Failure of US HHS to Submit Required Reports on Improved Vaccine Safety

Read the 2017 court ruling here.

The National Childhood Vaccine Injury Act of 1986 granted unprecedented, economic immunity to pharmaceutical companies for injuries caused by their products and eviscerated economic incentive for them to manufacture safe vaccine products or improve the safety of existing vaccine products.

Congress therefore charged the Secretary of HHS with the explicit responsibility to assure vaccine safety. Hence, since 1986, HHS has had the primary and virtually sole responsibility to make and assure improvements in the licensing, manufacturing, adverse reaction reporting, research, safety and efficacy testing of vaccines in order to reduce the risk of adverse vaccine reactions.

In order to assure HHS meets its vaccine safety obligations, Congress required as part of the 1986 Act that the Secretary of HHS submit a biennial reports to Congress detailing the improvements in vaccine safety made by HHS in the preceding two years.

The Informed Consent Action Network filed a lawsuit to force HHS to either provide copies of its biennial vaccine safety reports to Congress or admit it never filed these reports. The result of the lawsuit is that HHS had to finally and shockingly admit that it never, not even once, submitted a single biennial report to Congress detailing the improvements in vaccine safety.

In contrast, HHS takes the other portions of the 1986 Act, which require promoting vaccine uptake, very seriously, spending billions annually and generating a steady stream of reports on how to improve vaccine uptake. Regrettably, HHS has chosen to focus on its obligation to increase vaccine uptake and defend against any claim vaccines cause harm in the National Injury Vaccine Compensation Program (aka, the Vaccine Court) to such a degree that it has abandoned its vaccine safety responsibilities. If HHS is not, as confirmed in Court this week, even fulfilling the simple task of filing a biennial report on vaccine safety improvements, there is little hope that HHS is actually tackling the much harder job of actually improving vaccine safety.