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IPV safety reinforced ahead of worldwide adoption
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In anticipation of the worldwide replacement of live oral polio vaccine with inactivated polio vaccine, a comprehensive study has confirmed that the replacement vaccine is safe and effective.
“This analysis is the first comprehensive look at the safety profile of IPV-containing vaccines since an all-IPV schedule was introduced in the USA in 2000,” Walter A. Orenstein, MD, of the division of infectious diseases at Emory University School of Medicine, and colleagues wrote. “In the context of large numbers of doses distributed during the study period, the recorded frequencies of adverse events are relatively small.”
Walter A. Orenstein
The researchers analyzed IPV adverse events data submitted to the U.S. Vaccine Adverse Event Reporting System between 2000 and 2012. The researchers classified data by type of adverse events reported, including nonserious, nonfatal serious and death. They also noted the most commonly coded event terms to better understand the most common symptoms associated with IPV. Death reports were analyzed individually to determine the cause of death in each case.
Study results showed that of the nearly 250 million adults and children vaccinated between 2000 and 2012, there were 41,792 adverse events reported. Furthermore, of the 41,792 adverse events reported, 88% were nonserious, with another 10% recorded as nonfatal serious. The researchers found that 2% of the adverse events reported were the result of IPV-associated deaths.
Most adverse events were experienced by children, making up 95% of all adverse events reported. Likewise, 75% of nonfatal serious adverse events and 96% of deaths were recorded in children aged younger than 12 months.
The most common adverse events experienced by children aged younger than 12 months associated with IPV were nonserious symptoms such as injection-site erythema and pyrexia, whereas the most common nonfatal serious adverse events recorded were serious pyrexia, vomiting and convulsions. Sudden infant death was the cause of death most often associated with IPV in this population.
“Safety data from countries with experience in the use of IPV could provide important evidence in support of the Global Polio Eradication Initiative strategy to introduce IPV into the national childhood immunization schedule of all countries,” Orenstein and colleagues wrote.
In a related editorial on this study, Kimberly M. Thompson, ScD, of the University of Central Florida College of Medicine, wrote that a successful transition from live oral polio vaccine (OPV) to IPV requires preparation for the many challenges that can arise.
“Because of the risks of circulating vaccine-derived polioviruses emerging during the transition to an IPV-only schedule, high immunization coverage with poliovirus vaccines in the national immunization schedule, including OPV, must be a high priority for every country,” Thompson wrote. “Countries introducing IPV should also change their national immunization schedules to ensure that individuals with primary immune-deficiencies and their close contacts receive IPV and never receive OPV, as is done in the United States.” – by David Costill
Disclosure: The researchers report no relevant financial disclosures.
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Thompson KM, et al. Lancet Infect Dis. 2015;doi:10.1016/S1473-3099(15)00099-7.
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