Docket Management
Docket: 01N-0464 - Vaccine Adverse Event Reporting System; Revised Form VAERS-2
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Dr. Wesley Byerly Date/Time 2001-11-21 16:33:28
Organization Wake Forest University School of Medicine
Category Health Professional

Comments for FDA General
Questions
1. General Comments To: DHHS, FDA From: Wesley G. Byerly, Pharm.D. Date: November 21, 2001 Subject: Comments on Vaccine Adverse Event Reporting System; Revised Form VAERS-2 Docket No. 01 N-04641 The following details my comments regarding the revised VAERS form. Thank you for the opportunity to provide commentary. 1. In bringing the pdf-formatted form up in Adobe Acrobat 5.0 the following error was received A font required for font substitution is missing. Unable to find or create the font 'WP-IconicSymbolsA' some characters may not display or pint correctly. 2. The following fields have two dots where it appears numbers should be. In Box A: Date of Birth; Age at vaccination. In Box D: all fields. In Box E: all fields except 5. List results of relevant diagnostic procedures or lab testing and 6. Has the patient recovered to his/her original state of health? I expect this is related to the first problem. 3. Box A requests patient identifying information. While I expect VAERS falls under a HIPAA exemption, the frequently asked questions or form instructions should address HIPAA confidentiality and privacy concerns. 4. It is unclear why some field labels are bold and others are not. I would suggest all should be the same. 5. Box A, 9. Weight at birth (if under age 5). Does this mean that weight is not needed for all patients 5 years of age and older? MedWatch collect weight regardless of age. I would suggest weight be requested for all reports. 6. Box B, Responsible Physician. What is a responsible physician? Is this the physician who ordered the vaccine? Who administered the vaccine? The patient's primary physician regardless of whether they were involved with the vaccine administration? The reporting physician? This appears in the Vaccine Provider Information Box, perhaps, Physician Providing the Vaccine would be clearer, if this is what is intended. Clarify 7. Box B, 1. County where the vaccine was administered. Because of the location above the responsible physician address, I expect this will often be the responsible physician's county regardless of whether it is where the vaccine was administered. Consider moving the field. 8. Box C: 7. Date form completed. Does this need to be completed for all reports or only for those where reporter information is filled in? Because of its location I expect it will only be completed if reporter information is filled in. Consider moving the field if it is required for all reports. 9. Unknown is not an option for Vaccine was administered at; Vaccine was purchased by provider with; Did this event cause the patient to visit the doctor fields. This will require the reporter to leave the field blank if the information is unknown. From an analytical point it will be unclear whether the information was unknown or missing (i.e. the reporter neglected to fill it in). This may not be important for the use of the data but I would suggest that unknown be included as an option. 10. Box E, Date of onset. I would suggest this read Date of onset of event for clarity. 11. Box E, 5. List results of relevant diagnostic procedures or lab testing. This should be followed with (Attach additional sheets if necessary) as in the first field of this section. The response area for this field is so small that it is not useful. I would suggest incorporating it into the first field as follows: Describe the signs and symptoms that occurred after this vaccination and treatment, if any. List the results of relevant diagnostic procedures or lab testing. (Attach additional sheets if necessary). 12. Box E, Check below if the patient: Should only one be selected or can all that apply be selected? Clarify with Check below if the patient (check all that apply or select only one). This is consistent with the MedWatch form. In this same section, congenital anomaly is not available as a selection. I recommend including this selection for consistency with the MedWatch form and for consistency with FDA definitions for Serious Adverse Event. I would also include an Other choice as on the MedWatch Form. Without an Other choice you may receive a number of Experienced none of the above choices which will not provide outcome information. 13. Box F, 1. List recipient's pre-existing physician-diagnosed illnesses, allergies, and/or medical conditions. I believe the wording of this field description, especially the qualifier physician-diagnosed will result in extensive loss of information. I believe that, given the present wording, unless a reporter is sure of the medical validity of the information, the information will be excluded. This may result in the loss of extensive information of potential cofounders and effect modifiers for reported events. I would suggest the use of wording more similar to that of the MedWatch form - Other relevant history, including preexisting medical conditions (e.g., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) 14. Healthcare providers and manufacturers are required by law to report reactions to vaccines listed in the Reportable Events Table following immunization. Where is a Reportable Events Table located? I suggest providing a reference for the location of this information. 15. ICH Guidelines for Data Elements for Transmission of ADR Reports E2B and E2B(M) [http://www.ifpma.org/ich5e.html#GCP] should be reviewed. The proposed revisions should conform to these accepted standards. While acknowledging that some ICH variables may not apply to the specific case of vaccine adverse event reporting, I do note that the variables collected in some fields could be modified to make them consistent with ICH guidelines (e.g. the outcome variables in Box E, Check below if the patient; Box E, Has the patient recovered to his/her original state of health; Box A, only requesting weight if under age 5). 16. It appears manufactures are required to report serious adverse events both through the VAERS and MedWatch programs. The information on the VAERS form be sufficent in both content and format to allow it to stand in place of a MedWatch report. These reporting systems should be harmonized to reduce regulatory burden.




EC -1