“Immunology discoveries have changed the face of modern medicine, extending horizons in our understanding of how to treat significant health issues with immunotherapy, autoimmune diseases, and vaccines for emerging pathogens.”
One hundred twenty years ago, the U.S. Congress initiated the country’s first steps “to regulate the sale of virus, serum, toxin, and analogous products,” passing the 1902 Biologics Control Act to codify, oversee, and regulate a burgeoning field. By 1906, the legislation expanded to the Food and Drug Act, which formally established the U.S. Food and Drug Administration (FDA).
The United States’ investment in evidence-based vaccine development continued with an act that created the U.S. Public Health Services, which eventually evolved into the National Institutes of Health (NIH). With strict control over how vaccines were made, the federal government steered the process for safety and efficacy. Although vaccine development mostly involves the private sector, federal government agencies like FDA, NIH, and the Centers for Disease Control and Prevention (CDC) have final approval authority for public distribution.
Vaccines Are Safe and Effective
Under FDA’s purview, vaccines are strictly tested, reviewed, and verified before the agency approves them for public use. FDA’s Center for Biologics Evaluation and Research “ensures that FDA’s rigorous scientific and regulatory processes are followed by those who pursue the development of vaccines.” With checks and balances, the center works with public, private, educational, foundational, and corporate experts to develop vaccinations to inoculate society against diseases.
When manufacturers deem a vaccine ready for human use, it must first go through the clinical development stage, with FDA oversight throughout multiple review phases with different regimens for infants, children, and adults. The process is not always linear and approvals may be made spontaneously, but FDA coordinates clinical trial findings to ensure safety and evidence-based outcomes.
“As a medical doctor, I know all too well how important vaccinations are throughout life, helping people of all ages live longer, healthier lives. The World Health Organization estimates that immunization currently prevents 3.5–5 million deaths every year from diseases like diphtheria, tetanus, pertussis, influenza, and measles, and tens of millions of people are alive today because of the COVID-19 vaccines,” Robert M. Califf, MD, FDA commissioner, said in a blog post recognizing August as National Immunization Awareness Month.
Vaccinations’ U.S. Track Record
Both history and current practices define a clear line of success in identifying and employing vaccines during public health crises. Take, for example, polio: In the late 1940s and 1950s, the epidemic resulted in 15,000 cases of paralysis every year, but in 1955, FDA approved the trivalent inactivated poliovirus vaccine, dropping incidents dramatically. By the 1970s, fewer than 10 cases of polio were diagnosed the entire decade.
Measles is another historic example: When its vaccine was approved in 1968, CDC initiated a campaign to inoculate the country. By 1981, the United States saw pronounced decreases in cases, and by 2000, measles was classified as nearly nonexistent because of an extended period without any reports.
A more recent vaccination example that many of us remember or participated in is the human papillomavirus (HPV). In the early 2000s, FDA approved HPV vaccines for male and female patients to prevent the virus’s associated cancers. After public health awareness campaigns encouraged vaccination for young people, CDC reported noticeable drops in both squamous cell and adenocarcinoma cervical cancer across all age groups studied.
Policymakers Support Vaccinations
In 2019, a bipartisan group of U.S. House representatives introduced the Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act to increase immunization rates nationally. Positioned before the pandemic, that forethought supported the country’s national COVID-19 vaccination efforts.
VACCINES Act lead sponsors U.S. Representatives Kim Schrier, MD (D-WA), and Michael Burgess, MD (R-TX), lauded vaccinations’ benefits. “Vaccines are one of the greatest medical accomplishments of the 20th century and have been proven safe and effective at preventing diseases that once killed or greatly harmed people around the world,” Schrier, a pediatrician, said.
“Vaccines are safe and effective tools that can protect Americans from preventable suffering. As the most senior physician serving in Congress, I am glad to work to improve the health and well-being of the American people,” Burgess, an obstetrician, added.
In 2021, U.S. Representatives Annie Kuster (D-NH) and Larry Bucshon, MD (R-IN), drafted the Immunization Infrastructure Modernization Act to reinforce a faster national system for vaccinations. “The COVID-19 pandemic has brought with it dark times, from the devastating loss of life to the overwhelming closures of main street businesses across the country,” Bucshon said. “Thanks to Operation Warp Speed’s unprecedented development and rollout of two COVID-19 vaccines less than a year after the pandemic began, there is light at the end of the COVID-19 pandemic tunnel.”
The U.S. Senate simultaneously drafted bipartisan legislation to increase the development and distribution of vaccines. Senators Patty Murry (D-WA) and Richard Burr (R-NC), chair and ranking member, respectively, of the Health, Education, Labor, and Pensions Committee, introduced the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) to improve public health agency coordination, vaccine stockpiles, and monitoring of infectious disease threats.
Although both bills are still circulating in committees, Washington is working to prevent future pandemics and protect the public through vaccination.
ONS on Vaccinations and Cancer
Oncology nurses understand the interplay between cancer and the immune system and the reality of vaccines in their patients. “People with cancer have a particular risk for infection, and vaccines can be a powerful preventive tool. Not only is infection risk increased during cancer, but certain patients are more likely to have infections that become serious or life threatening. Immunocompromised patients may not be able to mount a sufficient immune response to a vaccine dose,” Chelsea Backler, MSN, APRN, AGCNS-BC, AOCNS®, VA-BC, oncology clinical specialist at ONS, said.
Because immunocompromised patients with cancer may not be able to protect themselves with their own vaccinations, ONS’s advocacy approach is focused on ensuring anyone patients come into contact with is vaccinated instead. If you and patients’ loved ones are inoculated against COVID-19, by default those patients are too. But misinformation and vaccination fears are thwarting ONS’s work.
FDA has the same struggle. Commissioner Califf cautioned that “getting the right information about immunization in the digital age can be like drinking from a fire hose. Trying to filter fact from fiction can be a challenge, but oh so critical when it comes to public health.”
And the U.S. Department of Health and Human Services has had to work almost as hard on communicating about vaccines’ safety and efficacy as providers have on administering the doses. “Vaccines save lives by protecting us from serious diseases, like COVID-19, measles, and whooping cough, throughout life. So, it’s important to know the facts about vaccines, immunization, and vaccine-preventable diseases,” the agency admonished in an August 2022 update about vaccination.
In the ever-polarizing political environment, separating facts from clutter is a constant challenge. Science and medicine are under assault, preventing traditional public health experts at the local, state, and federal levels from being trusted. Politicization of facts and the ease with which misinformation is obtained and recirculated has killed thousands of Americans.
A Washington Post editorial board message issued a stark admonition for policymakers: “This might be the age of the mRNA vaccines that saved millions of lives, but it is also a period in which antivaccine campaigns cost lives. A dangerous cocktail of doubt, suspicion and fear about vaccines has blended with mistrust of government and health authorities, often accelerated by social media and exploited by politicians. The response must be to broadcast the truth: Vaccines have proved safe, effective and lifesaving.”
As the most trusted profession, nurses speak truth to power. Use your power to broadcast the truth: to patients, providers, the public, and policymakers.