Latest FDA advice and actions on COVID-19


The US Food and Drug Administration (FDA) has remained lively and on prime of the COVID-19 pandemic. Over the course of the previous seven days, the company has launched scientific discoveries, issued authorizations for COVID-19 assessments, and taken motion in opposition to corporations falsely claiming to supply cures.

Virus therapy acceleration

The FDA has posted an up to date Coronavirus Treatment Acceleration Program (CTAP) webpage​. The webpage offers details about CTAP’s objective, technique and operations.

The current revisions embrace a dashboard depicting essential statistics associated to the event of potential COVID-19 therapeutics. Additionally, the useful resource shares are key steerage and hyperlinks for therapeutic builders, researchers, sufferers and customers.

Antibody response discovery

This week, FDA scientists reported they’ve recognized particular areas of the ‘spike proteins’ on the floor of the COVID-19-casuing virus that look like key to triggering robust protecting antibody responses in rabbits uncovered to the virus. The virus makes use of one a part of the spike protein to connect to a cell and one other to fuse with the cell membrane, enabling the virus to contaminate the cell.

The scientists studied antibody response to SARS-CoV-2 spike proteins, which might assist inform vaccine design by rising our understanding of the assorted triggered antibody responses.

The spike glycoprotein is the important thing goal for protecting antibodies in opposition to each SARS-CoV-2 (the COVID-19 virus) and the associated SARS-CoV-1 virus, in accordance with company scientists. Therefore, many vaccine candidates that set off antibodies — in opposition to particular areas on the SARS-CoV-2 spike protein — are being investigated.

To amass scientific information in regards to the high quality of antibody responses, the scientists uncovered rabbits to the virus and evaluated antibody responses triggered by varied SARS-CoV-2 spike antigens which are much like these getting used to develop vaccines to forestall COVID-19.

COVID-19 take a look at replace

As of mid-July, the company has approved a complete of 175 assessments beneath emergency use authorizations. These embrace 145 molecular assessments, 28 antibody assessments, and two antigen assessments.

This week, the FDA issued EUAs for 2 molecular-based assessments to 2 candidates:

  • The University of California-San Francisco’s Health Clinical Laboratories-UCSF Clinical Labs at China Basin, for its SARS-CoV-2 RNA DETECTR Assay
  • BioSewoom Inc., for its Real-Q 2019-nCoV Detection Kit

Fraudulent therapies and preventives

To date, there aren’t any FDA-approved merchandise to forestall, deal with or treatment COVID-19. The FDA has issued warning letters and taken authorized motion in opposition to corporations promoting and distributing unlawful therapies:

  • Ionegen LLC obtained a warning letter for promoting Ionopure Skin and Hands, a product falsely claiming to deal with the virus
  • Federal prosecutors charged 4 folks related to the Genesis II Church of Health and Healing for promoting Miracle Mineral Solution, a poisonous bleach-based product presupposed to treatment COVID-19.