Vaccine skepticism has worked its way from the fringes of the public to the highest levels of the federal government. The Trump administration is reportedly considering changes to a critical policy, the Vaccine Injury Compensation Program, that has protected domestic vaccine supply for 40 years, which could further jeopardize vaccine access and even create shortages in the United States. These attacks on vaccines could have much more far-reaching impacts than may appear at first blush: They could effectively blow up a key pillar of the industrial policy that has maintained stable vaccine access in the U.S. for four decades.
This could create a situation where Americans who want vaccines can no longer get them. But as I explain in a new paper, the Trump administration doesn’t have to have the final word. Policymakers at the state level can step in to directly produce vaccines to prevent shortages and harm to the American people.
Vaccine access in the U.S. hasn’t always been guaranteed. In the 1980s, a flood of lawsuits alleged that the vaccines for diphtheria, tetanus, and whooping cough caused severe seizures in children. While researchers belatedly debunked many of those claims, vaccine makers wound up on the hook for significant payouts to litigants. This led vaccine makers to increase prices, and some exited the market entirely. By 1984, only one company was left producing the whooping cough vaccine in the United States and had raised its price tenfold. This led to shortages and jeopardized supply.
In response, Congress created the Vaccine Injury Compensation Program (VICP), a program that provides reasonable compensation to patients injured by vaccines while capping the legal liability for vaccine makers. Because vaccines are exceedingly safe, VICP payouts are rare. According to the government’s own data, between 2006 and 2024, more than 5 billion doses of covered vaccines were distributed in the U.S. During that period, around 10,500 injury claims were awarded compensation under the VICP — or about one individual per 1 million administered doses. The VICP has sustained stable vaccine access while ensuring fair compensation for injured patients for 40 years.
But the Trump administration may be about to upend the VICP, and in doing so, could jeopardize the widespread access to vaccines that most Americans enjoy today.
First, reporting suggests that health secretary Robert F. Kennedy Jr. and one of his chief advisers may remove certain vaccines — such as the childhood vaccines it is attempting to render optional under federal recommendations — from the VICP, which would increase legal liability for producers of those vaccines.
Second, based on debunked claims connecting autism to vaccines, the administration may make conditions related to autism compensable “injuries” under VICP. That could quickly bankrupt the program: Such claims could produce $100 billion in awards, far eclipsing the VICP’s $4 billion balance, and approaching 20 times the amount the fund has paid out for all claims to date over its entire existence.
If the VICP is rendered a shell of itself by federal policy, private vaccine makers could retreat from the U.S. market, viewing it as too risky with too much legal exposure to do business. That could lead to vaccine shortages — and a situation where Americans who want vaccines can no longer get them — and ultimately declining immunization rates, more outbreaks of communicable diseases, and more avoidable deaths.
To avoid that outcome, states can step in to create public factories to directly produce vaccines. There is a strong tradition of public factories for vaccines in the United States. For example, in 1894, Massachusetts created a public drug manufacturer and research lab known as MassBiologics, which has produced vaccines for smallpox, tetanus, typhoid, and pertussis, among other biologic products. MassBiologics, now operated by the UMass Chan Medical School, remains the nation’s only nonprofit vaccine manufacturer, and currently produces a vaccine against tetanus and diphtheria that is distributed nationwide.
If the Trump administration persists in jeopardizing the country’s vaccine supply, Massachusetts and other states can mobilize new or existing publicly owned vaccine production facilities to produce those vaccines that would otherwise fall into shortage. Each state could use its health department or university system to establish production facilities to manufacture vaccines jeopardized by federal policy. Those states could license vaccine formulations from the private manufacturers exiting the U.S. market.
Because these production facilities are owned by states, they would be protected by the legal doctrine of sovereign immunity, which insulates states from lawsuits — allowing them to avoid the uncapped risk problem that would otherwise deter production by private manufacturers. To compensate patients with rare but legitimate vaccine-related injuries, each state could create a “mini-VICP” that provides modest, capped payouts for injuries.
These states can serve as a last line of defense against the Trump administration’s anti-vaccine policy. Moreover, states could join forces to create public factories to avoid shortages for critical vaccines.
State vaccine production could face a few conceivable roadblocks.
First, private vaccine makers may be reluctant to share proprietary information involved in vaccine formulation with state governments. States can make these companies more willing to license their vaccines by incorporating strict nondisclosure agreements and restricted use clauses in their licensing agreements.
Second, the Trump administration could try to prevent states from manufacturing vaccines. However, state-run vaccine production may be exempt from Food and Drug Administration regulation, which under the law is permitted to regulate “persons,” not states. This could limit the Trump administration’s ability to obstruct state-run factories.
There is a final impediment states could face: time. Building a new factory, outfitting it for production, and actually producing vaccine doses could require a significant amount of lead time. To expedite production, states should consider using existing facilities, such as purchasing or leasing space from public, nonprofit, or private entities.
Regardless, time is of the essence. There are few institutional barriers standing in the way of the Trump administration doing immense harm to public health by damaging vaccination in the United States. State governments should therefore begin contingency planning now. For more than 100 years, public factories have helped protect Americans’ access to vaccines — and they can meet the moment again now.
Joel Dodge is the director of industrial policy and economic security at Vanderbilt Policy Accelerator.
Source: www.statnews.com
