Public health and government officials are planning prevention, mitigation, and treatment strategies for the H1N1 pandemic in fall 2009 with some significant uncertainty as to its severity. With a vaccine currently in clinical trials, there is also uncertainty as to whether it will contain an adjuvant and/or require 2 doses. Given this complexity, communication about the H1N1 vaccine is enormously challenging. The additional factor of a possible EUA further complicates the communication challenge. Ensuring that people most at risk choose to accept the vaccine, should it be offered under an EUA, will require effective risk communication based on information about public attitudes and beliefs regarding vaccines and the EUA. Of additional concern is that EUA drugs will continue to be significant tools for treatment, thus requiring clear communication with the public and providers about such drugs.
Acceptance of a Vaccine
Our finding that the majority of people would not accept a new but not yet fully approved vaccine is very worrisome. In the 2007-08 flu season, acceptance of the seasonal flu vaccine was 17% among the healthy adult population aged 18-49 years of age, 38.8% among 18-64 year olds with conditions that put them at high risk of complications from influenza, and only 24.2% among pregnant women.4
We found that previous flu vaccine acceptance strongly affects willingness to accept an H1N1 vaccine that is not yet approved. Given the low seasonal flu vaccination rates among the priority populations for receiving the H1N1 vaccine,45
risk communication will need to articulate a strong case for the H1N1 vaccine, reinforce the potential course of treatment of 2 doses of the H1N1 vaccine, and provide a compelling rationale for why the public, particularly those at elevated risk, must take both the seasonal and H1N1 vaccines.
Worry about the offer of an unapproved vaccine or an EUA drug was highest among blacks and women. Worry increased the likelihood of refusal, presenting a challenge to risk communicators to clarify the unapproved nature of a drug or vaccine. Strategies to address worry include clear and frequent communication, communication from healthcare providers, the use of hotlines that allow individuals to ask questions, and, potentially, if time allows, training of lay health advocates who are trusted natural leaders in communities and who can be resources within their communities.
The large proportion of respondents that reported being unsure about the vaccine represents an important target group for messages. This group has a disproportionately large representation of racial and ethnic minorities and less educated people—the same categories that are also least confident in their decision about the vaccine. Even though this group is unsure about accepting the vaccine, they perceive greater personal consequences. This is a puzzling finding that calls for further research. However, it is possible that although this group had perceived personal consequences and lack of surety, they may lack specific knowledge about vaccines and H1N1 flu. On the other hand, this group may differ from those who made a definitive decision (yes or no) regarding the vaccine in terms of self-efficacy or confidence in their ability to protect themselves from the virus. This interaction between perceived personal consequences and making a decision regarding the vaccine is being actively analyzed.
In general, those who perceived greater personal consequences were less likely to refuse the vaccine and EUA drug. We found that people who reported having experienced or having had contact with someone who had flulike symptoms since April 2009 perceived greater personal consequences from H1N1 flu. If the number of cases increases in fall, we may expect more people to perceive greater personal consequences, which may increase acceptance of vaccination. On the other hand, if vaccination campaigns need to be carried out before a perceptible increase in the number of cases, risk communication techniques such as describing worst case scenarios46
may need to be employed to increase the public's level of perceived susceptibility. Alternatively, using narratives or case studies from real people who experienced H1N1 infection may be effective in increasing willingness.
Our findings include some inconclusive results. On one hand, we found that people are more likely to accept an EUA drug or vaccine if it is offered to them by their own healthcare provider. However, our analyses also found that having a healthcare provider and/or insurance was not associated with acceptance of an EUA vaccine. During the 1976 swine flu vaccination campaign, physicians' recommendations were found to be a significant predictor of people's vaccination behavior.47
Although having one's provider recommend an EUA vaccine will not guarantee acceptance, the literature suggests that a clear recommendation from the provider can be effective. We believe that the federal government must mount an intensive, ongoing campaign to reach healthcare providers, including school nurses, physicians, physician assistants, emergency medical services personnel, and others. It is essential that they fully understand the potential implications of an EUA vaccine, recognize the complexity of the vaccine schedule, have tools in hand to communicate clearly with patients, and put systems in place to remind those who may need a second H1N1 vaccine dose.
Our finding that people who said “yes” to the vaccine were significantly less confident in their decision than those who said “no” suggests that it is imperative that their tentative decision to accept the vaccine be reinforced through communication with their healthcare providers, in media campaigns, and through other trusted spokespersons. Unfortunately, there is increasing negative media and internet discussion about vaccines in general, and in the case of H1N1, there is a flurry of polarized media coverage that uses misinformation to contradict scientific evidence. Public controversy about potential links between vaccines and autism also fuel this fire and provide strong competing messages. There is some potential that the current furor over healthcare reform may even further confuse the public on health messages this fall. Public health professionals will need to aggressively address the myths and misinformation in order to increase understanding and acceptance of the vaccine.
Acceptance of an EUA Drug for Oneself or One's Child
There are clearly some distinct factors affecting the willingness to accept an EUA drug for oneself and one's child. Previous vaccine acceptance, trust, and perceived personal consequences were significant factors for those willing to take an EUA, while worry was a serious factor for those who refused. Worry was even more powerful a factor in willingness to accept an EUA drug for one's child. Because 2 EUAs are currently in place to facilitate access to antivirals for children, addressing worry is essential if we wish to increase the number of parents willing to allow their children to use a needed EUA drug. To do so will require that communication about those drugs be at appropriate literacy levels. Additionally, formative research to understand the sources of their worry would enable public health professionals to tailor fact sheets for both parents and providers to be more relevant to their concerns. Finally, up-to-date communication with pediatric providers will also enable them to provide key information to parents who must make the decision to use an EUA antiviral drug for their children.
Conditions under Which an EUA May Be Distributed
An EUA drug or vaccine could be dispensed under a variety of scenarios. Our finding that fact sheets would enhance the acceptance of EUA drugs makes it important that fact sheets be made readable and comprehensible to diverse groups. Currently, the fact sheets on 5 EUAs are available only in English.42,48–51
Preliminary readability assessments conducted with Microsoft Word's readability tools, which include the Flesch Reading Ease Score and the Flesch-Kincaid Grade Level Score, reveal that grade levels for the fact sheets range from 5.5 to 10.5 and that the ease scores (100 is easiest) range from 45.8 to 74.5. Using the Gunning Fog Index, fact sheets ranged from 9.78 to 12.33, with a score of 5 considered readable, 10 considered hard, and 15 difficult. Clearly, these findings create concern about the extent to which fact sheets are available for non-English speaking audiences or those with low literacy levels. Our sample included a significant over-sample of Spanish language–dominant Hispanics who, our results suggest, may be more willing to take a vaccine. Providing clear Spanish-language materials will be essential to ensuring that this population is adequately informed about the vaccine.
We found that respondents were least likely to accept an EUA drug or vaccine when it was dispensed by a non–health professional, which is allowable under FDA guidance. This has serious implications for vaccine campaigns that may need to be conducted outside clinical settings, in schools, worksites, and other community sites. Should it become necessary to use non–health professionals, the rationale and protections for the public must be clearly communicated. It may be most effective to use non–health professionals in support roles, such as intake in mass clinics, preserving the health professionals for actual administration of vaccine.
The reluctance to accept EUA drugs or vaccine demands that communication campaigns address the whole concept of the EUA. For example, if the vaccine is an EUA, the public and the media will need to understand the approval process for an EUA, that the vaccine did, in fact, go through limited clinical trials, and the system for reporting adverse events. It will be critically important that risks, benefits, and the individual's right to refuse the vaccine are clearly evident in all communications. Additionally, both the public and the media will need to be educated about adjuvants and how their use can also contribute to the ability to provide vaccine in an equitable manner both domestically and globally.35
Contextual Considerations for Communication
Trust in the government has been shown to play a role in compliance with policies: during the severe acute respiratory syndrome (SARS) epidemic in China in 2003, for example, attitudes toward the government's SARS prevention measures, including confidence in the government's ability to control the spread of SARS, were linked to engagement in preventive health behaviors.52
Rubin et al. have reported that, in the UK, government-recommended preventive health behaviors were practiced by people who reported that the authorities could be trusted.53
We find that Hispanics have a higher level of trust in the government's handling of H1N1; this is similar to the finding of Paek et al. that Hispanics had a higher level of trust in the government's ability to handle a flu pandemic.15
Additionally, our study points to the salience of previous vaccine acceptance, worry, and perceived personal consequences, in addition to trust, as predictors of EUA drug and vaccine acceptance.
During the anthrax attack, an unapproved vaccine offered as an investigational new drug was perceived as experimentation by recipients, especially African Americans.13
This fall, making an unapproved vaccine acceptable to blacks, with the continuing legacy of distrust associated with the Tuskegee study,54,55
represents a significant challenge to public health practitioners. The EUA needs to be clearly distinguished from investigational protocols and experimentation. Quinn et al. suggest that the government and public health agencies “work with media partners in the pre-event phase to prepare them to discuss EUAs and their use” and “ensure that those public health professionals responding have an adequate understanding of the importance of recognizing and acknowledging cultural and social barriers that may have an impact on uptake or response.”13(p330)
For racial and ethnic minority groups, beginning education efforts with community-based organizations and faith communities and engaging credible spokespersons is immediately necessary.56
Trust in government will remain a critical factor in determining the response to the vaccine campaign. It is essential for CDC and state and local health departments to communicate clearly about the rationale for the priority groups who will receive vaccinations first. There is significant potential for the public to misunderstand these priority designations. While this issue may be seen as separate from the issues of acceptance of EUA vaccine or drugs, it could create an undercurrent that would undermine efforts to increase vaccination acceptance.
Vulnerable groups, who already experience health disparities, will need to be a focus of communication about the vaccine if these disparities are not to be exacerbated during the flu pandemic. Additional qualitative research with these audiences needs to be done to understand the way they perceive the benefits and risks of the vaccine and to determine what messages and spokespersons would be most effective in addressing their concerns. Such formative research, followed by a more experimental approach to test the efficacy of messages, would support clear and cogent communication specifically targeted to these groups to enhance vaccine acceptance and confidence in their decisions. Communication strategies for these populations should include specific outreach to healthcare providers who serve these groups, targeted risk communication materials that are culturally relevant and appropriate, and specific attention to literacy levels.
The tension around communication about the H1N1 vaccine was evident in a recent Washington Post
article describing the testing process. This article framed the new vaccine as just another variant of the yearly seasonal flu vaccine:
The Food and Drug Administration may formally approve much of that vaccine before studies required to prove how well it works are completed, treating the new inoculations just like the recipe change that regular winter flu vaccine undergoes each year.57
We are concerned that this framing of the testing process in the media is prematurely reassuring and could backfire if the new vaccine produces many more side effects than the regular winter flu vaccine. Such over-reassurance in the face of uncertainty could seriously erode the government's credibility. The same article frames the possibility of an adjuvant-added vaccine very differently:
Make no mistake: Vaccines containing immune-system boosters called adjuvants are not candidates for the easier strain-change approval, the FDA said. Flu vaccine with this extra ingredient is widely sold in Europe but never has been sold here, and there's little information about their safety in young children or pregnant women. While both adjuvant-free and adjuvant-added swine flu vaccine is being tested in the U.S. and abroad, using it outside of those studies would require a completely separate government decision.57
While there is still so much uncertainty about the characteristics of the new vaccine, it seems appropriate to educate the public about the differences without framing one as familiar and safe and the other as unknown and potentially dangerous. Striking the balance between these 2 potential messages is a considerable challenge for public health professionals.
Understandably, the U.S. government has been focused on ensuring the availability of a vaccine in sufficient quantities to protect the American people in what may be a resurgence of H1N1 in the fall. The results of this study suggest that we cannot afford to be complacent about the risk communication that needs to occur before the public will accept a new vaccine. Surveys such as this one provide critical insight into how the public views the risk of H1N1 and how they weigh the risk of disease against the risk of a new vaccine or EUA drug. These results suggest important ways of segmenting groups and the kinds of information these different segments require to make good decisions for themselves and their families. Further research, both qualitative and quantitative, is necessary to monitor public acceptance of the H1N1 vaccine and drugs throughout the pandemic, and particularly to provide ongoing assistance to public health professionals responsible for key risk communication campaigns.