With the efforts to develop an effective COVID-19 vaccine across the country and around the world, it is good news that a Richmond-based research firm also is involved in the clinical trial process.
This is not the first pandemic of late that has required the rapid development of a vaccine. The most recent and well-known was the 2009 swine flu known as H1N1. A vaccine for that flu virus quickly was developed and effectively was delivered to millions of people toward the end of 2009 and thereafter.
A very small number of people, however, had serious reactions to the H1N1 vaccine. In response, the U.S. Department of Health and Human Services created a fund to compensate individuals who suffer legitimate, albeit rare, injuries from certain vaccines developed in response to public health emergencies such as H1N1 and the bird flu, as well as from rare events like anthrax exposure from biohazard attacks.
This federal fund, called the Countermeasures Injury Compensation Program, now also will cover any injuries caused by COVID-19 vaccines once they are approved and delivered to the general public.
This Countermeasures Injury Compensation Program is far from perfect, however, and has been characterized by many who have submitted claims as a “black hole.” Indeed, over the past 10 years of the countermeasures program, few if any claims have been granted.
Claimants also must file their claim with the program within one year of the vaccination at issue, which often is far sooner than they receive a diagnosis linking their rare injury to the vaccine. And ultimately there is no review process if a claim is denied; the administrative agency’s decision is final and there are no appeals.
There is a better solution, however. In the 1980s, Congress created the National Vaccine Injury Compensation Program, which is a no-fault compensation program. Most people don’t know that a single vaccine injury compensation fund exists, let alone that there actually are two such federal programs.
This older National Vaccine Injury Compensation Program differs from the newer countermeasures program as it covers more common vaccinations, such as the seasonal flu vaccine, as well as tetanus, hepatitis, meningococcal vaccines and others.
Seventy-five cents from every vaccination administered in the United States goes to this federal program’s compensation fund, which now totals about $4 billion.
And unlike the countermeasures program, the National Vaccine Injury Compensation Program is administered by what are known as “special masters,” who are appointed by the Court of Federal Claims in Washington, D.C., and preside like judges over the thousand or so vaccine injury claims filed each year.
This program also allows for claimants to be represented by an attorney, but their monetary award does not go to pay the lawyers. Instead, attorneys are paid out of the compensation fund after a claim is resolved, preserving the entire monetary award for the claimant.
Again, as mentioned, vaccines are extraordinarily safe and effective. But as with any medication, there can be rare side effects and sometimes adverse reactions in a very small percentage of the population.
This is why out of the billions of vaccinations given in the U.S. over the 32-year life of this program, only about 23,000 claims have been filed. But for that small percentage of adverse reactions, the compensation from the program has been life-saving and life-changing, covering future medical bills and expenses, and lost wages.
It will be important for lawmakers and federal agencies to closely watch the rollout of the COVID-19 vaccines once approved. Chances are there will be a small, albeit meaningful, number of recipients who have adverse reactions.
Under the current scheme, the options for those individuals are limited to the countermeasures program, and this is in reality no remedy at all.
Whether through legislative or executive action, COVID-19 vaccines should be placed within the National Vaccine Injury Compensation Program so that recipients of these vaccines are adequately covered from rare adverse events.
Glen Sturtevant is an attorney at Rawls Law Group in Richmond and a former Virginia state senator. Contact him at: email@example.com