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Welcome to the COVID-19 Vaccine Partner Newsletter! Here you'll find the latest news and information on COVID-19 vaccine related topics.
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Q: THERE HAS BEEN SO MUCH VACCINE NEWS THIS WEEK. WHAT DO I NEED TO KNOW?
A: It's certainly been a busy week in the world of COVID-19 vaccines! We've got lots of information in this newsletter, but here's a simple list of the most important things you need to know right now.
- Current monovalent mRNA COVID-19 vaccines are no longer authorized for use as boosters in individuals 12 years and older.
- The FDA authorized two bivalent COVID-19 vaccines for use as a booster dose; Moderna for 18+ and Pfizer-BioNTech for 12+.
- The bivalent vaccines contain an mRNA component from the original strain and and mRNA component in between the more recent Omicron BA.4 and BA.5 variant.
- A person is eligible to receive a bivalent booster if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
- The CDC recommend the updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.
- Novavax is now approved for use in people 12+.
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THE BIVALENT OMICRON BOOSTER VACCINE
NOW AUTHORIZED AND RECOMMENDED
FDA Authorization
On Wednesday, August 31, 2022, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Check out this video from Dr. Peter Marks to learn about the data that support their use.
Read the full FDA New Release
CDC, ACIP Recommendation
Yesterday, on September 1, 2022, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.
In the coming weeks, CDC also expects to recommend updated COVID-19 boosters for other pediatric groups, per the discussion and evaluation of the data by ACIP on Sept. 1, 2022.
Read the full CDC Media Statement
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 WHEN CAN PROVIDERS START ADMINISTERING THE OMICRON BIVALENT BOOSTER?
Now that the new COVID-19 bivalent booster dose has progressed through the formal approval process, there is one final piece needed before Washington state health care providers can administer the vaccine. Standing Orders are being finalized now and are expected to be published soon. Keep an eye out for a notification from the Washington State Department Health (DOH) letting you know when they are available!
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UPDATED! BOOSTER DOSE MESSAGING AND OUTREACH TOOLS
The Public Health Communication Collaborative has updated their communications resources — including topline talking points, answers to tough questions, sample social media posts and graphics — to you answer questions about updated COVID-19 booster doses and support your local vaccination outreach.
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COVID-19 VACCINE FORWARD SURVEY
The Washington State Department of Health (DOH) has committed in the state’s ForWArd Plan to supporting vaccination efforts throughout the state. We are committed to maintaining the system-wide capacity to administer 30,000 doses of COVID-19 vaccines per day and the ability to surge to 60,000 doses daily within seven days as needed. A survey will be used to measure the maximum capacity, on a monthly basis, that enrolled COVID-19 Vaccine Providers have to administer COVID-19 vaccines to patients.
Thank you for your participation in the August COVID-19 Provider Capacity survey. Your answers in the last survey showed that we are ready to meet this goal in the ForWArd Plan! Please take a few moments to answer the questions in the next survey to help us measure provider capacity to meet these state goals. The survey was sent on September 1st and will be closing on September 13th.
Please contact us at COVID.Vaccine@doh.wa.gov if you have any questions about this survey.
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 LABOR DAY 2022 HOLIDAY SCHEDULE
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NOVAVAX 12+ STANDING ORDERS NOW AVAILABLE
On Friday, August 19, 2022, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted in individuals 12 through 17 years of age and following, on Monday, August 22, 2022, the CDC recommended the vaccine as another primary series option for this age group.
The Washington State Health Department has published new Standing Orders for Novavax 12+ which can be found on the DOH website.
For more information and other Standing Orders, please visit the Clinical Information for COVID-19 Vaccine Providers page on the DOH website.
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BIVALENT BOOSTER ORDERING
- Ordering for the COVID-19 Pfizer-BioNTech bivalent booster will reopen in the Immunization Information System (IIS) next week on Tuesday, September 6.
- We expect to receive additional allocations of the Pfizer-BioNTech vaccine each week through September.
- The bivalent vaccine may only be administered as a booster dose.
- Only order the number of doses you feel you can administer within 2 weeks.
- Orders are approved on Mondays and Thursdays.
Per the CDC, we are unlikely receive additional Moderna bivalent vaccines until the week of September 12th. Ordering for this product will remain off until further notice. In the future, orders for this product may need to be decreased or denied until the program begins to regularly receive vaccines.
The office will be closed, and no vaccine orders will be delivered, on September 5 in observance of Labor Day.
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IMPLEMENTATION FOR BIVALENT COVID-19 VACCINE BOOSTERS
In preparation for bivalent booster dose administration, there are important details to be aware of.
- The vials are very similar to the original formulations; the only difference is the name of the vaccine on each vial - see photo above
- Both manufacturers' bivalent vaccines have grey label borders, but different injection volume
- Pfizer-BioNTech vaccine labels for both the monovalent and bivalent vials will have an identical grey cap/grey label border presentation
- Moderna bivalent vaccine will have dark blue cap/grey label border (similar to monovalent product for ages 6-11 years)
- Will be different from the red cap/light blue label border for the adult monovalent vaccine)
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BEFORE ADMINISTERING THE BIVALENT VACCINE...
Before you administer the new bivalent booster dose, here are a few suggestions to ensure the appropriate vaccine formulation is being used:
- Verify completion of primary series prior to initiating booster
- Check in IIS
- Use COVID-19 card
- Other medical documentation to verify (EHR)
- Verify product for each patient
- Separate booster vials from primary dose vials
- Both manufacturers are using similar labeling for booster and primary series vials
- Read the labels! Both manufactures have "Bivalent" on their labels
- Label syringe after draw, adding “bivalent” to label
- Document vaccination as Bivalent Pfizer-BioNTech or Moderna Booster
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STORAGE & HANDLING INFORMATION
For quick reference, below are the storage and handling instructions for FDA-authorized COVID-19 vaccines. They include recent updates for bivalent boosters.
The bivalent boosters have the same storage and handling parameters as the monovalent vaccine products.
- Novavax
- Pfizer-BioNTech
- Moderna
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TRAINING ON PFIZER-BIONTECH BIVALENT BOOSTERS
Pfizer Medical is offering virtual training for providers on the COVID-19 bivalent booster vaccine, authorized for individuals 12 years of age and older. To access dates and links for upcoming training sessions, visit the Pfizer website.
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DID YOU MISS THE ACIP MEETING?
In case you were unable to attend, yesterday the Advisory Committee on Immunization Practices (ACIP) met to provide updates on the SARS-CoV-2 variants, effectiveness of the COVID-19 vaccines, review the evidence to recommend (EtR) framework for the Pfizer-BioNTech and Moderna COVID-19 bivalent booster doses, and vote.
To review the materials that were presented, visit the CDC website.
The next ACIP meeting is scheduled for October 19-20, 2022.
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FOR SCHOOLS AND CHILD CARE FACILITIES
FOR LONG-TERM CARE FACILITIES
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SIGN UP FOR THIS NEWSLETTER!
If you aren't already signed up for the COVID-19 Vaccine Partner Newsletter, please visit the Department of Health's email subscribers page here. Once you enter your email, on the next page expand the Immunization topic, select the COVID-19 Vaccine Partner Newsletter, and click submit.
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This newsletter summarizes content from the week of August 28, 2022 and was sent out on September 2, 2022. |
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