A safe, effective childhood vaccine against pneumococcal disease, the most common cause of pneumonia in children, has been approved by the U.S. Food and Drug Administration.
Acting Director of the Centers for Disease Control and Prevention Thomas R. Frieden made the announcement at a press conference Monday morning.
A person infected with the bacterium, called pneumococcus, can cause the disease when the disease strikes a child or person without being sickened by the bacterium. Infection in children older than age 5 can cause lifelong effects in a person’s lungs, primarily breathing difficulties and even lung cancer.
The cause of pneumococcal disease in infants younger than 1 year old and adults age 65 or older is equally deadly.
“Infants and very young children and older adults are often not exposed to the appropriate vaccinations to protect against pneumococcal disease,” Frieden said. “Those most at risk of catching the disease are babies up to 18 months and adults age 65 and older.”
Each year, about 12,000 people in the United States die of pneumococcal disease. This year alone, nearly 12,000 people were hospitalized due to severe complications from the infection, according to a CDC press release.
CDC data shows that while pneumococcal disease was the most common cause of hospitalization and death in infants and children, about 25 percent of the hospitalizations and deaths due to the disease in 2011 occurred in adults, especially 65-year-olds. By contrast, pneumococcal disease was responsible for less than 1 percent of U.S. hospitalizations or deaths of children less than age 5.
The new vaccine, called called Prevnar 13, is a combination of two Prevnar products developed by Pfizer: Prevnar 11, which works by protecting against pneumococcal disease in healthy adults, and Prevnar 13, which uses an improved delivery system to protect children from the disease in both children and adults.
“Prevnar 13 can protect against many more strains of pneumococcal disease, including strains specific to children, than Prevnar 11,” Frieden said.
The vaccine contains a gene from the pneumococcal bacteria that ensures that a person will not be weakened by the vaccine, meaning no part of the genetic coding was changed in the vaccine. After years of research and development, the agency signed off on the vaccine in January 2014. The immunization process for all children ages 5 to 17 also took three years.
Additional evidence for the effectiveness of the vaccine is included in an FDA-sponsored study conducted between 2010 and 2013 of thousands of children that was recently published in the New England Journal of Medicine. This clinical trial proved that a person would not need to be sick to receive protection against pneumococcal disease caused by one of the most common strains of pneumococcal bacteria in both adults and children.
This vaccine has now received final approval in 13 countries and has been approved in eight additional countries. Prevnar 13 will be available at general practitioners’ offices or vaccination clinics, and at drug stores beginning March 10.
During the rollout phase, priority will be given to any child who is being denied a vaccine against pneumonia, according to the CDC.
“Although this is a new vaccine, children should still continue to receive three doses of the pneumococcal vaccine,” Frieden said.