Big news for folks who hate the sight — or prick — of needles. Researchers at the University of Texas at Austin have come up with an innovative way to administer vaccines without the use of needles. It’s a shelf-stable oral vaccine that’s delivered via a thin piece of dissolvable film you place on your tongue.
Needles to say, the process to create this ground-breaking invention was not a quick process, but it does appear to have been a successful one. After more than 450 attempts at different formulations, the research team led by Maria Coyle, Registered Pharmacist and Professor of Pharmaceutics, came up with a formulation that suspends viruses and bacteria in a film that is administered by mouth and quickly dissolves. It can also be used to deliver antibodies and enzymes.
Delivering a vaccine through an oral film will solve several challenges — and not just the obvious ones involving pain or fear.
- No refrigeration needed.
Access to refrigeration is generally not an issue in the US, but in some parts of the world it presents a significant barrier to obtaining adequate vaccination rates.
- Low-cost ingredients will make it affordable.
- It will eliminate medical waste.
Each vaccination that is delivered by an injection produces a used needle, alcohol swab and their respective packaging. Personnel delivering the injectable vaccines often wear disposable gloves as well. There are glass vials that the vaccines are stored in that also contribute to the landfills.
“Our film, by contrast, can be distributed by health care workers equipped with only an envelope containing the vaccine. Once taken, it will leave no trace, except for a healthy global population,” said Coyle on Fast Company.
What’s the Holdup?
Coyle’s goal is to get this new technology to market by 2022, but there are a couple more hurdles to jump. Namely, FDA approval and effectiveness.
University of Texas at Austin’s Office of Technology Commercialization Program Director of Marketing and Public Relations, Betsy Merrick tells Parentology that the timing for when it hits the market, “Will depend on the regulatory process because it is a therapeutic product and would therefore be regulated by the FDA. The technology hasn’t entered the regulatory process just yet. It’s being scaled for manufacturing.”
“I would love a painless vaccine delivery method!” says Amy Baxter, MD, FAAP, FACEP, founder and CEO of Pain Care Labs, which researches and produces drug-free pain solutions and medical devices. Pain Care Labs created and sells Buzzy, a clinically proven device that reduces needle pain and fear. However, Dr. Baxter explains that the primary reason we don’t use oral vaccines is that live viruses can cause injury in patients with weak immune systems. This is why polio is now injected. “Plus, the harsh environment of the enzymes in the mouth and stomach destroy biologic material. It’s not whether a virus can stay alive in a film or candy — it’s whether enough remains after our digestive tracts take a hack at it to induce immunity. Most of our current vaccines are inactivated or small particles of the offending disease, not live viruses.”
Science Advances published results of a study testing the effectiveness of the film in delivering a vaccine for influenza. Results were encouraging. The vaccine, “Induced antibody-mediated responses as good as or better than those achieved by intramuscular injection.”
The possibilities for this technology are welcome news for those trying to increase global vaccination rates as well as individuals who avoid vaccinations due to a fear of needles.