[NVIC] 4 in 1 Live Vaccine Licensed

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E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

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UNITED WAY/COMBINED FEDERAL CAMPAIGN

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" Protecting the health and informed consent rights of children since 1982. "

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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.

http://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi.pdf

http://www.forbes.com/lifestyle/health/feeds/hscout/2005/09/06/hscout527838.

html

FORBES

FDA Approves 4-in-1 Childhood Vaccine

By Reinberg

HealthDay Reporter

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

done before. "

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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