Moderna’s Covid-19 Vaccine Unveiled Amid Vaccine Regulation Changes

The Long Island Jewish medical center in New York was the location of a brief ceremony on June 22, 2022, witnessing the unveiling of Moderna’s Covid-19 vaccine. Amid recent disturbances and calls for stricter vaccine regulations that have pushed U.S. health organizations into the limelight, a particular immunization plan has emerged. Robert F Kennedy Jr, Head of the U.S. Department of Health and Human Services (HHS), asserted his intention to redefine this structure, an action that one might argue threatens to disrupt the vaccine business and obstruct financial relief for those anomalous mishaps occurring post a vaccine dose.

The manifold adjustments needed to revamp the National Vaccine Injury Compensation Program (VICP), a structure intended to assist those dealing with exceedingly uncommon vaccine side-effects, would demand congressional involvement. Nevertheless, Kennedy has the power to enact numerous measures that have the potential to reshape the program and its functionality. Opinions about Kennedy’s approach towards reshaping VICP are divided, with Anna Kirkland, a University of Michigan scholar, and author of ‘Vaccine Court,’ addressing the potential dualities in his strategy.

Radical modifications to this scheme could risk exposing vaccine manufacturers to a surge of legal disputes, thereby possibly thwarting their ability to maintain current vaccines in commerce or to introduce new immunizations. A retrospective look at the industry shows a noticeable decrease in vaccine producers from 18 in 1980 to just four by the end of the subsequent decade.

Recognizing the growing instability in the vaccine market, the U.S. Congress enacted legislation in 1986 that sprung forth the establishment of the VICP. Dorit Reiss, a law professor at the University of California College of the Law, stated that the program was initiated to counter the wave of manufacturers exiting due to extensive litigation expenses. She articulated her concerns about the potential exit of manufacturers leading to a scarcity of accessible vaccines.

As it stands, the number of vaccine manufacturers operating within the U.S. borders is dwindling. The business of creating vaccines is rarely profitable, a reality that extends not only to the companies responsible for manufacturing them but also to the medical professionals who administer them. Accordingly, the majority of commonly administered vaccines are encapsulated under the VICP.

The possibility of alteration or even dissolution of the VICP scheme raises concerns about the potential consequences for patients pursuing their grievances. A potential piece of legislation proposed by Arizona Republican Paul Gosar seeks to completely dismantle the VICP, a move which has garnered support within certain groups opposed to vaccination. As highlighted by Reiss, the repercussion of abolishing the VICP could very well lead to a dire vaccine deficiency.

Kennedy has made known two primary strategies: incorporating discovery in the current compensation claims, and tackling an existing backlog of claims. The existing rules of the program permit the discretionary use of discovery by the adjudicators referred to as special masters. By adding more of these special masters, the process of handling claims can possibly be accelerated.

However, the count of these special masters is determined by Congress and is not within the jurisdiction of the HHS. Furthermore, the special masters, although functioning as representatives for the secretary in claims, are directly accountable to the U.S. Department of Justice (DoJ). A potentially transformative action that Kennedy could advocate is for the special masters to concede to claims regarding certain post-vaccine diagnoses such as autism or allergic reactions, said Reiss.

As she further commented, the structure of the program was intentionally crafted to simplify the process of compensation. Another mechanism for resolving claims is in reference to a table of injuries that catalog vaccines endorsed by ACIP (the Advisory Committee on Immunization Practices) as well as potential injuries and relevant time periods. Kennedy holds the authority to modify this table, which includes adjusting its listings of side effects.

This proposed alteration would necessitate the distribution of public notice and the acceptance of public feedback. Should a new injury be added to the table, cases can then retroactively be filed for the preceding eight years, instead of the typical three-year window. However, the last attempt by a federal agency to modify the table was unsuccessful.

As per current guidelines, if the ACIP ceases to recommend a routine vaccine, it might be eliminated from the table. In the absence of VICP coverage, claims would need to proceed via the conventional legal system. This route presents more challenging standards, whereby plaintiffs are tasked with demonstrating faulty product or negligence.

The requirements for evidence are tougher within standard courts. In addition, potential claimants also face the fiscal responsibilities of legal representation as well as paying for expert testimonies. As such, the burden of enormous medical bills would inevitably fall on unsuccessful claimants navigating the private U.S healthcare market.

In a country such as the U.S., characterized by an individual being financially responsible for their medical expenses, the VICP serves as a crucial financial buffer for individuals encountering health incidents post-vaccination. Most claims currently processed by the VICP pertain to relatively small amounts of compensation—amounts that legal firms, particularly the infrequent ones with outsize pharmaceutical companies as opponents, may deem financially unattractive to champion.

Reiss acknowledged the need for reform within certain aspects of the VICP. According to her, the program requires an increased number of special masters, an update on payment caps that have remained static since their initial determination in the 1980s, and wider timelines allocated to claimants beyond the present three-year statute of limitations.

She advocates for these changes, in particular, to cater to the complex nature of diagnosing side effects among young children within that time frame. Hence, modifications are currently required to ensure the VICP is better suited to address these challenges, ultimately improving its crucial role in safeguarding public health.