Regulatory Bodies to Assess Alternate Vaccine Testing Methods

The US Food and Drug Administration (FDA) is widely known as the country's chief federal regulator of biological products. Lesser-known-but still important-is another federal program known as the National Toxicology Program (NTP), which works to help agencies to understand and accept the toxicological profiles of many chemicals, including those used in vaccines.

The NTP's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) on Thursday (26 July) announced it is launching a workshop in September to assess chemicals used in Leptospira vaccines and how they might affect its potency.

Leptospirosis is described by NTP as an "emerging and widespread bacterial zoonotic disease" responsible for more than half a million human cases each year. If treated inadequately, the disease can cause as many as 25% of those infected to die.

"The goal is to promote development of innovative testing methods and approaches that may provide improved accuracy, efficiency and worker safety and that are more humane and use fewer or no animals," explained NICEATM in a Federal Register statement. The phase-out of animals used as test subject is in line with a June 2012 announcement by NTP in which it released a five-year plan containing provisions to rely more upon in chemico and in silico methods of testing.

"[The] current testing methods require the use of large numbers of laboratory animals that experience significant unrelieved pain and distress, accounting for over one-third of the animals reported to the USDA in this pain category," NTP said.

New Regulatory Models

An in vitro enzyme-linked immunosorbent assay (ELISA) antigen quantification method developed by the US Department of Agriculture to assess the potency of Leptospira vaccines holds promise, but it only applies to "several" of the hundreds of Leptospira variants. The testing method is likely to be one of the focuses of the meeting, NTP wrote.

NTP also said an overarching goal of its workshop is to promote international acceptance and implementation of "scientifically valid alternative methods"-a goal aimed at regulatory agencies traditionally in charge of overseeing and validating such methods.

The workshop is the second in what NTP expects to be a series. Among NTP's many members are FDA, several divisions of the National Institutes of Health, the Department of Defense and the Environmental Protection Agency.

Those agencies will be joined at the workshop by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods, the Korean Center for the Validation of Alternative Methods and Health Canada. Cosponsors include EURL ECVAM, the Animal Health Institute, the International Alliance for Biological Standardization and the USDA Center for Veterinary Biologics.

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