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: 
https://youtu.be/owveMJBTc2I
https://twitter.com/US_FDA
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d

FDA Briefing Document

Pfizer Briefing Document

FDA Authorizes First COVID-19 and Flu Combination Test for use with home-collected samples

RC COVID-19 +Flu RT-PCR

Quest diagnostics

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

Summary

 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.

READ

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

If burned by face mask during an MRI, please report the event to the FDA. 


Image credit: FDA