine.
- Store vaccine in the original carton and protect from light.
- This vaccine MUST be discarded 6 hours after first puncture. (The vaccine is preservative free and does not require reconstitution or dilution.)
- The Novavax COVID-19 vaccine should be administered intramuscularly (IM).
- Each multiple-dose vial contains 10 doses.
- Dose: 0.5 mL should be administered for each dose.
- No dilution is required for this vaccine presentation.
- To find the expiration date, access www.NovavaxCovidVaccine.com, navigate to the United States Healthcare Professional section of the website, and enter the lot number printed on the carton or vial into the “Expiry Date Checker” tool.
There are currently no limitations on ordering, and orders will be accepted daily.
A full pack size order is 100 doses (10 vials). If providers would like to place a smaller order than the minimum pack size, the order should be made in increments of 10 doses (1 vial). Note, smaller orders will take a longer time to be delivered.
Considerations prior to ordering:
- As per COVID-19 policy, providers who have not reported their monthly inventory will be unable to order vaccine until they have completed this requirement in VAOS.
- Ensure your data logger certificates comply. Current data logger certificates are required to place orders in VAOS.
- More information to come on the Novavax COVID-19 vaccine order, ancillary kits.
Resources:
- Access the Novavax COVID-19 Vaccine Fact Sheet here.
- Access the Novavax Patients Fact Sheet here.
For any questions, email: COVID19VacShipments@dshs.texas.gov
COVID-19 Vaccine FAQ’s
Below are some frequently asked questions relating to the COVID-19 Vaccine:
Q: When will the fact sheets for the 6 months to 5-year-old vaccines be updated to Spanish?
A: Factsheets are available in various languages and can be found by utilizing the links in the article below “Reminder: COVID-19 Vaccine Translation Fact Sheets” in this e-Digest. For convenience, a compilation of all fact sheets can also be found in the resources section of every Texas Provider Webinar slide presentation.
Q: Where can I find the billing CPT codes for the Moderna and Pfizer Covid Vaccines?
A: We encourage providers to visit the centers for Medicare and Medicaid Services resource which includes CPT and CMS codes for the COVID-19 vaccines. The American Medical Association (AMA) has published an update to the CPT code set that includes new vaccine-specific codes to report immunizations.
Q: Texas Medicaid does not list Moderna 6 months to 5-year-olds (CPT 0111A and 0112A). Will the CPT for the Pfizer COVID vaccine 6 months to 4-year-olds be on Medicaid? All administration codes are saying not valid and will not pass through Availity to the insurance companies.
A: Yes, coverage has been added for the administration of both the Pfizer-BioNTech (procedure codes 0081A, 0082A, 0083A) and Moderna (procedure codes 0111A, 0112A, 0113A) COVID-19 vaccines for individuals 6 months through 4 and 5 years of age, respectively. Note that the actual vaccines (procedure codes 91308 and 91311) are informational only while the vaccines are distributed to providers free of charge. A provider notification is forthcoming and will be published on tmhp.com. Providers can reach out to the Medical and Dental Benefits Policy mailbox if they have further questions regarding Medicaid medical and dental benefits.
Q: We just received a shipment of 6 months to 4-year-old Pfizer vaccines and on the shipping label the expiration date is 12/31/22. Do we go by what the shipping label says of 10 weeks from when the shipment was received?
A: 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.
Q: I have a patient who had only 1 Pfizer COVID-19 vaccine on 02/2021 and never received the second dose. Should I restart the series or continue the series with second dose followed with a booster 5 months? What do I do if a patient misses the second dose, and comes in for second vaccine weeks/months overdue?
A: Do not restart the series or repeat the vaccine dose. There is no maximum interval. Doses administered at any time after the recommended interval are valid.
Q: What do we need to do if a child 6 months to 4 years receives different mRNA products for their dose 1 and dose 2 of the primary series?
A: Children ages 6 months to 4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered 8 weeks after the second dose to complete the 3-dose primary series.
COVID-19 Vaccine VAOS FAQ’s
Below are some frequently asked questions relating to the COVID-19 Vaccine for VAOS:
Q: In my new turnover role, I have now been assigned to be responsible for all COVID-19 vaccine orders for my organization. How do I update my coordinators in VAOS?
A: Providers are encouraged to reach out to the VacEnroll team (COVID19VacEnroll@dshs.texas.gov) to update coordinators in VAOS. Be sure to include the following:
- Provider Pin
- Org Code
- Full name of coordinator(s) replaced
Q: I tried to submit an order in VAOS, but it has been denied. Why am I not able to process my orders?
A: There are typically two reasons why ordering privileges have been paused. Ensure the following are in compliance with the DSHS COVID-19 Program requirements:
- Valid datalogger certificate is on file with the VacEnroll (COVID19VacEnroll@dshs.texas.gov) team.
- All COVID-19 vaccine inventory is self-reported into VAOS by the 5th of each month.
Q: Do I need to re-add my COVID-19 inventory to VAOS every month? Do inventory amounts transfer from month to month? What if my inventory has not changed from last month? How do I reconcile inventory in VAOS?
A: If you have previously reported your presentations, you do not need to add the presentation again each month. If there are any changes to your vaccine inventory, update “Reported Quantity on Hand” for the selected vaccine type and select “Save.”
Q: I am a dual provider; can I upload the same temperature log in VAOS for both routine and COVID-19 vaccines?
A: Providers do not need to upload a temperature log for COVID-19 vaccine ordering. Uploading a temp-log is not required for COVID-19 vaccine ordering.
Q: How do I dispose expired COVID-19 vaccines? How should I report any waste?
A: Waste should only be reported if a dose or vial goes bad once it is within the provider’s possession. Wasted vaccines are to be treated like any other medical waste. Following the TCEQ’s guidance on disposal of COVID-19 medical waste, dispose of needles and associated vials in a clearly labeled sharps container, treating it as a contaminated biohazard container. Wipe down and sanitize the work area. After disposing of vaccine, take off and dispose gloves, and thoroughly wash hands with soap and water for at least 20 seconds or use an alcohol-based hand sanitizer that contains at least 60% alcohol.
- From Providers: If COVID-19 vaccines are wasted, providers need to report the waste in VAOS and then dispose of the vaccines.
- To the CDC: DSHS then takes all the waste reported in VAOS and reports it directly to the CDC on behalf of providers.
Reminder: COVID-19 Vaccine Translation Fact Sheets
Providers can access the translated COVID-19 Vaccine Fact Sheets using the links below:
Translations of the Pfizer-BioNTech Fact Sheet for Recipients and Caregivers | FDA:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#translated
Pfizer Maroon Cap Recipient/Caregiver Fact Sheet (SPANISH):
https://www.fda.gov/media/159762/download
Translations of the Moderna/Spikevax™ Fact Sheet for Recipients and Caregivers | FDA:
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/spikevax-and-moderna-covid-19-vaccine#translated
Moderna/ Spikevax™ Magenta Border Recipient/Caregiver Fact Sheet (SPANISH):
https://www.fda.gov/media/159774/download
Moderna/ Spikevax™ Teal & Purple Border Recipient/Caregiver Fact Sheet (SPANISH):
https://www.fda.gov/media/159779/download
Reminder: Monkeypox & COVID-19 Vaccination Schedule
Smallpox/monkeypox vaccine (JYNNEOS™) may be given at the same time as other vaccines. Certain people at increased risk of myocarditis (swelling of the heart muscle), including adolescent or young adult males, might consider waiting 4 weeks after JYNNEOS™ vaccination before getting an mRNA COVID-19 vaccine.
Visit the DSHS Monkeypox webpage for questions related to Monkeypox.
Expert Tip! COVID-19 Vaccination Schedules
Use the schedules here to determine how many total COVID-19 vaccine doses are recommended based on primary series product, age, and immune status. This schedule does not include clinical details necessary for administering COVID-19 vaccines. For clinical details, see the resources below.
|
