Errata – FDA Briefing Document, Vaccines & Related Biological Products Advisory Committee Meeting, February 20, 2008

 

 

 

1.      Page 1, line 4: change non-proprietary name from “rotavirus, live, oral, monovalent” to “rotavirus vaccine, live, oral.”

 

2.      Page 6, Executive Summary, 4th paragraph: change subheading from “Non-fatal serious adverse events” to “Serious adverse events” according to the data that the sponsor provided for their original submission.

 

3.      Page 4, 3rd paragraph, 8th line: should be 17867

 

4.      Page 20, 1st paragraph, 9th line: should be and/or

 

5.      Page 20, 1st paragraph, 15th line:  should be ATP immunogenicity cohort

 

6.      Page 21, 3rd paragraph, 1st line: should just say “unsolicited AEs

 

7.      Page 28, 2nd paragraph, 3rd line: should say:  RR did include 1 ..the "not" should go away