How Public Vaccine Policy Violates Our Right to Informed Consent

How Public Vaccine Policy Violates Our Right to Informed Consent

Neither of the two HepB vaccines on the market recommended for use in both newborns and pregnant women were studied to determine the safety of these practices. The two vaccines are Merck’s Recombivax B and GlaxoSmithKline’s Engerix-B. Both products’ package inserts state explicitly that “no adequate and well-controlled studies” have been done to evaluate the vaccine’s safety in pregnant women. Merck did include infants in three clinical trials, but it included them with older children up to 10 years of age, rendering the results uninterpretable with respect to the safety of vaccinating babies. Furthermore, the studies included only 147 children, had no placebo control group, and had a follow-up period of only five days. Hence, the trials could not possibly have detected any but the most frequently occurring and immediate-term adverse events. GSK’s trials were larger, including 5,071 subjects. But once again, infants were included with healthy adults and children, there was no placebo control group for comparison, and the follow-up period was just four days.

For another example, take the flu shot. Inactivated influenza vaccines are also recommended by the CDC for use in pregnant women, as well as infants as young as six months. Whereas it was removed from other vaccines routinely recommended for children, multi-dose vials of the influenza vaccine still contain mercury. As with the HepB vaccine, flu shot manufacturers disclose in their package inserts that safety and effectiveness of the vaccine have not been established in pregnant women. A systematic review of the literature in 2014 by the prestigious Cochrane Collaboration—an international organization specializing in this type of study, also called a meta-analysis—noted that the number of randomized controlled trials to determine the safety of vaccinating pregnant women was zero. A 2012 Cochrane meta-analysis found no good evidence that the flu shot is effective at preventing the flu in children under age three and “no usable data” on the safety of vaccinating children under two. Given the CDC’s recommendation for vaccinating infants as young as six months, the study authors stressed that studies to determine the safety and effectiveness of this practice are “urgently required”.

These and numerous other Cochrane reviews have also warned that many of the included studies were industry funded, and that industry funding has, unsurprisingly, been shown to bias results in favor of the products under study.

As a 2012 review published in the American Journal of Obstetrics & Gynecology noted, “prelicensure data on influenza vaccine safety and effectiveness during pregnancy is virtually nonexistent because of strict research guidelines that govern the participation of pregnant women”.

This raises an obvious question: If it is considered unethical to include pregnant women in clinical vaccine safety trials, how is it not also unethical to recommend that all pregnant women be vaccinated in the absence of clinical trials demonstrating that this is safe?

How does this not treat pregnant women as the subjects of a mass uncontrolled experiment without their informed consent?

via Thuleanindependent How Public Vaccine Policy Violates Our Right to Informed Consent