Young children and their parents may soon have less of a reason to cry when going to the doctor.
A nasal spray vaccine for the flu virus has been shown to be more effective in children than the standard intramuscular needle injection currently being used.
In a study of nearly 8,000 children released today in the New England Journal of Medicine, children younger than 5 years old who received the nasal vaccine developed 55 percent fewer cases of the flu than those who received the injected vaccine.
"This vaccine will eventually lead to an easier process of vaccination and will substantially change the way pediatricians vaccinate children against the flu," said Dr. Robert Belshe, lead author of the study and director of the Center for Vaccine Development at Saint Louis University Health Sciences Center.
Not only did the nasal spray beat out the injectable vaccine against the strains of influenza actually contained in the vaccines, but it also prevented more infections caused by strains that were genetically drifted, or different, from the vaccine strains.
"It's as though you get a double-bang effect," said Dr. William Schaffner, chair of the department of preventive medicine at the Vanderbilt Medical School in Nashville, Tenn.
"You get protection against the kind of influenza that is in the vaccine, as well as the kind that sometimes occurs out in the community and is a little bit different," Schaffner said.
Should all children now start to receive the nasal vaccine? There are precautions. Children who are 6 months to 1 year of age were almost twice as likely to develop wheezing and other illnesses within six weeks of their immunization if they received the nasal vaccine rather than the injected one.
In addition, all children with a history of wheezing or asthma -- even older children -- were slightly more likely to be hospitalized if they were given the nasal vaccine.
The reason for the rise in other illnesses is unclear, but it is concerning enough that Belshe says, "The nasal spray vaccine should become the vaccine of choice for children over 1 year of age without a history of wheezing [or asthma]. It is easier to use and has greater efficacy."
Flu vaccines are still very important for infants between 6 months and 1 year, and the injected vaccine should continue to be used.
Dr. Kathleen Neuzil, chair of the Pandemic Influenza Task Force of the Infectious Disease Society of America, said, "If the nasal vaccine causes some side effects, then we need to weigh the risks and benefits in each patient."
Future studies may investigate a combination of the injected and nasal vaccines in an effort to balance efficacy and safety in children younger than 1 year old.
The nasal vaccine contains virus that is still alive but disabled, so it doesn't cause the flu itself. In children, the live virus multiplies in the body and causes a stronger immune response than the injectable vaccine, which contains only inactivated virus particles.
This form of the vaccine is not as effective in adults, whose more mature immune systems do not allow the virus to replicate as much.
Influenza Can Be Serious in Children
The Centers for Disease Control and Prevention recommend that all children 6 months to 5 years of age receive yearly immunizations against influenza. This is because influenza can cause very serious illness in small children.
According to Schaffner, "Children between 6 months to 2 years -- if they get influenza -- have rates of complications that are similar to those in people age 65 or over." These complications can include middle ear infections, pneumonia and even death.
Children who are 2 to 5 years old visit the doctor frequently for flu-related illness, are subjected to unnecessary tests, and are often given antibiotics they don't need. Typical antibiotics are not effective against the flu.
Belshe said, "Children get the flu twice as often as adults do, and they are also the main spreaders of flu. Thus, vaccinating children has a secondary benefit, to family members and especially the elderly, who can have serious consequences and death from influenza."
FDA Approval Necessary
The nasal vaccine, which is marketed under the name FluMist, is currently approved by the Food and Drug Administration for use only in people between 5 and 49 years old. The manufacturer has already submitted application data to the FDA, and approval for the use of FluMist in children under 5 years of age will hopefully occur in time for the next flu season.
Schaffner predicts that the vaccine will soon be licensed for young children, but that doctors may be cautioned about using it.
As a note to parents, he said, "Your doctor will tell you which vaccine will be best for your child."