Coverage

Black Americans distrust the government so much they're not participating in large numbers in COVID-19 clinical trials, and many say they won't get a COVID-19 vaccine – at least not until many others get it. Although the first two large clinical trials…
Extraordinary and unusual measures may be needed to rapidly develop and distribute a vaccine against SARS-CoV-2, but those efforts should not compromise the safety and efficacy of any product that reaches the market, according to the FDA Vaccines and…
Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. government’s $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to…
Executive Summary CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge. Federal officials are now confronting another challenge for the uptake of a potential coronavirus vaccine –…
Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness.
The Food and Drug Administration is preparing for the eventual rollout of one or more COVID-19 vaccines — by identifying the concerns that some people have about taking such a vaccine. At a meeting Thursday of experts advising the FDA on COVID-19…
Dive Brief: The Centers for Disease Control and Prevention does not back mandates that healthcare workers or other essential employees receive COVID-19 vaccines, with a CDC official stating Thursday the agency would prefer instead to "build trust and…
Any coronavirus vaccine that could be authorized for emergency use by the U.S. Food and Drug Administration (FDA) faces several additional hurdles after completing the final stage of clinical trials. That was the theme of key issues addressed today by…
COVID-19 vaccine safety, dueling efficacy standards, and representation of groups from racial and ethnic minorities to children drew focus Thursday at arguably the most watched FDA advisory committee meeting ever.
In less than a year, scientists around the world have rallied against COVID-19 and developed promising vaccines that could stem the pandemic. Concerns remain, however, and, against this backdrop, senior government experts took over Thursday to discuss…