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COVID-19 vaccine updates: Bivalent boosters
ICYMI
On August 31, 2022, FDA amended the 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.
Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 (TTY 1-888-720-7489) to find COVID-19 vaccines and boosters near you in the U.S.
New Just a Minute! videos:
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Regulatory science update
On September 6, 2022, FDA published the 2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report, which outlines topics the agency has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making and improve guidance to sponsors.
Public health preparedness and response is a focus area, including medical countermeasures and preparedness for emerging infectious diseases. Learn more: www.fda.gov/FARS
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Emergency Use Authorization (EUA) updates
In vitro diagnostic (test) EUAs
As of September 6, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,108 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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September 8, 2022: FDA Grand Rounds: Polio Vaccines: Past, Present and the Future (webcast, 12:00 - 1:00 p.m. ET) - To discuss the evolution of vaccines against poliomyelitis driven by the change in disease epidemiology, socio-economic circumstances, and advances in biotechnology.
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September 12-13, 2022: DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop (virtual, 5:30 - 9:30 a.m. EDT) - Embracing The Future: Regulatory Considerations And Industry Perspectives On Advanced Manufacturing - FDA's India Office and the Drug Information Association (DIA) India Office will host a two-day workshop on regulatory policies, guidance and support for the adoption of advanced manufacturing technologies.
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September 14, 2022: An Overview of Sentinel’s Publicly Available Analytics Tools webinar (12:00 p.m. ET) - This webinar will explore the resources available in Sentinel for individuals unfamiliar with Sentinel’s analytics tools and the Sentinel Common Data Model. Please register in advance.
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September 19, 2022: FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs (virtual) - The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. Advance registration required.
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September 20-22, 2022: 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium (12:00 - 4:00 p.m. ET, virtual) - To discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. Advance registration required.
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September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) (virtual) - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting is open to all stakeholders at no cost.
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September 27, 2022: FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines (webinar, 1:00 - 2:15 p.m. ET) - To provide an overview of the development and federal regulations for vaccines in the United States, including key statutes that grant FDA authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval.
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October 5, 2022: Study Data Standards Update for CBER: Your Guide to a Successful Submission (webcast, 1:00 - 2:00 p.m. ET) - CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog.
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October 6, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 12:40 p.m. ET) - The committee will meet in open session to discuss strain selection for influenza virus vaccines for the 2023 Southern Hemisphere influenza season.
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New! October 11, 2022: FDA NanoDay Symposium 2022 (webinar) - To address drug development of products that contain nanomaterials in their formulation and how the guidance to industry for products that contain nanomaterials finalized in April 2022 can be implemented in filings to the FDA. Discussion will include case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
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October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
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Information for industry and health care providers
Bivalent COVID-19 booster updates
Check the FDA Moderna COVID-19 Vaccines and Pfizer-BioNTech COVID-19 Vaccines pages for additional information, including:
- A new letter (PDF) to note that Moderna COVID-19 Vaccine, Bivalent for individuals 18+ is supplied in a multiple-dose vial with a dark blue cap and a label with a gray border. It is important to carefully read the labels to differentiate between this and other Moderna COVID-19 vaccines.
- Updated Important Prescribing Information for Vaccine Providers on Vial Presentation Available to Provide Doses for Ages 6 Years Through 11 Years (PDF) to inform vaccination providers that the Moderna vial with dark blue caps and labels with a purple border labeled “BOOSTER DOSES ONLY” is authorized to provide primary series doses (0.5 mL each) for individuals 6 through 11 years of age.
- A new letter to health care providers (PDF) with important prescribing information for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. Comirnaty (COVID-19 Vaccine, mRNA), one formulation of the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, are all supplied in multiple dose vials with gray caps and labels with gray borders. It is important to carefully read the labels to differentiate between the vaccines:
- Comirnaty (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine are for use in individuals 12 years of age and older to provide a primary series.
- The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 12 years of age and older to provide a single booster dose.
As noted on the COVID-19 Bivalent Vaccine Boosters page, with FDA’s authorization:
- The monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Appointments for individuals 12 years of age and older for previously-authorized monovalent Pfizer-BioNTech or Moderna boosters need to be rescheduled for when locations have the bivalent COVID-19 vaccines available.
- Both mRNA monovalent vaccines remain authorized for primary series use, and the monovalent Pfizer-BioNTech COVID-19 vaccine may be used as a single booster dose in individuals 5 through 11 years of age.
FDA safety communication
FDA issued a letter to alert health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets (placements shown by black circles in the pictures above) and can cause potential injuries or death when use of the mask with magnets interferes with certain implanted metallic medical devices or metallic objects in the body.
These potential adverse events can occur in people who use the masks, or people near a person using the mask. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks. (September 6, 2022)
The letter includes:
- A list of recalled masks with magnets.
- Potential risks if magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body.
- Recommendations for health care providers.
- Background on the issue and the FDA’s actions to address the issue.
- Instructions for reporting problems with a recalled mask to the FDA.
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
Resources to keep yourself and others safe from COVID-19
Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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