The US began vaccinating the population against the Corona Virus in December 2020. But widespread mistrust persists. This might have something to do with the fact that if anything goes wrong with the vaccine, the drug-makers that produce them aren’t responsible. Ultimately, if we want any chance of returning to life as it was, mass vaccination is going to be critical. So, how do you convince a public to take a vaccine made in record time, using technology that has never before been licensed? And is anyone to blame if something goes wrong?
Frontrunners Pfizer and Moderna built their COVID vaccines with a new kind of technology that has never before been licensed in the US. Typically, a vaccine puts a weakened inactivated virus into our bodies to trigger an immune response. But the coronavirus vaccine relies on messenger RNA, or mRNA, which contains a piece of genetic code with instructions for our body. The mRNA tells our cells to make a protein, which triggers the immune response to COVID-19, that then produces antibodies. These antibodies are what ultimately protect us from getting infected if we ever encounter the virus. Both companies have said that taking their vaccines could result in side-effects similar to mild COVID symptoms, such as muscle pain, chills, and a headache. Both of these vaccines are about 95% effective, but it’s still unclear how long this protection lasts, which is what worries some doctors more than the potential for any long-term side-effects.
If someone suffers severe side-effects from the vaccine, there is basically no one to blame in the US court of law. Alex Azar, Secretary of the Department of Health and Human Services, invoked the Public Readiness and Emergency Preparedness (PREP) Act in February 2020, which protects the makers of COVID-related products, such as vaccines and treatments, from legal action. This protection lasts until 2024, meaning that until then, companies like Pfizer and Moderna can’t be sued for money damages in court over injuries related to the administration or use of products to treat or protect against COVID-19. But drug-makers, like Pfizer, continue to reassure the public that no shortcuts were taken.
It was the FDA that actually cleared the vaccine for use. So, does the federal government bear any responsibility? No, because approving or disapproving a drug for use is part of their sovereign immunity. There are limited exceptions, but legal experts say they don’t provide a viable legal path to hold the government responsible for a vaccine injury, and the workplace now introduces a unique set of legal challenges related to the vaccine. Once the FDA upgrades its emergency authorisation to a full approval in a few months from now, there’s a speculation that employers could require staff to get inoculated. While this is partly a PR tactic, it’s also legally within an employer’s rights to extend this kind of requirement.
Some employers could apply to be exempt from a blanket requirement. If a workforce is unionised, the collective bargaining agreement may require negotiating with the union before mandating a vaccine. Anti-discrimination laws also provide some protections, but legal experts say that if an employee is forced to get a vaccine and suffers a debilitating injury from it, claims would be routed through workers compensation programs and treated as an on-the-job injury. The National Vaccine Injury Compensation Program, better known as the Vaccine Court, is relatively easy to use generous in terms of what it’s willing to pay out to those who are eligible. But because the COVID vaccine has not yet been recommended for routine administration to children or pregnant women, it doesn’t qualify. Another program is a fund attached to the PREP Act. The Countermeasures Injury Compensation Program (CICP) has existed for around a decade, but experts specialising in vaccine law say it’s a lot more difficult to navigate.
However, if a case for compensation through the CICP is successful, the program provides up to $50,000/year for reimbursed lost wages and any out-of-pocket medical expenses. It won’t cover legal fees nor anything to compensate for pain and/or suffering. It’s also capped at a death benefit of $370,376, which is the most that a surviving family member receives in the event that a COVID vaccine proves to be fatal. There’s also a strict one-year statute, which means that all claims have to be filed within 12 months of getting the vaccine. The best fix is to change the rulebook of the Vaccine Court. Should that legislative change happen, lawyers say that there usually is a retroactive provision once a new vaccine is added to the Court. That would be good news for injured by the vaccine, who would then have access to a much larger pool of cash that has a better track record for rewarding compensation. But for now, it remains to be seen whether Congress will actually make the change or not, meaning that compensation options are currently limited.