 COVID-19 vaccine updates FDA updates Janssen COVID-19 vaccine fact sheets with information for patients, doctors to include information on Guillain Barré Syndrome FDA announced revisions to the vaccine recipient (PDF) and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. (July 13, 2021) Additional lot release FDA authorized the use (PDF), under the Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility. To date a total of five batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized. 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 has concluded that 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. (July 13, 2021) Myocarditis and pericarditis update Acting FDA Commissioner, Janet Woodcock, M.D. and Director, FDA Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., discussed the suggested increased risks of myocarditis and pericarditis following COVID-19 vaccination with stakeholders on June 29, 2021. The recording is available on YouTube (47 minutes). Vaccine recipient EUA fact sheet updates in multiple languages Did you know? FDA posts COVID-19 vaccine EUA fact sheets for recipients in more than 25 languages. If you reference these fact sheets, or share them with patients, please bookmark these pages so you'll always have the latest information. SARS-CoV-2 regulatory science updates FDA Grand Rounds lecture On July 8, 2021, FDA hosted a Grand Rounds lecture about regulatory science research funded by the FDA: SARS-CoV-2 Host-Pathogen Interaction, Vaccines & Variants of Concern. This lecture discussed work from two FDA Medical Countermeasures Initiative (MCMi) projects analyzing coronavirus samples to help inform development of COVID-19 medical countermeasures, conducted by Public Health England and the University of Liverpool. A webcast recording (1 hour, 6 minutes) is available. Assessing the role of additive manufacturing in support of the U.S. COVID-19 response FDA has taken creative and flexible approaches to address availability of critical medical products in response to COVID-19. In addition, non-traditional manufacturers and community responders have helped address shortages and gaps in medical supplies during the COVID-19 pandemic, and yielded millions of pieces of equipment and supplies, such as masks, face shields, and other 3D-printed medical devices. In September 2020, FDA funded a study, conducted by America Makes, to summarize the impact of 3D printing on the overall COVID-19 response. FDA has now made publicly available this report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges, and key lessons learned to build on and improve future crisis response. FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies. CURE ID moves to automated data collection in light of COVID-19 pandemic The FDA's Center for Drug Evaluation and Research has published a From Our Perspective on the FDA's Clinical Methodologies Group's recent HHS award, which will fund expansion of the CURE ID platform. The platform will allow automated anonymized data collection from electronic health records and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases. This work may facilitate the clinical, research, and regulatory communities to identify signals of potentially safe and effective COVID-19 therapies that may also be candidates for additional study in randomized clinical trials. In the future, CURE ID's expansion will also include a platform for patients with long COVID to upload information on their treatments, in addition to the treatment outcomes they consider most important. (July 13, 2021) Hear from FDA leaders on EUAs FDA to discuss COVID-19's impact on medical product operations at SBIA REdI Annual Conference July 19-23, 2021, virtual 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. Share our new video about this event, and read more in FDA Voices. | |  | |
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