FDA Should Commit to Transparency, Rigorous Standards, and Ethics when Evaluating COVID-19 Vaccines
CSPI President Dr. Peter G. Lurie to Address FDA Vaccine Panel Today
When considering potential vaccines for COVID-19, the Food and Drug Administration should commit to transparency, scientific rigor, and high ethical standards according to remarks that Center for Science in the Public Interest president Dr. Peter G. Lurie will give before an agency advisory panel this afternoon.
Lurie, who served as associate commissioner of the FDA from 2014 to 2017, will urge members of the FDA’s Vaccines and Related Biological Products Advisory Committee to assure that the agency honors its commitment to hold another Advisory Committee meeting on particular products before issuing an Emergency Use Authorization (EUA) for a COVID-19 vaccine. Companies producing potential vaccines should also be more transparent, according to Lurie, by releasing clinical trial protocols, statistical analysis plans, and stopping rules for clinical trials.
Lurie will also address the lower legal standard for vaccines offered under EUAs as opposed to the standard for fully approved vaccines and will urge the committee to follow trial participants for up to a year—even if a trial is halted because the vaccine is shown effective—in order to detect late-occurring adverse effects and to establish whether participants’ vaccine-induced immunity wanes.
“Until now, the process of developing these products has been inappropriately politicized with an eye on the election calendar rather than the deliberate timeframes that science requires,” according to Lurie. “Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward.”
Earlier this month, CSPI praised the FDA staff for publishing, over the objection of the White House, guidelines for emergency authorization of COVID-19 vaccines. Earlier in the pandemic, Lurie voiced his concern over the EUAs granted for convalescent plasma and for hydroxychloroquine, the antimalarial drug once favored—and taken, without evidence, prophylactically—by President Trump.