Challenges and opportunities in current vaccine technology and administration: A comprehensive survey examining oral vaccine potential in the United States

Abstract

This study provides a snapshot of the current vaccine business ecosystem, including practices, challenges, beliefs, and expectations of vaccine providers. Our team focused on providers’ firsthand experience with administering vaccines to determine if an oral vaccine (e.g. pill or oral-drop) would be well-received. We interviewed 135 healthcare providers and vaccine specialists across the US, focusing questions on routine vaccinations, not COVID-19 vaccines. Improving workflow efficiency is a top concern among vaccine providers due to shrinking reimbursement rates—determined by pharmacy benefit managers (PBMs)—and the time-intensiveness of injectable vaccines. Administering injectable vaccines takes 23 minutes/patient on average, while dispensing pills takes only 5 minutes/patient. An average of 24% of patients express needle-fear, which further lengthens the processing time. Misaligned incentives between providers and PBMs could reduce the quality and availability of vaccine-related care. The unavailability of single-dose orders prevents some rural providers from offering certain vaccines. Most interviewees (74%) believe an oral vaccine would improve patient–provider experience, patient-compliance, and workflow efficiency, while detractors (26%) worry about the taste, vaccine absorption, and efficacy. Additional research could investigate whether currently non-vaccinating pharmacies would be willing to offer oral vaccines, and the impact of oral vaccines on vaccine acceptance.

Perspective Chapter: The Most Natural Possible Vaccine Administered in the Most Natural Possible Way – Noninvasive over Injectable Vaccine Delivery Routes

“…The majority of all routine prophylactic (preventive) vaccinations and therapeutic (postinfection) vaccine administrations in the US, and globally, use invasive, needlebased methods-including those with the option to be administered either intramuscularly or subcutaneously-despite the needle-associated discomfort and potential blood-contamination issues, adverse side-effects, and cold chain-associated high storage/transportation costs [2,14,[17][18][19][20][21]. The term "cold chain" refers to a supply chain that maintains low-temperature control of a product from its manufacture to consumption.…”

“…This systematic approach is crucial in maintaining the safety and efficacy of temperature-sensitive vaccines, which can significantly increase distribution costs and limit the availability of vaccines in areas that are either remote or have insufficient infrastructure [22]. Other challenges and limitations of using needle-based vaccines include (i) the discomfort of administering multiple vaccines during either a single visit or over a multiple-dose series, (ii) a higher incidence of needle fear among children [20], which reduces vaccine availability in certain settings (e.g., supermarket pharmacies) where providers seek to avoid noisy disruptions, (iii) the need for a dedicated (often private) space to administer vaccines, (iv) specialized training requirements and the associated regulatory limitations on the healthcare professionals who are eligible to be trained on vaccine administration, and (v) high cost, minimum-order requirements that preclude some locations in low-demand, rural areas from ordering or offering certain vaccines [2].…”

“…Greater acceptance (due to safety and comfort) and compliance. Enhanced vaccine acceptance and adherence in routine prophylactic and reactive outbreak vaccination programs results in more widespread vaccine distribution and access, particularly in resource-limited settings [2,56,57].…”

“…accessibility, acceptance, cost-effectiveness, and consumer compliance rates, etc.) of the healthcare system [2]. Though the survey was conducted in the United States (US), we believe that the perspectives we present in this chapter are applicable on a global scale.…”

“…Over the past couple of decades our understanding of the microbial factors and host immune responses that contribute to effective control of infection and longlasting immunity have enabled exciting new advances in next-generation vaccine technologies against multiple globally-problematic diseases (e.g., noninvasive vaccine delivery methods such as mucosally active oral vaccines against mucosally acquired infections, shelf-stable vaccines to avoid cold chain requirements, and mRNA-based vaccine technologies) that are changing the landscape of infection prevention [1][2][3][4][5]. Vaccines remain the most cost-effective infection intervention, and today's vaccines are much safer and more effective than ever before.…”