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Regulatory Focus™ > News Articles > FDA, CDC Put $18M Behind Adverse Event System for Vaccines

FDA, CDC Put $18M Behind Adverse Event System for Vaccines

Posted 17 November 2014 | By Alexander Gaffney, RAC

FDA, CDC Put $18M Behind Adverse Event System for Vaccines

The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years.

The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release. SRA has supported FDA's VAERS program since 1999, it said.

VAERS is used by FDA to collect and analyze reports of vaccine-related adverse events. Data from the reporting system can be used to identify potential safety, efficacy or quality problems associated with vaccine products, which can then be used by FDA to launch investigations or new studies.

The system collects information from patients, doctors, vaccine manufacturers and other healthcare providers.

"Under the contract, SRA will apply a wide range of skills and expertise to support the system including application development and maintenance, data processing/management, medical coding, clinical research, information technology and outreach to the public, vaccine manufacturers and immunization programs," SRA explained in a statement.

Accommodating Changes

The contract comes just as FDA is both undertaking changes to the program and considering new ones as well.

Under recently announced rules, vaccine manufacturers must submit adverse events reports to FDA electronically using the International Conference on Harmonisation's (ICH) Individual Case Safety Reporting (ICSR) format and FDA's electronic submission gateway (ESG). FDA is also evaluating the potential for future changes to the VAERS program, it said in May 2014.


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