Teens need one less hepatitis B shot
FDA approves two-shot vaccine
The Food and Drug Administration in Wash ington, DC, recently approved a two-dose regimen of Recombivax HB manufactured by Merck & Co. in West Point, PA. The two-dose regimen is an alternative to the three-dose regimen currently used for children from birth to age 19.
A retrospective study conducted by Merck in 1998 found that 54% of adolescents 11 to 12 years of age had never received any hepatitis B vaccine. Of those teens 11 to 12 years of age who started the three-dose regimen, Merck found that one in four failed to complete the regimen. Among those who did receive all three required doses, more than 90% did not receive the doses according to the recommended schedule and finished late. A company spokesman says the alternative two-dose regimen may help providers improve the vaccination coverage in this hard-to-reach population.
"Adolescents can be the hardest age group to fully vaccinate for hepatitis B," notes Tom Vernon, MD, vice president of public health and medical affairs for the Merck Vaccine Division. "Busy schedules leading to missed or postponed appointments, changes in physicians and health care plans, and fear of injections: These are real-world challenges which make compliance among adolescents difficult."
Roughly 90% of all hepatitis B cases occur in adolescents and young adults, according to the Centers for Disease Control and Prevention (CDC) in Atlanta. Vaccinating children ages 11 to 12 years has been a health care priority in the United States since 1994, when the CDC Advisory Com mittee on Immunization Practices announced a new catch-up strategy to better protect adolescents against hepatitis B and other diseases such as measles, tetanus, and diphtheria. That new strategy was designed to reach teens who were born before 1991, when the hepatitis B vaccine was universally recommended for all children from birth to age 19.
"Seeking FDA approval for a two-dose indi cation for adolescents 11 to 15 years of age was Merck’s solution for reaching a particularly vulnerable population that might not otherwise receive all three doses of the standard regimen," says Vernon.
(For more information, visit the Merck Web site at www.merck.com.)
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