> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Researchers List Needed Covid Vaccine Safeguards
- URL: https://www.fdaweb.com/researchers-list-needed-covid-vaccine-safeguards/
- Published: 2020-07-06T12:00:00.000Z
- Updated: 2026-09-14T16:19:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147128

Three academic researchers say the best response to concerns raised about the Trump administration’s Operation Warp Speed approach to developing a Covid-19 vaccine “is a transparent and rigorous approach to vaccine development and regulation, including for licensure or any pre-licensure use permitted by FDA. For this effort to be successful, it is critical that the independence of the agency be respected, standards maintained, and politicians kept from pronouncements that create the appearance of interference such as that engendered by the emergency use authorization of antimalarial drugs to treat Covid-19.”

Writing in a *JAMA* Viewpoint, former FDAers **Joshua Sharfstein** and **Jesse Goodman** and former HHS assistant secretary **Nicole Lurie** say plans should be transparent about these four needed safeguards in Covid-19 vaccine development: 

- strong evidence of effectiveness, including in key populations;
- strong evidence of safety, including in key populations;
- informed consent for vaccine use before approval; and
- comprehensive safety monitoring systems.

“As the U.S. and other nations race to develop Covid-19 vaccines,” the three conclude, “these safeguards must be in place to reach the goal of developing a safe and effective vaccine to end the pandemic as quickly and as safely as possible, while earning and keeping public trust and confidence.”