Lessons for the coronavirus (COVID-19) “not safe at any speed” thinking for the United States Food and Drug Administration (FDA) still applies

Abstract

Copyright: © 2020 Bennett C, et al. Published by NobleResearch Publishers. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. There has been extensive news coverage about the USA Food and Drug Administration’s (FDA’s) role in approving medications to treat the coronavirus (COVID19) and vaccines to prevent the virus while at the same time, ensuring medication safety. COVID-19 treatment was initially focused on hydroxychloroquine and now has changed to remdesivir. Coronavirus vaccination development is now a competitive and collaborative 14industry program that USA President Donald Trump has named “Operation Warp Speed”. With the goals of having FDA approved treatments in the clinic as soon as possible and vaccines in mass production by the end of the year, safety is likely to be overlooked—again.