Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses among Children Aged 5-11 Years—United States, October 1, 2022–January 1, 2023” published in MMWR
After CDC’s October 2022 recommendation for bivalent COVID-19 booster vaccination for children aged 5–11 years, children in this age group received approximately 953,359 bivalent booster doses during October 12, 2022–January 1, 2023.
Early safety findings from v-safe and the Vaccine Adverse Event Reporting System (VAERS) for bivalent booster vaccination in children aged 5–11 years are similar to those described for monovalent booster vaccination. Most VAERS reports represented vaccine errors rather than adverse events. Neither myocarditis nor death were reported after bivalent booster vaccination. These preliminary safety findings should be provided when counseling parents or guardians about bivalent booster vaccination. All eligible persons should receive a bivalent booster dose.
Access the MMWR article in HTML or PDF.
Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness
What is already known about this topic?
The SARS-CoV-2 Omicron BA.2-related sublineage XBB.1.5 is gaining predominance nationwide. Vaccine effectiveness against XBB and XBB.1.5 is unknown.
What is added by this report?
Using spike (S)-gene target presence as a proxy for BA.2 sublineages, including XBB and XBB.1.5, during December 2022–January 2023, the results showed that a bivalent mRNA booster dose provided additional protection against symptomatic XBB/XBB.1.5 infection for at least the first 3 months after vaccination in persons who had previously received 2–4 monovalent vaccine doses.
What are the implications for public health practice?
As new SARS-CoV-2 variants emerge, continued vaccine effectiveness monitoring is important. All persons should stay up to date with recommend COVID-19 vaccines, including receiving a bivalent booster dose when eligible.
Single-Dose Vials: A Success Story-CDC
On November 14, 2022, HHS opened ordering to jurisdictional and federal entity administration partners for a limited amount of the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine for people 12 years of age or older in single-dose vials (SDVs).
SDVs provide administration partners with greater flexibility in their vaccine distribution strategy. Administration partners have used SDVs to expand access at doctors’ offices and community health centers that have consistently low or irregular patient traffic or might not otherwise offer the COVID-19 vaccine. SDVs are a one-for-one match for potential customers, making them particularly useful in locations where few doses are administered each day, such as rural areas. Thus, SDVs increase access to COVID-19 vaccine while also reducing waste.
The Pfizer SDV product is customer-friendly and ready for commercialization:
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Minimum order quantity of 50 doses.
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Ready to use (no diluent and no need for low-dead-volume syringes & needles).
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Storage and handling improved to allow 10 weeks in a refrigerator.
This is a vast improvement over Pfizer’s multi-dose vials from earlier in the COVID-19 response:
- Minimum order quantities of 975 – 1170 doses.
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Not ready to use (preparation with diluent was required).
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Storage and handling requirements that were never seen before (ultra-low temperatures).
With Pfizer SDVs being easier to use, the burden of vaccine redistribution no longer falls on Public Health hubs and depots. SDVs can now be shipped directly to small providers. Over 2,500 providers have ordered over half a million doses of the SDVs since it became available in November 2022. Providers ordering SDVs do not need to be served by a hub & spoke operation. Over the past two years, more than 40,000 providers received vaccines from their local health department or state-supported hub & spoke depot.
Since distribution began, a primary concern of the COVID vaccine provider network has been reducing waste from multi-dose vials. By July 2021, all channels of distribution and administration began requesting SDVs and pre-filled syringes as demand plummeted. With Pfizer’s SDV product, providers can administer doses to individual patients without worrying about doses being wasted at the end of day.
Monovalent Pfizer EUA to BLA
Based on current ordering patterns, the remaining inventory of Pfizer adult monovalent EUA-labeled vaccine is expected to be depleted in the coming weeks. However, there will be no loss to the overall availability of Pfizer monovalent vaccine for people aged 12 years and older.
EUA-labeled Pfizer monovalent vaccine (NDC 59267-1025-04) will no longer be available for ordering after 9:00 a.m. ET on Tuesday, January 31, 2023. Awardees will order the BLA-labeled (COMIRNATY) product (NDC 00069-2025-10). Pfizer BLA-labeled vaccine is interchangeable with the EUA-labeled product and has received the same shelf-life extension as the EUA-labeled product.
Current Vaccine Thresholds-CDC
Monovalent vaccines have transitioned to open ordering without thresholds. Orders are still limited to 10,000 doses per order. Out-of-cycle (OOC) requests are no longer necessary for monovalent products.
Thresholds remain in effect for all bivalent vaccines:
- Weekly threshold top-offs will be applied to multidose vial (MDV) bivalent vaccines for people aged 5 years and older.
- Monthly threshold top-offs will be applied to Pfizer’s single-dose vial (SDV) bivalent vaccine for people aged 12 years and older.
Remember, urgent needs can be fulfilled by OOC requests. In addition, pharmacies may submit OOCs requests for Pfizer SDVs. This is encouraged so long as the need is justified.
Presidents’ Day Deliveries – February 20th
The schedule for COVID-19 vaccine deliveries on Presidents’ Day (Monday, February 20th) will be business as usual. If you plan to be closed on Presidents’ Day and would like to hold your deliveries, you must notify Pfizer or McKesson no later than Wednesday, February 15th.
Please send an email requesting your orders be held to the addresses below:
Vaccine Medical Trainings
CDC Releases Two Respiratory Disease Dashboards
COVID-19, influenza, and respiratory syncytial virus (RSV) can cause severe disease resulting in preventable deaths, thousands to hundreds of thousands of hospitalizations, and millions of illnesses each year in the United States. This combined disease burden can impose a strain on healthcare systems during periods of intense circulation or cocirculation. We know that access to timely data is critical for understanding trends in virus circulation, estimating disease burden, and responding to outbreaks. While CDC tracks COVID-19, flu, and RSV hospitalizations through sentinel surveillance systems, until now, there has not been one place to find integrated data on all three viruses.
The CDC released two dashboards to aid in data collection. First, the Respiratory Virus Hospitalization Surveillance Network (RESP-NET) interactive dashboard comprising data from three networks that conduct population-based surveillance for laboratory-confirmed COVID-19, influenza, and RSV -associated hospitalizations among children and adults. The networks gather data from acute care hospitals in select counties in 13 states covering more than 29 million people and include an estimated 8-10 percent of the U.S. population.
Second, the CDC is also releasing another dashboard that provides a view of emergency department visit data for multiple respiratory diseases tracked by the National Syndromic Surveillance Program (NSSP). NSSP is a collaboration between CDC, federal partners, state and local health departments, and academic and private sector partners to collect, analyze, and share electronic data received from multiple health care settings. Data are monitored for a subset of emergency departments across the United States. By tracking symptoms of patients in emergency departments—before a diagnosis is confirmed—public health can detect unusual levels of certain respiratory illnesses, which can serve as an early warning system for troubling increases or outbreaks.
Monovalent Thresholds (CDC News)
On Tuesday, January 3, 2023, thresholds were removed for Pfizer, Moderna, J&J and Novavax vaccines listed below.
For these monovalent vaccines that are no longer under threshold, awardees/partners can order using the same process as other routine vaccines as Vtrcks no longer applies any threshold-related business rules to orders.
While there are no thresholds for these COVID vaccines, orders are still limited to 10,000 doses per order. This standard ordering rule still applies in the CDC vaccine ordering systems in an effort to minimize ordering errors.
See Chart Below
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Material (NDC)
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Material (NDC) Description/Brand Name
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00069-2025-10
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COV-19; MDV6; 10-pack/Comirnaty
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59267-0078-04
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COV-19 (Pfizer);(PED 6m-4y) MDV10;10-pk
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59267-1025-04
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COV-19 (Pfizer); TRIS; MDV6; 10-pack
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59267-1055-04
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COV-19 (Pfizer);(PED 5-11) MDV10;10-pk
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59676-0580-15
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COV-19 (Janssen); MDV5; 10-pack
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80631-0100-10
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COV-19 (Novavax); MDV10; 10-pack
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80777-0273-99
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COV-19 (Moderna); MDV10; 10-pack
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80777-0275-99
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COV-19 (Moderna); MDV5; 10-pack
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80777-0279-99
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COV-19 (Moderna)(PED 6m-5y) MDV10;10-pack
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All monovalent vaccines are now correctly displaying 0s in the Order Thresholds by NDC table. We also added a note for clarification.
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New Initiative to Increase COVID-19 Vaccination among Older Adults in Long-term Care Settings
As we enter the winter months with increasing cases of respiratory diseases, including COVID-19, we need your help to encourage older adults to receive the updated (bivalent) COVID-19 boosters, especially those living in long-term care settings (LTC).
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