FDA authorizes Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) for people age 12 and older; CDC recommends use as authorized
On October 3, 2023, the FDA issued emergency use authorization (EUA) of the updated Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula), for people age 12 and older. The monovalent vaccine was updated to include the spike protein from the SARS-CoV-2 Omicron variant lineage XBB.1.5.
At the time of authorization, the Novavax product was automatically included among options recommended for use by CDC under the terms of the September 12 Advisory Committee on Immunization Practices (ACIP) vote for a broad recommendation for all 2023–2024 updated monovalent, XBB-containing COVID-19 vaccines as authorized or approved by FDA. Insurance coverage under Medicaid, Medicare, and all Affordable Care Act-compliant insurance plans is triggered by the FDA authorization.
Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) is authorized for use in people age 12 years and older as follows:
- People previously vaccinated with any COVID-19 vaccine: one dose of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) may be administered at least 2 months after receiving the last previous dose of an original monovalent (Original) or bivalent (Original and Omicron BA.4/BA.5) COVID-19 vaccine
- People not previously vaccinated with any COVID-19 vaccine: two doses of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula), should be administered 3 weeks apart
- Immunocompromised individuals: an additional dose of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) may be administered at least 2 months after the last dose of a COVID-19 vaccine (2023–2024 Formula). Additional doses of Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.
Vaccinators should follow instructions provided within Fact Sheets specific to each COVID-19 vaccine, as well as the guidance in CDC's Interim Clinical Considerations. A standing order template is anticipated to be posted on the CDC website in coming weeks. As part of the October 3 action, Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.
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CDC issues updated standing order templates for 2023–2024 formula COVID-19 mRNA vaccines; standing orders for updated Novavax COVID-19 vaccine to follow
On September 29, CDC issued standing order templates for the 2023–2024 formula Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines. These templates may be adapted for use in any setting where the vaccines are administered. All previous templates should be discarded. The templates include:
Moderna COVID-19 Vaccine (2023–2023 Formula)
Pfizer-BioNTech COVID-19 Vaccine (2023–2024 Formula)
Please note that a standing order template for the Novavax COVID-19 Vaccine, Adjuvanted (2023–2024 Formula), authorized by FDA on October 3, is not yet available from CDC.
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“Use of the Pfizer Respiratory Syncytial Virus Vaccine during Pregnancy for the Prevention of Respiratory Syncytial Virus–Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices—United States, 2023
” published in MMWR Early Release
CDC published Use of the Pfizer Respiratory Syncytial Virus Vaccine during Pregnancy for the Prevention of Respiratory Syncytial Virus–Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices—United States, 2023 on October 6 in MMWR Early Release. The vaccine recommended for use during pregnancy is the same Pfizer RSV vaccine recommended for use in adults age 60 years or older with shared clinical decision-making. A portion of the summary appears below.
Nirsevimab is recommended in infants to prevent respiratory syncytial virus (RSV)-associated lower respiratory tract infection (LRTI). In August 2023, the Food and Drug Administration approved Pfizer RSV vaccine for pregnant persons at 32–36 weeks’ gestation to prevent RSV-associated LRTI in infants aged <6 months. . . .
On September 22, 2023, CDC’s Advisory Committee on Immunization Practices recommended RSV vaccine for pregnant persons at 32–36 weeks’ gestation using seasonal administration (meaning September–January in most of the United States) to prevent RSV-associated LRTI in infants aged <6 months. . . .
CDC recommends protecting all infants against RSV-associated LRTI through use of either the maternal RSV vaccine or infant receipt of nirsevimab.
Access the MMWR article in HTML.
Two studies from CDC's MMWR
show RSV causes serious illness in older adults
On October 6, CDC published two studies in MMWR that confirm that respiratory syncytial virus (RSV) causes serious illness in older adults and highlight the potential value of RSV vaccination in preventing severe illness in this population:
Main points from the CDC media summary appear below.
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- Most RSV-associated hospitalizations in this age group occurred among those 75 and older, and 17% of all patients resided in long-term care facilities. Most patients hospitalized with RSV had one or more underlying medical conditions, such as obesity, chronic obstructive pulmonary disease (COPD), diabetes, or congestive heart failure.
- During February 1, 2022–May 31, 2023, older adults had fewer hospitalizations for RSV than for COVID-19 or flu; however, patients with RSV had more serious outcomes, such as ICU admission and needing standard flow oxygen therapy or advanced respiratory support (high-flow nasal cannula or non-invasive ventilation)
Many changes for fall 2023: review your COVID-19 resources with the latest version of Immunize.org’s “Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools”
Immunize.org reviews and updates the Checklist of Current Versions of U.S. COVID-19 Vaccination Guidance and Clinic Support Tools at least monthly, prominently indicating when it was last revised at the top of the page. The October 6 update includes links to updated CDC and FDA documents related to the 2023–2024 formula COVID-19 vaccines and recommendations for their use:
- Revision of materials related to the updated 2023–2024 formula COVID-19 mRNA vaccines
- Updated CDC interim clinical considerations, at-a-glance vaccine summaries, fact sheets, package inserts, schedules, infographics, and standing order templates
The checklist will be revised once materials for the 2023–2024 Novavax COVID-19 vaccine become available.
All COVID-19 vaccination providers should review the checklist regularly; download the current CDC schedule and standing order documents, and discard all outdated versions. The checklist remains one of Immunize.org’s most in-demand resources, and is posted on Immunize.org's Vaccines: COVID-19 main page.
“Drawing up Vaccine Doses in Advance”: watch the 1-minute answer, part of the Ask the Experts Video Series
on Facebook, LinkedIn, X (Twitter), YouTube, and Instagram
Immunize.org's social media channels make it easy for you to learn a little more every day. This week, our featured episode from the Ask the Experts Video Series is Drawing up Vaccine Doses in Advance. This is available on our YouTube channel, along with our full collection of quick video answers to popular Ask the Experts questions.
Like, follow, and share Immunize.org’s social media accounts and encourage colleagues and others interested in vaccination to do likewise:
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Every American household can once again order four free COVID-19 tests, delivered to their residence
Each United States household can now order one set of four at-home COVID-19 tests at COVID.gov/Tests. One order includes four individual rapid antigen COVID-19 tests that will ship at no charge.
The U.S. government will continue to make COVID-19 tests available to uninsured individuals and underserved communities through existing outreach programs. Please contact a HRSA health center, Test to Treat site, or Increasing Community Access to Testing (ICATT) for COVID-19 location near you to learn how to access low- or no-cost COVID-19 tests provided by the federal government.
Order free COVID-19 tests.
Before you throw out "expired" tests, check FDA's website to see if your COVID-19 tests' expiration dates were extended.
Spotlight: Immunize.org resources focused on influenza vaccination
Immunize.org offers many useful materials on influenza for healthcare professionals and caregivers.
Ask the Experts: Influenza main page offers answers to influenza disease and vaccine-related questions as well as vaccine delivery guidance (e.g., administration, billing, documenting) from Immunize.org experts.
Vaccines: Influenza main page is the one-stop shop for all of Immunize.org's available influenza resources for patients and staff. Important influenza-related resource links include handouts, Vaccine Information Statements (VISs), Ask the Experts popular questions and answers, state laws and mandates, standing order templates, and CDC immunization schedules.
Handouts: Influenza main page offers influenza-specific educational pieces for healthcare professionals and their patients. Check out Communicating the Benefits of Influenza Vaccination, one of Immunize.org's highly recommended handouts on discussing flu vaccination with patients.
Immunize.org also features a companion set to address misunderstandings about influenza vaccination: Not Sure If You Can Get an Influenza Vaccine? for patients and, for healthcare professionals, Talking with Your Patient about Contraindications and Precautions to Influenza Vaccination.
Vaccine Information Statement (VIS) documents are information sheets produced by CDC that explain both the benefits and risks of a vaccine to intended recipients. Translations are available in dozens of languages. Influenza VIS main pages include:
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These recent articles convey the potential risks of vaccine-preventable diseases and the importance of vaccination.
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Moderna offers Bench2Practice, a resource center for healthcare providers to facilitate vaccination discussions with patients; registration required
Moderna is offering Bench2Practice, a website where U.S. healthcare providers can register for a free account to access credible, data-driven information in an aggregated resource center to increase knowledge of vaccines and enhance patient communication. Bench2Practice contains:
- Dashboards that synthesize and visualize data on vaccine update and disease burden
- Educational programs created by leading experts
- Roundtable discussions, informative videos, and role-playing scenarios
- Comprehensive library of resources from global experts
Sign up for access.
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Montgomery County Immunization Coalition (Pennsylvania) releases Halloween-themed social media toolkit and other social media images and text in four languages
Montgomery County Immunization Coalition (MCIC) of Pennsylvania created a social media campaign and toolkit, Say Boo to the Flu, RSV, and COVID Too! The social media campaign contains images and text to make it easy to get the word out to your community about the importance of getting vaccinated before Halloween.
MCIC also created new social media images with sample text to make it easy to get the word out to communities about the importance of getting influenza, COVID-19, and RSV vaccines this season. MCIC worked with its partner organizations to translate the new resources into several languages, including English, Spanish, Chinese, and Korean.
Find the social media images with sample text in MCIC's AmVAXador Library under “Featured Resources."
Please use and share these campaigns across your networks.
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NFID posts podcast episode featuring researcher Carol J. Baker, MD, on developing vaccines and antivirals and conducting clinical trials during pregnancy
Infectious IDeas, a podcast series from the National Foundation for Infectious Diseases (NFID), brings leading experts together for thought-provoking conversations. The latest entry in the series, A Career Dedicated to Protecting Pregnant Mothers and Infants, features Carol J. Baker, MD. A description from the web page appears below.
In this episode, hosts Marla Dalton, PE, CAE, and William Schaffner, MD, talk with Carol J. Baker, MD, a leader in group B Streptococcus prevention and a passionate advocate for maternal immunization to help protect mothers and infants. She shares her perspectives on the most significant changes throughout her career, including the development of vaccines and antivirals as well as the inclusion of pregnant women in clinical trials for vaccines and drugs.
CHOP’s Vaccine Education Center shares “Aluminum & Vaccines: 3 Things to Know” infographic in English and Spanish
Children's Hospital of Philadelphia's (CHOP) Vaccine Education Center (VEC) developed an infographic, Aluminum & Vaccines: 3 Things to Know, that is available in English and Spanish.
VEC offers many infographics (available in PNG and PDF formats) at its Vaccine- and Disease-Related Infographics main page. Each provides a brief overview related to a disease, vaccine, or related topic.
Voices for Vaccines releases podcast with former CDC communications chief Glen Nowak on analyzing vaccine communication
Voices for Vaccines (VFV) posted a new entry in its Vax Talk podcast series: Vaccine Communication Breakdown featuring Glen Nowak, PhD, former CDC communications chief and risk-communication expert. A description from the VFV web page appears below.
In this episode, we break down vaccine communication, from the days of “Let the Science Speak for Itself” to the political partisanship of the pandemic.
Order Immunize.org’s child, adult, and lifetime immunization record cards—wallet-sized, designed to last!
Immunize.org's personal immunization record cards, printed on rip-proof, smudge-proof, water-proof paper, are designed to last a lifetime. They fit in a wallet when folded. The record cards are for you to give to your patients as a permanent personal vaccination record and are sold in boxes of 250.
Make bulk purchases and receive quantity discounts. For quotes on larger quantities or customizing, or to request sample cards, call 651-647-9009 or email email@example.com.
“COVID-19–Associated Hospitalizations among U.S. Adults Aged ≥65 Years—COVID-NET, 13 States, January–August 2023
” published in MMWR
CDC published COVID-19–Associated Hospitalizations among U.S. Adults Aged ≥65 Years—COVID-NET, 13 States, January–August 2023 on October 6 in MMWR. A portion of the summary appears below.
Adults aged ≥65 years have increased risk for COVID-19–associated hospitalization and other severe outcomes compared with younger age groups. . . .
During January–August 2023, adults aged ≥65 years accounted for 62.9% of all COVID-19–associated hospitalizations. Most hospitalized adults aged ≥65 had multiple underlying conditions. Only 23.5% had received the recommended COVID-19 bivalent vaccine. . . .
Adults with increased risk for COVID-19–associated hospitalization, including all adults aged ≥65 years, should reduce their risk for severe COVID-19 by receiving recommended COVID-19 vaccinations, adopting measures to reduce risk for contracting COVID-19, and seeking prompt outpatient antiviral treatment after a positive SARS-CoV-2 test result.
Access the MMWR article in HTML or PDF.
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“Disparities in COVID-19 Vaccination Status among Long-Term Care Facility Residents—United States, October 31, 2022–May 7, 2023
” published in MMWR
CDC published Disparities in COVID-19 Vaccination Status among Long-Term Care Facility Residents—United States, October 31, 2022–May 7, 2023 on October 6 in MMWR. A portion of the summary appears below.
Long-term care (LTC) facility residents are vulnerable to SARS-CoV-2 infection because of their advanced age, medical complexity, and congregate living situation; vaccination is an effective means for reducing COVID-19 incidence in this population. . . .
COVID-19 vaccination coverage among residents of participating LTC facilities within the National Healthcare Safety Network differed by race and geography. Bivalent COVID-19 vaccination rates were lowest among LTC facility residents in the South and Southeast U.S. regions and among Black or African American and multiracial residents. . . .
Strategies aimed at increasing COVID-19 vaccination coverage should consider these demographic disparities to develop and implement targeted strategies to reduce inequities in COVID-19 morbidity and vaccination coverage.
Access the MMWR article in HTML or PDF.
“Updated Guidance regarding the Risk of Allergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment and International Consensus Approach” published in Journal of Allergy and Clinical Immunology
In the June 7 issue, Journal of Allergy and Clinical Immunology published Updated Guidance regarding the Risk of Allergic Reactions to COVID-19 Vaccines and Recommended Evaluation and Management: A GRADE Assessment and International Consensus Approach. A portion of the article appears below.
Though immediate, severe COVID-19 vaccine allergic reactions occur rarely, many health authorities around the world contraindicate vaccinating persons with a history of allergy to the vaccine or its excipient. However, this may not be necessary in the majority of instances. Additional data have emerged since the 2021 publication, providing evidence to evolve recommendations made earlier in the pandemic. This updated guidance specifically focuses on the approach to assessing a patient with a history of mRNA COVID-19 excipient allergy or an immediate presumed allergic reaction to a dose of a mRNA COVID-19 vaccine, in determining whether an initial or additional doses should be given and how to assess such patients.
"Unexpected Vaginal Bleeding and COVID-19 Vaccination in Nonmenstruating Women" published in Science Advances
In the September 22 issue, Science Advances published Unexpected Vaginal Bleeding and COVID-19 Vaccination in Nonmenstruating Women. The abstract appears below.
The association between coronavirus disease 2019 (COVID-19) vaccination and vaginal bleeding among nonmenstruating women is not well studied. The Norwegian Institute of Public Health followed several cohorts throughout the pandemic and early performed a systematic data collection of self-reported unexpected vaginal bleeding in nonmenstruating women. Among 7725 postmenopausal women, 7148 perimenopausal women, and 7052 premenopausal women, 3.3, 14.1, and 13.1% experienced unexpected vaginal bleeding during a period of 8 to 9 months, respectively. In postmenopausal women, the risk of unexpected vaginal bleeding (i.e., postmenopausal bleeding) in the 4 weeks after COVID-19 vaccination was increased two- to threefold, compared to a prevaccination period. The corresponding risk of unexpected vaginal bleeding after vaccination was increased three- to fivefold in both nonmenstruating peri- and premenopausal women. In the premenopausal women, Spikevax was associated with at 32% increased risk as compared to Comirnaty. Our results must be confirmed in future studies.
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“Maternal Pertussis Vaccination, Infant Immunization, and Risk of Pertussis” published in Pediatrics
On October 9, Pediatrics published Maternal Pertussis Vaccination, Infant Immunization, and Risk of Pertussis. A portion of the abstract appears below.
Following the introduction of jurisdictional maternal pertussis vaccination programs in Australia, we estimated maternal vaccine effectiveness (VE) and whether maternal pertussis vaccination modified the effectiveness of the first 3 primary doses of pertussis-containing vaccines. . . .
Pertussis vaccination near 28 weeks’ gestation was associated with lower risk of infection among infants through 8 months of age. Although there was some evidence of lower effectiveness of infant vaccination among maternally vaccinated infants, this did not appear to translate to greater risk of disease.
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WHO recommends R21/Matrix-M vaccine for prevention of malaria in children
On October 2, World Health Organization (WHO) recommended a new vaccine, R21/Matrix-M, for the prevention of falciparum malaria in children. The recommendation followed advice from WHO's Strategic Advisory Group of Experts on Immunization (SAGE) and Malaria Policy Advisory Group (MPAG), and was endorsed by the WHO Director-General. The vaccine was developed by the University of Oxford and the Serum Institute of India, using a Novavax adjuvant. A portion of the news release appears below.
The R21 vaccine is the second malaria vaccine recommended by WHO, following the RTS,S/AS01 vaccine, which received a WHO recommendation in 2021. Both vaccines are shown to be safe and effective in preventing malaria in children and, when implemented broadly, are expected to have high public health impact. Malaria, a mosquito-borne disease, places a particularly high burden on children in the African Region, where nearly half a million children die from the disease each year.
Demand for malaria vaccines is unprecedented; however, available supply of RTS,S [Mosquirix, GSK] is limited. The addition of R21 to the list of WHO-recommended malaria vaccines is expected to result in sufficient vaccine supply to benefit all children living in areas where malaria is a public health risk. . . .
At least 28 countries in Africa plan to introduce a WHO-recommended malaria vaccine as part of their national immunization programmes. Gavi, the Vaccine Alliance has approved providing technical and financial support to roll out malaria vaccines to 18 countries. The RTS,S vaccine will be rolled out in some African countries in early 2024, and the R21 malaria vaccine is expected to become available to countries mid-2024.
Virtual: Pfizer offers educational webinars “Pfizer RSV Vaccine – A New Maternal Indication” Tuesdays, Wednesdays, and Thursdays through October 19
Only one RSV vaccine is approved and recommended during pregnancy. Pfizer’s Vaccines U.S. Medical Affairs team is providing several webinars titled Pfizer RSV Vaccine – A New Maternal Indication, Tuesdays, Wednesdays, and Thursdays through October 19. These live sessions include topics:
- RSV burden of disease in infants
- Mechanism of maternal immunization
- ACIP recommendations and clinical considerations
- Clinical trial data: safety and efficacy
- Question and answer session
Additional live sessions may be added, so check the website for the latest schedule. On-demand content will be made available soon.
This event will not offer continuing education.
View schedules, resources, and register for the webinar
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Virtual: Watch October 25–27 ACIP meeting. Topics include immunization schedules and eight vaccine-preventable diseases.
CDC will convene an extended, 3-day meeting of the Advisory Committee on Immunization Practices (ACIP), October 25–27, starting at 8:00 a.m. (ET). ACIP will discuss child and adolescent immunization schedules, adult immunization schedule, influenza, chikungunya, COVID–19, meningococcal, mpox, pneumococcal, and polio vaccines, as well as RSV vaccines for older adults. Votes on immunization schedules, meningococcal vaccines, and mpox vaccine are scheduled.
No registration is required to watch webcasts of live ACIP meetings or listen via telephone. Opportunities for public comment are described on the website.
- ACIP main page for access to webcast, agendas
- ACIP: Meeting Information for presentation slides, content from previous meetings, and information about future meetings
Hybrid: Clinical Care Options hosts webinar “Ready, Set, Vaccinate! Clinical Implementation of RSV Vaccination for Older Adults” on October 26 at 7:30 p.m. (ET); CME, CNE, and CPE available
Clinical Care Options (CCO) is offering a webinar titled Ready, Set, Vaccinate! Clinical Implementation of RSV Vaccination for Older Adults, 6:30–8:00 p.m. (CT) on October 26, virtually and in-person in Chicago, IL. Join expert faculty as they discuss the burden of respiratory syncytial virus (RSV), approaches for differentiating RSV from other respiratory viruses, and integrating the latest data and guideline recommendations for RSV vaccines in older adults.
Free CME, CNE, and CPE are available for this event.
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Register for the webinar.