by Lew Rockwell, Lew Rockwell:
According to news sources at least one COVID-19 coronavirus vaccine may be licensed by the Food and Drug Administration before the November 2020 election.
The decision to vaccinate will likely be the biggest healthcare decision any American will ever make in their lifetime. Will Americans voluntarily line up and get immunized against the COVID-19 coronavirus? The vaccine will have been rushed to market. All of its side effects won’t be known till millions of Americans have been vaccinated.
The National Health Federation teams with investigative health journalist Bill Sardi to introduce a regulatory-compliant consent form that will help protect consumers from any pitfalls in the vaccination process.
Title 21 of the Code of Federal Regulations (CFR) states that Americans in a clinical study must give their written consent to any medical treatment such as vaccination. Since vaccines gain licensure from the FDA by passing through 3 out of 4 safety trials, the side effect ratio is never truly known till the vaccine is used widely by millions. All Americans who receive the vaccine will still be enrolled in surveillance studies (Stage-4) and subject to the CFR protections.
According to Title 21 of the CFR, informed consent requires candidates for vaccination to be given the right to refuse vaccination; have the right to confidentiality (privacy) that their vaccination data will not be shared with other parties without their consent; and have the right to know if there are any alternatives to vaccination.
Furthermore, any American considering vaccination for COVID-19 coronavirus should avoid signing hold-harmless clauses in consent forms because important rights would be waived should malpractice occur. Vaccination of individuals who are at high-risk to develop side-effects and are less likely to positively respond to vaccination may not be good candidates for immunization.
COVID-19 vaccination will likely be voluntary in the beginning, and mandatory thereafter, just as State and Federal government health agencies did with social distancing, face masks and quarantine. Manufacturers of COVID-19 coronavirus vaccines are producing a quantity of vaccines for the entire population.
There are many other things that informed consent should reveal to those who are considering immunization, such as the name and production lot number of the vaccine and the estimation of the numerical chance of benefiting from vaccination (i.e. how many need to be vaccinated to prevent 1 infection or prevent 1 death). Furthermore, those who are vaccinated should always be given a copy of the consent form to take home.