PASADENA, Calif. May 22, 2013 The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published today in Vaccine.
The U.S. Food and Drug Administration approved PCV13 for use beginning in 2010 after a series of trials. These trials found that PCV13, which protects against a broader range of pneumococcal types than the previously used PCV7, did not increase the risk for any serious adverse events related to the vaccine.
In a study funded by the Centers for Disease Control and Prevention, Kaiser Permanente researchers evaluated the electronic medical records of nearly 600,000 children, ages 1 month to 2 years, who received PCV13 over a two-year period. Comparing the number of rare adverse events associated with the PCV13 vaccine to the number of events associated with the previously used PCV7 vaccine, the study authors found there were no increased risks for any of the following pre-specified conditions: febrile seizures, encephalopathy (a type of brain disorder), hives/angioedema, asthma, low platelet counts or systemic allergic reactions.
"It is important that children receive the pneumococcal conjugate vaccine as it provides protection against very serious and potentially fatal infections, including meningitis and bloodstream infections. The new vaccine protects against an additional six types of pneumococcal bacteria," said study lead author Hung Fu Tseng, PhD, MPH, a research scientist at the Kaiser Permanente Southern California Department of Research & Evaluation.
Early in the study, there was a statistically significant but very small increase in the risk of Kawasaki's disease, a rare condition in children that causes inflammation of the blood vessels, associated with PCV13 (7 diagnoses per 52,000 doses, compared to 4.24 expected). At the end of the study,
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