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PCV13 appeared as safe as PCV7
The new 13-valent pneumococcal conjugate vaccine appears to be as safe as the previous version used before 2010, the 7-valent pneumococcal conjugate vaccine, according to study results published in Vaccine.
“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,” Hung Fu Tseng, PhD, MPH, of Kaiser Permanente Southern California Department of Research and Evaluation, said in a press release. “The new vaccine protects against an additional six types of pneumococcal bacteria.”
Hung Fu Tseng
The cohort study included 599,229 children aged 1 month to 2 years to monitor the risk of prespecified events after receiving PCV13 (Prevnar 13, Pfizer) during a 90-week period. Children with febrile seizures, encephalopathy, urticaria and angioneurotic edema, asthma, anaphylaxis, thrombocytopenia and Kawasaki disease were identified using computerized data.
Researchers found there was a small increase in the risk for Kawasaki disease associated with PCV13 (seven diagnoses per 52,000 vs. 4.24 expected). When diagnoses were confirmed by medical record review, the risk for Kawasaki disease in the 28 days after receiving PCV7 (Prevnar 7, Pfizer) was one per 100,000 doses and two per 100,000 doses of PCV13.
They also found that there was no increased risk for febrile seizures, encephalopathy, hives/angioedema, asthma, low platelet counts or systemic allergic reactions.
“Based on 90 weeks of data including approximately 600,000 doses of PCV13 collected at the Vaccine Safety Datalink Project, we identified no significant increased risk of prespecified adverse events associated PCV13 vaccine comparing to PCV7 vaccine,” the researchers wrote.
Disclosure: Tseng reports support from Novartis Vaccine.
