An advisory panel of the Food and Drug Administration Tuesday afternoon recommended approval for FluMist, a new, nasal flu vaccine developed by the biotech firm MedImmune ( MEDI), in partnership with drug maker Wyeth ( WYE). But on a key vote, the panel recommended against approval for people aged 50-64, on grounds of efficacy which could hamper the drug's revenue-generating potential. The Vaccines and Related Biological Products Advisory Committee decided that FluMist was safe for all three age groups considered: people 5-17, 18-49 and 50-64. Several panel members did ask MedImmune to provide follow-up safety data, especially on the risk that the influenza virus is transmitted from vaccinated people to unvaccinated people. FluMist contains live, but weakened, influenza virus, that when sprayed up the nose allows the body's immune system to build up a defense against the flu without actually causing flu-like symptoms to occur. But a second vote on FluMist's efficacy was split. Panel members said the vaccine was effective for people aged 5-17 and 18-49, but voted overwhelmingly that there was insufficient data to support efficacy in people 50-64. MedImmmune and Wyeth badly wanted the panel's recommendation for older individuals since the age group is a prime target market for flu vaccinations. The split safety/efficacy vote from the panel raises the risk that FluMist might not be approved for these people by the FDA. The other significant target group for flu vaccinations is kids under 5, but MedImmune agreed to exclude FluMist's use by this group due to concerns about increased incidences of asthma and wheezing episodes. The panel's recommendations will be forwarded to the full FDA for review. A final decision on FluMist's approval is expected in March. Unlike traditional vaccines that are injected, FluMist is supposed to be easier and less painful to administer, which could lead to higher use and sales.
The biggest markets for FluMist would be toddlers, young children and older folks, so the suggested age restrictions might hamper the vaccine's launch, some analysts say. The higher cost of FluMist -- estimated to be as much as double or triple that of traditional vaccines, could also cause insurance reimbursement problems. Lazard biotech analyst Joel Sendek has taken a conservative stance on FluMist sales -- $100 million in 2003, $188 million in 2004 -- due to these concerns. He rates MedImmune a hold and his firm doesn't have a banking relationship with the company. UBS Warburg analyst Meirac Chovav is more bullish, especially when it comes to FluMist's long-term potential. Her 2003-2004 sales forecast is $450 million and $700 million, respectively. She rates MedImmune a strong buy and her firm doesn't do banking for the company. Shares of MedImmune were halted Tuesday, but closed Monday at $24.99.