Topic: Clinical Data

2 chapters across the catalog

Gorby Chips
Episode 1482 1:04:52 - 1:09:52

1482: Gorby Chips

FDA Peter Marks, Booster Data Transparency

FDA chief scientist Peter Marks defended the decision to authorize new boosters without full human clinical data, arguing that waiting for such data would leave the population unprotected against rapidly evolving variants. Marks stated that the goal is to provide the longest duration of protection possible, though he acknowledged that parents are concerned about children being "left behind" in the vaccination schedule.

Guidepost
Episode 1424 41:11 - 43:05

1424: Guidepost

Pfizer FOIA Timeline and Financial Risk Disclosures

A federal judge has restructured the timeline for the FDA to release Pfizer vaccine trial documents, requiring 20,000 pages to be released monthly through April. Concurrently, Pfizer has added new language to its financial earnings reports regarding risks associated with preclinical and clinical safety data. These disclosures follow legal pressure to increase transparency regarding the vaccine's original approval process.