“A rose is a rose is a rose,” said Gertrude Stein,1 but is a vaccine always a vaccine? Traditionally, the medical definition of the word vaccine has been, “Injection of a killed microbe in order to stimulate the immune system against the microbe, thereby preventing disease.”2
More recently, the term has been applied to personalized medical interventions against an individual’s specific type of cancer.3 In other words, the word vaccine is being used to describe treatment for those who are already ill. It’s a confusing change.
I have long believed in an individual’s right to decide whether or not to vaccinate, and whether to make that decision across the board or on a vaccine-by-vaccine basis. If a doctor asks me, “Do you want the flu shot?” I have my answer ready. I don’t have to think about it because I have done my homework already and I know I don’t want it, for me or my family.
If that same doctor asked instead, “Do you want me to inject your baby with a vaccine against lung cancer?” I probably would still say, “No, thank you.” Not because I’m not afraid of lung cancer, but because I believe strongly in the power of the natural immune system and that protecting my child from that terrible disease lies with education and a toxin-free breathing environment. Also, no one in my extended family or my husband’s family has ever had lung cancer, so I have evidence that my children are not genetically predisposed to it. If the cancer in question was colon cancer, it might give me pause, since we have had numerous cases of that type of cancer on all sides of the family going back generations. I probably still would say no, but it would make me think.
However, if I were to be diagnosed with cancer tomorrow and the doctor asked if I wanted a personalized vaccine against my own personal tumor type, using my own cells… that to me is a totally different scenario.
What Makes a Vaccine a Vaccine?
I was perplexed about the word “vaccine.” Why not call it a medical breakthrough, the future of cancer treatment, personalized therapy, or, most accurately, immunotherapy? The fact that it is a manipulation of the immune system is presumably how it falls under the umbrella of vaccination, but it differs dramatically from all other vaccines in that it is a tool against a specific, already-active disease, not a scatter-shot (no pun intended), generalized toxic injection designed to cause massive inflammation of the immune system in the hopes it will prevent some future possible illness. In 1996, an article was published that reads, “The oxymoron ‘Therapeutic Vaccines’ requires an Explanation… A vaccine is an entity used with the INTENT of preventing disease; a prophylactic: this is in contradistinction to a therapeutic which is an entity used with the INTENT of curing a disease.”4
The College of Physicians of Philadelphia described the hoped-for mechanism of the preventive anti-cancer vaccine Gardasil, saying, “By preventing the viruses from infecting body cells, these vaccines block the process that might eventually result in runaway cancer cell growth and damage to the body.”5 They describe cancer vaccines as “therapeutic vaccines,” that are used “to treat cancer after it has already appeared.” The Journal of Clinical Oncology echoes that idea, saying there are now two types of vaccines: prevention vaccines and treatment vaccines. “
Cancer treatment vaccines, also called therapeutic vaccines, are a type of immunotherapy.”6 Explaining how they work, they say, “Often, cancer cells have certain molecules called cancer-specific antigens on their surface that healthy cells don’t have. When these molecules are given to a person, the molecules act as antigens. Then, they stimulate the immune system to recognize and destroy cancer cells that have these molecules on their surface.” Immune therapy designed to use the body’s own immune system to recognize and fight its own cancer is still, for the most part, in the experimental stages and such treatments are only available through clinical trials.
Why Does the Label Matter?
Immunotherapy and vaccination are not synonyms. This is not a case of “a rose is a rose is a rose.” The usual timeline for gaining approval for a new medical drug or intervention is a long one: “It takes on average 12 years and over $350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1,000 compounds that enter laboratory testing will ever make it to human testing.”7
According to the FDA, “Vaccine clinical development follows the same general pathway as for drugs and other biologics”8 Biologics may be “fast tracked” if the new vaccine is considered necessary to address a serious threat. The difference is that relatively few drugs are fast-tracked, while the FDA is fast tracking many experimental vaccines to licensure today. A few of the recent vaccines that have undergone an accelerated approval process that by-passes normal licensing procedures with higher standards for proof of safety and effectiveness include those for human papilloma virus (HPV), adjuvanted influenza, anthrax, Ebola, and most recently, Zika.
Legal Rights Following Vaccine Adverse Reactions
Perhaps most important, what rights do consumers have if something goes wrong? If a patient has an adverse reaction to a drug, there are numerous options available for compensation. Injured patients may sue the clinic, the doctor, and the pharmaceutical company that produced the drug.9
Vaccines, like any medical intervention, are not safe for everyone and may be associated with adverse events from minor redness and pain at the injection site to brain damage and death. Unlike other pharmaceutical products, however, injured patients may not sue vaccine manufacturers or doctors. Nobody can be held accountable in a civil court of law in front of a jury when vaccines cause injury or death. The doctors, nurses, clinics, and the pharmaceutical companies are totally exempt from responsibility, as are public health officials who recommend and, in many cases, mandate the vaccine for school entry or employment.
The only recourse for a vaccine injured person is the federal vaccine injury compensation program (VICP), which is an admittedly long and frustrating process in which two out of three plaintiffs are denied compensation for their vaccine injuries.10 11
It wouldn’t be surprising if every medical innovation isn’t soon described as a “vaccine.”
1 University of Pennsylvania. Gertrude Stein. EPC Digital Library.
2 MedicineNet. Definition of a Vaccine. May 13, 2016.
3 Li QX et al. Oncolytic Virotherapy as a Personalized Cancer Vaccine. International Journal of Cancer May 23, 2008.
4 Spier RE. Therapeutic Vaccines: A Pandoric Prospect. S. Cohen et al. (eds.), Novel Strategies in the Design and Production of Vaccines. Springer Science+Business Media New York, 1996.
5 The College of Physicians of Philadelphia. Cancer Vaccines and Immunotherapy. The History of Vaccines January 2016.
6 Cancer.Net. What Are Cancer Vaccines? Journal of Clinical Oncology December 2015.
7 U.S. Food and Drug Administration. New Drug Approval Process. Copyright 200-2016.
8 FDA. Vaccine Approval Process. Aug. 24, 2015.
9 National Institutes of Health. When Can Patients Sue Drug Companies? NCBI May 2009.
10 Liebowitz B. Supreme Court Vaccine Ruling: Parents Can’t Sue Drug Makers for Kids’ Health Problems. CBS News Feb. 28, 2011.
11 HRSA. Vaccine Injury Compensation Program Data & Statistics. June 1, 2016.