In the notice to readers, "FDA Licensure of Diphtheria and Tetanus Toxoids
and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant), and Poliovirus
Vaccine Combined (PEDIARIX™) for Use in Infants," there were two potentially
misleading statements in the paragraph following the heading "ACIP Approval
for DTaP-HepB-IPV for the Vaccine for Children Program." First, the statement
"3 doses of PEDIARIX™ can be administered to an infant who is born to
a woman who is hepatitis B surface antigen (HBsAg)-positive or whose HBsAg
status is unknown" is potentially misleading. A birth dose of single-antigen
vaccine is preferred for all infants but must be administered to infants who
are born to women who are HBsAg-positive or whose HBsAg status is unknown.
The birth dose can then be followed by 3 doses of PEDIARIX™ at ages
2, 4, and 6 months. Second, the third dose of PEDIARIX™ should be administered
at least 16 weeks after the first dose and at least 8 weeks after the second
dose but not before age 6 months.