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Clarification: Vol. 52, No. 10
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.
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