Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement
The Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
Speaker presentations will be available by 8 AM on Dec 10, 2020
The online web conference meeting will be available at the following:
FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples
RC COVID-19 +Flu RT-PCR
INDICATION FOR USE: Simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus and/or influenza B virus in nasal swab specimens self-collected at home using the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals suspected of respiratory viral infection
Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Specimens collected using the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu can be transported at ambient temperature for testing
Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.
REG PATHWAY: Emergency Use Authorization
COVID-19 Precision Immunology App-a-thon
To develop innovative applications to explore the relationship between personalized immune repertoires and COVID-19 disease variables and associated factors
- Phase I: Extracting knowledge from molecular sequencing data from T Cell Receptors/B Cell Receptors and associated clinical variables. Facilitate understanding of relationship between personalized immune repertoires and COVID-19 disease characteristics such as severity and associated factors. For participants from the general data science community and the computational immunology community
- Phase II: Create research tools and apps to report the outputs from Phase I to be incorporated into an easily interpretable format for healthcare professionals
Deadline: January 29, 2021.
Reminder patients should not wear any metal during an MRI
Patients may be injured by face masks with metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. Metal parts may become hot and burn the patient
- Patients should not wear any metal during an MRI
Image credit: FDA