Coronavirus Disease 2019 (COVID-19) updates  Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last 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) Upcoming events -
August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens - Register by July 26, 2021. - 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 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. | |  | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
No comments:
Post a Comment