In late 2019 a new virus emerged from China which would become the worst pandemic the world had experienced since the flu pandemic of 1918. Over one year later, the virus has infected over 100 million people and claimed the lives of over 2 million people. In this article, we first offer a brief overview about the COVID-19 pandemic. We review efforts to slow the spread and flatten the curve to contain the disease such as mask-wearing, hand hygiene, and testing. Unprecedented funding and collaborative efforts have resulted in highly effective and safe vaccines, rolled out in December 2020. We also briefly discuss the history of vaccine development and previous outbreaks and lessons learned, followed by new vaccine technologies; barriers related to vaccination; vaccine hesitancy; successful vaccination programs; and vaccine hesitancy in healthcare providers. We conclude with implications for nurses to consider as they serve as trusted sources of vaccine information in their roles as frontline workers.
The 1918 influenza pandemic killed up to 50,000,000 people globally (Centers for Disease Control and Prevention [CDC], 2019a). There has since been no other pandemic which has caused as much disease and death until the SARS-CoV-2 virus emerged in December 2019. The resulting disease, COVID-19, has infected over 100 million people worldwide, with over 2 million confirmed deaths as of January 31, 2020 (World Health Organization [WHO], 2020a).
Meanwhile, all eyes were on the vaccines under development.As hospitals became overwhelmed and healthcare resources (including staffing, supplies, personal protective equipment, and ventilators) were stretched, solutions to end the pandemic became critical. Strategies to mitigate the damage caused by COVID-19 included public health measures such as testing and quarantining, social distancing, wearing masks, and hand hygiene. Nurses emerged as key players, caring for patients in unprecedented times and educating the public about ways to reduce the spread of COVID-19. Meanwhile, all eyes were on the vaccines under development.
This article will provide an overview of the COVID-19 pandemic and the strategies used to control the spread of the virus. We describe the need for a safe and effective vaccine to battle COVID-19 and provide a brief history of recent outbreaks of infectious disease. We also address the challenges in administering a vaccine to a global population, particularly during an era of rising vaccine hesitancy and misinformation. Finally, we outline the role of nurses in these challenges and offer recommendations (Fawaz, Anshasi, & Samaha, 2020).
COVID-19: A Brief Overview
The race to develop a vaccine against COVID-19 quickly began as the virus swept across the globe. In December 2019, a new virus emerged in Wuhan, China. The virus, which would soon cause a worldwide pandemic, was named SARS-CoV-2. SARS-CoV-2 is a member of the coronavirus family and is related to severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). COVID-19 is the disease caused by SARS-COV-2 and is responsible for a range of symptoms including dry cough, shortness of breath, fever or chills, loss of taste or smell, myalgias, sore throat, diarrhea, fatigue, nausea, vomiting, congestion, or runny nose. For some, it may cause more serious symptoms such as respiratory failure, renal failure, or death (Sauer, 2020).
COVID-19 is thought to be spread when respiratory droplets from an infected individual enter the body through the mouth, eyes, or nose. The virus then infects the lungs and possibly spreads to other organs (Sauer, 2020).
Sanche et al. (2020) describe the basic reproductive number (R0) as “...the average number of secondary cases attributable to infection by an index case after that case is introduced into a susceptible population” (Sanche et al., 2020, p.1470). The median R0 of COVID-19 was calculated to be 5.7 with a 95% CI (3.8–8.9), making this a highly infectious disease. Sanche et al. recommended early and active surveillance, quarantine, and especially strong social distancing efforts to slow the spread of COVID-19 (Sanche et al., 2020). Three months after the discovery of SARS-CoV-2, hospitals in New York City were already overwhelmed with patients infected with COVID-19 (Marquez & Moghe, 2020).
Implementations to Slow the Spread of COVID-19: Flatten the Curve
Masking and Hand Hygiene
Classic public health measures for respiratory disease include wearing facemasks and performing hand hygiene... Classic public health measures for respiratory disease include wearing facemasks and performing hand hygiene to reduce transmission of the virus. Data have shown masks to be effective to prevent transmission of COVID-19 (Liang et al., 2020), but there has been considerable disagreement over mask-wearing mandates (Godoy, 2020).
Large-scale restrictions, physical distancing, and mandatory city shutdowns have been employed as emergency measures to slow the spread of SARS-CoV-2, but these are not long-term plans. Furthermore, they come at significant costs to entire cities, such as job loss, and individuals. As of August 2020, over 400 million jobs were lost globally, with 13 million jobs lost in America (Ip, 2020). Social isolation in abusive homes may result in exacerbations in abuse, neglect, and exploitation (Lee, 2020). Children whose schooling has been interrupted may struggle, particularly those with mental illnesses or developmental delays (Lee, 2020).
The development of at-home rapid antigen tests is complicated...Rapid antigen tests are one way to reduce the spread of COVID. Paper-strip testing that people can take at home at frequent intervals may identify asymptomatic cases and allow these people to remain at home in isolation until no longer infectious (Mina, 2020). The development of at-home rapid antigen tests is complicated: The U. S. Federal Drug Administration (FDA) regulates clinical medical devices, and not public health tools; forcing these tests to be subjected to medical device regulations is slowing down the development process (Mina, 2020).
Vaccination as a Solution
Global vaccination is the way forward to induce herd immunity and stop the pandemic with the lowest cost to human livesGlobal vaccination is the way forward to induce herd immunity and stop the pandemic with the lowest cost to human lives (WHO, 2020b). The race to develop a vaccine against COVID-19 quickly began as the virus swept across the globe. In early November 2020, almost a year after COVID-19 was discovered, Pfizer announced a vaccine candidate had achieved 95% efficacy in preventing COVID-19 during its phase III trial. By December 11, 2020, the FDA authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States (US) (Pfizer, 2021).
Research performed in real-world conditions continued to reinforce high efficacy rates...Shortly after the Pfizer-BioNTech COVID-19 vaccine was authorized for emergency use in the US, the Moderna and Johnson & Johnson Janssen vaccines were also authorized by the FDA for emergency use (CDC, 2021c). As of April 12, 2021, 189,692,045 U.S. citizens were vaccinated against COVID-19 (CDC, 2021b). Ongoing monitoring systems such as v-safe, the vaccine adverse event reporting system (VAERS); the clinical immunization safety assessment (CISA) project; and the vaccine safety data (VSD) link received very few reports of serious adverse events and no patterns to indicate safety problems with the COVID-19 vaccines (Shimabukuro, 2021). Research performed in real-world conditions continued to reinforce high efficacy rates among the Pfizer-BioNTech and Moderna vaccines (CDC, 2021d).
The speed of vaccine development became crucial as SARS-COV-2 variants developed. Variants. The speed of vaccine development became crucial as SARS-COV-2 variants developed. All viruses change over time, and with increased opportunities to spread, the virus had more opportunities to undergo changes (WHO, 2021a). Depending on where in the virus genome the changes occur, these mutations may increase disease transmission or disease severity (WHO, 2021a). Variants of SARS-COV-2 emerged in fall 2020 in the United Kingdom (known as B.1.1.7), South Africa (B.1.351), and Brazil (P.1) (CDC, 2021a). The B.1.1.7 strain is associated with increased disease transmissibility, and early reports indicate that it may be responsible for higher rates of death. To date there is no evidence that this strain causes more severe disease or has an impact on vaccine efficacy (CDC, 2021a). The P.1 strain is associated with a potential increase in transmissibility and potential for re-infection.
Herd Immunity. “Herd immunity” or “community immunity” is defined as a high percentage of community members who attain immunity to a disease, thereby reducing the chance of further spread of that disease (WHO, 2020b). Today, herd immunity is the goal of large-scale vaccine initiatives - inoculating enough of a community with safe vaccines to prevent the spread of infectious diseases. However, some have suggested attaining herd immunity to COVID-19 through natural infection (Kulldorff, Gupta, & Bhattacharya, 2020). Achieving herd immunity through natural infection as an answer to controlling the COVID-19 pandemic has been criticized by the Infectious Disease Society of America (IDSA) as “inappropriate, irresponsible, and ill-informed” (File & Feinberg, 2020, para. 1). The WHO has called it “scientifically problematic and unethical” to allow herd immunity to replace public health measures such as masking, handwashing, and social distancing (WHO, 2020b, para. 7). Foregoing public health measures would result in tens of millions of cases, and millions of deaths.
...herd immunity is the goal of large-scale vaccine initiatives...Past examples of successful herd immunity through vaccination include global eradication of smallpox and regional eradication of wild polio virus. Indeed, widespread vaccination efforts have proven time and time again to decrease or eliminate the spread of dangerous diseases including measles, mumps, rubella, pertussis, chickenpox, and others (Fine, Eames, & Heymann, 2020).
History of Vaccine Development
Three centuries of vaccines have had positive effects on health...Three centuries of vaccines have had positive effects on health by reducing morbidity and mortality, reducing antibiotic resistance, inducing herd immunity, and preventing cancer. Vaccinations also have positive effects on economics by increasing cost savings, productivity gains, and minimizing family impact on frequent illnesses and time off work (Rodrigues & Plotkin, 2020). It is estimated that between 2011 and 2020, 23 million lives were saved with vaccination against infectious illnesses (Lee et al., 2013).
Historically, vaccines were developed using one of several methods:
- Live-attenuated vaccines were developed using weakened forms of the bacteria or virus, inducing lifelong or nearly lifelong immunity (Office of Infectious Disease and HIV/AIDS Policy [OIDP], 2021). Live-attenuated vaccines are used for measles, mumps, rubella, rotavirus, chicken pox, smallpox, and yellow fever.
- Inactivated vaccines use the killed virus. This method is safe for all populations, including the elderly and immunocompromised, and usually provides short-term immunity, with the need for boosters. Inactivated vaccines are used for hepatitis A, flu, polio, and rabies (OIDP, 2021).
- Sub-unit, also known as conjugate vaccines, use a specific piece of the germ, such as the sugar, protein, or capsid. This vaccine also requires boosters for long-term immunity. These vaccines are used for Hib (haemophilus influenzae type B), hepatitis B, human papillomavirus (HPV), whooping cough, pneumococcal, meningococcal, and shingles (OIDP, 2021).
- Toxoid vaccines use the toxin part of the germ (although chemically inactivated) which is what causes disease. These vaccines require boosters, and are used for diphtheria and tetanus (OIDP, 2021).
Previous Outbreaks and Lessons Learned
Some lessons learned during other pandemics may be useful during current times as we battle the coronavirus pandemic. The H1N1 and Ebolavirus pandemics effectively demonstrated the need for new technologies, emergency preparedness, and public and private partnership collaboration to develop vaccines efficiently and rapidly.
On April 15, 2009, the influenza H1N1 virus emerged, causing a global pandemic that resulted in thousands of hospitalizations and deaths in the US. By October 5, 2009, the first doses of the H1N1 vaccine were administered in the US (CDC, 2019b).
The H1N1 pandemic outlined the importance of researching new, and more efficient, vaccination technologies for use in response to pandemics.Despite the urgent response, vaccine timing and availability remained challenging. The H1N1 vaccine was not available during the southern hemisphere winter season and was not available for everyone until after cases peaked in the northern hemisphere (Broadbent & Subbarao, 2011). This was largely due to reliance on viral egg cultures, a process shown to be too slow in responding to the first wave of the H1N1 pandemic and provided only one third of the global population with vaccines annually (Fineberg, 2014). The H1N1 pandemic outlined the importance of researching new, and more efficient, vaccination technologies for use in response to pandemics.
During the H1N1 pandemic, the vaccine was inaccessible to many high-priority adults (SteelFisher, Blendon, Bekheit, & Lubell, 2010). Among this group, 21% of adults tried to receive the vaccine but 66% of them failed to receive it.
The Ebolavirus outbreak in West Africa in 2014 killed 11,000 people. After this event, extraordinary measures were implemented to develop a vaccine, which was expedited and licensed 5 years later (Wolf et al., 2020). Developers built on work that had been done earlier but never completed. Expanded access prior to approval ensured that another Ebola outbreak would be met with a faster response and high vaccination rates, such as when 300,000 people in the Congo were vaccinated during an Ebola outbreak in 2018-2020.
Wolf et al. (2020) propose harmonization of regulatory agencies and public-private partnerships with clear roles and expectations to efficiently navigate the variability and complexity of regulatory processes and requirements to develop vaccines. Setting clear goals and ensuring transparency allows the public to know when to expect vaccine licensure and availability; this can facilitate trust and uptake of a new vaccine.
New Vaccine Technologies
Like live-attenuated vaccines, recombinant vector vaccines use the live virus to induce an immune response. However, this method is safer for riskier pathogens such as HIV, since it uses a harmless vector to introduce viral genetic material into the host (Bull, Nuismer, & Antia, 2019).
Novel vaccine technologies include DNA vaccines. These work by injecting a segment of the virus DNA code into the recipient, inducing the host to produce the viral protein and generate an immune response (Burke, 2020). Advantages include stimulation of B- and T- cell responses, strong vaccine stability, ability to manufacture large-scale vaccines, and avoidance of using infectious material (WHO, 2020c).
...messenger RNA (mRNA) vaccines work by injecting the code for the viral antigen protein into the host...Like plasmid-DNA vaccines, messenger RNA (mRNA) vaccines work by injecting the code for the viral antigen protein into the host, allowing the recipient to produce the antigen and induce a strong immune response (O’Callaghan, Blatz, & Offit, 2020). In the case of the Pfizer and Moderna vaccines, the mRNA codes for a single protein which produces the spike, triggering the immune cascade to now recognize the virus.
Barriers Related to Vaccination
Vaccine Access and Storage
While the CDC has set guidelines as to who is first to receive the vaccines, each state may choose how to roll out the vaccine administration schedule. Many states have widened eligibility criteria to allow increased vaccination of different populations, including teachers, people with obesity, immunocompromised people, and those over age 65. The inadequate vaccine rollout has been blamed on inadequate federal assistance with distribution and logistics; overburdened public health departments; stretched hospitals and medical centers; inadequate staffing and vaccinators; and technological challenges which make signing up for a vaccine appointment difficult (Robbins, Robles, & Arango, 2021).
Many states have widened eligibility criteria to allow increased vaccination of different populations...Distribution of the Pfizer mRNA vaccine is complex due to the need to keep the vaccines in a deep freeze of -80â„ƒ from manufacture to injection across state lines, countries, and continents (Gelles, 2020). Airplanes and storage facilities had to be outfitted with freezers, and the glass vials needed to withstand icy temperatures. The Moderna vaccine only requires freezing at -20â„ƒ, which is more familiar to laboratories and healthcare facilities (Simmons-Duffer, 2020).
The brunt of COVID-19 has fallen largely on people of color: more Black and Latino people have tested positive for COVID-19 than White people, and these populations had disproportionately higher hospitalization rates (Centers for Medicare and Medicaid [CMS], 2020). Blacks are 2.3 times, and Latinos and Pacific Islanders are 2.5 times more likely to die of COVID-19 than Whites (APM Research Lab, 2021).
Vaccination patterns also reveal lower rates of uptake among people of color. Longstanding disparities in healthcare for people of color include lower rates of insured patients and less healthcare access, coverage, and utilization (Artiga & Orgera, 2019). Vaccination patterns also reveal lower rates of uptake among people of color. While about half of White people generally receive the flu shot, less than 25% of people of color receive this vaccination (Artiga & Orgera, 2019). This is often due to access problems as well as generalized mistrust of the medical establishment (Recht & Weber, 2021). As of January 31, 2021, only 9% out of 125,000 older New Yorkers who were vaccinated are Black (Fitzsimmons, 2021). In New Jersey, only 3% of vaccine recipients are Black, even though 15% of the state population is Black.
Several steps are needed to increase vaccination in Black and other minority communities, such as: ensure vaccination centers are set up in minority neighborhoods; provide educational initiatives, including reminders that vaccines are available at no cost and town halls to discuss the safety of the vaccine. Using Black and Latino physicians and community members as trustworthy sources to disseminate vaccine information may increase uptake of vaccination (Kolata, 2020).
Trust in vaccine safety has eroded over the last several decades, with vaccine hesitancy now listed by the WHO as one of the top ten public health threats (WHO, 2019). When the H1N1 vaccine was rapidly developed during the 2010 pandemic, 40% of adults polled felt that the safety of the vaccine could not be trusted (SteelFisher et al., 2010). The authors predicted that should a future influenza pandemic occur, public uptake of a vaccine would be challenging, primarily due to public concern about vaccine safety and perception of risk.
...vaccine hesitancy [is] now listed by the WHO as one of the top ten public health threats During the spring and summer of 2020, over 75% of Americans believed a vaccine would be licensed before proven to be safe or effective. Intent to receive a COVID-19 vaccine dropped from 72% in May 2020 to 51% in September 2020 (Tyson, Johnson, & Funk, 2020). Of the half of Americans who planned to refuse the vaccine, 76% cited concerns about vaccine side effects, and 72% stated they would want to know more about how well it would work.
A significant portion of the American population has questioned the severity of COVID-19 and the need for vaccines, social distancing, lockdowns, and masks. According to a poll of 835 National Adults, 30% of respondents were “not very concerned” or “not concerned at all” about the spread of COVID-19 in their community (Marist Poll, 2020). Approximately 30% of individuals replying to a Pew research study indicated that they do not believe they need a COVID-19 vaccine (Tyson et al., 2020).
With 2020 being an election year, U.S. citizens were concerned the COVID-19 vaccine would be rushed through clinical trials to meet politically charged deadlines (Schwartz, 2020). Indeed, even popular scientific news sources, such as Scientific American began publishing articles highlighting the concerns of fast tracking COVID-19 vaccine approval (Hasteltine, 2020). According to YouGov, an international Internet-based market research and data analytics firm, two thirds of registered voters who said they would not get a COVID-19 vaccine, were concerned about the vaccine’s safety due to its fast-tracked approval process (Frankovic, 2020).
Successful Vaccination Programs
Several strategies to increase vaccine uptake have been documented in the literature. These strategies include decreasing financial barriers, ensuring convenient vaccination locations, and education about benefits of the vaccine (Walling et al., 2016).
...programs based on environmental strategies were the most successful in consistently reaching the most participants and achieving the highest vaccination rates.The HPV vaccine was introduced to the US in 2006, providing the opportunity to analyze vaccine uptake in modern culture (The College of Physicians of Philadelphia, 2018a). Walling et al. (2016) compared informational, behavioral, and environmental strategies in a systematic review. Informational strategies were described as “to increase knowledge of HPV, HPV-related disease, or the HPVV;” behavioral strategies were defined as “to change behavior by providing necessary skills to make a decision regarding the HPV;” and environmental strategies were defined as, “to change the social environment to facilitate vaccination, ie, decreased financial barriers, novel vaccination locations” (Walling et al., 2016, Table 2, p.3). The authors discovered that programs based on environmental strategies were the most successful in consistently reaching the most participants and achieving the highest vaccination rates. Interestingly, the authors also discovered that participants were more likely to get the HPV vaccine if they knew someone with cervical cancer.
In another systematic review on increasing influenza vaccination among healthcare workers in hospitals, Hollmeyer et al., (2012) discovered that vaccine availability and education about benefits of vaccination were the two most successful strategies. Thus, current vaccination efforts should focus on availability and education (Hollmeyer, Hayden, Mounts, & Buchholz, 2012) and underscore the high prevalence of COVID-19 and the safety of the vaccine (Walling et al., 2016).
COVID-19 Vaccine Hesitancy in Healthcare Providers
More concerning than vaccine hesitancy among Americans are new indications that healthcare providers are reporting concern over the safety of the vaccine. Recent polls among healthcare workers have shown that 37% of healthcare workers have stated they have no intention of getting the COVID vaccine (Dror et al., 2020).
A recent study that analyzed healthcare provider interest in receiving the COVID-19 vaccine showed that only 61% of nurses were interested in vaccine acceptance (Dror et al., 2020). Physicians were more interested in vaccination, with acceptance rates at 78%. Further analysis showed that providers working in COVID-19 units were more likely to accept vaccination (94%) versus providers in non-COVID units (77%). The most commonly cited reason for hesitation was concern over the speed of the vaccine development and concern about side effects (Dror et al., 2020).
Particularly during a pandemic, it is worrisome that there is significant hesitancy by nurses surrounding the COVID-19 vaccine.Another survey of healthcare workers who were overwhelmingly pro-vaccine in general, found that 66% intended to delay COVID-19 vaccination (Gadoth et al., 2020). Only 30% of responders were interested in vaccine acceptance and 49% planned to “wait and see” how the vaccine affects others who receive it (Gadoth et al.). Noted as the main reason for hesitation was concern about the speed of vaccine development. Again, physicians were more interested in vaccine acceptance compared to nurses.
Patients most commonly interact with nurses. Nurses are the providers who very often administer vaccines, and who provide patient education. Particularly during a pandemic, it is worrisome that there is significant hesitancy by nurses surrounding the COVID-19 vaccine.
Concerns Regarding “Warp Speed”
Vaccine development usually requires 10-15 years, but this process has been expedited in the past during infectious disease outbreaks (The College of Physicians, 2018b). The COVID-19 vaccine was developed in an unprecedented 9 months. There are many reasons for the speed in vaccine development. Prior epidemics and pandemics spurred bursts of funding and science, only to be quietly abandoned once the pandemic was over (Yong, 2020). The widespread effect of COVID-19 meant that scientists all over the world now collaborated frenetically, using unprecedented funding and novel technologies to create an effective vaccine. Studies on SARS and MERS in the early 2000s were shelved after the pandemics passed, but with new funding scientists were able to build on two decades of data. Further, mRNA had been analyzed as a possible treatment modality since 1990 (Wolff et al., 1990). In 2016, nanoparticles were developed as a delivery mechanism to allow the mRNA to enter cells (Johnson, 2020). After thirty years of studying mRNA as a mechanism for triggering the body to create specific proteins, breakthroughs in the spring regarding mRNA stability allowed for clinical trials to develop as early as January 2020.
The COVID-19 vaccine was developed in an unprecedented 9 months. There are many reasons for the speed in vaccine development. Other factors contributed to the speed of the vaccine development. These included: huge interest in volunteering for the trials; high infectious rate which meant that placebo groups became ill faster and therefore results for efficacy were found rapidly; combined phase I/II and phase II/III, which are often done for urgent cancer trials were performed now; and finally, using mRNA strands instead of viral cultures meant less time spent culturing millions of doses (Yong, 2020).
Concerns Regarding Side Effects
The second major concern regarding the COVID-19 vaccine is concern about possible side effects. The Pfizer phase III trial monitored 38,000 patients who were evenly randomized into a placebo or vaccine group, and the Moderna phase III trial monitored 30,000 patients who were similarly randomized. In studies this large, it is anticipated that side effects which occur in 1-in-10,000 incidences would be evident (Nirenberg, 2020). The Pfizer and Moderna vaccines are reactogenic, which means they cause side effects which may be uncomfortable, such as arm soreness, chills, fatigue, fever, myalgias, and headaches. These were the most widely reported side effects reported in the two studies.
The Pfizer and Moderna vaccines are reactogenic, which means they cause side effects which may be uncomfortable...Side effects even more rare than 1-in-10,000 may become evident during post-marketing licensure. Once the vaccine is licensed and distributed, data on reported side effects are analyzed to determine if rare events are occurring and if they are related to the vaccine. However, in many decades of vaccine administration, long-term or serious side effects have occurred very rarely (Pollard & Bijker, 2020). The most common of all the rare side effects from vaccination is anaphylaxis, typically occurring in 1 out of 1 million doses (Pollard & Bijker, 2020).
Safety. There are multiple monitoring systems in place to trigger an alarm if patterns of serious adverse events occur. VAERS, self-reported data, and the Vaccine Safety Datalink (VSD), which is used to verify the reported data from VAERS, have been around for a long time (CDC, 2021g). The government also created new monitoring systems for the COVID-19 vaccines including V-safe, a smartphone-based health checker. (CDC, 2021g). These numerous monitoring systems and the different methods used to observe the newly vaccinated population all add layers of safety to the COVID-19 vaccine.
There are multiple monitoring systems in place to trigger an alarm if patterns of serious adverse events occur.We can observe this safety mechanism occurring in real time, since there have been rare reports of severe allergic reactions and blood clots. In December 2020, the Vaccine Adverse Event Reporting System (VAERS) detected rare anaphylaxis occurrences after administration of the Pfizer vaccine (CDC, 2021a). Most reactions happened within 30 minutes of vaccine administration (CDC, 2021e). Worldwide, over 300 million people have received at least one vaccine (Ritchie et al., 2021). As of this writing, in the US alone the number is over 120 million, the number of total doses is 189 million. (CDC, 2021b). Out of all those 189 million doses, using self-reported data from VAERS, between 2-5 people per million doses reported anaphylaxis and 3,005 deaths (0.00158%) were reported. (CDC, 2021e).
In early March 2021, several countries in Europe suspended use of the AstraZeneca vaccine after reports of blood clots circulated (Wise, 2021). The European Medicines Agency (EMA) investigated 86 clots that occurred among 25 million vaccinated individuals and determined that unusual blood clots and low platelets should be added to the list of very rare adverse effects of the vaccine (EMA, 2021).
In the US, VAERS triggered a safety signal for the Johnson and Johnson vaccines due to a rare blood clot called a cerebral venous sinus thrombosis (CVST), occurring in patients together with thrombocytopenia. According to a joint statement by the FDA and CDC, a total of six cases out of 6.8 million doses have been reported. All of the CVSTs happened in women between the ages of 18 and 48, and symptoms showed up six to 13 days post-vaccination. Noting an abundance of caution (CDC 2021f), administration of the Johnson and Johnson vaccines was paused. The Advisory Committee on Immunization Practices (ACIP) will meet to study the cases and the FDA will review the ACIP analysis. As per the CDC and FDA, until the process is completed, the vaccine will be paused. (Marks, 2021)
Nurses may be reassured to observe the safety systems work as they are intended...Nurses may be reassured to observe the safety systems work as they are intended, to detect safety signals that are too rare to detect in clinical trials which number in the tens of thousands. Once given to millions of people, the truly rare adverse effects may be picked up in post-marketing surveillance and this process ensures ongoing safety and risk assessment.
Effectiveness. Studies from Israel show great promise. Israel has fully vaccinated nearly 60% of the population so far, (Ritchie et al., 2021), the largest percentage of any country. One study from February took data from 596,618 vaccinated and 596,618 unvaccinated individuals. The outcome showed a 94% effectiveness in symptomatic COVID-19 and 92% for documented infection (Dagan, et al., 2021).
Implications for Nurses
Nurses are in a direct position to inform patients about the most up to date and evidence-based information about available COVID-19 vaccines.Nurses need to be aware of concerns held by the American public to effectively communicate with patients. These concerns include the severity of COVID-19 and the safety of the COVID-19 vaccine. Nurses are in a direct position to inform patients about the most up to date and evidence-based information about available COVID-19 vaccines. To successfully communicate with community members, it is imperative nurses stay informed about vaccine concerns and also discern between credible and non-credible sources.
There are several sources of credible information nurses can use to stay informed regarding COVID-19 vaccines.There are several sources of credible information nurses can use to stay informed regarding COVID-19 vaccines. These sources include government websites, non-government entities, and scientific literature. Federal government websites, such as the CDC and FDA sites, provide some of the most up to date information for healthcare providers, including COVID-19 vaccine safety, distribution, administration, storage, and handling (CDC, 2020; FDA, 2020). Local government websites, including state and county health department websites, provide additional information regarding vaccine related information in a specific area (Texas Department of Emergency Management, 2021). The WHO provides excellent information about vaccination from a global perspective (WHO, 2020d). Lastly, private organizations such as the Immunization Action Coalition offer recommendations, information, and up-to-date resources on vaccines (Immunization Action Coalition, 2020). The Table provides concise answers to common questions about COVID-19 vaccine concerns.
Table. Quick Answers to Common COVID-19 Vaccine Concerns
How was the vaccine produced so quickly?
Built on decades of prior studies of mRNA and coronavirus vaccines
Huge volunteer cohorts for trials
High infectious rate = rapid results seen in both arms
mRNA strands are quicker to develop than viral cultures
Slaoui, M., & Hepburn, M. (2020). Developing safe and effective Covid vaccines—Operation Warp Speed’s strategy and approach. New England Journal of Medicine, 383(18), 1701-1703.
Can mRNA change my DNA?
Messenger RNA can only enter the cell when wrapped in a lipid protective layer. Once in the cell, the mRNA is taken up by ribosomes to transcribe the message. It cannot and does not approach the DNA which is stored in the nucleus.
Global Alliance for Vaccines and Immunizations. (2020, December 15). Will an mRNA vaccine alter my DNA? #VACCINESWORK. Retrieved from https://www.gavi.org/vaccineswork/will-mrna-vaccine-alter-my-dna?
If the trial only monitored participants for a median of 2 months, how do we know there will not be long-term side effects?
In the last 100 years of vaccines, it has been rare for someone to develop a syndrome that is causally linked to a vaccine given months or years early. Vaccine side effects, which are immunological, are seen within the first several weeks, and this is why clinical trials monitor participants for this amount of time. Post-licensure studies can detect rare side effects after the vaccine is given to millions of people.
Children’s Hospital of Philadelphia (CHOP). (2021, February 4). Long term side effects of COVID vaccine? What we know. News. Retrieved from https://www.chop.edu/news/long-term-side-effects-covid-19-vaccine
Should I be concerned that fertility may be affected by this vaccine?
This misconception stems from a misunderstanding of a shared amino acid sequence that is in the spike protein and also in the placenta, leading people to assume that an immune attack against the spike protein will lead to an immune attack against the placenta. The reality is that the shared amino acid sequence is much too short to be that significant. Furthermore, if this were true, we would assume that pregnancy loss in COVID patients would be high from the immune response, but it is not so.
Iacobucci, G. (2021). Covid-19: No evidence that vaccines can affect fertility, says new guidance. British Medical Journal, 372, 509
Discern Credible versus Non-credible Information
It is important that nurses can discern the credibility, or lack thereof, of sources in order to provide patients with accurate information regarding COVID-19 vaccines. Several guides are available to assist nurses to evaluate sources for credible information regarding vaccines, as well as rigorously evaluated websites that nurses can use to find trustworthy information.
Many webpages and articles that discuss evaluation of credible information about vaccines are accessible to both nurses and the public.Many webpages and articles that discuss evaluation of credible information about vaccines are accessible to both nurses and the public. The Georgetown University Library (2021) offers several tips to evaluate internet sources of information. Another approach, often used by libraries to teach students about evaluating sources, is the CRAAP Test (i.e., Currency, Relevance, Authority, Accuracy, Purpose). This easy to remember mnemonic can be used by nurses to avoid substandard resources on vaccines (Lewis, 2018).
The National Institute of Health (NIH) offers additional evaluation strategies, such as determining whether a site is advertising a product; how to navigate information on social media; and using mobile apps to find information about COVID-19 vaccines (NIH, 2021).
The Vaccine Safety Net (VSN) is a screening process created by UNICEF, WHO, and the Global Advisory Committee on Vaccine Safety (GACVS) to help individuals find credible information on vaccines. The VSN utilizes rigorous criteria to evaluate websites based on their use of unbiased, current evidence-based information. Once a website meets the criteria, it will be added to a list of sites in multiple languages that can be accessed on the WHO website (WHO, 2020e; 2020f).
There are a multitude of websites that meet the VSN criteria that nurses may use to find in-depth information about vaccines...There are a multitude of websites that meet the VSN criteria that nurses may use to find in-depth information about vaccines, including articles that discuss ethical considerations, safety concerns, and common vaccine myths. The Children’s Hospital of Philadelphia’s vaccine education center provides a wide variety of material that discusses vaccine-related topics ranging from the use of fetal cells in vaccines to how vaccines are created (Children’s Hospital of Philadelphia, 2021). The History of Vaccines website is an educational website created by The College of Physicians of Philadelphia that provides blogs, timelines, and activities that nurses may use to learn more about vaccines so they can better inform patients (The College of Physicians, 2021a).
Utilize Evidence-Based Practice
...the positive outcomes of vaccination are well documented in scientific literature. Using evidence to guide nurses in practice is pivotal to the delivery of high quality, cost effective care. Indeed, evidence-based practice (EBP) dates to the 1800s when Florence Nightingale improved patient health when she demonstrated that exposure to unsanitary conditions and restricted ventilation lead to poorer outcomes (Eastern Illinois University, 2018). Regarding vaccines, the positive outcomes of vaccination are well documented in scientific literature. For example, Roush et al. (2007) demonstrated a greater than 92% decline in cases and a 99% or greater decline in deaths in 13 vaccine-preventable diseases for which vaccine recommendations were in place prior to 2005. Discussion of the evolution of evidence to support consideration of the COVID-19 vaccine can be helpful as patients consider these options.
Serve as Role Models
...nurses can advocate for vaccines by citing credible evidence for practice and addressing misinformation on social media.Nurses are among the most trusted healthcare professionals in the United States and have consistently ranked #1 for most ethical and honest profession according to the most recent Gallup polls (Saad, 2020). Remaining informed about accurate and current vaccine information is important, but it is equally important to advocate for vaccination and public health. Specifically, nurses can advocate for vaccines by citing credible evidence for practice and addressing misinformation on social media. Nurses have been prioritized as some of the first to receive the COVID-19 vaccines. This has provided the opportunity to not only communicate the importance of vaccination for COVID-19, but also to serve as role models by getting the vaccine themselves as we move to achieve herd immunity and overcome the COVID-19 pandemic (American Nurses Association, 2020).
The Year of the Nurse and Midwife ends by featuring nurses as powerful, empathic, and heroic healthcare workers, in ways no one could have anticipated (WHO, 2021b). The largest pandemic in 100 years brought nurses to the forefront of healthcare, both to advocate for safety measures during the virus’ spread, and to care for the hundreds of thousands of patients infected by the virus.
Nurses need to remain vaccine-fluent as they will meet patients along the entire continuum of care...Vaccine hesitancy continues to rise. Nurses need to remain vaccine-fluent as they will meet patients along the entire continuum of care, including infants, children, adults, parents, elderly patients, and special populations. All of these patients will require vaccinations of some type at some point; the ability to understand common and novel concerns regarding vaccines and vaccine safety will help nurses remain sources of credible information and trust.
As the COVID-19 vaccine rollout continues in the United States, we will rely on nurses to advocate, educate, and vaccinate many millions of Americans. Prior pandemics have provided research findings to inform us about how to improve vaccine uptake. Nurses must remain current and comfortable in vaccine science to feel confident both to make the decision to receive the COVID-19 vaccine, and to answer questions about the vaccine to contribute to increased public confidence in global immunization.
Blima Marcus, DNP, RN, ANP-BC, OCN
Blima Marcus is an oncology nurse practitioner, adjunct professor at Hunter College Bellevue School of Nursing, City University of New York, and public health advocate. Her work on increasing vaccine confidence in providers and parents has been featured in the New Yorker, the Wall Street Journal, and the Washington Post.
Lindsey H. Danielson, MS, FNP-C
Lindsey Danielson received a MS degree with a focus in family nurse practitioner from Georgetown University in 2018. She currently resides in Houston, Texas where she practices in cardiology. Lindsey has a passion for community health and ensuring her patients and colleagues have up-to-date, evidence-based information on vaccines.
Tamar Y. Frenkel, BSN, RN
Tamar Y. Frenkel graduated from Phillips Beth Israel School of Nursing in 2011 and received a BSN in 2014 from Chamberlain College of Nursing. She currently works as a medical-surgical nurse in Brooklyn, NY. She is also a board member of the EMES Initiative, a non-profit promoting vaccination and health literacy in vulnerable communities.
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