Rudimentary information about vaccine safety is still MIA

I wrote the testimony below for my state legislature almost 3 years ago, but it is equally relevant today:

My name is Dr. Meryl Nass.  I am an Ellsworth physician and expert on the anthrax vaccine.  I have testified before 6 different Congressional committees and served on and chaired a Commission established by the Legislature in 2007 “To Protect the Lives and Health of Members of the Maine National Guard.”  

We know from the federal Vaccine Injury Table that vaccines can cause very serious side effects and death.  We lack conclusive evidence of precisely what the range of side effects can be, and how frequently they occur. 

There are basically 3 sources of data that inform us about vaccine adverse effects. The first is the Vaccine Adverse Event Reporting System (VAERS), established by Congress as part of the 1986 National Childhood Vaccine Injury Act, co-managed by CDC and FDA. It collects voluntary reports of adverse events following vaccination from patients, families, and medical professionals. The GAO estimated that only 1% of adverse events get reported. 

According to the FDA, fifteen percent of reported events are determined to be serious; this “includes hospitalizations, life threatening events and deaths.”

https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaers-overview

The second source of information is called the Vaccine Safety Database, electronic medical records covering several million Americans, which CDC pays managed care organizations to access.  The third source is clinical research studies, especially clinical trials performed in order to license a vaccine.  These are usually conducted and paid for by the vaccine’s manufacturer, which selectively provides information to the public.

Congress charged the Institute of Medicine (IOM) with studying vaccine safety when it passed the 1986 Vaccine Injury Act.  The IOM has issued about a dozen individual reports on vaccine safety since then.  Its 2011 report reviewed the data on 8 different vaccines, and concluded that for the most needed information (such as whether specific vaccines like DTaP cause autism) “the evidence is inadequate to accept or reject causality.”  

https://www.ncbi.nlm.nih.gov/books/NBK190028/table/tab_10_6/?report=objectonly

https://www.ncbi.nlm.nih.gov/books/NBK190020/

The IOM report stated:

"the task of this committee was to assess dispassionately the scientific evidence about whether eight different vaccines cause adverse events (AE), a total of 158 vaccine-AE pairs, the largest study undertaken to date, and the first comprehensive review since 1994.

“In the process, we learned some lessons that may be of value for future efforts to evaluate vaccine safety.  One is that some issues simply cannot be resolved with currently available epidemiologic data, excellent as some of the collections and studies are.”

The IOM’s lesson for us is that epidemiological, statistical research, using the available data, has not been able to answer the most basic questions about whether adverse events are caused by vaccines.  The science is clearly not settled.  Additional approaches are called for—but have been avoided by federal health agencies.  These include:

·      Better research into biological mechanisms

·      Toxicity studies of individual vaccine ingredients

·      Case control studies comparing vaccinated and unvaccinated children

LD1616 would begin to collect additional, hopefully useful data on putative vaccine injuries in Maine.  If serious vaccine reactions are rare, then the data should show it—and the cost of collecting the information will be minimal.  We need to know what illnesses are caused by vaccines, how commonly they occur, and who is at high risk for them.  Let’s collect the data.  LD1616 provides a way to begin doing so.