Latest FDA advice and actions on COVID-19

The US Food and Drug Administration (FDA) has remained active and on top of the COVID-19 pandemic. Over the course of the past seven days, the agency has released scientific discoveries, issued authorizations for COVID-19 tests, and taken action against companies falsely claiming to offer cures.

Virus treatment acceleration

The FDA has posted an updated Coronavirus Treatment Acceleration Program (CTAP) webpage​. The webpage provides information about CTAP’s purpose, strategy and operations.

The recent revisions include a dashboard depicting crucial statistics related to the development of potential COVID-19 therapeutics. Additionally, the resource shares are key guidance and links for therapeutic developers, researchers, patients and consumers.

Antibody response discovery

This week, FDA scientists reported they have identified specific areas of the ‘spike proteins’ on the surface of the COVID-19-casuing virus that appear to be key to triggering strong protective antibody responses in rabbits exposed to the virus. The virus uses one part of the spike protein to attach to a cell and another to fuse with the cell membrane, enabling the virus to infect the cell.

The scientists studied antibody response to SARS-CoV-2 spike proteins, which could help inform vaccine design by increasing our understanding of the various triggered antibody responses.

The spike glycoprotein is the key target for protective antibodies against both SARS-CoV-2 (the COVID-19 virus) and the related SARS-CoV-1 virus, according to agency scientists. Therefore, many vaccine candidates that trigger antibodies — against specific areas on the SARS-CoV-2 spike protein — are being investigated.

To amass scientific knowledge about the quality of antibody responses, the scientists exposed rabbits to the virus and evaluated antibody responses triggered by various SARS-CoV-2 spike antigens that are similar to those being used to develop vaccines to prevent COVID-19.

COVID-19 test update

As of mid-July, the agency has authorized a total of 175 tests under emergency use authorizations. These include 145 molecular tests, 28 antibody tests, and two antigen tests.

This week, the FDA issued EUAs for two molecular-based tests to two applicants:

• 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 treatments and preventives

To date, there are no FDA-approved products to prevent, treat or cure COVID-19. The FDA has issued warning letters and taken legal action against companies selling and distributing illegal treatments:

• Ionegen LLC received a warning letter for selling Ionopure Skin and Hands, a product falsely claiming to treat the virus
• Federal prosecutors charged four people associated with the Genesis II Church of Health and Healing for selling Miracle Mineral Solution, a toxic bleach-based product purported to cure COVID-19.