Tags: FDA | Approves | Vaccine | for | Children

FDA Approves Vaccine for Children

Wednesday, 15 May 2002 12:00 AM

"We're hopeful that it will help alleviate the supply situation significantly," Karen Midthun, director of FDA's office of vaccines, told United Press International on Wednesday.

The vaccine, called Daptacel, is manufactured by the French company Aventis Pasteur, which also makes Tripedia, another vaccine for diphtheria, tetanus and pertussis, also known as DTaP. The company said it will produce both vaccines.

Other than Tripedia, before Wednesday's announcement, the only other DTaP vaccine on the market was Infanrix, made by GlaxoSmithKline.

The vaccine shortage began in 2000 when Wyeth Lederle of Pearl River, N.Y., and Baxter Hyland of Baltimore decided to discontinue marketing their DTaP products, Bill Egan, deputy director of FDA's Center for Biologics Evaluation and Research, told UPI.

DTaP vaccines generally are given to children at 2, 4, 6 and 17 months, followed by a fifth dose at 4-6 years of age. But the shortage led an advisory committee from the Centers for Disease Control and Prevention to recommend delaying the shot at 17 months, which means some children have not been fully protected against the diseases, Midthun said.

Approval of Daptacel is expected to ease the shortage immediately because "there will probably be a couple of million doses available in the near future," Midthun said, adding that the new vaccine "will significantly help" in the long term.

"The availability of Daptacel ought to bring to a close the shortage issue," Michael Decker, Aventis' vice president of scientific and medical affairs, told UPI.

Decker noted the company would begin taking orders for the vaccine on May 28, and it should be available across the country "a couple of weeks after that."

Although Daptacel is slightly different from Tripedia and Infanrix, FDA considers it to be no different in effectiveness and safety than the other vaccines, Midthun said. She said it had been shown to be safe and effective in a large trial sponsored by the National Institutes of Health.

Daptacel has not yet been approved for the fifth and final dose of the vaccine, but the company is working on that issue, Decker said.

"We expect it to be as effective as the other DTaP vaccines," FDA's Egan said.

One advantage of Daptacel is it was shown to be highly effective against all cases of pertussis, even mild cases, Decker said. The main clinical concern regarding pertussis is it can develop into whooping cough, but people can also have much milder cases of the disease.

If Daptacel protects against mild and serious forms of pertussis, then the "whole rate should go down, thereby protecting babies who are too small to be vaccinated," Decker said.

Although diphtheria and tetanus are extremely rare, with less than 50 cases of each occurring annually in the United States, as many as 70,000-80,000 cases of pertussis may occur each year, he said.

"So maintaining our vaccination is important," he said. Copyright 2002 by United Press International.

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We're hopeful that it will help alleviate the supply situation significantly, Karen Midthun, director of FDA's office of vaccines, told United Press International on Wednesday. The vaccine, called Daptacel, is manufactured by the French company Aventis Pasteur, which...
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2002-00-15
Wednesday, 15 May 2002 12:00 AM
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