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FDA approves 4-IN-1 childhood vaccine



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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 approved the vaccine, brand-named Proquad, manufactured by Merck, on Tuesday. The vaccine -- a combination of the company's measles, mumps, rubella 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 says in a statement.

"The advantage of putting two vaccines together has been recognized by medical authorities," says 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 says. "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 says.

Shinefield also says there is an advantage to the community.

Having to get only one shot instead of two may mean that more children get vaccinated, he says. "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 (rubella), we expect Proquad to become a primary option for prevention of measles, mumps, rubella and chickenpox," said Dr.

Mark Feinberg, vice president of policy, public health and medical affairs in Merck's Vaccine Division, 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 says. "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 says. "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," says 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 done before."

Fisher notes 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 (rubella) 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 says.

As far as Proquad is concerned, Fisher says 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."

(The HealthDay Web site is at www.HealthDay.com.)

c.2005 HealthDay News

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