FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

U.S. Food and Drug Administration sent this bulletin at 08/31/2023 04:00 PM EDT

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The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include:

August 29, 2023: FDA Roundup including publication of priorities for calendar years 2024 - 2028 by the Interagency Food Safety Analytics Collaboration (IFSAC) — a collaboration between CDC, FDA, and the USDA Food Safety and Inspection Service (FSIS).
August 25, 2023: FDA Roundup including updated Hurricane Season: Be Prepared with additional information and resources for consumers.
August 23, 2023: FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program.
August 21, 2023: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants.
August 18, 2023: FDA Roundup including an update to the list of ultraviolet (UV) wand products that may present a risk of injury.

MCM approval updates

On August 21, 2023, FDA approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy.
The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

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Guidance updates

On August 28, 2023, FDA announced the availability of a final guidance for industry entitled Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies.
This guidance describes FDA’s compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023.

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On August 28, 2023, FDA announced the availability of a final guidance for industry entitled Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products.
This guidance discusses the applicability of FDA’s investigational new drug application (IND) regulations under part 312 (21 CFR part 312) to various clinical study designs that utilize RWD and also clarifies the Agency’s expectations concerning clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness and safety of a drug (e.g., as part of a new drug application (NDA) or biologics license application (BLA)) when such studies are not subject to part 312.

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Emergency Use Authorization (EUA) updates

EUA revocations

FDA revoked the following EUA for the reasons noted in the revocation letter (PDFs):

August 23, 2023: Hymon SARS-CoV-2 Test Kit (dba SpectronRx)
August 18, 2023: SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratories)
August 18, 2023: COVID-Flu Multiplex Assay (Exact Sciences Laboratories)

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.

EUA quick links

Emergency Use Authorization - about EUAs, and links to current EUAs
EUAs for Drugs and Non-Vaccine Biological Products (CDER)
EUAs for Medical Devices (CDRH)
COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
Historical Information about Device EUAs

Events

September 12-13, 2023: Good Clinical Practice: Considerations for Trials with Pragmatic or Decentralized Features to convene international experts in the conduct of clinical trials with pragmatic or decentralized features. Registration now open
September 26-27, 2023: FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing (virtual)
September 28-29, 2023: Complex In Vitro Model (CIVM) Qualification Framework Public Workshop (Bethesda, MD) - Hosted by the Critical Path Institute (C-Path) Predictive Safety Testing Consortium, with stakeholders from FDA, academia, model developers, and the pharmaceutical industry, this workshop aims to form a consensus on model standards and features to improve performance of liver CIVMs as a tool for drug development and regulatory assessment. The meeting will also include sessions to discuss system optimization and cell sourcing, model validation and performance, and defining contexts of use to address unmet needs in regulatory decision making. Please register in advance.
October 04-06, 2023: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska) - two and one half-day (2 days for virtual attendees) interactive course allows participants to enhance knowledge and integrate practical considerations for the planning and operation of clinical research protocols involving medical countermeasures for high consequence pathogens. Registration now open
November 29-30, 2023: Public Workshop to Enhance Clinical Study Diversity
to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. Registration now open

Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.

Information for industry and health care providers

Expiration date extension

Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions.

In case you missed it

Quick COVID-19 resources

Check expiration date extensions for your COVID-19 tests
Get the latest on COVID-19 vaccines
Know your treatment options for COVID-19

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency

List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.

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