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FDA approves combo vaccine against five childhood diseases

Tuesday, December 17, 2002

WASHINGTON -- Parents, expect fewer screams in the pediatrician's office: A new vaccine that promises to cut out six of the 20 injections that babies get before age 2 won federal approval Monday.

The vaccine, called Pediarix, combines into one injection today's shots that protect against five different diseases -- diphtheria, tetanus, whooping cough, hepatitis B and polio.

Until now, it has taken nine separate injections for babies to get that much protection. Pediarix requires only three shots staggered through the first six months of life.

Pediarix won Food and Drug Administration approval after studies involving thousands of babies proved it was as effective as the nine separate shots. The combination vaccine will begin selling early next month, and cost about the same as the separate injections added together, said manufacturer GlaxoSmithKline.

Pediarix doesn't cover everything: Babies still will need separate shots to protect against two types of meningitis and pneumonia. After their first birthday, they start getting shots against other diseases, such as measles and chickenpox.

In 1980, babies were immunized against just four diseases. Today, by age 2 most children have had up to 20 shots to protect against 11 diseases. That mean more and more protection against deadly illnesses -- and it also means more crying.

For parents, eliminating the need for six of the shots is good news.

Take Yehoshua Halle, who at age 6 months got a whopping six shots -- the usual four immunization injections in addition to shots for the flu and another dangerous respiratory infection, needed because he was born premature.

"Even the nurse was amazed she had to administer six shots at one time," said his mother, Tamara Halle of Silver Spring, Md., recalling that October visit. "He did well, he did a fantastic job, but it's a lot for a little person to have to handle."

Fewer shots per visit doesn't eliminate the fact that babies still will cry through some injections at ages 2, 4 and 6 months, noted Mimi Laver, a Washington mother who remembered her now 17-month-old's inoculations as not being too bad.

"It's sad to see him crying. Once he was crying, the extra shot didn't really matter," she said. Her son, Noah Freedman, would calm down after a few minutes, leading her to conclude that while fewer shots are nice, "it doesn't rank high on my priorities for child health."

Need more room for shots

Decreased pain isn't the only reason for combination vaccines, said Dr. Mark M. Blatter of Primary Physicians Research in Pittsburgh, one of the Glaxo-funded study sites for Pediarix.

Scientists are working to create vaccines against more and more diseases, and without combining shots there simply won't be room on babies' tiny thighs for more inoculations, he said.

Vaccine makers have long tried to combine inoculations. Already there are three-in-one shots for diphtheria, tetanus and whooping cough, commonly abbreviated as DTaP, and measles, mumps and rubella, or MMR. Also, there is a combination shot that combines protection against hepatitis B and meningitis-causing Haemophilus influenza B.

Adults commonly get a diptheria-tetanus combination shot, and each year's flu shot contains protection against three strains of influenza.

But with five-in-one protection, Pediarix becomes the biggest combination vaccine yet.

In studies, side effects were similar in babies who got Pediarix and those who got separate shots, the FDA said. There was one exception: Pediarix patients were slightly more likely to have a low fever, in one study 19 percent of them compared with 12 percent of babies getting the separate shots, Blatter said.

As for babies' fussing on vaccination day, "I've always had the impression, 'What's a minute or two more of crying?"' said Blatter -- until he compared administering Pediarix to separate shots and concluded babies cry for more than a few minutes while the doctor prepares each injection. "We're going to decrease the amount of craziness that goes on in the typical pediatrician's office."

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On the Net

FDA: www.fda.gov

Glaxo: www.gsk.com


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