COVID-19 and Vaccine Hesitancy

A Challenge the United States Must Overcome

Abstract

A significant portion of the U.S. population may experience vaccine hesitancy of a new COVID-19 vaccine, which poses dangers to both the individual and their community, since exposure to a contagious disease places the person at risk, and individuals are far more likely to spread the disease to others if they do not get vaccinated. Many individuals are doubtful, and without the healthcare community, speaking with one voice has led to distrust. Experience from the influenza vaccines have shown vaccine acceptance has not been optimal, and this new vaccine, even though it is not approved, is already showing layperson skepticism compounded by political influences.

THE COVID-19 pandemic has brought to the forefront a long-standing debate regarding vaccination hesitancy. COVID-19 virus has infected more than 33 million people, with about 1 million deaths worldwide, including nearly 200 000 deaths in the United States (^{Johns Hopkins University, 2020}). In response to this need, the US government launched a program known as Operation Warp Speed. It aimed to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 2021. It is part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (^{Department of Health and Human Services [HHS], 2020a}).

The Centers for Disease Control and Prevention (CDC) has notified public health officials in the United States to prepare to distribute a coronavirus vaccine as soon as late October or early November 2020. This earlier-than-expected launch has heightened concerns that political motives may be seeking to rush distribution of a vaccine or hype one before the November US election. The CDC guidance (COVID-19 Vaccination Program Planning Assumptions for Jurisdictions) noted that health care professionals, including long-term care employees, would be among the first to receive the product along with other essential workers and national security employees (^{Dooling, 2020}). As part of Operation Warp Speed, the US administration has worked with manufacturers and distributors to eliminate barriers and develop a product pipeline much sooner than usual (^{HHS, 2020b}). Many other countries have started their programs with the World Health Organization (WHO) to find a vaccine, including China, Russia, Germany, and Great Brittan (^{Cohen, 2020}). The Oxford study in Great Brittan, in conjunction with AstraZeneca, paused the phase 3 study due to an adverse event on September 9 and resumed it three days later (^{AstraZeneca, 2020}). Russia approved its first vaccine to prevent COVID-19 (Sputnik V), although it had not started phase III clinical trials and moved up its phase III trial to begin on August 31 (^{Burki, 2020}). Finally, China also has vaccines entering large-scale clinical trials (Table).

Table. - Selected Immunizations^a in Development at Phase III Stage to Prevent COVID-19^b

Manufacturer/Developing Entity for COVID-19 Vaccine	Vaccine Platform & Type	Dosing (# of Doses and Timing of Doses)	Status	Sponsor Country
University of Oxford/AstraZeneca	Non-Replicating Viral Vector/ChAdOx1-S	1	Phase III	UK/US
CanSino Biological Inc./Beijing Institute of Biotechnology	Non-Replicating Viral Vector/Adenovirus Type 5 Vector	1	Phase III	China
Gamaleya Research Institute	Non-Replicating Viral Vector/Adeno-based (rAd26-S+rAd5-S)	2 (0,21 days)	Phase III	Russia
Janssen Pharmaceutical Companies	Non-Replicating Viral Vector/Ad26COVS1	2 (0,56 days)	Phase III	US
Sinovac	Inactivated	2 (0,14 days)	Phase III	China
Wuhan Institute of Biological Products/Sinopharm	Inactivated	2 (0,14 or 0,21 days)	Phase III	China
Beijing Institute of Biological Products/Sinopharm	Inactivated	2 (0,14 or 0,21 days)	Phase III	China
Moderna/NIAID	RNA/LNP-encapsulated mRNA	2 (0,28 days)	Phase III	US
BioNTech/Fosun Pharma/Pfizer	RNA/3 LNP-mRNAs	2 (0,28 days)	Phase III	US

Abbreviations: LNP, lipid nanoparticle; mRNA, messenger RNA; RNA, ribonucleic acid.

^aMultiple other vaccines under development in Phase I and Phase II studies.

^bAdapted from ^{World Health Organization (WHO). (2020a}, September 9). Draft landscape of COVID-19 candidate vaccines. Retrieved September 10, 2020, from https://www.who.int/publications/m/item/draftlandscape-of-covid-19-candidate-vaccines.

In the United States, many individuals are skeptical, and without the health care community speaking with one voice has led to distrust. This distrust is even more critical considering there are more than 34 vaccines in development to prevent COVID-19 and more than 70 vaccines in the global pipeline, with 260 entities being studied for several diseases (^{WHO, 2020a,2020b,2020c}). The United States has 4 potential vaccines in phase III testing in a diverse population of thousands of people to demonstrate efficacy (see the Table). AstraZeneca, Pfizer, and Moderna have trials underway, with large populations already enrolled. In addition, the medical care systemʼs distrust may be more prevalent among racial and ethnic minority populations due to a history of discrimination and past medical experimentation (^{Grohskopf et al., 2020; Prins et al., 2017}). Exacerbating factors have included inequities in education, employment, income, and housing, decreasing employee flexibility to self-isolate or quarantine when needed (^{CDC, 2020a}). Considering these social factors, the lack of trust of vaccines, and to ensure herd immunity, much work needs to be done when a COVID-19 vaccine is released.

If the COVID-19 vaccine resembles an influenza vaccine, effectiveness could be 50% or lower (^{CDC, 2020b}). People may have strong preferences for a vaccine to be highly effective, and a vaccine with a low effectiveness estimate could impact peopleʼs willingness to be vaccinated. It is also possible that individuals will perceive a pandemic vaccine to be less safe based on its newness or perceived lack of testing (^{Sun et al., 2020}). Safety perceptions could also influence vaccination acceptance. Some concerns for consumers include knowing the time frame for a vaccine, who will have access to it, adverse effects, cost to consumers, if anything, and how states and the federal government will determine vaccination methods. The possibility of a COVID-19 vaccine in the United States has created the need to examine current policy if vaccination will be mandatory for public schools, health care, and government workers and if these populations will accept getting vaccinated or not.

VACCINE HESITANCY—A REAL THREAT TO SUCCESS

Developing a safe, effective, and affordable vaccine is already challenging, but vaccine hesitancy confers a different and unique hurdle to researchers, scientists, government, and community leaders. Vaccine hesitancy and anti-vaccine messaging have become more of an issue with outbreaks of diseases once considered rare. “Vaccine hesitancy” means the reluctance or unwillingness to be vaccinated or have oneʼs children vaccinated against a disease, even if proven safe and effective. Vaccine hesitancy poses dangers to both the individual and his or her community, since exposure to a contagious disease places the person at risk, and individuals are far more likely to spread the disease to others if they do not get vaccinated (^{Zitner, 2020}).

The impacts from the propagation of misinformation and subsequent distrust of vaccines and government have been demonstrated in recent polls. The results from a May 2020–Associated Press poll suggested 50% of Americans reported they would get a vaccine, about 30% were not sure they would get vaccinated, and 20% refused to get vaccinated. Only 20% expected a COVID-19 vaccine would be available this year. The poll found that 67% of people 60 years and older reported they would get vaccinated compared with 40% who were younger. It was also noticed that just 25% of African Americans and 37% of Hispanics would get a vaccine compared with 56% of non-Hispanics Whites. Among people who did not want a vaccine, about 40% stated they were concerned about catching COVID-19 from the shot and some fear side effects from an untested vaccine (^{Neergaard & Fingerhut, 2020}).

Of 2 other polls, one from Gallup reported that 65% of respondents answered they would take the vaccine whereas 35% would not. Of these groups, 33% were non-Hispanic White respondents and 41% non-White stated as not willing to take the vaccine (^{O'Keefe, 2020}). The second one from Amerispeak (where 57.6% of Americans would take an accelerated vaccine, 31.7% were not sure, and 10.8% would not) yielded similar results, showing a low uptake of a purported vaccine, but many respondents would not get vaccinated even if it is free (^{Fisher et al., 2020}). Participant attributes were linked with a greater likelihood of responding “no” or “not sure” were female, or Black or Hispanic, being younger (<60 years), having lower educational attainment, and having a lower family income. Another survey published in August 2020 found a 67% acceptance of a COVID-19 vaccine; however, there were noticeable demographic factors in vaccine acceptance. Black Americans reported lower COVID-19 vaccine acceptance (40%) than all other racial groups (^{Malik et al., 2020}).

WHAT CAN HEALTH CARE PROFESSIONALS DO?

Health care professionals can help get the coordinated messaging out if done appropriately. The following points should be included in messaging to promote transparency in factual and scientific information.

• Adverse events happen, but they are incredibly rare, with less than 1% experiencing a severe reaction (^{WHO, 2020d}).
• Early distribution needs to be based on need (high-risk patients and frontline health care workers) (^{American Society of Health-System Pharmacists [ASHP], 2020}).
• Health care workers should be a priority, as they are at high risk of exposure (^{CDC, 2020c}).
• Regulatory systems such as the US Food and Drug Administration (FDA) are designed to prioritize safety above all else before a vaccine can move to the next phase (^{FDA, 2020}).
• The safety and tolerability goals of a vaccine have been demonstrated in phase I and phase II clinical trials. If a drug is causing any significant adverse events, the trial is stopped (^{FDA, 2020}).
• Transparency is vital for a high acceptance rate (^{ASHP, 2020}).

CONCLUSION

A significant portion of the US general population may experience vaccine hesitancy and be skeptical of a new COVID 19 vaccine. There are also significant demographic differences in vaccine acceptance. Experiences from the influenza vaccines and others have shown that vaccine acceptance has not been optimal, and this vaccine, although it is not approved, is already showing layperson skepticism compounded by political influences. Although the intention is high, intent does not always translate into behavior. Mandating its use or not will be essential for the future of the US population health regardless of who is elected.