As you’ll recall from prior updates, the attorneys that represent ICAN are representing the plaintiff in a lawsuit against the FDA to obtain Pfizer’s COVID-19 vaccine documents. April’s production of the Pfizer documents is made up of 52 PDFs – you may want to check these out for yourself:
- This study appears to contain a detailed two-page list of miscarriages that occurred after vaccination, as well as adverse events suffered by infants who were exposed to the vaccine via breastfeeding.
- This study shows that one way Pfizer determined whether an adverse event was related to vaccination was based on timing. The study looks at adverse events in different intervals of time. A “risk interval” for certain adverse events was 1-42 days after a dose and a “post-vaccination control interval” was 43-84 days after a dose (or less in some cases). In many cases, if an individual happened to suffer a health event both during the year prior to vaccination as well as during the “risk interval,” the event will “not be counted.” Meaning if an individual suffered from Guillain Barré Syndrome during the year prior to vaccination (say, for example, after a flu vaccine) and then had another case of it during the 42 days after a dose of the Pfizer vaccine, it would not be counted. As the document itself notes, “an erroneously short risk interval may similarly result in underestimation of effect when using post-vaccination time intervals for self-control.”
- Both this document and this document list the individuals in the study who died, suffered an adverse event or serious adverse event, withdrew, or who got COVID after vaccination.
- This document curiously references “reactogenicity data changes as requested [by the Center for Biologics Evaluation and Research (CBER)] (including flags) in the teleconference held on April 8, 2021 and nothing additional,” which appears to suggest that Pfizer was changing some data at the request of the FDA.
- This document appears to be another textbook example of how Pfizer simply glossed over adverse events, stating, “Few severe AE [(Adverse Events)] were reported but were considered not related to study intervention.”
You can find a copy of April’s complete production here.
ICAN will continue to review the incoming Pfizer documents as they become available and will continue to share them with our supporters.
See below for more of ICAN’s updates on the Pfizer documents: