The May 2012 updated anthrax vaccine package insert (a.k.a. label) provides cause for concern. Would you give this vaccine to your dog, let alone your child? Next week the Presidential Commission for the Study of Bioethical Issues will have their final meeting to discuss giving anthrax vaccine to children. Whose children would be sacrificed?
“The percent of serious adverse events was similar between the BioThrax combined groups (193/1303 or 1.5%) and the placebo group (38/260 or 1.5%).” page 6
Dr. Wright also notes that the trial analyses were completed in mid 2009 and a final report sent to FDA then. The trial results have not been made public.
2. Table 2 (pages 7 and 8 of the label) is a breakdown of local and systemic adverse events in trial participants. However, half the subjects in the CDC trial are not included. The number of subjects in Table 2 totals only 775, while there were 1563 trial subjects. The adverse events for 788 anthrax-vaccinated subjects are missing. The number of “moderate/severe systemic adverse reactions” in Table 2 totals 65. There were 127 “moderate/severe local adverse reactions”. Yet the 2008 JAMA paper reported 229 serious adverse events for which VAERS were filed.
“BioThrax can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.” page 3 of the package insert
“Of women who received vaccine within 90 days of the estimated date of conception (n = 14), 2 spontaneous abortions and a first trimester intra-utero fetal death were reported, along with one report of a healthy term infant with mild right clubbed foot abnormality. ” page 6
“Pregnancy or plans to become pregnant for the duration of the study and/or not agreeing to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination.”
The package insert tells practitioners, “Advise women of the potential risk to the fetus.” page 15
“Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system.” page 9
“Up to 11% of subjects rated the brief pain or burning they experienced immediately after vaccine injection as 8 out of 10 or greater.” page 5
What are the possible or reasonably likely side effects of BioThrax?
- Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot
- Muscle aches
“There is positive evidence of human fetal risk based on adversereaction data from investigational or marketing experience or studiesin humans, but potential benefits may warrant use of the drug inpregnant women despite potential risks”