Pediatricians praise pentavalent vaccine, question cost

Lowering the number of injections may increase the number of children vaccinated, but experts worry that inadequate reimbursement levels could stall widespread use.

By Victoria Stagg Elliott, AMNews staff. Dec. 9, 2002. Additional information

Kids can expect fewer vaccine shots in the future.

With the promised, year-end introduction of a vaccine to include antigens for diphtheria, tetanus, pertussis, polio and hepatitis B, doctors will be able to reduce the number of injections their youngest patients must endure in a single visit.

The pentavalent vaccine, which insiders expect to be approved by the Food and Drug Administration this month, will be manufactured by GlaxoSmithKline and is expected to be the first of an increasing number of vaccines that protect against five and even six diseases.

"It's less painful for the child. It is less stressful for the medical staff that is administering the vaccine, and it's less stressful for the parent who's watching it," said Edgar Marcuse, MD, MPH, professor of pediatrics at the University of Washington, Seattle.

Experts say multivalent vaccines may increase vaccination rates and make parents more willing to let children get all the shots they need in one visit, rather than scheduling multiple appointments, which can lead to late vaccinations.

"I'm excited about it," said Robert Yetman, MD, professor of pediatrics at the University of Texas Medical School at Houston. "If the number of vaccines we are currently giving patients is a reason for some parents to avoid getting their children immunized, then this will help eliminate this roadblock to improving our immunization rates."

Reimbursement barrier

Vaccines with antigens for five or six diseases are already in widespread use around the world. But in the United States no currently available vaccine includes more than three. Still, as much as physicians say multivalent vaccines are a significant step in the right direction, there are many concerns that reimbursement issues may impact the number of doctors who administer the new vaccine.

The cost of the vaccine may not be adequately covered by insurance.

In addition, physicians may receive less reimbursement for administering fewer injections in one visit despite the fact that the same number of antigens are being delivered to the patient.

With the number of combination vaccines expected to increase significantly over the next few years, the issue is one of great concern and is expected to come up at this month's American Medical Association Interim Meeting in New Orleans.

"Without reimbursement, this will not be adopted," said Gary L. Freed, MD, MPH, director of general pediatrics at the University of Michigan School of Public Health in Ann Arbor.

There are also concerns that problems with record keeping combined with a mobile population may lead to overimmunization.

Children may shift from one doctor to another, both of whom may stock different combinations. Records may be incomplete or get lost.

"As we get additional combinations licensed, and the combinations share common components but also have different components, it's going to increase the chance of confusion and miscommunication and make far more important the maintenance of very accurate records," Dr. Marcuse said.

Children also may shift back and forth between public-sector vaccine sources and private physicians. Most believe that the public sector may be the slowest in adopting the multivalent vaccines, primarily because of cost issues.

"The public sector may choose not to buy this vaccine if it costs a lot more than the individual vaccines themselves," Dr. Freed said.

Also, not all vaccines included in the pentavalent vaccine are always delivered at the same time. Currently, hepatitis B is also frequently administered at birth, by itself, as well as additional doses during the visits at two and six months when it is given along with IPV, DTaP and several other vaccines not planned to be included in the five-valent mix.

"If a physician or hospital gives a child the newborn dose of hepatitis B yet wants to use this vaccine for at least a portion of the primary immunization series, they will have to be careful they don't give a child too many vaccines," Dr. Freed said. "There's no known harm to giving an extra vaccine, but we need to realize that that is a possibility."

And despite recent anxieties expressed by certain vaccine awareness and parent advocacy groups over the combined measles, mumps and rubella vaccine, physicians say that most of their patients would prefer the reduction in needlesticks.

"More than likely, parents will welcome the chance for the child to get fewer injections," Dr. Freed said.

The initial hope is that the multivalent vaccines will reduce the number of needlesticks kids must endure. In addition, though, many suspect it will simply make room in the schedule for new vaccines that are just around the corner.

"We need to make room because there are more vaccines that will be coming, and you just can't keep giving more shots to children," said Mark Blatter, MD, medical director of Primary Physicians Research in Pittsburgh, the company that ran many of the trials on the new vaccine. "After years of increasing the number of shots, for the first time, we will be able to decrease the number of shots by as many as six."

ADDITIONAL INFORMATION:

Increased protection

The first pentavalent vaccine in the United States is expected to protect against:

Diphtheria
Tetanus
Pertussis
Polio
Hepatitis B

Weblink

Vaccine topics from the FDA's Center for Biologics Evaluation and Research (http://www.fda.gov/cber/vaccines.htm)

CDC National Immunization Program (http://www.cdc.gov/nip/)

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