|
COVID-19 vaccine updates
FDA authorizes Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in younger age groups
FDA amended the Emergency Use Authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.
The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical. (October 12, 2022)
|
Monkeypox response updates
EUA for first commercial test
FDA issued an EUA (PDF) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection.
The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox. The Alinity m MPXV test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of PCR and in vitro diagnostic procedures and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. Learn more: Monkeypox Emergency Use Authorizations for Medical Devices (October 7, 2022)
|
|
|
Emergency Use Authorization (EUA) updates
Reminders: COVID-19 and monkeypox tests
FDA is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. Also see: Policy for Monkeypox Tests to Address the Public Health Emergency and FAQs on Testing for Monkeypox
FDA announced updates to its COVID-19 test policy, encouraging most COVID-19 test developers to pursue a traditional premarket review pathway for their tests, rather than EUA. See: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
COVID-19 in vitro diagnostic (test) EUAs
As of October 11, 2022, 436 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,127 revisions to test EUAs. Also see: COVID-19 Test Basics
|
|
|
Events
-
October 12, 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. This town hall will be on the topic of monkeypox only.
-
October 13, 2022: FDA Grand Rounds - Quality Considerations for the Multi-Attribute Method (MAM) for Therapeutic Proteins (webcast, 12:00 - 1:00 p.m. ET) - MAM is a liquid chromatography-mass spectrometry based peptide mapping approach used for the identification and quantitation of product quality attributes in therapeutic proteins.
-
New! October 13, 2022: CDC webinar: Melioidosis in the United States: What Clinicians Need to Know Following Newly Discovered Endemicity (2:00 - 3:00 p.m. ET) - The causative bacteria Burkholderia pseudomallei was recently found in soil and water in the southern United States. This bacterium causes a rare and serious disease called melioidosis. During this COCA Call, presenters will provide updates on the new and evolving epidemiology of melioidosis in the U.S. and discuss what clinicians need to know to prevent, diagnose, and treat melioidosis.
-
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.
-
New! 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.
-
New! 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.
-
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.
Reminder: 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 24, 2022.
|
|
Information for industry and health care providers
New bivalent COVID-19 booster information for health care providers
On October 12, 2022, FDA posted new Dear Health Care Provider letters with important prescribing information:
Additional information, including updated fact sheets and letters of authorization:
Also see the press release, which includes information about the data supporting these authorizations: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups.
Tips for clinicians: Keeping your patients’ connected medical devices safe
Educating patients about cybersecurity of connected medical devices shouldn’t be a scary conversation for health care providers. Connected medical devices are often an important part of patients’ and their families’ lives since they rely on such devices to stay safe and healthy. FDA released a new video (3 minutes, YouTube) to help clinicians discuss cybersecurity of connected medical devices with patients. These tips focus on communicating with patients and aim to increase clinician comfort in approaching this topic. (October 7, 2022)
Total Product Life Cycle Advisory Program (TAP)
FDA’s Center for Devices and Radiological Health (CDRH) has launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP is intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors. (October 11, 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.
|
|
In case you missed it
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.
|
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.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
