Vaccine injury compensation programs overwhelmed as congressional reform languishes

More than 5,000 of those are directly related to the Covid-19 vaccines, with injuries ranging from a sore shoulder to death, according to the Health Resources and Services Administration. An additional 3,000 complaints related to everything from drugs and devices to the failure of hospital staff to limit infection spread have also been filed.

Yet the pandemic fund has paid zero claims, in part because officials are waiting for people to submit detailed medical records and documentation to back up their allegations.

“Compensation determinations are made based on individual case reviews, and the statute sets a very high standard that a claimant must meet to be eligible for compensation,” HRSA spokesperson David Bowman said.

Should Covid-19 shots become routine once the pandemic ends, alleged injuries would eventually be handled by the already over-burdened standard Vaccine Injury Compensation Program. Patient advocates, attorneys and the pharmaceutical industry fear that without drastic reforms, that program could collapse.

Despite bipartisan calls for change, Congress has failed to act, frustrating those who say that the VICP — which covers nearly three times as many vaccines today as it did when it was created three decades ago — is overwhelmed.

There are fears those optics could fuel vaccine hesitancy if the public mistakes the situation as too many injuries flooding the program, when in fact the number of vaccines covered by the program has grown without a commensurate increase in resources.

“The cost of this program failing will be like throwing kerosene on the antivax fire,” said Renee Gentry, director of George Washington University’s Vaccine Injury Litigation Clinic.

Covid-19 shots have proven to be safe for the overwhelming majority of people, but injuries do occur, as they do for all vaccines. Allergic reactions are possible, and some specific adverse events have been associated with the shots, such as myocarditis and pericarditis after messenger RNA vaccination, and thrombosis with thrombocytopenia after receiving the Johnson & Johnson shot.

“The Covid vaccine injuries are still rare, but there are some very significant injuries that have destroyed lives,” Gentry said. “It’s frustrating to tell those people who did everything right … that they get nothing for that.”

Congress created the national Vaccine Injury Compensation Program in 1986, partly as a means to avoid lawsuits against vaccine makers and health care providers amid fears that litigation could deter drug companies from producing vaccines and dampen consumer confidence in immunizations.

The program originally covered six routine childhood vaccinations, including measles and polio. But it’s grown to include 16 vaccines — including influenza shots, which tens of millions of people receive every year — without commensurate growth in staff or money needed to handle the additional claims.

The current backlog of cases is more than two years long, said Susan Steinman, senior director of policy and senior counsel at American Association for Justice, which lobbies for plaintiffs’ lawyers. There were 2,057 VICP petitions filed in fiscal 2021.

“It’s not supposed to take longer than actually going to court,” Steinman said. “We have this program backward right now.”

VICP is funded by a 75-cent excise tax on each dose of the 16 CDC-recommended vaccines and currently has nearly $4.3 billion on hand. Congress must also appropriate money from the fund to cover Department of Justice attorneys’ and the federal claims court’s work to process claims, in addition to the claims themselves.

Meanwhile, the CICP was created in 2010 to cover vaccines, medications and devices developed in response to a public health emergency. Injured patients and their survivors must submit a request for compensation within one year of receiving the vaccine or drug to HRSA, including medical documentation of the injury or death, with one opportunity for reconsideration if their initial petition is denied.

“HHS just accepts or denies the claims, there’s no judicial review, and there’s very little information about why things have been denied,” said Christina Ciampolillo, president of the Vaccine Injured Petitioners Bar Association.

A novel vaccine has never been transferred from the pandemic program to VICP — the H1N1 flu shot that debuted after that flu season began became part of the next season’s annual vaccine cocktail.

Should the Covid-19 vaccines become routinely recommended by the CDC — and be approved by the FDA for all age groups — it’s unclear how and when they’d be shuffled under the VICP umbrella.

“We think it’s very important to make sure the program is robust and patients’ claims get filed and heard in a timely fashion, and part of that is about adequate staffing and resources in the U.S. government,” said Phyllis Arthur, vice president for infectious diseases and diagnostics policy at the Biotechnology Innovation Organization.

A handful of bills introduced in the House and Senate would revamp both programs, but advocates are focused on two measures — one, H.R. 3655 (117) to overhaul the VICP, and another, H.R. 3656 (117) to automatically impose the excise tax that funds the program on any new vaccines the HHS secretary adds to the vaccine injury table. Currently, Congress must act for the tax to be collected on any new immunization added to the schedule.

The broader VICP reform legislation, an effort led by Rep. Lloyd Doggett (D-Texas) in the House, would set a minimum number of special masters appointed to the court that hears vaccine injury claims, requiring a minimum of 10 compared to the current maximum of eight.

The legislation would change the amount of time the HHS secretary has to add a vaccine to the injury table from two years to six months and would ensure the table covers vaccines routinely recommended by the CDC to adults as well as children and pregnant people.

It also would increase the maximum amount of compensation for vaccine injuries and deaths from $250,000 to $600,000 for 2021, a figure that could be adjusted for inflation in later years.

Doggett, who leads the House Ways and Means Health Subcommittee, indicated in a statement to POLITICO that some Republicans are holding up progress on the measure, which he cosponsored with retiring GOP Rep. Fred Upton of Michigan.

A Republican aide suggested the bill’s potential price tag is to blame. But CBO hasn’t released an estimate for the bill, agency spokesperson Deborah Kilroe said, adding that the office is legally required to conduct a formal cost estimate after a bill is reported out of a congressional committee. Neither bill has advanced out of Energy and Commerce or Ways and Means.

Pennsylvania Democratic Sen. Bob Casey (D-Pa.) is working on a similar legislative effort to automate the VICP excise tax and to clarify how Covid-19 vaccines would transition from the CICP to the VICP.

“We don’t really know how the process works or what it would look like,” a Casey aide said.

The senator is still working on the measure, the aide added, including finding bipartisan cosponsors that could help increase the chances of the bill moving on some legislative vehicle this session. Those options are few, with a bipartisan and bicameral effort to reauthorize FDA’s medical product user fees already well underway. An omnibus spending package could also carry the measures.

The bills’ advocates say ensuring the programs work well is critical to bolstering public confidence in U.S. vaccination programs, so people know that, in the rare case they experience a serious adverse event post-immunization, they can be compensated for their pain.

As the U.S. moves closer to transitioning away from the public health emergency, Doggett said, the longstanding injury compensation program for vaccines must be ready to handle Covid-related claims.

“The system could easily be crushed by the new burden if the existing backlog is not quickly addressed and the program modernized,” he said.