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.