Immunizations for Vaccinations

Last week, CDC published an interim COVID-19 vaccination schedule that recommends unapproved COVID-19 vaccines for routine administration to children less than twelve years of age. This is the first time CDC has placed an unapproved vaccine on the childhood vaccination schedule, permanently transferring liability for these vaccines from the manufacturer to American taxpayers, even after the emergency ends.  Only Congress can change this now.

We knew this was coming.  The PREP Act Declaration issued by the Secretary of HSS more than two years ago granted immunity “from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration or use of a covered countermeasure” while the nation is under the COVID-19 emergency declaration.  “Countermeasures” include vaccines.

PREP Act immunity is not permanent.  When the emergency declaration is finally lifted, continued use of COVID-19 vaccines will expose the vaccine manufacturers to liability unless it becomes a “covered vaccine” under the National Vaccine Injury Compensation Program. 

What is a covered vaccine?

For a vaccine to be covered, the Centers for Disease Control and Prevention (CDC) must recommend the category of vaccine for routine administration to children or pregnant women.  

Those where not my words; they come directly from the HRSA website.  Once covered, the vaccine is protected for all recipients, not just children and pregnant women.  By recommending COVID-19 vaccines for children, the CDC transferred all associated product liability to the American taxpayer.

This action is an assault on many levels, but I want to focus on only one.  The recommendation applies to an unlicensed product.  No matter your opinion of FDA’s approval and licensing process, the process should be completed before a product is recommended for routine use.  An emergency use authorization does not apply to non-emergent administration.

COVID-19 vaccines are not approved for anyone younger than 12 years of age.  Furthermore, approved COVID-19 vaccines remain unavailable to Americans of any age—although that will probably change now that permanent immunity has been secured.  A vaccine that is not approved for children should not be recommended for children, and it has never happened before.  This is the first time that the recommendation for routine administration has preceded FDA approval.

FDA approval is a slow and laborious process with many critics.  Despite decades of attempts at acceleration, at the pandemic’s outset the FDA’s process was seen as a liability that put Americans at greater risk than citizens of other nations.  The fear that the FDA would slow down an effective pandemic response led to the emergency declaration by HHS and the use of Emergency Use Authorizations to bring new countermeasures to market.  Although careful, meticulous approvals can be painstaking, rapid approvals compromise safety.  I did not take an oath to eliminate frustration; I took an oath to do no harm. 

But what harm is there in vaccine?  Surely vaccines are the most benevolent of therapies, protecting against dread diseases while rarely causing harm.

This thinking is an example of association fallacy.  A risk-benefit analysis that favors some vaccines is not a favorable risk-benefit calculation for all vaccines.  Each vaccine must be carefully evaluated on its own merits.  The slow, methodical FDA approval process meets that standard.  Or at least I thought so.

FDA’s approval process has let us down, plenty of times.  Think of television commercials promising large litigation settlements to victims of injury by various drugs.  There will be no such advertisements for COVID-19 vaccine injuries since these vaccines have immunity under the law.  Unless the law changes.

Congress has the power to change law, and Congress has the duty to change bad laws.  

Although Congress did not directly grant liability protection to COVID-19 vaccine manufacturers, by passing the National Childhood Vaccine Injury Act of 1986, the 99^th Congress created a loophole that gave the CDC power to shelter COVID-19 vaccine manufacturers from liability, setting the stage for what happened last week.

CDC’s actions are unprecedented.  Recommending an unapproved vaccine for children is reckless. Transferring product liability risk from manufacturers to taxpayers is corrupt.  Congress owns this.  Congress can change this.

The election for the 118^th Congress is only days away, and early voting has already begun.  Please keep this in mind as you consider your vote.