People Harmed by Coronavirus Vaccines Will Have Little Recourse

The U.S. government paid out $4.4 billion over more than 30 years covering injuries relating to a host of vaccines—from flu to polio—but payouts for potential injuries from Covid-19 vaccines will be covered by a far less-generous program.

Covid-19 vaccine injuries will be covered under a program known as the “countermeasures injury” compensation fund, which was set up in 2010 to cover harm resulting from vaccines for a flu pandemic, or drugs to treat an anthrax or Ebola outbreak, for example.

This year, Secretary of Health and Human Services Alex Azar said the countermeasures fund should also cover injuries from Covid-19 vaccines, giving drug companies immunity from potential liability lawsuits.

But the fund isn’t expected to offer much of a remedy to the public, according to lawyers and vaccine experts. Since it began processing claims, the fund has paid out $6 million on 29 claims, averaging $207,000 per person, compared with $585,000 on average per person for an older vaccine injury fund.

Behind the gap: The new fund has a tougher threshold for proving a relationship between an injury and the vaccine, experts say. The newer fund has a shorter statute of limitations, no avenue for appeals and doesn’t pay damages for pain or suffering like the older vaccine program does.

“The recourse for the people that get it initially is not going to be great” if they are harmed by any Covid-19 vaccines, said Renée Gentry, director of the Vaccine Injury Litigation Clinic at George Washington University Law School. “The countermeasures compensation program is effectively a right to file and lose.”

Several companies, including

Pfizer Inc.


PFE -0.27%

and

Moderna Inc.,


MRNA 0.10%

are testing whether experimental vaccines safely protect people from Covid-19 in late-stage clinical trials. Initial results could be available in the coming weeks, and if they are positive the U.S. government could authorize emergency use of the shots.

Vaccines generally are safe, but they can cause side effects—called “adverse events” in studies—including shoulder injuries related to injections, allergic reactions, fainting and certain neurological conditions like encephalitis. Some of the side effects are rare, and public-health officials say the benefits of vaccines in preventing diseases like polio, measles and rotavirus outweigh the risks.

Some people receiving experimental Covid-19 vaccines have experienced fatigue, chills and injection-site pain, studies show. Drug companies have said most of the events are mild or moderate, and that the vaccines were generally well tolerated.

Yet some of the symptoms have been pronounced. In a small study of Moderna’s vaccine in healthy volunteers ages 18 to 55, about 40% of people receiving the dose level now being tested in a larger trial experienced fever after the second of the two-injection regimen, and 80% had chills.

Nearly all study subjects had injection-site pain, according to results published online by the New England Journal of Medicine in July.

Ian Hayden received the two-dose Moderna vaccine regimen at a study site in Seattle. After the second shot in May, he experienced fever and chills, which became severe enough to send him to an urgent-care facility, where he was treated with IV fluids and Tylenol.

The symptoms went away within two days and weren’t life-threatening, said Mr. Haydon, 29 years old, a science communications manager at the University of Washington. He said he’d been warned at enrollment that symptoms could arise, and he doesn’t expect any compensation beyond the medical care paid for by the study leaders.

Moderna says temporary flulike symptoms could be a sign that the vaccine is having the desired effect on the immune system.

One patient in the Moderna Phase 1 trial withdrew after the first dose, after developing hives on both legs, according to the New England Journal of Medicine paper. The case of hives was judged to be “related to the vaccine,” the article said.

Drugmakers say such protection for liability is especially important during the pandemic because they are expected to develop and manufacture vaccines as quickly as possible.

“It’s important for people, if there would be side effects, that they get compensated,”

Johnson & Johnson

Chief Scientific Officer Paul Stoffels said in an interview. “But for the industry to make multiple billion vaccines available you also have to have” liability protection for companies, he said.

J&J, which is developing a Covid-19 vaccine, also is having discussions in other countries to secure liability protections, he said.

Pfizer, a leading Covid-19 vaccine developer, expects to receive broad protections against personal-injury claims that may arise from its vaccine in the U.S. It is also pursuing liability protections in other countries through contractual or legislative efforts, general counsel Douglas Lankler said on a conference call with analysts in July.

The Countermeasures Injury Compensation Program provides liability protection for companies that develop vaccines, drugs and other products that are intended to end a pandemic or other emergency.

Federal declarations have specified which countermeasures are covered by the program. For example, the countermeasures program covered a rare neurological disorder, Guillain-Barre syndrome, that occurred in some people who received the vaccine against the H1N1 flu strain that caused a pandemic in 2009.

For any Covid-19 vaccine, HHS says people are eligible for compensation if they can show compelling medical evidence that it caused a serious injury.

The countermeasures program generally makes it tougher to file claims than the older National Vaccine Injury Compensation Program, which was enacted by Congress in 1986 to try to stem the tide of drugmakers exiting the vaccine business over liability concerns after a rash of lawsuits relating to childhood vaccines.

The National Vaccine Injury Compensation Program generally shields manufacturers of vaccines from product-liability lawsuits over harm suffered after receiving vaccines recommended for routine use in children or pregnant women. More recently, conditions linked to the flu vaccine have also been covered. The program is funded by a 75-cent excise tax paid by drug companies on each vaccine administered.

Congress established the fund as a no-fault system and mandated that it should make awards quickly and easily, according to the legislation.

HHS can negotiate settlements of some claims, while a special court, known among lawyers as the “vaccine court,” can order payouts for claims that HHS contests.

Dorothy Smith, of Odessa, Texas, took her case to vaccine court in 2018 after she developed a condition known as transverse myelitis—an autoimmune response to an infection that in severe cases can lead to paralysis. Ms. Smith is seeking $1.5 million to cover future medical costs.

Ms. Smith, 74, developed the condition about three weeks after the flu vaccine and was soon unable to walk, according to the complaint she filed with the U.S. Court of Federal Claims. A former church worker, she now is using a wheelchair, said David Calvillo, her Houston lawyer.

Her case is awaiting a final hearing or ruling from vaccine court, Mr. Calvillo said.

Transverse myelitis has been a suspected condition in testing of the

AstraZeneca


AZN 1.16%

/Oxford Covid-19 vaccine, factoring into halts of large clinical trials of the shot.

All studies of the AstraZeneca/Oxford vaccine were halted in September, after a study subject developed an unexplained illness that a U.S. health official described as a spinal-cord problem. Regulators in the U.K. and elsewhere have allowed studies to resume after concluding it was safe to do so.

But a trial is still halted in the U.S. as the company’s safety experts and regulators weigh the evidence.

Write to Peter Loftus at [email protected] and Susan Pulliam at [email protected]

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