Robert F. Kennedy’s Proposed Vaccine Regulations Spark Concern

New York City’s Long Island Jewish medical center is one of many locations that provide Moderna’s Covid-19 vaccine, a topic that has been under discussion due to the ongoing societal unrest and ever-changing vaccination regulations. Recently, spotlight fell on Robert F. Kennedy Jr., the US Department of Health and Human Services (HHS) secretary, who pledged to ‘fix’ a particular vaccine initiative. His promise has sparked concerns among specialists who believe that this reform could introduce significant disruptions to the vaccine industry and potentially block financial assistance for individuals who experience rare vaccine side effects.

The National Vaccine Injury Compensation Program (VICP), which offers financial compensation to individuals who experience uncommon side effects from vaccinations, is the program Kennedy has in his sights. Although some modifications to the VICP must be authorized by Congress, Kennedy has the power to implement various changes that could have substantial impact on the operations of the program.

Anna Kirkland, a university professor and author, provided insight into Kennedy’s plans, noting that his approach seems to promote conflicting theories for modifying the VICP. Major alterations to the VICP could expose vaccine manufacturers to additional legal challenges, making it harder for them to maintain vaccines in the market or develop new ones.

There is an understanding of the inherent challenges in the vaccine industry drawn from its history. In 1980, there were 18 firms in the US producing vaccines, but by 1990, there were just four. To prevent further disruption in the vaccine market, Congress enacted a law in 1986 that led to the formation of the VICP.

Dorit Reiss, a law professor in San Francisco, highlighted that ‘VICP was adopted because manufacturers were leaving the market over litigation.’ If such litigation were to reoccur, manufacturers may exit the market again, potentially reducing the accessibility of vaccines. This scenario becomes particularly worrisome when considering that there aren’t many vaccine manufacturers left in the US.

A majority of routine vaccines fall under the coverage of the VICP, and their production and administration is not generally a highly profitable venture for manufacturers or healthcare providers. As such, introducing changes or even abolishing the VICP could put significant obstacles in the way of patients seeking redress for vaccination-related issues.

Fueling these speculations is a bill, introduced by Arizona Republican Paul Gosar, which seeks to completely dismantle the VICP. This proposition is gaining popularity among anti-vaccination groups. Reiss warned that the elimination of VICP might result in no available vaccines.

Kennedy has proposed two explicit strategies: include discovery in current compensation claims, and eliminate the backlog of claims. The existing rules of the program permit discovery, but this is contingent on the discretion of the adjudicators, known as special masters.

Special masters could potentially speed up the claim processing time, however, the count of these special masters is determined by Congress and not HHS. Moreover, their accountability primarily lies with the US Department of Justice (DoJ) rather than HHS, even though they represent the health secretary during claims.

Asserting his influence, Kennedy might direct the special masters to grant automatic approval for certain claims – for example, cases that claim diagnoses of autism or allergies subsequent to vaccination, as per Reiss. The current structure of the program was deliberately designed for easy compensation, noted Reiss.

An alternate method to settle a claim is through the established injury table, which catalogues vaccines included in the ACIP [the Advisory Committee on Immunization Practices], potential injuries and their time frames. Kennedy has the ability to modify this table by including more side effects or changing existing ones, but this would necessitate public notice and comment collection.

If a new injury is incorporated into the table, cases can be put forth for the previous eight years, instead of the customary three. However, past attempts by government agencies to alter the injury table have been unsuccessful.

Should the ACIP stop recommending a routine vaccine, it might be removed from the injury table. Claims associated with that vaccine would then have to go through the traditional legal system. This system has a higher burden of proof, as the claimants have to demonstrate product defect or negligent actions.

In the conventional court system, stringent evidence rules apply, and claimants have to bear the costs of legal representation, expert witness fees, and often face substantial medical bills if they lose their case. Providing a financial safety net for citizens dealing with post-vaccination medical conditions, particularly in a country like the US where individuals are responsible for their medical bills, is the underlying principle of the VICP.

Most of VICP’s current claims are for relatively small compensation amounts. These cases often involve complex legal battles against prominent pharmaceutical companies, making them unattractive to law firms that view them as not financially worthwhile.

Reiss suggested that the VICP could benefit from a reform, advocating for more special masters, updating the caps on payments from their original 1980s values, and extending the statute of limitations beyond three years, in order to account for the difficulty of diagnosing side effects in young children within that timeframe.