Researchers from the University of Texas have developed a new method of stabilizing live viruses into a vaccine that can be consumed in a “rapidly dissolving film.” Unlike most vaccines, this film would not require refrigeration and can be administered via the mouth. The research group, led by co-author Maria Croyle, says that the vaccine in this form could be mass distributed as the materials to make the film are inexpensive and the manufacturing process is fairly simple. The study was published in the journal Science Advances.

Maria Croyle writes in The Conversation that her team began developing the technology way back in 2007, after the National Institutes of Health had asked the researchers to develop a needle-free delivery medium for vaccines. As she describes it, “The idea of developing a film was inspired by a documentary about how the DNA of insects and other living things can be preserved for millions of years in amber. This got us thinking about hard candy, like my grandmother used to make.”

Vaccines like those for measles, polio, influenza, hepatitis B and Ebola, as well as many of the therapeutic antibodies used to treat infections and cancer, can be carefully sandwiched between protective layers. | Stephen C. Schafer, CC BY-ND

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The challenge presented to them was difficult. The researchers had to find a way to develop the film without destroying the virus or bacteria they were trying to store in it. This was especially important as there was no known method in the manufacturing process where one could suspend a live virus while crystalizing the film. Croyle writes, “Initially, many of the preparations we tested either killed the organism as the film formed or crystallized during storage, shredding the virus or the bacteria we were trying to preserve. But finally, after about 450 tries over the course of a year, we found a formulation that could suspend viruses and bacteria in a peelable film.”

Benefits of the thin-film in mass production

Once the team found a way to suspend a live virus in the film, they moved on to simplifying the manufacturing process. This is maybe one of the most important factors during large-scale distribution. If a world-wide pandemic were to occur, billions of vaccine films would have to be produced in various locations around the world within a short span of time. With more than 100,000 confirmed cases already, the coronavirus outbreak is rapidly expanding, and a vaccine distribution medium such as the “hard candy” thin-film would be required once a vaccine is ready to manufacture.

The film can stabilize the vaccine in a space-saving format, making it easier to ship and distribute around the globe. | Stephen Schafer and Maria Croyle, CC BY-NC-SA

Vaccine potency

Another huge benefit of the film distribution method is long-term vaccine potency. Traditional vaccines have to be refrigerated at all times in order to maintain its potency, or ability to effectively deliver within the body. In remote parts of the world, it becomes very difficult as the energy required for refrigeration won’t be available. Even if vaccines are air-dropped, they would have to be distributed and administered immediately to prevent deterioration. Being able to store and transport a needle-less vaccine at room temperature brings a huge advantage to very large scale distribution.

“The biggest breakthrough for this project came when we were finishing up our Ebola vaccine project and found films containing virus made three years ago, stored in a sealed container on the lab bench. On a whim, we rehydrated them and tested them to determine if the vaccine was still capable of inducing an immune response. To our surprise, more than 95% of the viruses in the film were still active. To achieve this kind of shelf-life for an unrefrigerated vaccine was astonishing,” Croyle writes.

Hazardous waste elimination

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It is very well known that needles and injections have to be disposed of very carefully, as they are classified as toxic, hazardous waste. There are even many forms of nonhazardous waste that piles up, such as syringes, cotton, vials, wrappers, etc. The 2004 Philippine Measles Elimination Campaign, that vaccinated 18 million children in a month, generated around 143 tons of sharps waste and around 80 tons of nonhazardous waste.

If a global pandemic were to occur, disposal of the waste becomes a pressing issue – especially since the waste itself holds the risk of spreading the outbreak it was made to curb. The team’s film distribution method would eliminate almost all waste produced by vaccines.

Bringing the technology to life

Croyle says she is already involved in a startup that aims to bring this technology to a consumer level in the next two years. There may be concerns regarding the effectiveness of a film-delivered vaccine compared to an injected vaccine. Vaccines, such as the H1N1 vaccine, had oral delivery methods via sprays designed for kids. However, there are studies that have shown that these were less effective than traditional vaccines.

Hopefully, these concerns will be put to rest soon and with a little bit of government support, the method could be applied to the COVID-19 virus that is under development.

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