The Reagan-Udall Foundation for the FDA has received funding from The Rockefeller Foundation to support the COVID-19 Diagnostics Evidence Accelerator launched earlier this year in collaboration with Friends of Cancer Research. As a science-driven philanthropy focused on building collaborative relationships with partners and grantees, The Rockefeller Foundation seeks to inspire and foster large-scale human impact that promotes the well-being of humanity throughout the world by identifying and accelerating breakthrough solutions, ideas, and conversations.

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 Related Biological Products Advisory Committee.

However, the committee did not make any recommendations for ensuring the products are not compromised.

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 communities.

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 – patient warehousing – along with waning public confidence in product safety and efficacy.

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 vaccines, the concerns of front-line workers and people of color were read aloud verbatim, highlighting the crucial project of communicating the safety and effectiveness of a vaccine in an environment of deep political distrust.

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 confidence" in the vaccine candidates.
• Along with state and local governments, the CDC is preparing for a national vaccination program and, as part of that plan, is rolling out a marketing campaign that aims to address worries over vaccine safety.

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 the FDA’s vaccine advisory committee — which includes a group of health and science experts who advise the regulatory agency on the best way to approach the path forward for a COVID-19 vaccine.

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.