As pharmaceutical companies make unprecedented progress on the production of COVID-19 vaccines with the end goal of vaccinating the public to produce protective antibodies against the coronavirus (SARS-CoV-2), many of us want to know what liabilities if any, will fall on pharma companies for vaccine-related injuries. This is because, vaccines, though lifesaving, have not always had a clean past. With controversies, conspiracy theories, coverups, and litigations, it is easy to see why some people might be skeptical or overly cautious when it comes to getting vaccinated.
In 2014, Time Magazine published an article about a Centers for Disease Control and Prevention (CDC) whistleblower who was not only a senior scientist at the CDC, but also a member of the team that studied the correlation of autism to measles, mumps, and rubella (MMR) vaccination. According to the whistleblower, although the official study results of the study stated that the MMR vaccine did not contribute to autism, a subset of the study which revealed that a higher incidence of autism existed in MMR-vaccinated children, especially African American boys, had been excluded in the final report thereby skewing the results.
The first recognized attempt to create immunity against a disease was conducted in 1796 by Edward Jenner who is credited as the father of vaccinology. At the time of his experiments, smallpox, one of the deadliest diseases known to mankind was devastating the world with a fatality rate of up to 98%. The few who survived developed immunity for life. Jenner realized that milkmaids who had previously had cowpox, did not get infected with smallpox and so he decided to inoculate mater from fresh cowpox lesions of a milkmaid into an 8-year old boy. The boy received full immunity against smallpox after two doses, and two years later, in 1798, the first vaccine, the smallpox vaccine, was created. Jenner termed the process of getting the vaccine, “vaccination” after the Latin words vacca for cow and vaccinia, cowpox.
But vaccines have come a long way since 1798 and over the years, considerable health gains have been made with the eradication or reducing the spread of diseases like tetanus, diphtheria, pertussis, polio, measles, mumps, rubella, and many more. To ensure the safety of vaccine recipients, vaccines are heavily regulated around the world, and in the U.S., the Food and Drug Administration (FDA), through the Biologics Control Act of 1902, regulates all vaccines. Incidentally, the smallpox vaccine was the first biologic ever licensed. Biologics, also known as biological products, are drugs derived from living organisms such as microorganisms, animals, and humans. They include a vast range of medical products such as vaccines, gene therapy, blood, and blood products. They are often developed through the process of biomedical research and biotechnology. Since biologics can be made from blood, proteins, viruses, and living organisms, they tend to be more susceptible to temperature and light. Traditional drugs, on the other hand, are more defined structurally and manufactured through chemical synthesis by combining different chemical substances. Since most biologics are often cutting edge, or used for treating serious conditions, they tend to undergo expedited approval and can get to the market quicker than non-biologics. For example, Hemlibra, is a biologic. Some products like insulin and growth hormones, however, are regulated as drugs rather than biologics.
The Vaccine industry is a 60-billion-dollar industry even before COVID and the reason that the industry is so profitable is that it is exempt from safety testing. Today, in order for a child to go to school, the child must take 72 doses of 16 vaccines. All of these does are mandated for children before the age of 18. Not one of those doses, however, has ever been safety tested against placebo in pre-clinical studies. The exemption from safety testing is an artifact of CDC's legacy as the public health services, which was the original predecessor agency. The CDC was the Public Health Service, which was a quasi-military agency. That's why people at CDC wear military uniforms and have military ranks like the Surgeon General. The CDC still has a strong connection to the U.S. military.
The vaccine program was initially launched as a national security defense against potential biological attacks on the United States. If another country wanted to attack the U.S. with anthrax or some other biological agent, the U.S. government needed to quickly formulate a vaccine and then deploy it to 300 million Americans with no regulatory impairments. If pharma called a vaccine a medicine, it would have to go through double-blind placebo testing and that takes five years. Why does it take five years to do proper safety testing? There's a lot of injuries, particularly autoimmune diseases, and cancers have a long diagnostic delay or long incubation periods.
Even with some evidence of the benefit of immunizations and government oversight, the late 1970s and 1980s were a period of high litigations against vaccine manufacturers leading to great financial losses to pharmaceutical companies and decreased incentives to manufacture much-needed vaccines. As a compromise to encourage pharmaceutical companies to continue producing vaccines while offering a solution to patients and families who may have suffered untoward effects from getting vaccinated, the U.S. Department of Health and Human Services (DHHS) set up the National Vaccination Injury Compensation Program (VICP) in 1986. This program, also known as the National Childhood Vaccine Injury Act of 1986 (NCVIA) of the Vaccine Act of 1986 is funded by a tax paid by the manufacturer on each vaccine dose.
This act requires providers to obtain informed consent as well as report adverse effects through the Vaccine Adverse Event Reporting System (VAERS). Providers are required to provide Vaccination Information Statements (VIS) detailing the risks and benefits of the vaccine to potential recipients or their legal guardians.
The main objectives of NVICP are to stabilize vaccine costs, ensure enough production and supply of vaccines, encourage future vaccine research by pharma companies, and provide an avenue for discussions and compensation for persons injured by vaccines covered under the act. On December 13, 2016, the 21st Century Cures Act was also enacted to amend VICP to include more vaccines not previously covered, and clarify that vaccine injury claims could be filed for injuries sustained by women while pregnant as well as by their live-born babies who were in utero at the time the women got vaccinated.
NVICP provides compensation to people who have been injured or may have been injured by covered vaccines through legal settlements rather than directly from the pharmaceutical company. It works as a no-fault program with short and informal hearings which serves as an alternative to civil litigation against vaccine companies and also as a way to reduce the number of claims filed annually against vaccine companies. Under the NVICP program, anyone who believes they were injured from a vaccine that is covered by the program can file a petition with the U.S. Court of Federal Claims. The petition goes through a process and if the petitioner is found to be eligible for compensation, the court orders the U.S. Department of Health and Human Services to award a certain amount of compensation. The petitioner can accept or reject the compensation choosing instead to either appeal the decision or file a claim in civil court against the vaccine company and/or the health care provider who vaccinated them. Since this process is often quietly done, the general public may not be aware that since 1988, almost 24,000 petitions have been filed with the VICP, and of that, 19,609 were adjudicated, 11,735 dismissed, and 7,874 compensation for a total of $4.5 billion paid out for vaccine-related injuries. As of date, the largest vaccine injury settlement was $101 million paid for an infant who suffered a severe reaction to the Measles, Mumps, and Rubella (MMR) vaccination including brain injury, vision impairment, kidney failure amongst other disabilities that require her to receive specialized medical care and supervision 24/7 for the rest of her life.
Vaccines produce active immunity against viruses and bacteria to protect us from infections. But just like every other medical product, there are other sides to the story. Most times, the benefits greatly outweigh the risks but knowing the other side of the story as well as available resources, can help us make informed decisions with regards to vaccination