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 Vaccines and Related Biological Products Advisory Committee meeting On June 10, 2021, FDA held a meeting of the Vaccines and Related Biological Products Advisory Committee to provide considerations on data to support licensure and Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in pediatric populations. The committee met in open session, and discussed in general the data needed to support an authorization and/or licensure of a vaccine intended to prevent COVID-19 in these younger age groups. FDA takes steps to increase availability of COVID-19 vaccine Following careful review and deliberation, FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available. On June 11, 2021, FDA announced that it is authorizing for use (PDF), under the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management. Additionally, the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 Vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months. Health care providers may check the expiration date by lot number at the company's website: https://vaxcheck.jnj/ Related links: Updated Pfizer-BioNTech COVID-19 Vaccine recipient fact sheets (translations) Updated Pfizer-BioNTech COVID-19 Vaccine fact sheets for recipients and caregivers are available in multiple languages. (June 12, 2021) FDA approves StrataGraft for the treatment of adults with thermal burns FDA approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also referred to as deep partial thickness burns). StrataGraft was developed in conjunction with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority. (June 15, 2021) Upcoming events -
New! June 22, 2021: Sentinel Innovation and Methods Seminar series - Measure what you treasure- the challenges and opportunities of collecting real world endpoints, 1:00 p.m. ET -
New! June 22, 2021: FDA Drug Topics webinar: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers, 1:00 - 2:00 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 #VaccineReady social media toolkit Check out our latest toolkit, with social media posts and graphics on vaccine development and authorization, and the benefits of getting vaccinated against COVID-19. | |  | 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 225 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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