Alongside the introduction of novel vaccine platforms like mRNA and adenovirus vector technologies, manufacturers are exploring other advancements that could enable self-administered vaccination (e.g., intranasally, orally, using a skin patch). These alternative routes of administration may present opportunities to increase vaccine uptake and improve vaccination rates by addressing hesitancy and simplifying delivery and administration.

Several studies have demonstrated positive patient and healthcare provider attitudes about self-vaccination and its potential to increase vaccine uptake. However, given the limited precedents for self-administered vaccines, manufacturers should be mindful of key regulatory, policy, and distribution/logistics considerations.

Regulatory Pathway

Any vaccine being developed, including for self-administration, requires review by the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). In addition to routine clinical testing, manufacturers seeking approval of a self-administered vaccines will need to conduct usability testing (e.g., human factors testing) in settings and scenarios where self-administration is most likely to occur. These assessments are necessary to demonstrate that a self-administered vaccine is easy to use and can be administered properly by individuals without medical training.

The FDA has approved several self-injectable medicines that could serve as precedent. However, safety standards for vaccines are more stringent because they are intended for administration to a broad, healthy population. Additionally, like self-injectable drugs, vaccines for self-administration may require a device (e.g., intranasal device), potentially necessitating review by both CBER and the Center for Devices and Radiological Health.

Recommendations and Guidelines

After obtaining FDA approval, a self-administered vaccine will need a positive recommendation from the Advisory Committee on Immunization Practices (ACIP) to be covered by public and private payers and used by providers. While publications describe a potentially favorable attitude among providers relative to self-administered vaccines, a positive ACIP recommendation is necessary for broad provider acceptance.

In its evaluation, ACIP considers the epidemiological data for disease burden, evidence of efficacy from clinical trial data, and data from a cost-effectiveness analysis. ACIP might also consider the scenarios and populations evaluated and may issue self-administration recommendations that are more restrictive than the approved label (e.g., limited to adults or adolescents in school-based vaccination clinics under the supervision of a healthcare provider).

In addition to ACIP’s recommendation for use, clinical guidance from professional medical societies (e.g., the American Academy of Pediatrics) can also serve to encourage or discourage use in the provider populations they serve. Optimal uptake by patients, caregivers, and healthcare providers is more likely when ACIP’s and professional medical societies’ recommendations and guidance are aligned.

Distribution and Logistics

Depending on product characteristics, self-administered vaccines could expand distribution channels due to simpler supply chain requirements. Beyond where vaccines are typically distributed, including hospitals and other traditional sites of care, these vaccines could be distributed to vaccination sites in rural communities with access to fewer healthcare resources or infrastructure. Further, vaccines with manageable storage and distribution requirements have the potential for home delivery, which could be particularly valuable during future pandemic preparedness activities. Providing individuals access to secure vaccine ordering and delivery in a manner that maintains product integrity and includes easy-to-understand self-administration and disposal instructions are important factors for home delivery.

A mechanism for tracking adherence may also be necessary to ensure that a vaccine was administered per its requirements and captured within an individual’s medical record and other immunization registry. While some infrastructure for self-administration is already in place (e.g., virtual appointments, mail delivery of prescriptions), confirmation of administration is needed for vaccines.

Conclusion

The COVID-19 pandemic will continue to accelerate the need for evolving technologies and platforms to target new and existing infectious diseases. Developing alternative routes of administration that enable self-administration builds upon these innovations in ways that could expand vaccine uptake.

It is critical to understand how stakeholders will consider these new vaccine offerings within their approval, recommendation/guideline, and utilization decisions. Manufacturers need to assess the value proposition self-administered vaccines offer and develop effective stakeholder engagement strategies to understand and generate the needed evidence. Broad acceptance and use by patients, caregivers, and healthcare providers may be enhanced through policy changes that provide adequate reimbursement, ensure coverage and access, and support administration by non-physician immunizers.

Once approved and recommended for use, attention will shift toward maximizing access and ensuring patients and caregivers can easily order, receive, administer, and dispose of vaccines in a safe and effective manner. This includes a mechanism for patients and caregivers to record and document the vaccine’s administration for medical record tracking and proof of vaccination.

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