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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- August 31, 2022: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose - Also see: COVID-19 Bivalent Vaccine Boosters (new page)
- August 30, 2022: FDA Roundup including a safety communication to alert patients, caregivers and health care providers that Philips Respironics recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP or BPAP) machines that may contain a plastic contaminated with a non-compatible material
- August 29, 2022: Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation
- August 26, 2022: FDA Roundup including approval of a single dose vial presentation of Comirnaty (COVID-19 Vaccine, mRNA)
- August 26, 2022: FDA updated Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab for the Treatment of COVID-19 (PDF) to revise information about distribution of this product
- August 26, 2022: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply
- August 26, 2022: FDA updated the Paxlovid Patient Eligibility Screening Checklist and Drug Interaction Tool (PDF) for prescribers, to add additional drugs
- August 26, 2022: The FDA material threat medical countermeasure priority review voucher (MCM PRV) web page has been updated to include a table listing redeemed MCM PRVs
- August 25, 2022: FDA's Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) published its FY2021 Report on the State of Pharmaceutical Quality (PDF) to provide information on the quality of the U.S. drug supply and OPQ’s quality surveillance during COVID-19
- August 19, 2022: Sentinel Initiative report: Differences in COVID-19 Testing, Positivity, Hospitalization, and Mortality by Race and Ethnicity in the Sentinel Distributed Database: A Descriptive Analysis
Quick links: COVID-19 updates from FDA, FDA Monkeypox Response
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COVID-19 vaccine updates
 FDA authorizes Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose
Watch live today: FDA will host a media call live on YouTube at 10:45 a.m. ET, August 31, 2022
Today, 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. The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.
The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.
With today’s authorization, FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. (August 31, 2022)
Comirnaty single-dose vial
FDA approved (PDF) a single-dose vial presentation of Comirnaty (COVID-19 Vaccine, mRNA). The single-dose vials have gray caps and labels with gray borders, and the vaccine must not be diluted before use. Each vial contains 1 dose of 0.3 mL. This presentation is approved for use in individuals 12 years of age and older. Comirnaty is manufactured by Pfizer Inc. for BioNTech Manufacturing GmbH. (August 25, 2022)
Updated fact sheet translations
An updated Fact Sheet for Recipients and Caregivers (PDF) for the Novavax COVID-19 Vaccine, Adjuvanted is now available in five additional languages. (August 26, 2022)
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Monkeypox response updates
Important information for human cell, tissue, and cellular and tissue-based product (HCT/P) establishments
FDA is working closely with the CDC and other federal and international agencies to monitor reports of monkeypox and populations at greatest risk of infection. FDA issued a communication to provide information regarding monkeypox virus and donation of human cells and tissues. (August 29, 2022)
Reminder: Jynneos vaccine EUA fact sheet and storage updates
FDA granted an EUA amendment (PDF) for changes to preparation and storage instructions on the Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) for Prevention of Monkeypox Disease in Individuals Determined to be at High Risk for Monkeypox Infection (PDF). Once thawed, the vaccine may be kept at +2°C to +8°C (+36°F to +46°F) for 8 weeks. To get the most 0.1 mL doses for intradermal use from each vial make sure to use low dead volume needles and syringes. (August 16, 2022)
ICYMI:
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FDA Fast Facts: Jynneos (PDF) is available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese.
- The Fact Sheet for Recipients and Caregivers about Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-Replicating) is also available in multiple languages.
- Currently, there is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access, or “compassionate use.” FDA Fast Facts: TPOXX (PDF) is available in Chinese (Simplified), Korean, Spanish, Tagalog, and Vietnamese.
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Emergency Use Authorization (EUA) updates
Paxlovid checklist updated
FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time (a listing of additional resources is provided at the end of the checklist). Please see the updated Prescriber Patient Eligibility Screening Checklist (PDF) for more information. (August 26, 2022)
Bebtelovimab FAQs
FDA updated Frequently Asked Questions on the Emergency Use Authorization of Bebtelovimab for the Treatment of COVID-19 (PDF) to revise information about distribution of this product. (August 26, 2022)
Lagevrio (molnupiravir) fact sheet updated
FDA updated the Fact Sheet for Health Care Providers (PDF) for Lagevrio (molnupiravir) to link to the most current information for health care providers related to medical conditions and factors associated with increased risk for progression to severe COVID-19. (August 26, 2022)
EUA revocation
FDA revoked the EUA for this test, for the reasons noted in the revocation letter:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
In vitro diagnostic (test) EUAs
As of August 30, 2022, 439 tests and sample collection devices are authorized by FDA under EUAs. These include 302 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 1,101 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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New! September 1, 2022: The First Annual Report on Progress Towards Implementation of the American Pandemic Preparedness Plan webinar (1:30 - 3:00 p.m. ET) - The White House Office of Science and Technology Policy (OSTP) is hosting a webinar on the occasion of the release of the American Pandemic Preparedness Plan Annual Report. Also see the initial report (Sept. 2021), from the White House: American Pandemic Preparedness: Transforming Our Capabilities (PDF)
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New! 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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New! 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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New! 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 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
Also see EUA updates above for Paxlovid, Bebtelovimab, and Lagevrio (molnupiravir) info.
FDA removes N95 respirators from medical device shortage list
FDA announced the removal of N95 respirators from the agency’s medical device shortage list, signaling that demand or projected demand for this type of face protection device commonly used in health care settings no longer exceeds the supply. This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators. Also see: Supplies of Medical Devices for COVID-19: Frequently Asked Questions (August 26, 2022)
FDA Safety Communication: Certain Philips Respironics BiPAP machines recalled due to a plastic issue
Philips Respironics (Philips) has recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. However, this new recall does apply to some of the devices recalled in June 2021. Read more (August 29, 2022)
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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FDA Medical Countermeasures Initiative (MCMi) News)
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