Expert calls for research into safety of anthrax vaccine in children

Nicole Lurie, the assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, recently asked the National Biodefense Science Board to investigate the safety concerns of collecting data on the effects of the anthrax vaccine absorbed vaccine in children.

The U.S. government currently stockpiles AVA in order to potentially provide post-exposure care for at-risk populations in the case of an anthrax attack.

In a letter written to the chair of the NBSB, Dr. Patricia Quinlisk, and its members, Lurie said that recent national-level exercises highlighted the need to address particular questions regarding a lack of available data.

There is currently no safety, immunogenicity or efficacy data in pediatric and special populations that would allow the U.S. Food and Drug Administration to evaluate the drug for its utilization under an Emergency Use Authorization.

In the case of an emergency, adults could receive the countermeasures under the less stringent EUA status, while an investigational protocol would still need to be developed for its use in children and special populations. This would present an array of logistical, clinical and communication challenges during a public health crisis.

Lurie concedes that the simple solution is to gather the data in pediatric and special populations ahead of an urgent need, but acknowledges that there are legitimate concerns regarding the risk of testing AVA with no clear benefit at the time of conducting the study.

The NBSB has been asked for its recommendations on the best course of action to prepare for the use of AVA in a specifically pediatric population.

Lurie is primarily interested in the NBSB’s evaluation of the risks and benefits of conducting AVA safety studies in children before or after an emergency, to what extent there are ethical concerns regarding an attempt to gather enough data to permit the vaccine’s use under an Emergency Use Authorization, what planning needs to be in place to perform an investigational protocol after an attack and how the government should approach discussing the issue with parents and public health officials.

The next NBSB public meeting begins on September 22, and Lurie hopes to hear the board’s recommendations at that time.