Moderna Vaccine: To receive FDA EUA

  • Positive Vaccines and Related Biological Products Advisory Committee Meeting
  • FDA has informed Moderna about finalization and issuance of EUA
  • FDA has notified CDC and and Operation Warp Speed to execute plans for timely vaccine distribution   

READ

Pfizer-BioNTech COVID-19 Vaccine FAQs

  • New webpage to cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure

FAQ page

 BinaxNOW COVID-19 Ag Card Home Test   

Abbott

  • For prescription use at home with self-collected nasal swab samples, 15 years or older
  • Also for use with adult-collected nasal swab samples, 4 years or older
  • Antigen test that detects fragments of proteins from SARS-CoV-2
  • eMed portal and certified guide to support testing process to ensure a successful testing experience
  • Results within 20 minutes; also shared with public health authorities to monitor and manage virus spread
  • $25 / test

ANNOUNCEMENT

ELLUME COVID-19 Home Test

Ellume

  • First over-the-counter (OTC) fully at-home diagnostic test for COVID-1
  • Rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample
  • From any individual 2 years of age or older
  • Can be sold in drug stores, where a patient can buy it, swab their nose, run the test and find out results in 20 minutes
  • Mobile app requires individuals to input their zip code and date of birth and reports results to public health authorities to monitor disease prevalence

EUA Letter

PIXEL Home Collection Kit

Labcorp

  • Allows a person to self-collect a nasal sample in their home and then send to LabCorp for testing
  • Can be used by anyone aged 18 or over, and purchased online or in a store without a prescription
  • For use with LabCorp’s COVID-19 RT-PCR Test

EUA Letter


Image credits: FDA, Abbott, Ellume, LabCorp