The world's only authorized monkeypox vaccine, Bavarian Nordic's Jynneos vaccine, is set to be split into fifths after the FDA cleared the strategy on Aug. 9 — a solution that could indicate the future for resolving emergency drug shortages, pharmacy and supply chain experts said.
States and cities have been clamoring for more monkeypox vaccines for months as cases steadily rose across the country, causing the FDA to consider "drug-sparing," a strategy last studied in 2015 where one Jynneos dose was divided into five syringes and was administered between, rather than under, layers of skin. The research found that patients with the smaller dose had a similar immune response to the full two-dose series.
With the FDA reporting 123 drugs that are in short supply, this decision could point to future supply issues during public health emergencies.
"I think this is really exciting," David Dobrzykowski, PhD, director of the University of Arkansas' supply chain master's program in Fayetteville, told Becker's. "All of a sudden, if you take 440,000 doses and split that into five, now it's over 2 million doses. It's just a huge increase in supply that really came out of innovative thinking and the application of the vaccine."
Dr. Dobrzykowski said that before implementing the strategy with other drugs, there would need to be clinical tests for specific medications.
Erin Fox, PharmD, a pharmacy professor at the Salt Lake City-based University of Utah, said she expects logistical issues to pop up because clinicians will be the ones dividing the doses into fifths, not the suppliers. If other drugs pass similar regulatory steps, though, the drug-sparing strategy could be more common.
"The concept absolutely needs to be on the radar screen and top of mind with chief supply chain officers and clinical leaders in hospitals and health systems," Dr. Dobrzykowski said.