As bird flu (H5N1) continues to receive public attention regarding reported cases and controversial research, ICAN investigated the three U.S. licensed H5N1 vaccines. Our review raises serious concerns, including the use of toxic ingredients, serious adverse events, and defective clinical trials. ICAN’s attorneys have therefore issued FOIA requests for clinical trial records and all internal FDA and HHS communications regarding these vaccines.
Lead Counsel, Aaron Siri, Esq., lays out the details here:
In the meantime, here are some of the troubling facts that have been uncovered.
GSK’s Influenza A (H5N1) Virus Monovalent Vaccine was licensed in 2013 for use in all persons ages 6 months or older. Findings about this vaccine:
- This vaccine contains thimerosal, with up to 1.25 mcg of mercury per pediatric dose. Thimerosal is a mercury-based preservative that was removed from most routine childhood vaccines in the U.S., Canada, Europe, Australia, and the United Kingdom as a “precautionary measure” in the early 2000s after claims it causes serious harm.
- This vaccine also contains squalene, which has been linked to autoimmune disease.
- The adult safety trial involved 4,561 subjects (3,422 active/1,139 placebo). GSK solicited adverse event data for only 7 days and tracked unsolicited events for one year, during which the vaccine group had 4 times the rate of new immune-mediated diseases.
- The placebo-controlled pediatric safety trial involved only 838 children ages 6 months to 17 years (607 active/231 placebo).
Seqirus’s Audenz H5N1Monovalent Vaccine was licensed in 2020 for use in all persons ages 6 months or older. Findings about this vaccine:
- The adult Phase 3 safety trial included 3,191 participants (2,395 active/796 placebo). Adverse events were solicited for only 7 days following vaccination and unsolicited reports were collected for up to one year, during which 11 deaths (0.5%) were reported in the active group and only 1 (0.1%) was reported in the placebo group.
- The pediatric safety study consisted of only 329 children who received the active vaccine. It does not appear to have included a placebo group, and 26% of participants reported an adverse event within 21 days of vaccination.
- The multi-dose vials of this vaccine contain thimerosal, with up to 25 mcg of mercury per adult or pediatric dose, and this vaccine contains squalene.
Sanofi Pasteur’s Influenza Virus Vaccine, H5N1, was licensed in 2007 for adults ages 18-64. Findings about this vaccine:
- Licensing was based on a safety trial that included only 151 adults (103 active/48 placebo) and adverse event data was tracked for 56 days post-vaccination, during which there were 4 serious adverse events in the vaccine group, including 1 death.
- This vaccine contains thimerosal, with approximately 50 mcg of mercury per adult dose.
ICAN will provide additional data as it is received from HHS and FDA.
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