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 vaccine updates Update on ongoing evaluation of adverse event reports of myocarditis & pericarditis following vaccination with Moderna and Pfizer-BioNTech COVID-19 vaccines On June 25, 2021, FDA announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. For each vaccine, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has been revised to include a warning about myocarditis and pericarditis and the Fact Sheet for Recipients and Caregivers has been revised to include information about myocarditis and pericarditis. This update follows an extensive review of information and the discussion by CDC's Advisory Committee on Immunization Practices meeting on June 23, 2021. The data presented at this meeting reinforced the FDA's decision to revise the fact sheets and further informed the specific revisions. The warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination. Additionally, the Fact Sheets for Recipients and Caregivers for these vaccines note that vaccine recipients should seek medical attention right away if they have chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination. The FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months. FDA authorizes drug for treatment of COVID-19 On June 24, 2021, FDA issued an EUA (PDF) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.  FDA warns that vapors from alcohol-based hand sanitizers can have side effects Consumers should use hand sanitizer in a well-ventilated area FDA issued a Drug Safety Communication for hand sanitizers, warning that symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin and inhaling the vapors that linger. FDA reviewed case reports submitted to FDA and cases from calls to U.S. poison control centers of adverse events after applying alcohol-based hand sanitizers to the skin. While the majority of cases resulted in minor or minimal effects, some cases resulted in treatment by a health care professional. These reports have occurred after the start of the COVID-19 pandemic. Listen to the FDA Drug Safety Podcast and view the transcript. (June 16, 2021) | Upcoming events -
Today! June 30, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host additional webinars in this series on July 14 and 28. -
New! July 8, 2021: FDA Grand Rounds webcast - SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern, 12:00 - 1:00 p.m. ET -
July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA's use of EUAs and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic. -
Save the date! August 2-4, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens In case you missed it Find a COVID-19 vaccine near you Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov. | |  | Your EUA questions answered In a new episode of FDA's Health Equity Forum podcast, Associate Commissioner for Minority Health RADM Richardae Araojo discusses FDA's EUA process with FDA Chief Scientist RADM Denise Hinton. | |  | 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  |
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