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."
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ADDITIONAL INFORMATION:
Increased protection
The first pentavalent vaccine in the United States is expected to
protect against:
- Diphtheria
- Tetanus
- Pertussis
- Polio
- Hepatitis B
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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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