Amending the Vaccine Injury Table
Does the Secretary of HHS have sole or shared authority?
Much has been written or stated about potential changes to the Vaccine Injury Table within the National Vaccine Injury Table. Whether expanding the emerging injuries from vaccines or redefining existing injuries or even adding or removing vaccines requires several steps. In doing so, who has the authority to make these changes?
Let’s examine who has the authority to add or remove vaccines from the Table and also how can specific medical conditions or injuries be added or removed from the Table as well.
What is the Vaccine Injury Table and how is it used.
The Table was established by statute, 42 U.S. Code § 300aa-14, to provide a list of CDC approved vaccines for children or pregnant mothers.
As stated in statute, “The following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program.” click here to read the entire table.
The Act required the Secretary of HHS to consult with the IOM to review scientific literature related to a set of serious adverse events following immunizations recommended for use in children. Two reports were issued (IOM, 1991, 1994). These reports contain a framework for causality assessment of adverse events following vaccination. Note: Adverse events are distinguished from adverse effects in that an event is something that occurs but may not be causally associated, whereas an adverse effect implies causation. All adverse effects are adverse events, but not all adverse events are adverse effects.
Adding or Removing Vaccines.
The authority of adding a new vaccine or removal of a vaccine from the Table belongs with the Secretary of HHS, Robert F. Kennedy Jr. However, he needs the approval of the CDC (ACIP cmte), needs to consult with his own advisory commission the ACCV, and for Congress to add a tax or levy for all new vaccines. Removal of a vaccine, Secretary of HHS Kennedy does not need Congress.
To add, the Secretary needs a recommendation from CDC (the ACIP cmte) for administration of the new vaccine to children or pregnant mothers. Then the Secretary must ask his own advisory commission, The Advisory Commission for Childhood Vaccines (ACCV), publish his intentions in the Federal Registry, allowing 180 days for posting and public comment. The last hurdle is asking Congress to attach a levy to all sales of the vaccine. Those proceeds will be remitted to the US Government on a monthly basis and deposited into the account for the Vaccine Injury Trust Fund.
To remove a vaccine, The Secretary must follow the steps outline above except he does not need for Congress to act.
The Look-Back Provision.
When adding a new vaccine or injury to the Table and to promote fairness within the NVICP for those who were injured prior to the enactment and acceptance of a new vaccine or injury, a look-back provision in the VICP serves to protect individuals from being denied compensation due to the timing of vaccine recognition.
The Look-Back provision adopted by the NVICP allows those who have been injured by a the vaccine or suffered injuries from the vaccine, a two (2) year window to submit a claim to the NVICP, for a period of eight (8) years prior to the vaccine or injury being added to the table. The filing period will become effective the day of the Table modification.
Imagine what would happen if the COVID-19 vaccines were added to the Table. Would all those who were dismissed because of the short one year to file period, were granted opportunity to refile because of the eight year look-back?
Removing an injury condition from existing Table.
One of most controversial actions by any Secretary of HHS was done in the mid-90’s by Secretary Donna Shalala in the Clinton Administration. Secretary Shalala removed residual seizure disorder (RSD) from the table for DTP vaccines.
Also under Secretary Shalala, the definition of encephalopathy was redefined to make it extremely difficult for any baby or toddler who suffered this injury.
The Secretary reviewed the IOM recommendation and following an 8 to 1 vote by the ACCV to support the Secretary’s intention. What I find interesting is the ACCV voted 5-4 to keep RSD as a table injury for the MMR vaccine.
Challenges to the Secretary’s authority.
There was a significant challenge to the Secretary’s authority to make changes of the Table, whether it is adding or removing a vaccine or adding or removing medical outcome or injury.
In Terran v HHS, one of the central legal issues revolved around the interpretation and application of the Presentment Clause of the U.S. Constitution. The Presentment Clause requires that legislation passed by Congress be presented to the President before it becomes law. The case also examined how this constitutional principle applies to the Vaccine Injury Compensation Program (VICP).
The plaintiff contended that the Secretary of HHS and the processes governing the NVICP, including the amendment of the Vaccine Injury Table and the rules for claim processing, lacked the requisite presidential approval. They argued that this failure undermined the intended checks and balances established by the Presentment Clause.
The US Federal Circuit Court of Appeals ruled the Secretary has authority to make changes to the Table without first “presenting” actions to the President for approval.
Adding a medical condition or injury from an existing vaccine listed on the Table.
SIRVA - Shoulder Injury Related to Vaccine Administration.
On July 29, 2015, the Secretary of HHS published a Notice of Proposed Rulemaking (NPRM) to revise the Vaccine Injury Table, proposing among other changes to add SIRVA (and vasovagal syncope) as listed injuries.
In January 2017, HHS published a final rule in the Federal Register (82 Fed. Reg. 6294) amending the Table, which included adding SIRVA.
The effective date was delayed until March 21, 2017.
In July 2020, the Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) proposing to amend the Vaccine Injury Table by removing SIRVA.
The reasoning given: HHS asserted that the scientific evidence did not adequately support a causal relationship between specific vaccine components and SIRVA (they viewed SIRVA as due to administration technique, not the vaccine itself) and that the Table should only list injuries caused by the vaccine’s components rather than “how the vaccine was administered.”
On January 21, 2021 HHS published a Final Rule that would remove SIRVA from the Table, with an effective date originally February 22, 2021 but later delayed to April 23, 2021.
The take around the office water cooler was Walgreens, CVS, Rite-Aid and other retail pharmacies that are administering vaccines were screaming at Secretary Azar for this attempt to remove SIRVA from the Table, thus creating potential liability onto the pharmacies. I have been told that the screaming turned to threats of stopping administering vaccines thus putting a big damper on the CDC’s efforts to expand flu shot campaigns. It appears that Secretary Azar blinked.
The ACCV unanimously voted to oppose the proposed changes to the Table, and sent a recommendation to the Secretary opposing the draft NPRM.
However, on April 22, 2021 HHS published a Rescission of that Final Rule, effectively withdrawing the removal. So SIRVA remains on the Table. Many thanks to Ron Klain, Chief of Staff for President Biden to placing a hold on this Final Rule.
GBS - Guillain-Barré Syndrome
GBS was added to the Vaccine Injury Table after federal health authorities determined there was sufficient medical and epidemiologic evidence of a causal association between certain vaccines—especially influenza vaccines—and the onset of GBS within a specific time window.
As mentioned in my first book, The Vaccine Court, the connection between GBS and influenza vaccination dates back to the 1976 “Swine Flu Fiasco” vaccination campaign, when an increased incidence of GBS (about 1 per 100,000) was observed in the months following vaccination.
On January 19, 2017 the Department of Health & Human Services (HHS) issued a Final Rule amending the Vaccine Injury Table. Federal Register
The rule was effective February 21, 2017 (for petitions filed on or after that date).
Both medical conditions are subject to the look-back provisions. Two year filing window with a “look-back” of eight years.
Keep Learning, Keep Challenging Yourself, and Always, Always Question Authority.
Wayne Rohde, author of 2 books on the National Vaccine Injury Compensation Program and Legal Research Fellow at IPAK-Edu.org
Thank you for your dedication to educating us all!
Thank you, very informative article. I had only heard of the ACCV recently so looked them up and found no meetings since July 2024. Are they still in existence? I've been trying to get clarification on an important point you raise on the authority of the federal agencies. They sound very independent if it has been ruled that they are not required to follow the Presentment Clause. There must be more to this as I've heard administrative law is murky.