Do you hate the idea of getting a shot? Do you cringe at the sight of a needle? If so, you may be happy to hear the news that earlier this week an FDA advisory panel recommended the approval of a new flu vaccine that’s delivered by nasal spray instead of injection. But there’s a catch. Actually a few catches.
FluMist is the name of the new vaccine, developed to be needle-free, and therefore ideal for infants and anyone who hates to see that syringe coming at them. But when FluMist was first presented to the FDA in 2001 it was rejected because tests revealed that some young children developed asthma attacks. So this time MedImmune (manufacturer of FluMist) cut out part of their original target market and presented the vaccine to be used by those aged 5 to 65. And while the advisory panel didn’t say no, they didn’t exactly give it a resounding “Yes!”
Because studies have not yet been conducted on subjects over age 65, or on people with asthma or other illnesses, the panel agreed to recommend the vaccine only for people aged 5 through 49. So FluMist finally got a thumbs-up (sort of), but it’s still awaiting final approval from the FDA, which does not always follow the recommendations of its advisory panels. And the approval in this case is far from a lock, because there are even more problems.
For one thing, in a study of over 4,500 adults, ages 18 to 64, those who received FluMist were found just as likely to experience a flu-like illness as those receiving placebo. Not exactly a ringing endorsement.
But wait – it gets worse. FluMist is made from a live flu virus. The flu shots currently in use are made of killed virus. But no trials have yet been conducted to test the safety and efficacy of one vaccine against the other. So without any data to go on, doctors would have no way of weighing the merits of the two vaccines in trying to decide which to offer a patient.
Is this any way to run the launch of a new pharmaceutical? Calling Dr. Larry, Dr. Curly, Dr. Moe.
To Your Good Health,
Health Sciences Institute