FDA released another 180,000 pages of COVID-19 vaccine documents in January, as required by court order. Many files in this production are case reports of individual clinical trial participants. According to FDA, this is the final batch of documents related to the authorization of the Pfizer vaccine for ages 12-15.
As ICAN supporters will recall, the attorneys who represent ICAN have won several lawsuits that have resulted in FDA being required to release documents related to the authorization of the COVID-19 vaccines.
The January 2024 release of documents related to the Pfizer vaccine for ages 12-15 consisted of 67,924 pages. While FDA says this is the last batch for this age group, rest assured ICAN will be reviewing the documents to determine if anything critical is missing or was improperly redacted. Here are some areas of interest in this month’s release:
- There were 4 separate case reports of appendicitis, which was a prespecified adverse event of special interest. Appendicitis adverse events included an approximately 14-year-old boy (18 days after second placebo dose), an approximately 15-year-old boy (nearly 5 months after second vaccine dose), an approximately 16-year-old boy (nearly 6 months after second vaccine dose), and an approximately 13-year-old girl (3 days after second vaccine dose). The first 3 cases were deemed “unrelated” but on the final one there was disagreement: “In the opinion of the investigator, there was a reasonable possibility that the appendicitis was related to the study intervention…. Pfizer did not concur….”
- An approximately 16-year-old boy developed myopericarditis 2 days after his second dose of the vaccine (prior to that he had two placebo doses). Pfizer admitted that “there was a reasonable possibility that the myocarditis was related to the study intervention….” FDA also stated that “FDA agrees that this SAE [serious adverse event] was possibly related to vaccination.”
- A Pfizer Pharmacovigilance Plan reported the results of a myocarditis survey of approximately 360 individuals ages 12-29: “Thirteen (4%) patients reported readmission to the hospital, including 8 of 13 (62%) patients who were readmitted because of a concern with the heart. Seventy-one (20%) patients were prescribed medication for their heart as of their last appointment with the provider.”
- An sBLA Clinical Review Memorandum dated July 8, 2022, contained an FDA reviewer’s praises of the vaccine efficacy of the 12-15 age group, which was assessed for only 7 days post-second dose: “Additionally, descriptive VE analyses, the VE after 7 days post Dose 2 was 100% (95% CI: 86.8; 100.0) in participants 12-15 years of age without prior evidence of SARS-CoV-2 infection and provided compelling direct evidence of clinical benefit in addition to the immunobridging results.” She enthusiastically concluded her report with: “[C]urrently available data support a benefit-risk balance that is clearly favorable for approving Comirnaty for use in individuals 12-15 years of age.”
The January release of documents related to Moderna’s Spikevax consisted of 112,345 pages, including several case reports noting gastrointestinal adverse events. Notably, intestinal perforation has been linked to thrombosis and COVID-19 infection and, yet, in each of the following cases, the adverse event was deemed “unrelated” to the clinical trial:
- A 60-year-old man with a health history that included IBS, high blood pressure, and testicular cancer was hospitalized with a “2 cm ulcer in the duodenal bulb [small intestine] with clot present” 22 days after his second vaccine dose.
- A 73-year-old man whose pre-existing conditions included heartburn, hypertension, high cholesterol, hernias, and blood clots, had emergency surgery for a “closed loop bowel obstruction” 2 days after his second vaccine dose.
As always, we encourage those interested to download the productions and review the data. ICAN will continue to keep you updated as more Moderna documents are released.
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In the meantime, you can catch up on some of ICAN’s other updates related to COVID-19 vaccines at the links below:
