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April 2003 • Volume 37 • Number 4

 

News

 

Nine vaccines in three doses

Pediarix Simplifies Vaccine Schedule—or Does It?
Impact on hepatitis B birth dose unclear.

Nancy Walsh
New York Bureau
 

ATLANTA —The pentavalent vaccine Pediarix is beneficial for children and physicians, but concerns remain about the impact of its use on the hepatitis B birth dose, cost, and adverse events, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices said.

While simplification of the immunization schedule clearly is advantageous—Pediarix combines nine separate vaccines into a three-dose series—concerns have been raised as to whether the use of Pediarix would diminish the practice of providing a birth dose of hepatitis B vaccine. This issue was raised at the meeting by Dr. Deborah L. Wexler, executive director of the Immunization Action Coalition. “We have received numerous e-mails and phone calls inquiring whether the birth dose is still needed, just as we did when Comvax [Haemophilus influenzae type b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine] became available,” she said.

Pediarix combines DTaP, hepatitis B (recombinant), and inactivated poliovirus vaccines.

Dr. Scott Harper of CDC replied, “It's still early in the game, but a telephone survey has suggested no negative impact so far.”

Another question is whether administration of the birth dose of hepatitis B vaccine in addition to the three doses of the Pediarix course would affect overall vaccine reactogenicity and safety, but this does not appear to be the case, according to Dr. Anthony Fiore of the CDC's National Center for Infectious Diseases (NCID).

A recent study assessing the safety and efficacy of four, rather than three, doses of hepatitis B vaccine found no increase in reactogenicity when the birth dose was given. In the study, which included 550 neonates, severe (grade 3) reactions were seen after any of the three Pediarix doses in 22.6% of those given the birth dose and in 23.2% of those not given the additional dose. All of the infants achieved antibody titers of 10 mIU/mL, which is considered protective (Pediatr. Infect. Dis. J. 21[9]:854-59, 2002).

There is, however, an increased incidence of low to moderate fever in children given the combination vaccine.

“This is probably easily managed with premedicating with acetaminophen,” said Dr. Martin Mahoney, the American Academy of Family Physician's liaison to the Advisory Committee on Immunization Practices (ACIP).

“With the introduction of an increasing number of new and improved vaccines to prevent childhood diseases in recent years, up to 20 injections now are needed to fully immunize children from birth to 2 years of age,” said Dr. Barbara Howe, vice president of vaccine clinical research and development, GlaxoSmithKline, manufacturer of Pediarix.

“With combination vaccines, the benefits are obvious for children, who receive fewer injections, but there are also advantages for health care providers and the community,” she said.

For clinicians, combination vaccines enhance parental acceptance of vaccination, simplify storage and administration, and help free up of staff for other medical activities. The advantages to the community are potentially improved vaccination coverage and more effective vaccination programs, she said.

As is customary, the ACIP also recommended that Pediarix be included in the federal government's Vaccines for Children program.

“This will assure access for all children,” said Dr. Mahoney of the State University of New York at Buffalo.

It also could result in an estimated 14 million fewer injections for American infants each year, according to the manufacturer.

The cost of Pediarix is currently 4%-5% above the combined cost of DTaP, hepatitis B (recombinant), and inactivated poliovirus vaccines, said Dr. Howe.

Reimbursement is in place, with 90% of insured patients having coverage, she commented.
 

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