|
Coronavirus Disease 2019 (COVID-19) updates
Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
|
|
|
COVID-19 treatment updates
FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
On July 30, 2021, FDA revised the Emergency Use Authorization (EUA) (PDF) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus -- only after exposure to the virus.
REGEN-COV also remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA-authorized COVID-19 vaccines.
Also see: Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (PDF), updated July 30, 2021.
Olumiant (baricitinib)
On July 28, 2021, FDA revised the EUA (PDF) for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19.
COVID-19 vaccine updates
New vaccine FAQs
FDA recently added three new frequently asked questions (FAQs) on COVID-19 vaccines and the approval process to our website. Questions include:
- Is an approval (or biologics license approval) different from an emergency use authorization? Does it change the availability of COVID-19 vaccines?
- How long will it take to approve COVID-19 vaccines?
- How important is it to make sure approved vaccines are available versus other public health measures? Do you have the resources to do this quickly?
Shelf life extension - Janssen COVID-19 Vaccine
On July 28, 2021, FDA authorized an extension (PDF) for the shelf life of the refrigerated Janssen (Johnson & Johnson) COVID-19 Vaccine, allowing the product to be stored at 2-8 degrees Celsius for 6 months. This extension from 4.5 months to 6 months was granted following a thorough review of data submitted by Janssen, and applies to all refrigerated vials of Janssen COVID-19 Vaccine that have been held in accordance with the manufacturer’s storage conditions.
Vaccines that are authorized under an emergency use authorization (EUA) do not have fixed expiration dates, and their expiration dates may be extended based on data submitted by the manufacturers. Health care providers administering the vaccine should check the company’s website, www.vaxcheck.jnj, to obtain the most up-to-date expiration dates for specific lots of the Janssen COVID-19 vaccine.
FDA’s Budget: Medical Device Supply Chain and Shortages Prevention Program
The establishment of a permanent device shortages program will help ensure U.S. patients and health care providers have access to the critical medical devices they need and help reduce U.S. dependence on devices from other nations. (July 21, 2021)
|
|
Emergency Use Authorization (EUA) updates
FDA authorizes imported Becton Dickinson sodium citrate blood specimen (light blue top) collection tubes
FDA issued an EUA (PDF) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport and store blood samples for coagulation testing. The device authorized under this EUA is for use in coagulation testing, performed by authorized laboratories, to aid in the identification and treatment of coagulopathy in patients, including patients with known or suspected COVID-19. The FDA also posted frequently asked questions about sodium citrate blood specimen collection tubes. (July 22, 2021)
EUA revocation - Gravity Diagnostics COVID-19 Assay
Gravity Diagnostics, LLC (Gravity) requested that FDA revoke the EUA for the Gravity Diagnostics COVID-19 Assay initially issued on June 1, 2020. Gravity confirmed that it is no longer using the Gravity Diagnostics COVID-19 Assay at Gravity’s laboratory, having transitioned to another EUA-authorized test. Accordingly, FDA revoked the EUA (PDF) for the Gravity Diagnostics COVID-19 Assay, pursuant to section 564(g)(2)(C) of the Federal Food, Drug and Cosmetic Act. As of July 21, 2021, the Gravity Diagnostics COVID-19 Assay is no longer authorized for emergency use by FDA. (July 21, 2021) A list of archived EUAs is available on FDA's website.
In vitro diagnostic (test) EUAs
As of August 3, 2021, 398 tests and sample collection devices are authorized by FDA under EUAs. These include 279 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 32 antigen tests. There are 53 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 6 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 13 antigen tests and 8 molecular tests for serial screening programs. The FDA has also revised 595 test EUAs. Also see: Coronavirus Testing Basics
|
|
|
Events
-
July 28, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional webinars in this series each Wednesday in August.
-
August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
-
August 25, 2021: Manufacturing, Supply Chain, and Inspections during the COVID-19 Public Health Emergency webinar, 9:00 a.m. - 1:00 p.m. ET, hosted by FDA's Center for Drug Evaluation and Research (CDER)
-
August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy public workshop, hosted by FDA CBER and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID)
-
New! September 20-21, 2021: Pharmacodynamic Biomarkers for Biosimilar Development and Approval public workshop, hosted by FDA and Duke-Margolis, 10:00 a.m. - 2:30 p.m. ET both days - advance registration required
|
|
Information for industry
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
Why you should not use ivermectin to treat or prevent COVID-19 Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
|
List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 250 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)
|
|
|
|
|