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Moderna COVID-19 Vaccine
… /vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/moderna-covid-19-vaccine … Fact Sheets Fact Sheet Translations …
Novavax COVID-19 Vaccine, Adjuvanted
… ogics/coronavirus-covid-19-cber-regulated-biologics/novavax-covid-19-vaccine-adjuvanted … Fact Sheets Novavax Fact Sheet Translations Vacunas contra el COVID-19 On October 3, 2023, the Food and Drug Administration …
Pfizer-BioNTech COVID-19 Vaccine
… /vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccine … Pfizer-BioNTech Fact Sheets Fact Sheet …
International Engagements to Respond to Covid-19 Pandemic
… /international-activities/international-engagements-respond-covid-19-pandemic … CBER has substantially increased its international efforts in addressing the COVID-19 pandemic. This includes regulatory and research …
Janssen COVID-19 Vaccine
… /vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/janssen-covid-19-vaccine … Fact Sheets Fact Sheet Translations …
COVID-19 Vaccine Safety Surveillance
… /vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance … Vaccines … December 7, 2021 … (CBER) at the FDA is monitoring the safety of authorized COVID-19 vaccines through both passive and active safety …
Recommendations for Investigational COVID-19 Convalescent Plasma
… nds-cber-regulated-products/recommendations-investigational-covid-19-convalescent-plasma … January 10, 2022 FDA issued an EUA … to health care providers and investigators on the use of COVID-19 convalescent plasma under the EUA or investigational …
Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
… /vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2023 … FDA's … make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in …
Update: COVID-19 Vaccine Booster Composition
… /vaccines-blood-biologics/update-covid-19-vaccine-booster-composition … June 30, 2022 FDA’s Vaccines … a change to the current vaccine strain composition of COVID-19 vaccine booster doses is necessary for the 2022 fall …
Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation
… iologics/updated-information-blood-establishments-regarding-covid-19-pandemic-and-blood-donation … January 11, 2022 FDA … agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. …
Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older
… -biologics/initial-results-near-real-time-safety-monitoring-covid-19-vaccines-persons-aged-65-years-and-older … Vaccines … The … any new causal relationships between the Pfizer-BioNTech COVID-19 Vaccine and potential adverse events of special …
Updated Instructions for Submitting Lot Release Samples and Protocols for CBER-regulated Products During the COVID-19 Pandemic
… … March 19, 2020 In response to the ongoing COVID-19 pandemic, the … Submitting Lot Release Samples and Protocols During the COVID-19 Pandemic FDA: Coronavirus Disease 2019 (COVID-19) …
CDC and FDA Identify Preliminary COVID-19 Vaccine Safety Signal for Persons Aged 65 Years and Older
… ailability-biologics/cdc-and-fda-identify-preliminary-covid-19-vaccine-safety-signal-persons-aged-65-years-and-older … May 31, 2023 At the April 19, 2023 meeting of the Advisory Committee on Immunization … older who received the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine in one safety monitoring system, the Vaccine …
Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2
… is the virus that causes the respiratory disease, COVID-19. The rapidly evolving global pandemic of COVID-19 necessitates that FDA provide updated information to …
Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
… information-about-correct-dosage-and-administration-moderna-covid-19-vaccine-2023-2024 … November 1, 2023 The Food and Drug … advising healthcare providers who administer the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals 6 months …
Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic
… agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. Respiratory … date, there have been no reported cases of transmission of COVID-19 via these products. Routine screening measures are …
Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19
… “SARS-CoV-2” and the disease it causes has been named “COVID-19.” The Food and Drug Administration (FDA) is informing … prepared from stool from donors who are asymptomatic for COVID-19. Actions FDA is in the process of notifying IND …
COMIRNATY
… … STN: 125742 Proper Name: COVID-19 Vaccine, mRNA Tradename: COMIRNATY Manufacturer: BioNTech … active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome …
Coronavirus (COVID-19) | CBER-Regulated Biologics
… /vaccines-blood-biologics/industry-biologics/coronavirus-covid-19-cber-regulated-biologics … CBER’s Document Control Center … efforts. CBER is working on multiple fronts to address the COVID-19 pandemic such as: Expediting clinical trials for …
Emergency Use Authorization for Vaccines Explained
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
… availability, as soon as possible, of vaccines to prevent COVID-19 - vaccines that the public will trust and have confidence … during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of …
Explicación de la Autorización de Uso de Emergencia para las Vacunas
… lo antes posible, de vacunas para prevenir el COVID-19 – vacunas en las que el público confiará y en las que … de salud pública, como la actual pandemia causada por el COVID-19. En virtud de una EUA, la FDA puede permitir el uso …
Important Information About Directed Blood Donations that are Not Medically Indicated
… from individuals who have not been vaccinated for COVID-19. Summary of the Issue FDA is aware that some blood … blood donations from individuals who have not received COVID-19 vaccines. In addition, FDA is aware of several …
FY 2020 Report from the Director
… response to SARS-CoV-2, the virus responsible for COVID-19. This response has involved every product office and every … authorized one Emergency Use Authorization request for COVID-19 Convalescent Plasma during the fiscal year. …
Development of New Immunological Assays and Animal Models to Evaluate Vaccine Safety and Efficacy Against Emerging Diseases
… Zika infection and vaccination. In response to the current COVID-19 pandemic, our lab developed several analytical tools for … being used in a project to understand the pathogenesis of COVID-19 that involves cytokine storm and high levels of …
2021 Safety and Availability Communications
… and availability of biological products. December 2021 COVID-19 Vaccine Safety Surveillance (Updated) December 7, 2021 … Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older July 12, …