FDA Gene-Editing mRNA Vaccine Chief – Peter Marks – has always been a strong proponent of vaccine mandates. Marks also has as a history of overruling large expert panels for FDA approval of gene therapies at the agency.
STAT News reported that “Marks was one of the architects of Operation Warp Speed, the $18 billion U.S. effort to speed development of Covid-19 vaccines. He regularly embraced regulatory flexibility. And he spoke not infrequently about the importance of accelerated approval for next-generation treatments, including with those whose potential benefits weren’t always crystal-clear in clinical trial data.”
“Vaccine Mandates Are Not Going to Get Us THERE. It’s Got to Be Compelling Evidence.” – Vaccine Chief Peter Marks
During a 4-hour Public Health Workshop hosted by Duke University on March 20, 2025, Marks alluded to having contentious disputes with the higher-ups of the new Health & Human Services (HHS) administration (aka – Secretary Kennedy) over ‘the need for vaccine efficacy and vaccine safety data’ when FDA-approved vaccines can just be mandated.
“How We Generate Evidence Going Forward”
Throughout the 4-hour workshop, Marks and his colleagues strategically avoided discussing retrospective data analyses (i.e. analyzing the adverse events of vaccines in the US government databases) and the specifics on how to measure safety data going forward.
“By Definition, Vaccines Are Very Safe Medical Products”
“By definition, when we are developing vaccines for broad use, one of their direct benefits has to be that they are very safe medical products. That just goes without saying, because that goes to getting acceptance for the individual’s direct benefit.”
Hellbound and Down 