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ACTIV Public-private partnership to speed COVID-19 vaccine and treatment options

NIH announced ‘Accelerating COVID-19 Therapeutic Interventions and Vaccines’ (ACTIV) partnership with FDA and others to speed the development of COVID-19 vaccine and treatment options

  • Standardize and share preclinical evaluation methods in open forum allowing for comparison and validation
  • Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential
  • Maximize clinical trial capacity and effectiveness
  • Advance vaccine development

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Protecting Public Health from Fraudulent and Potentially Harmful Products

Temporary injunction against the Genesis II Church of Health and Healing (Genesis)

  • Unlawfully distributing MMS: When combined with included activator, has a chlorine dioxide content equivalent to industrial bleach
  • There is danger that defendants will continue violating the law without temporary restraining order; defied previous Warning letter

Warning letter to Nova Botanix LTD DBA CanaBD

  • Selling unapproved and misbranded cannabidiol (CBD) product deliberately misleading claims for prevention and treatment of COVID-19
  • Currently NO FDA-approved products to prevent or treat COVID-19

Expansion of COVID-19 Testing by Using Synthetic Swabs 

FDA, Gates Foundation, UnitedHealth Group, Quantigen, U.S. Cotton Collaborate to Address Testing Supply Needs

Synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose

U.S. Cotton

  • Developed polyester-based, synthetic Q-tip-type swab  for compatibility with COVID-19 testing
  • Plans to produce the new swabs in large quantities for increased diagnostic testing

UnitedHealth Group, Quantigen, Gates Foundation

  • Clinical investigation to support synthetic swab use
  • Testing to support swabbing at  front of nose used enabling more comfortable, self-collection by patients and limiting exposure of healthcare providers

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Emergency Use Authorization (EUA): Seraph 100 Microbind Affinity Blood Filter device

INDICATION FOR USE: Extracorporeal blood purification (EBP) device) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure to reduce pathogens and inflammatory mediators from the bloodstream

  • Designed to reduce bacteria, viruses, toxins, cytokines and other inflammatory mediators from whole blood
  • Form factor very similar to other blood filters, such as hemodialyzers or hemoperfusion filters – compatible with hemodialysis systems that use industry standard bloodline connectors for ease of operation, training, and utility

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COVID-19 Diagnostics Update

 

Published by Drug & Device Advisory Group