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"Protecting the health and informed consent rights of children since 1982."
NVIC Note: NVIC president, Barbara Loe Fisher expresses her concern about
this vaccine at the end of the article. Take a look at the package insert.
FDA Approves 4-in-1 Childhood Vaccine
By Steven Reinberg
TUESDAY, Sept. 6 (HealthDayNews) -- Parents and children may breathe a sigh
of relief with the introduction of a new single shot vaccine that protects
kids against measles, mumps, rubella and chickenpox.
This could mean one less shot and one less doctor visit, advocates say.
The U.S. Food and Drug Administration Tuesday approved the vaccine, called
Proquad, manufactured by Merck. The vaccine -- a combination of the
company's measles, mumps, rubella (MMR II) vaccine and its chickenpox
shot -- is designed for children from 12 months to 12 years of age.
Proquad is the first and only vaccine approved in the United States to help
protect against these four diseases in a single shot, according to Merck. It
is also approved for use in children 12 months to 12 years of age if a
second dose of measles, mumps, and rubella vaccine is to be given.
The approval of this new vaccination combination came after it was tested in
over 5,000 children, the drug company said in a statement.
"The advantage of putting two vaccines together has been recognized by
medical authorities," said Dr. Henry Shinefield, a clinical professor of
pediatrics and dermatology at the University of California, San Francisco
School of Medicine and a consultant to Merck.
"There is an obvious advantage to the children," Shinefield said. "They only
get one shot." In addition, there are advantages to doctors, who can limit
the number of different vaccines they have on hand, he said.
Shinefield also said there is an advantage to the community. Having to get
only one shot instead of two may mean that more children get vaccinated, he
said. "The community benefits by having less disease."
"Based on the public health benefits realized following the introduction of
other combination vaccines, such as MMR II, we expect Proquad to become a
primary option for prevention of measles, mumps, rubella and chickenpox,"
Dr. Mark Feinberg, vice president of policy, public health and medical
affairs in Merck's Vaccine Division said in a prepared statement.
Proquad can help reduce the gap that exists in the United States between
vaccination rates for chickenpox -- which were an estimated 87.5 percent in
2004 -- and rates for measles, mumps and rubella -- which were an estimated
93 percent in 2004, Feinberg said. "The main goal for any vaccine is to help
eliminate disease, and this is possible when very high vaccination rates are
achieved in the community."
In terms of potential side effects, Shinefield doesn't see any more danger
than there is with the current two vaccines. "It is important that children
and parents be made aware of every side effect," he said. "The side effects
with this vaccine are inline with what we see with other vaccines."
One critic of vaccines is cautious about the use of this new vaccine.
"The FDA should have required far larger studies," said Barbara Loe Fisher,
the co-founder and president of the National Vaccine Information Center.
"You are combining five live viruses into one vaccine, which has never been
Fisher noted that there are still unanswered questions about some of these
vaccines and the likelihood of having long-term adverse effects on children.
"Particularly in regard to continuing reports of regression after MMR
vaccine; the hypothesis that exposing children to three live viruses at once
is causing some genetically susceptible children to regress and have a
persistent measles infection leading to autism and intestinal bowel
disorders," she said.
As far as Proquad is concerned, Fisher said it hasn't been truly tested,
because it has only been tested against other vaccines and not against a
placebo. "With a new vaccine like this, you should be comparing it against
placebo to find out the true adverse reaction rate."
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