Finally an Ear Infection Vaccine - GlaxoSmithKline develops Vaccination in Effort to Prevent Middle Ear Infections

March 3rd 2006

Middle Ear

Researchers from GlaxoSmithKline have developed a vaccine that may help prevent ear infections in children under the age of 2. It is hoped the vaccine will successfully prevent one of the most commonly diagnosed childhood ear infections, the Acute otitis media (middle ear infection) caused by the bacteria Streptococcus pneumoniae and Haemophilus influenzae.

The drug was tested by researchers in the Czech Republic. A vaccine containing 11 different strains of pneumoniae attached to a protein derived from H. influenzae was tested on more than 4,000 infants. They set up control groups between the ages of 3 and 15 months.

After all of the kids turned two, the researchers compared the two groups. There were 333 otitis media ear infections in the vaccinated group. There were 499 unvaccinated kids that got the ear infections. According to the article originally published in British medical journal Lancet; results reveal the vaccine not only protects against pneumoccal otitis media, but also against the infection when it is caused by H. influenzae.

The vaccine reduced the number of middle ear infections by one third. This is significant when you consider that there are nearly 20 million pediatrician visits every year for this condition. CNN claims that 90% of all children have had acute otitus before school age.

The condition causes fever, pain and can lead to hearing loss. The American Academy of Pediatrics (AAP) says that the infection usually occurs between the ages of 6 months and 4 years.

Since the vaccine reduced the frequency of ear infections by 65.5 percent, the drug company considers the work “very promising”. Dr. Roman Prymula, who led Phase III of the study, called the results statistically significant. "This study showed a statistically significant and clinically relevant reduction in episodes of acute otitis media," Prymula said.

Glaxo will be submitting the vaccine, called Streptorix, for regulatory approval in Europe in 2007. They hope to file for approve in the US soon after that.