Flu season is just around the corner, and the Centers for Disease Control and Prevention (CDC) and American Academy of Pediatrics have withdrawn their recommendations for the FluMist, leaving thousands of children and adults with only one option: the shot.

In anticipation of the 2016-17 flu season, manufacturers had originally planned on the distribution of approximately 170 million doses of the vaccine, 14 million of which would be made in the popular nasal spray form; However, in May the U.S. Influenza Vaccine Effectiveness Network found the live attenuated nasal spray vaccine to be unsuccessful at preventing the virus, with an effectiveness of just 3% last year.

The technology behind FluMist was first developed by Hunein Maassab, professor of Epidemiology at the University of Michigan at Ann Arbor.  After decades of research and thousands of clinical trials, Maassab had finally created an efficacious and safe vaccine using a live, attenuated strain of influenza.

Though commercial development began shortly after, FluMist wasn’t approved by the FDA until 2003.  MedImmune, a subsidiary of AstraZeneca, had just acquired the mist a year earlier, after purchasing vaccine-developer Aviron for roughly $1.5 billion.  Medimmune has since continued to strengthen its patent portfolio and licenses, acquiring the rights to intellectual property owned by organizations like Mount Sinai School of Medicine for reverse genetics, as well as related technology from the Wisconsin Alumni research Foundation and St. Jude Children’s Research Hospital.

In 2015, U.S. FluMist Quadrivalent sales reached just over $200 million, though the latest announcement from the CDC’s Advisory Committee on Immunization Practices will significantly impact the demand of FluMist in the U.S. this year.