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COVID-19 vaccine updates
Novavax booster authorized
FDA authorized (PDF) the Novavax COVID‑19 Vaccine, Adjuvanted for use as a first booster dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. The vaccine may be administered at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. Learn more: Novavax COVID-19 Vaccine, Adjuvanted (October 19, 2022)
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COVID-19 therapeutics updates
Evusheld FAQs updated
Frequently asked questions on the EUA (PDF) for Evusheld (tixagevimab co-packaged with cilgavimab) for pre-exposure prophylaxis (PrEP) of COVID-19 have been updated to include answers to questions including:
Q: Is Evusheld still an appropriate option for eligible patients? (in light of SARS-CoV-2 circulating variants)
A. Yes. FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants.
Q: Are people who have received Evusheld eligible to receive COVID-19 treatments if they develop COVID-19?
A. There are several treatments – for example, Paxlovid, Veklury (remdesivir), and Lagevrio (molnupiravir) – that are expected to retain activity against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether these treatments are right for their patients in the event the patient develops mild-to-moderate COVID-19. FDA is closely monitoring the variants circulating in the U.S. that may impact the use of the available COVID-19 therapeutics, including Evusheld. The Agency will provide further updates as new information becomes available. (October 20, 2022)
Monkeypox response updates
LDTs: FDA provides lists of laboratories offering notified laboratory-developed monkeypox tests
FDA updated its Monkeypox and Medical Devices page to provide lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test, modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency. (October 20, 2022)
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Emergency Use Authorization (EUA) updates
EUA revocations
FDA revoked EUAs for these tests for the reasons noted in the revocation letters:
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.
COVID-19 in vitro diagnostic (test) EUAs
As of October 25, 2022, 435 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 77 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 4 EUAs for molecular OTC at-home tests. FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,136 revisions to EUA authorizations. Also see: COVID-19 Test Basics
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Events
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October 26, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov. FDA will hold additional events in this series on November 9 (monkeypox only), November 30, and December 14, 2022.
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November 9, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory Committee (virtual, 9:00 a.m. - 5:00 p.m. ET) - The committee will discuss the request for EUA 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome.
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November 15-16, 2022: 14th Annual Sentinel Initiative Public Workshop (virtual) - Hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, participants will hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic and monkeypox public health emergency.
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November 17, 2022: FDA Grand Rounds - Medical Extended Reality: Applications and Challenges (webcast, 12:00 - 1:00 p.m. ET) - FDA Physicist and CDRH Office of Science and Engineering Laboratories (OSEL) Medical Extended Reality (MXR) Program Coordinator Ryan Beams, Ph.D., will present an overview of augmented and virtual reality technology and of the landscape of potential medical applications. He will also discuss regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine.
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December 6, 2022: Save the date for FDA Broad Agency Announcement Day (webinar) to learn more about how FDA funds research, the types of projects we’re looking for to support regulatory science and innovation, and how you can apply.
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New! December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022 (webinar) - To promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
Deadline extended! Call for abstracts: 2023 Preparedness Summit
The Preparedness Summit, the country’s first and longest running national conference on public health preparedness, is now accepting abstracts. The theme, Recover. Renew: Reprioritizing All-Hazards Preparedness, will provide an opportunity to revisit pressing issues in preparedness and share resources, shape policies, and build skills to mitigate a variety of threats. The event will be held April 24-27, 2023 in Atlanta, GA. Submit abstracts by October 31, 2022.
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Information for industry and health care providers
COVID-19 health care professional resources
Bookmark our updated web page for the latest COVID-19 news for health care professionals, including safety alerts, and information about medical countermeasures and shortages. (October 18, 2022)
FDA announces new Advancing Real-World Evidence Program
On October 19, 2022, FDA announced the Advancing Real-World Evidence (RWE) Program. The agency developed the program to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness (e.g., new indications, populations, dosing information) or for meeting post-approval study requirements.
For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research before protocol development or study initiation—to discuss the use of RWE in medical product development. The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage the agency will continue to be available. The program will proceed through September 30, 2027. Sponsors may submit initial meeting requests for the program through March 31, 2027.
Reminder: Apply to become FDA’s next CERSI partner
FDA is seeking applications for Centers of Excellence in Regulatory Science and Innovation (CERSIs), to conduct collaborative regulatory science research and foster information sharing. Letters of intent are due by October 31, 2022, and applications are due by December 22, 2022.
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Lagevrio shelf-life extension
The Administration for Strategic Preparedness and Response (ASPR) and FDA announced the authorization of an extension to the shelf life for all lots of the Merck antiviral therapy, Lagevrio (molnupiravir) capsules from 24 to months to 30 months. Lagevrio capsules are currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
As a result of this extension, certain lots of Lagevrio capsules may be stored for an additional six months from the labeled date of expiry (see Table 1 here). As required by the emergency use authorization, unopened cartons of Lagevrio capsules must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF). FDA granted this extension following a thorough review of data submitted by Merck. (October 21, 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
It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)
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Update your antibodies
The virus that causes COVID-19 changes over time. Keep your protection against COVID-19 up to date by getting a bivalent COVID-19 vaccine booster dose. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.
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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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