By Kelly Mitchell, HealthyImmunityNow.org
When Congress passed the National Childhood Vaccine Injury Act in 1986, shielding vaccine makers from liability, they were nervous. They knew that the pharmaceutical industry had a dark history of criminal and civil fraud, putting customers in harm’s way if it meant maximizing profit. Take away financial liability for product injury and death and where would the incentive to improve product safety come from? In order to try to protect consumers from the unprecedented bill and its potential negative impact on safety, Congress said that every patient/parent must be given an information pamphlet for every vaccine, and they mandated what must be in them. These pamphlets were around ten pages long.
Doctors hated them. But why?
Because in a modern, allopathic medical office, time is big money, and appointments are around ten minutes on average (unlike naturopathic office visits that typically range a half hour to an hour.) It’s impossible to answer all of a parent’s questions when they are given pamphlets with so much information. So they lobbied for, and got, the information pamphlets shortened to single sheets.
In exchange for this paperwork reduction, doctors were supposed to serve as “Learned Intermediaries.” That’s a legal term that simply means the doctor is supposed to know all the important information about a vaccine and pass on what he thinks the patient needs to know in order to make an informed decision.
The problem is, of course, most doctors know very little about the actual vaccines they administer, they are incentivized to maximize rates of vaccination, and educated only on how to overcome hesitancy. The entire system is designed for high uptake and rapid turnover of patients, not for ensuring individualized care and informed consent. It’s a system many doctors are frustrated with, and that leaves patients on their own to find information to make informed decisions.
And now we are being faced with experimental COVID-19 vaccines. They don’t fall under the 1986 ACT, they were all placed under the Emergency Preparedness (Prep) Act, which shields their makers, doctors, and many others from liability. We haven’t yet seen what sort of information will be required to be given to those who decide to take the risk. Will people be told about the Prep Act? About the experimental nature of the vaccines? If they are getting the Moderna or Pfizer mRNA vaccine, will they be told that mRNA vaccine technology has never been used in humans before? Or that there has never been a successful coronavirus vaccine before because animal models have always revealed they increased risk of severe disease rather than protect from disease? And that adequate animal model studies have not been completed? Or that in late October, the FDA came out with this draft list of adverse outcomes they would likely be looking out for in the general population?
In the past couple weeks, several groups of scientists and doctors have filed petitions with European and U.S. agencies to halt the release of COVID-19 vaccines because of very serious safety concerns that have not yet been studied, as well as concerns about effectiveness. Will the agencies listen? Doubtful. It seems like they are determined to launch the products no matter what.
Bottom line? The coming experimental vaccines are a big unknown for effectiveness and safety. But luckily, the vast majority of the population handles COVID-19 just fine and develops natural immunity, so there is no need to panic or take the risk if your gut is telling you to wait for more science. You can instead explore the many existing preventive and treatment options.