FDA, CDC Preparing Updated Form to Record Vaccination Problems

Regulatory NewsRegulatory News
| 24 November 2014 | By Alexander Gaffney, RAC

The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form.


In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form.

VAERS is used by FDA and CDC, which co-administer the program, 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. All told, there are about 30,000 VAERS reports each year, according to CDC data.

At present, reporting using the VAERS system is mandatory for two groups: Product manufacturers and healthcare providers. Under recently announced rules, vaccine manufacturers must submit adverse event 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). Patients and providers, however, utilize the paper-based VAERS reporting form.


According to a CDC presentation before the National Vaccine Advisory Committee (NVAC) in September 2014, there are several reasons behind the shift from VAERS 1.0 to VAERS 2.0.

The new form will sport a modernized appearance, will allow the form to be filled out and saved electronically, will update some data reporting fields on the forms to have additional regulatory or public health value, clarify language, eliminate redundant fields and collect additional information such as race, ethnicity and pregnancy status.

The new form would also be fully digital, eliminating costly and time-consuming paper-based reporting. The switch should notably allow filers to take advantage of so-called "smart-features" like drop-down menus and check boxes, allowing reporters to complete the forms more quickly and easily.

The form has already been tested with physicians, nurses, pharmacists, patients and parents, CDC noted in its Federal Register posting.

Comments on the proposed form will be accepted until 23 January 2014.


Federal Register Notice


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