This paper examines oral dissolvable films (ODFs) as an alternative to conventional injectable vaccines. It outlines the limitations of injection-based delivery — including cost, cold-chain dependence, needle phobia, and restricted access in developing regions — and argues that ODF technology addresses each of these barriers. The paper describes the pharmaceutical stabilization processes required for ODF vaccine formulations, highlights a rotavirus vaccine prototype developed by Johns Hopkins students, and discusses the potential of 3D and inkjet printing for vaccine production. Evidence from Ebola vaccine film studies is cited to support long-term storage viability without refrigeration, with implications for global public health and infant mortality in low-resource settings.
A majority of currently available vaccines are delivered through injection. The primary disadvantage of this method is that injections can only be administered by a trained healthcare professional [1]. This hinders vaccine delivery, and people in poor and developing countries suffer the most, as there is no cost-effective method of reaching them. A further disadvantage is that needlestick injuries can occur, potentially causing the transmission of infectious disease. There are instances when a healthcare professional may be distracted and make a wrong injection, or may not locate the intended vein, resulting in multiple attempts before the vaccine can be administered. This jeopardizes the health of the individual receiving the vaccine, as the needle puncture sites may become infected after leaving the hospital [2].
Individuals with needle phobia may avoid vaccination altogether out of fear, which can increase their chances of contracting or transmitting disease. The manufacturing process for current vaccines is generally expensive and cannot be easily implemented in developing countries [1]. The dosage forms — mainly glass vials or prefilled syringes — are not cost-effective for transportation, large-scale storage, or distribution. As a result, during mass vaccination campaigns a significant proportion of vaccines can be damaged in transit, at substantial cost.
The oral route is one of the most preferred routes of drug administration, being more convenient, cost-effective, and easier to administer, all of which lead to increased patient compliance. However, swallowing difficulties in geriatric and pediatric patients present a concern, including the fear of choking. These challenges have driven the development of safer and newer drug delivery systems such as Oral Dissolvable Films (ODFs). The development of quick-dissolving thin films can assist in remedying many of the problems associated with conventional vaccine delivery.
Using ODF, it is possible to develop and manufacture vaccines that are compact in size and weight, making distribution considerably easier [3]. The safety of vaccines is improved because there is no longer a need to store them in glass vials. Manufacturing costs are lowered because vaccines are printed directly onto a thin film and measured at the point of printing. Dosage accuracy is improved since the vaccines are already pre-measured and require no reconstitution [2]. Large-scale storage is more feasible because film strips are thin and occupy very little space.
Developing countries stand to benefit the most from this technology, as vaccines can be distributed widely and administered at home. The need for a professional healthcare worker to administer the vaccine is eliminated, making delivery more efficient and enabling more people to be vaccinated. The challenge of delivering vaccines to hundreds of millions of patients in a quick, cost-effective manner becomes far more achievable. Patients no longer need provider contact before receiving the vaccine, and they do not have to travel long distances to access it. Mailing the vaccine directly to the patient becomes possible, which will increase both compliance and reach.
Using thin films for vaccination will also encourage people with needle phobias to participate in vaccination programs. Hard-to-reach areas can be covered more easily, as there will be no need to dispatch medical teams alongside the vaccines. Overall, ODFs represent a transformative shift in the accessibility and practicality of vaccine administration.
There is a need to ensure a pharmaceutical stabilization formulation that eliminates the complex drying process typically required when using ODF. Some drug manufacturers have succeeded in developing a thin film formulation and manufacturing process in which a thermally labile live virus vaccine is successfully encased, achieving storage stability at high temperatures while completely preserving biological activity. With the capacity to store vaccines at high temperatures, transport becomes easier without risk of spoilage due to extreme weather, and the requirement for refrigerated trucks is eliminated [4].
In essence, ODF can be considerably safer and more cost-effective in transportation compared to conventional glass vials. Safety is critical when it comes to vaccines, and with ODF the integrity of the vaccine can be guaranteed even during transport to remote areas [3]. The ultimate goal is to reach as many people as possible; therefore, a methodology that allows vaccines to be transported to the most remote locations — without requiring cold rooms or refrigerated trucks — is essential. Currently, all vaccines must be stored in cold storage, which increases costs and renders vaccines ineffective if left unrefrigerated for extended periods. Using ODF, vaccines can be stored at room temperature, substantially increasing their viability.
The development of oral vaccines through ODF is highly relevant to public health. Considering the reduced capacity in the workforce for public health officers and the remoteness of some communities [4], it is vital to have a method by which large numbers of people can be effectively vaccinated. Remote villages are often the hardest hit by preventable diseases, primarily due to inadequate vaccine access. This can be substantially addressed by promoting the use of ODF in vaccine programs.
"Remote access, pandemic response, and mail delivery"
"Johns Hopkins prototype strip for infant vaccination"
"Printed films retain potency for years without refrigeration"
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