New Vaccine Delivery Method May Yield Clinical Advantages, Reduced Costs

May 13, 2020

Investigators are developing a new needle-less vaccine delivery method that would eliminate the need for refrigeration and could significantly reduce costs associated with immunizations.

Investigators are developing a new needle-less vaccine delivery method that would eliminate the need for refrigeration and could significantly reduce costs associated with immunizations.

Maria A. Croyle and her team in the Division of Molecular Pharmaceutics and Drug Delivery at The University of Texas at Austin have created a peelable, lightweight film that stabilizes biologics and can endure extreme heat as a new possible vaccine delivery method, according to a release from the university.1

“The biggest clinical advantages of our technology are that it allows for needle-free and self-administration of vaccines and other biological medicines,” Croyle told Drug Topics®.

Croyle said injections are often the “most common reason for iatrogenic pain in childhood” and can deter parents from vaccinating their children.

 “In 1 study, 90% of 15- to 18-month and 45% of 4 to 6-year-old children experienced ‘serious distress’ during immunizations,” she said. “This coupled with the general stress and fear of doctor’s visits is often a significant barrier for obtaining secondary boosting doses of vaccines in rural and low economic communities leaving portions of the population with only partial immunity to certain diseases.”

The new lightweight film matrix developed by researchers could help increase adherence and improve public health around the globe, she said.

 

Croyle said the technology was created with developing countries in mind and relies on inexpensive formulations that use primarily sugar, salt and some cellulose. Costs are also driven down because the new delivery method does not require refrigeration.  

Croyle estimates that in traditional vaccine delivery methods approximately 40% of the cost of a vaccine or biologic drug is dedicated to supporting the complex facilities that are needed to store and distribute these vaccines.

The cold chain often needs to be maintained during transportation and storage of these vaccines; however, breaks to the cold chain can significantly drive up immunization costs.

For example, in 2011, UNICEF reported that more than $1.5 million worth of vaccines were damaged in countries in West and Central Africa in just 5 months because of breaks in the cold chain.2

“Vaccines embedded in our film technology would not require such strict environmental monitoring for storage and shipment,” Croyle said. “The space required to store our film is only a fraction of that of traditional vaccines, reducing the cost associated with renting temperature-controlled warehouses to store traditional vaccines to that of a filing cabinet in an office-where sheets of our vaccine could be stored.”

Investigators have already developed proof of concept of the vaccine delivery model for Ebola and H1N1 vaccines, but believe it could be used for other vaccines as well, including a possible coronavirus vaccine.

“Once we know the specific qualities of a vaccine candidate, we can adapt the film’s components to meet those requirements, suspending and sealing it within the film matrix in a way that allows it to withstand extreme temperature changes and release the vaccine components in a precise and controlled manner,” she said in the press release.

Croyle told Drug Topics® that the that the delivery method has yet to be tested in humans, but investigators are currently seeking financial support to make that next leap.

Investigators are also working on how to scale up the process used to produce the film, but are hopeful that the new delivery method could significantly improve access and adherence to immunizations in the years ahead.

References:

1. New Delivery Method Could Transform Vaccine Distribution to Remote, Developing Areas. News Release. The University of Texas at Austin; March 4, 2020. Accessed May 12, 2020. https://news.utexas.edu/2020/03/04/new-delivery-method-could-transform-vaccine-distribution-to-remote-developing-areas/.

2. Vaccinating Children Beyond the ‘Cold Chain’: Extending the Heat Stability of Vaccines. Issue Brief. Médecins Sans Frontières. https://www.msf.org/sites/msf.org/files/msf_access_issuebrief_thermostability_en.pdf.