| 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: - December 28, 2020: COVID-19 Update including an updated letter of authorization, health care provider fact sheet, and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial, and an update to the Device Shortage List
- December 22, 2020: COVID-19 Update including translations of the Moderna COVID-19 Vaccine fact sheet in multiple languages, and new abbreviated new drug application (ANDA) approvals
- December 21, 2020: COVID-19 Update including translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet in multiple languages, and a new guidance
Bookmark www.fda.gov/coronavirus for the latest. | |  | | | Additional information about the Pfizer-BioNTech COVID-19 vaccine FDA posted an updated letter of authorization, health care provider fact sheet, and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial. These updates are consistent with previous FDA advice that it would be acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue. However, since the vaccine does not contain preservative, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.(December 23, 2020) Translations of the Pfizer-BioNTech vaccine fact sheet for recipients and caregivers are now available in 20+ languages. Additional information about the Moderna COVID-19 vaccine FDA posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations. (December 21, 2020)
Upcoming events -
January 14, 2021: CDER Compliance Conference - Participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. CE credit available. - New! February 2-3, 2021: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials (remote only) - The Duke-Margolis Center for Health Policy, under a cooperative agreement with FDA, is convening this public webinar to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant women in clinical trials.
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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