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Scientist in the laboratory with test tube and virus.

Vaccines should come with protection against risks, experts say

Editor’s note: With the recent vaccine news, the Legal Examiner is publishing this updated followup version of a previously published article.

UPDATE: As the country gears up for a massive program to administer COVID-19 vaccines, some experts are recommending increased protections for anyone who may experience what are expected to be rare negative side effects from taking the shots.

As Legal Examiner reported in June, in order to encourage needed innovation and medical treatments, the law protects makers of vaccines and other treatments developed to address the pandemic from lawsuits. This liability immunity also applies to those who distribute and administer these treatments and vaccines.

Even the safest medical treatment can cause harmful side effects in rare instances. So, the government has created a program that’s stated purpose is to compensate injured patients who are blocked from being able to sue, the Countermeasures Injury Compensation Program or the CICP. 

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However, critics say the CICP pays few claims and provides patients little in the way of protection or transparency. The program is compared unfavorably to the Vaccine Injury Compensation Program, or VICP, which compensates patients injured by routine vaccines, mostly the kinds administered to children.

Legal experts suggest either allowing COVID vaccines to be covered by the VICP or a program that has many of the elements of the VICP to provide patients with a better shot at being compensated.

The office of President-elect Joe Biden’s transition did not respond to emails from the Legal Examiner asking about the incoming administration’s plans regarding vaccine injury compensation.

According to the VICP program description: “The United States has the safest, most effective vaccine supply in history. In the majority of cases, vaccines cause no side effects, however they can occur, as with any medication—but most are mild. Very rarely, people experience more serious side effects, like allergic reactions. In those instances, the National Vaccine Injury Compensation Program (VICP) allows individuals to file a petition for compensation.”

Less than 10% of vaccine injury claims made under the CICP for prior vaccines resulted in compensation to patients, according to Peter H. Meyers, professor emeritus at George Washington University of School of Law, who filed a Freedom of Information Act request with the Department of Health and Human Services.

That contrasts with nearly 40% of adjudicated claims deemed compensable under VICP since 1988, according to data from the program.

Under the CICP program, for example, there were 407 claims made for injuries people said they suffered after receiving the H1N1 vaccine in 2009. According to the DHS data, just 35 of those claims were paid. 

Meyers said tens of thousands of people volunteered to participate in phase 3 clinical trials for vaccines. “I think we owe it to the brave volunteers,” he said, “to have a good vaccine injury compensation program in place as soon as possible.”

According to VICP program information, 19,356 petitions were adjudicated since 1988, with 7,666 being deemed compensable and 11,690 being dismissed.

Drug manufacturers have announced at least three vaccines should be ready for distribution in coming weeks and months. 

The CICP is also criticized for being secretive, for example, while the VICP is transparent. The VICP pays for patients’ legal representation, while the CICP does not. The CICP covers fewer expenses. For example, VICP reimburses for counseling, special education and diminished earnings capacity. These things are not covered by CICP.

Andrew Heinrich, a lecturer at the Yale School of Public Health, specializing in regulatory affairs, global health and behavioral sciences. He coauthored an article in the New England Journal of Medicine recommending governments around the world provide no-fault compensation programs for vaccine injury in exchange for giving manufacturers immunity from lawsuits.

“For a vaccine that will most likely be distributed worldwide, there is an inevitable risk of serious adverse events, such as seizures and allergic reactions, even with a very safe product,” the article says. “Such events might not begin surfacing until a substantial number of people have been vaccinated.”

Speaking to the Legal Examiner, Heinrich said one advantage CICP has over the VICP is the ability to add new injuries in real time. 

Heinrich recommended adopting a hybrid program providing the protections and compensation levels of the VICP and the adaptability of the CICP. This would include an evolving table of covered injuries that could be changed as new information became available regarding side effects that could be connected to the vaccines. This would be, he said, “a living document that changes over time.”

One challenge is convincing Americans to accept a vaccine. The politicization of COVID treatments, along with the fast development of vaccines, has left a portion of the population reluctant to trust the safety of vaccines.

 A recent Gallup poll found 58% of Americans reporting willingness to get a COVID vaccine. This was an increase over 50% in September. But still, 42% said they would not get a vaccine. Of those who say they would refuse, 37% cited the rushed timeline, with 26% preferring to wait to confirm the vaccine is safe. Another 12% said they don’t trust vaccines, and another 10% wanting to see how effective it will be. Others report concerns about the politicization of the vaccine and seeing it as unnecessary.

Heinrich said a reliable compensation program could contribute to easing some people’s concerns about taking a vaccine. While some anti-vaxxers might never trust any vaccine, “I would suspect there are also people who would find it comforting,” he said.

Sam F. Halabi, director for intellectual property and entrepreneurship at the University of Missouri School of Law, coauthored the New England Journal of Medicine article.

Halabi said he personally prefers the components of the VICP, but that Congress chose to create the CICP for pandemic treatments. “I think they should have just incorporated vaccines deployed during public health emergencies into the vaccine injury compensation program,” he said. 

Halabi was skeptical that a good compensation program would influence willingness to be vaccinated. “There isn’t any evidence, at least there’s no evidence that I’m aware of, of a relationship between the existence of a compensation program between vaccine hesitance and vaccine confidence,” he said. 

The bottom line, he added, is “People don’t want to be made ill by a medicine. The whole thing about vaccines is you give them to healthy people. I suspect most people think ‘I would rather have my health’” than be compensated for being harmed by a treatment.

Still, Halabi noted the protections provided by the VICP, as well as the fact that it has a mechanism to fund compensation through a 75-cent fee paid by manufacturers on each vaccine. “I think it’s more likely to be viewed favorably and transparently by the American public.”

Contact Elaine Silvestrini at Elaine@legalexaminer.com. Follow her on Twitter at @WriterElaineS.