Background: In the environment of an infectious pandemic, vaccines are a primary public health strategy to prevent the spread of disease. With the COVID-19 pandemic, there is heightened interest in safe and effective vaccines and their use in the context of clinical oncology practice.
Objectives: This article provides foundational information about vaccines in general and vaccines developed to protect against the SARS-CoV-2 virus in the United States, as well as clinical nurse strategies to apply vaccines in clinical oncology practice.
Methods: The article is based on a review of public health literature and reputable websites about vaccines and their development in clinical care.
Findings: This foundational information about vaccines reviews their history and development, as well as the development of COVID-19 vaccines specifically, and discusses COVID-19 vaccines as part of clinical oncology care. Supporting best practices in clinical oncology care, nurses can provide factual, evidence-based information about vaccine safety, effectiveness, and safe administration.
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As a public health staple, vaccines are an important component of comprehensive programs to reduce the spread of disease during a pandemic. Although vaccines rarely provide complete protection from infection in all individuals, the coverage vaccines do provide is significant (American Cancer Society [ACS], 2020b; American Society of Clinical Oncology [ASCO], 2020b; Centers for Disease Control and Prevention [CDC], 2020f). A clinical foundation for COVID-19 vaccines continues to develop. This article reviews the latest on COVID-19 vaccines related to clinical oncology practice in the United States as of December 2020.
To address morbidity and mortality associated with the COVID-19 pandemic, there is intense interest in vaccines and the infection control capabilities they promise. To provide background for clinicians in practice in the United States, this article reviews vaccines, vaccine development, and how vaccines are a component of oncology clinical practice. In the context of the COVID-19 pandemic, the article also reviews the role of COVID-19 vaccines in oncology clinical practice and how oncology nurses can provide factual, evidence-based information about vaccine safety and efficacy. Issues associated with vaccine hesitancy as a public health concern are also reviewed. That hesitancy can include distrust of the vaccine’s safety and efficacy; political, cultural, and values-based influences; and general and specific misinformation about vaccines.
When written in December 2020, this article was a prelude to many milestones associated with the development and launch of safe and effective COVID-19 vaccines. Figure 1 provides a resource list of sources for updated information about vaccines in general, COVID-19 vaccines, and clinical guidelines about implementing vaccination in oncology clinical practice.
History of Vaccines
As one of the more effective strategies to ensure public health, vaccines have a storied history that goes back centuries. As a time stamp for vaccines as a focus in public health, Edward Jenner used material from cowpox pustules as a foundation to protect against smallpox in 1796. Centuries later, that work ultimately led to the eradication of smallpox (College of Physicians of Philadelphia [CPP], 2020).
The scientific basis for effective vaccines has advanced, building on an understanding of molecular biology. In the 1700s, the vaccinia virus was identified as the active component of the vaccine that eradicated smallpox. During the 1800s, Louis Pasteur and Emile Roux demonstrated that infection protection was possible using inactivated and attenuated organisms (Doherty et al., 2016).
Scientific work in the 1900s advanced effective vaccine development, eradicating smallpox and nearly ridding the polio virus as a public health threat. Preventable infectious diseases, such as measles, diphtheria, and whooping cough, have been contained by the development of effective vaccines (CDC, 2018). Through the 1930s, antitoxins and vaccines were developed against diphtheria, tetanus, anthrax, cholera, plague, typhoid, and tuberculosis (CPP, 2020). The development of safe vaccines has since accelerated because of advanced techniques, such as the ability to grow live viruses in the laboratory, advances in recombinant DNA/RNA technologies, and sophisticated designs of targeted data-driven clinical trials (CPP, 2020; Sun & Singh, 2019).
The Science of Vaccines
To boost the immune system to fight viral or bacterial infections, the body mobilizes an immune process to recognize infection. This recognition involves T lymphocytes (or T cells) and antibodies (CDC, 2018). Unfortunately, the body’s response to infection can become ineffective, confused by the addition of vector processes or from changing molecular behavior. Therefore, in their effort to mimic or intensify the body’s immune response to infection, vaccines require constant updating and reformulation. Only when refined and shown to have durable effects will the U.S. Food and Drug Administration (FDA) (or regulators in other countries) approve a vaccine to be licensed and distributed (CDC, 2018, 2020e; Lewnard & Cobey, 2018).
Factors that contribute to vaccine development are the population at risk for the bacteria or virus, environmental conditions (temperature and risk exposure), and vaccine acceptance. Before a vaccine is approved as safe by the FDA in the United States, vaccines emerge from development and testing phases, which follow steps similar to the development of treatments or drugs (see Figure 2 for types of vaccines). Vaccines are developed in the laboratory with animals and then tested extensively with human participants. To develop and test vaccines, an involved contemporary infrastructure supports this work. This infrastructure can include sophisticated laboratory testing, open-source data sharing, regulatory requirements, quality methods of manufacturing, ongoing quality controls, informed consent of human participants, detailed clinical trial protocols, and use of data-collection and data-reporting platforms (Bhatti et al., 2020; CDC, 2020e, 2020f). Figure 3 highlights the development steps toward approval of a safe vaccine in the United States.
In clinical trials, phase 3 is the final phase of vaccine testing toward vaccine licensing and can last many years. Phase 3 is the trial period when the vaccine’s effectiveness in various populations is monitored. Vaccine trials focus on vaccine-related symptoms, adverse events, reactions in populations with high or prior infection exposure or susceptibility, populations from various age groups and/or comorbidities, seasonal severity of vaccine potency, and the vaccine’s evolution or obsolescence (CDC, 2020e, 2020f; Lewnard & Cobey, 2018).
After a vaccine is shown to be safe and effective, the FDA requires the manufacturer to apply for licenses for the product (the vaccine) and manufacturing of the product (production of the vaccine). These licensing procedures need to satisfy FDA regulators so that the vaccine is safe and can be marketed and distributed to the public (CDC, 2020e). Additional approvals are needed from the Advisory Committee on Immunization Practices, which develops recommendations on the use of vaccines to control disease, and the CDC, an arm of the U.S. Department of Health and Human Services (CDC, 2020e).
After a vaccine is licensed and approved for use, the collection of phase 4 trial data continues, with that data supporting ongoing monitoring of the vaccine’s safety and effectiveness, including the manufacturer’s processes (i.e., vaccine potency, purity, and labeling) (CDC, 2020e).
A primary focus to end the COVID-19 pandemic is development of safe and effective vaccines that would be administered broadly to populations. Herd immunity is viral spread through a population without safeguards in effective treatment or protection against the virus, which can pose significant risk to vulnerable populations (CDC, 2020a, 2020b; World Health Organization [WHO], 2020b). Most epidemiologists emphasize that herd immunity is associated with unnecessary morbidity and mortality (Speiser & Bachmann, 2020). From the time that the SARS-CoV-2 virus was identified as the source of the virulent, deadly disease, researchers have amped up their work and timeline to develop vaccines to address the pandemic (Chen et al., 1994; Kaur & Gupta, 2020; Mayo Clinic, 2020).
As one of the coronaviruses, SARS-CoV-2 is associated with the common cold and other respiratory diseases. When starting work on COVID-19 vaccines, researchers advanced previous work that developed vaccines to combat severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) vaccines (Mayo Clinic, 2020). Strategies from previous vaccine development included targeting the S protein to prevent it from binding to human cells, stopping reproduction of the virus (Chen et al., 1994; Kaur & Gupta, 2020; Mayo Clinic, 2020).
COVID-19 Vaccine Development
Challenges to developing COVID-19 vaccines have included establishing a seminal understanding about the pathogenic mechanism of SARS-CoV-2; encouraging limited effectiveness of prototype vaccines in human trials after promising animal trials; discovering unacceptable vaccine adverse effects (e.g., lung damage); and ensuring durable, long-term viral protection, particularly for older and younger populations (Mayo Clinic, 2020; Yang et al., 2020). Because of the deadly effects of the COVID-19 pandemic, the timeline to develop and produce a vaccine has been accelerated. However, only so many steps in vaccine development can be condensed toward producing a safe and effective vaccine (Badgujar et al., 2020; Chen et al., 1994; Dos Santos, 2020; Mayo Clinic, 2020; Yang et al., 2020). Initial COVID-19 vaccine trials included adults; other selected populations (e.g., children, pregnant women, patients in cancer treatment) require additional trial data to confirm vaccine safety and effectiveness (CDC, 2020a).
As mechanisms of action, the initial vaccine candidates are based on messenger RNA/DNA, which are nanoparticle, synthetic, and modified virus-like particles. These substances can serve as antigens to induce neutralizing antibodies, prompting protective response (Badgujar et al., 2020; Chen et al., 1994; Dos Santos, 2020; Hamed, 2020; Shi et al., 2020).
Distribution of COVID-19 Vaccines
After safe and effective vaccines are developed and approved by the FDA, the distribution of COVID-19 vaccines will be daunting. As of December 2020, most of the world’s population has no immunity to the COVID-19 virus. Once vaccines become available, specific vaccine administration protocols can require that individuals receive two injections spaced three to four weeks apart. Immunity to the SARS-CoV-2 virus is not expected to be immediate; to confirm effective protection, study data are being compiled to determine how long inoculation protects against the virus (Mayo Clinic, 2020).
As the number of individuals vaccinated against COVID-19 rises, the number of individuals diagnosed with COVID-19 will decrease. It is expected that some individuals will have adverse reactions to the vaccine, but those reactions are anticipated to be mild based on what has been learned during the clinical trial phases of vaccine development and use. Still, adverse reactions to the vaccines may generate distrust in the concept of vaccines as safe and effective. If COVID-19 vaccination levels plateau or decrease, incidents of illness will rise accordingly. This volatility of vaccination rates and outbreak of the novel SARS-CoV-2 will continue until the there is a high enough threshold of vaccination in the general population (Mayo Clinic, 2020). Of note, elimination of disease because of vaccination methodology has only occurred with smallpox (Chen et al., 1994; Mayo Clinic, 2020).
Rollout and Allocation
Comprehensive vaccine rollout plans are in development while vaccine clinical trials continue. These vaccine rollout plans require considerable expertise, relying on detailed and specific strategies. Rollout plans will be tailored to jurisdictions, population needs, resources, and distribution strategies (California Department of Public Health, 2020). In the United States, states and healthcare systems will determine distribution strategies and implementation plans (CDC, 2020b).
In October 2020, a phased approach to rollout and allocation of the COVID-19 vaccine was first proposed by the National Academies of Sciences, Engineering, and Medicine (NASEM) (see Figure 4). The NASEM report was requested by the National Institutes of Health and the CDC (Medline Plus, 2020). This NASEM-designed approach informs final guidelines when plans are announced to introduce and distribute the COVID-19 vaccines. The CDC’s Advisory Committee on Immunization Practices recommends distribution priorities, but states and health systems ultimately make distribution decisions (NASEM, 2020).
Although manufacturers have jump-started the process to manufacture millions of doses of vaccine before any vaccine formulations are approved, the process to ship and deliver doses requires complicated processes and systems (NASEM, 2020).
Based on the NASEM-proposed approach to launch and distribute COVID-19 vaccines, NASEM recommendations will guide states and healthcare systems as they begin to distribute vaccines. Rollouts will focus on maximizing benefit to society and prioritizing distribution to high-risk groups and those at risk of severe illness or death.
Vaccines and Individuals Diagnosed With Cancer
The decision to proceed with vaccination of individuals diagnosed with cancer is based on many factors, including the degree of immunosuppression of the patient (usually because of systemic treatment), the postsurgery status of the patient, and overall clinical status and/or degree of patient illness (CDC, 2020g). In general, healthcare providers (HCPs) recommend that patients receive any vaccination that can maintain general health. These recommendations can include vaccinations for the flu and pneumococcal pneumonia (Ward et al., 2017). For HCPs, decision-making platforms for COVID-19 inform decisions about recommending COVID-19 vaccines when those vaccines are available (ASCO, 2020a).
Flu Vaccinations as a Template for Practice
In the case of immunization for the flu, individuals diagnosed with cancer may be particularly susceptible to the flu and, therefore, may be more susceptible to the COVID-19 virus (ACS, 2020a; ASCO, 2020b; Mikulska et al., 2019; Ward et al., 2017). Seasonal flu vaccination is recommended for individuals diagnosed with cancer, taking into account risk factors, including age, comorbidities, metastatic sites and organs involved in disease, and functional respiratory impairment (ACS, 2020a; Bersanelli et al., 2019; Kamboj & Shah, 2019; Mikulska et al., 2019).
Aside from the flu vaccine for patients with cancer who are in treatment, oncologists may consider other strategies to protect against the flu, such as administering more than a one-shot series, increasing the antigen dose, and using adjuvant therapies (ASCO, 2020b). Historically, oncologists have applied scheduling strategies to protect against the flu if a flu vaccine response could be suboptimal because of immunosuppressive treatments (Bosaeed & Kumar, 2018). Seasonal flu vaccinations are also recommended for cancer survivors, as well as patients’ caregivers (ACS, 2020a; ASCO, 2020b; Bosaeed & Kumar, 2018)
With COVID-19 vaccines, oncologists may apply similar strategies (e.g., timing vaccine administration between cytotoxic treatments or at the end of treatment; for transplantation patients, waiting two to three months after transplantation to start administration of the vaccine) (ASCO, 2020a). Initial COVID-19 vaccine trials did not specifically evaluate vaccine response and safety with a cohort of patients in cancer treatment. However, COVID-19 trial data confirm efficacy and safety; oncologists anticipate similar vaccine efficacy and safety for patients with cancer with few contraindications. The extent of vaccine effectiveness is associated with a patient’s immunosuppression status because immunosuppression may blunt the effectiveness of the vaccine (ASCO, 2020a). Therefore, to guide COVID-19 vaccination for patients diagnosed with cancer, oncologists may use established flu vaccination scheduling recommendations to inform decision making and scheduling (ASCO, 2020b).
Vaccinations During Cancer Treatment
The timing of vaccination administration may be important in a patient with cancer’s overall plan of care. If patients have been ill or recently received immunosuppressive treatment (e.g., chemotherapy, immunotherapy, radiation therapy, stem cell transplantation), oncologists can decide if the immunosuppression status excludes safe administration of a vaccine or if scheduling the vaccine requires adjustments related to the disease status or treatment (ASCO, 2020a).
In general, oncologists encourage patients with cancer to schedule their vaccinations as soon as they are clinically stable and when symptoms from illness or treatment have resolved (ASCO, 2020a; CDC, 2020g). For patients diagnosed with and/or treated for cancer, guidelines for type, timing, and dosing of licensed COVID-19 vaccines will be established and disseminated based on additional trial data and more population experience after vaccines have been administered (Alhalabi et al., 2020; ASCO, 2020a; CDC, 2020g; FDA, 2020; National Marrow Donor Program, 2020).
Trust in Vaccines
An individual’s decision to vaccinate is associated with trust of HCPs and healthcare systems. Some individuals may delay or refuse vaccination because of a lack of confidence in the safety or effectiveness of vaccines and concern about side effects (Cornwall, 2020). Others are against vaccines in principle, seeing them as being incongruent with their belief in healthcare authority and/or their own value systems.
Confidence in Vaccine Safety and Efficacy
In a literature review of 185 articles about vaccine hesitancy among HCPs, Paterson et al. (2016) suggested that awareness and knowledge about vaccine efficacy and safety are key to having confidence in vaccines and recommending them to patients. In addition, confidence in vaccines was associated with societal endorsement, peer support, factual information, and the ability to stay updated about vaccine recommendations and changes. The review also noted that, to boost HCP confidence to support vaccine recommendations, HCPs can contribute their clinical experience and expertise as guidelines and policies are established (Paterson et al., 2016).
Distrust of public health efforts is complex and multifactorial. Patient adherence to vaccine recommendations can be influenced by social inequities, access and affordability of health care, and individual reluctance to receive vaccines because of age; culture; ethnicity; geography; and political, psychosocial, and spiritual belief systems (Doherty et al., 2016; Maltezou et al., 2019; Shen & Dubey, 2019).
For example, some from the anti-vaccine movement (sometimes called “anti-vaxxers”) believe that vaccines have been associated with autism (Cornwall, 2020; Shen & Dubey, 2019). Despite a lack of evidence of a link between vaccines and autism, some individuals strongly hold to their anti-vaccine beliefs (Medline Plus, 2020).
Vaccine Program Effectiveness
Any vaccine program has its limitations. To date, no vaccine can provide absolute, lifelong protection to all individuals who decide to become vaccinated. Coupled with the concept of herd immunity, individuals still may not develop disease. Herd immunity takes considerable time to achieve. Despite high mortality rates in the context of herd immunity, some believe waiting for herd immunity without the benefit of vaccine administration is a viable strategy to eradicate virulent infection (CDC, 2020b; WHO, 2020b). Therefore, not everyone endorses vaccine administration, which is promoted to reduce mortality while achieving herd immunity. Even a small group of unvaccinated people in a population can reduce a vaccine program’s success in protecting the overall population (CDC, 2018; Doherty et al., 2016). To quell the COVID-19 epidemic, epidemiologists estimate that more than 70% of the population may need to develop immunity, either through being vaccinated or becoming infected (Cornwall, 2020).
Other factors influencing confidence in vaccine program recommendations include individual complacency, a perceived lack of convenience to access the vaccine, and lack of follow-through to become vaccinated (Shen & Dubey, 2019).
COVID-19 Vaccines and Misinformation
Increasingly sophisticated anti-vaccine messages—many touted on social media platforms—attempt to stir hesitancy and turn the public away from vaccines as a viable strategy to protect against infection. Therefore, an undeniable component of vaccine prevention is providing clear, accurate, and evidence-based information that supports informed decision making. This information can counter unsubstantiated claims, rumors, and conspiracy theories about the risks of vaccination (CDC, 2020a, 2020b, 2020f; WHO, 2020c).
The environment of misinformation and suspicion may be difficult to counteract related to launching COVID-19 vaccines. The rush to license COVID-19 vaccines has emphasized speed and a perception that steps to ensure safety and efficacy have been condensed or bypassed entirely (Boodoosingh et al., 2020; Cornwall, 2020), which may contribute to distrust in COVID-19 vaccines before any are licensed and approved to distribute.
Before COVID-19 vaccines were approved by the FDA for emergency use, survey data suggested that about half of the U.S. population would agree to vaccination, and at least another quarter of the population was undecided (Cornwall, 2020). Suspicion is particularly concerning in underrepresented groups, who are well aware of the context of systemic racism, coercion, and exploitation associated with the Tuskegee syphilis study, which sanctioned no treatment for Black men with syphilis (Boyd et al., 2020; CDC, 2020c). In 2019, WHO named vaccine hesitancy as 1 of 10 major global health threats (WHO, 2020a, 2020b, 2020c).
The CDC is working to develop strategies to improve the messaging surrounding COVID-19 vaccination, speaking directly to individuals with more nimble, personal messages with an emotional component. Storytelling rather than dry, fact-heavy communication may be more effective to relay the vaccine message (CDC, 2020b; Cornwall, 2020). An additional plan is to bring vaccination options to the workplace or commercial spaces rather than isolating vaccine administration to healthcare settings (Cornwall, 2020).
Implications for Nursing
Studies have consistently demonstrated that knowledgeable clinicians can best support vaccine-related recommendations and individuals’ decision making about vaccines (Geoghegan et al., 2020; Maltezou et al., 2019). Capitalizing on teachable moments and based on clinicians’ trusting relationships with patients, the most potent tool in vaccine adoption is clear and accurate communication. The teachable moment with patients and their caregivers can be as simple as relaying factual information, offering clinician transparency about what is known and not known, and being a credible and accountable source of reliable information (Cornwall, 2020). To support best practice in clinical oncology care, nurses can provide factual, evidence-based information about vaccine safety and effectiveness, as well as the safe administration of vaccines in clinical oncology practice (see Figure 5).
In the environment of an infectious pandemic, vaccines are a primary public health strategy to prevent the spread of disease. Supporting clinical oncology patient care, clinical nurses can be equipped with foundational information about vaccine development, testing, safety, and effectiveness in clinical cancer care; an understanding about the development and rollout of approved COVID-19 vaccines when they become available; and safe vaccine administration. As operational platforms emerge to vaccinate the public, oncology nurses can seek out reliable and updated resources about approved COVID-19 vaccines, how they will be integrated into oncology clinical practice, and how best to provide clear and accurate patient education.
About the Author(s)
Ellen Carr, PhD, RN, AOCN®, is the editor of the Clinical Journal of Oncology Nursing at the Oncology Nursing Society in Pittsburgh, PA. The author takes full responsibility for this content and did not receive honoraria or disclose any relevant financial relationships. The article has been reviewed by independent peer reviewers to ensure that it is objective and free from bias. Carr can be reached at CJONEditor@ons.org. (Submitted October 2020. Accepted October 23, 2020.)
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