What We're Reading: FDA Reconsiders Antibody Tests; Fauci Discusses Concerns; Death Toll Estimates Rise

May 5, 2020
AJMC Staff

After first relaxing regulations that let them enter the market, the FDA will now require companies manufacturing antibody tests for the coronavirus disease 2019 (COVID-19) to submit data on their efficacy; Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, said that current research indicates that COVID-19 evolved naturally; a novel COVID-19 mortality model predicts nearly double its initially projected death toll after factoring in some states beginning to ease social distancing restrictions and allowing businesses to reopen.

FDA Enforces Companies to Submit Antibody Testing Data

Amid backlash from Congress and scientists after a number of companies have issued coronavirus disease 2019 (COVID-19) antibody tests without regulation from the FDA, the agency announced yesterday that if companies do not submit data proving the accuracy of their tests within the next 10 days, they will face removal from the market. Reported in The New York Times, the FDA had been allowing dozens of manufacturers to sell antibody tests without providing evidence of their efficacy; a report by more than 50 scientists said that just 3 out of 14 antibody tests gave consistently reliable results. Flaws still existed in the top performers.

Fauci Shoots Down Man-Made Virus Theory, Stresses Need for More Testing Capacity

Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, dismissed theories indicating that COVID-19 was man-made or released accidentally from a Chinese lab. In an interview with National Geographic, Fauci said that based off of available research, the virus had evolved naturally, which contradicts statements put forth by President Trump and others in his administration claiming, without evidence, that the virus is man made. Fauci also said he is concerned about a second wave of the virus and stressed that the country should continue social distancing and use the summer to build up testing and reinforce healthcare systems' capabilities to cope with a resurgence later this year.

Researchers Double Expected US COVID-19 Death Toll

Researchers from the University of Washington’s Institute for Health Metrics and Evaluation (IHME) said that a newly revised COVID-19 mortality model predicts that approximately 135,000 Americans will die from the virus, nearly double previous projections, as states nationwide begin to ease social distancing measures. Reported in Reuters, the IHME projections were presented as a statistical range of outcomes, in which the latest forecast predicted anywhere from 95,092 to 242,890 US deaths by August 4, with 134,475 lives lost representing the median, and most likely outcome.