ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Thursday, August 1, 1996 TAG: 9608010078
SECTION: NATIONAL/INTERNATIONAL PAGE: B-7 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
Parents afraid to vaccinate their babies against whooping cough because of side effects got their first alternative Wednesday: a vaccine that promises millions of infants safer shots.
The Food and Drug Administration approved Connaught Laboratories' Tripedia, saying it prevents whooping cough as well as existing shots do but causes 50 percent to 90 percent fewer cases of fever, swelling and other side effects.
Parents have long awaited an ``acellular'' vaccine, made with only part of the whooping cough bacterium instead of the entire bug so as to be safer. Indeed, many parents were so reluctant for their babies to get the existing shots that the nation experienced its first whooping cough outbreaks in 40 years in the 1980s, and the government created a program to compensate the victims of vaccine side effects.
Tripedia, which beat out at least three competitors to become the nation's first acellular vaccine, does cause fewer of the side effects such as fever that frightened parents who had heard of the shots' very rare but serious complications: seizures or even brain damage.
It's too early to know if Tripedia causes fewer of those problems - they are so rare they take tens of thousands of injections to detect. Connaught will continue studying Tripedia to answer that question.
But the FDA has seen no red flags from Japan, where toddlers have received acellular vaccine - the same one Connaught buys from Japan to put into Tripedia - since 1981 and infants since 1993.
``The bottom line is that it is a safer vaccine from everything we've seen,'' FDA Commissioner David Kessler said.
``There was a stigma'' about existing shots, said National Institutes of Health vaccine expert David Klein, who had his own child vaccinated with Tripedia in a research study. ``Parents are going to feel a great deal of relief.''
Whooping cough, or pertussis, is a highly contagious disease that most often hits children under age 3. It causes severe coughing, difficulty in breathing, vomiting and a rapid inhaling of air that can cause the ``whooping'' sound that gives the disease its name.
While the ailment is generally mild, it can cause pneumonia, brain damage or even death.
Worldwide, whooping cough attacks 50 million children annually, killing about 350,000. In the United States, mandatory vaccination in most states limits the number of cases to about 4,000 each year, with eight deaths reported in 1994, although the government estimates 10 times as many Americans may actually get sick but go uncounted.
Tripedia already was approved for booster doses given to older children, but the FDA on Wednesday cleared it to be given at ages 2, 4 and 6 months - the three doses given when babies are most vulnerable to neurologic effects.
Connaught, based in Swiftwater, Pa., said Tripedia is available for infants immediately and will cost doctors about $17 a dose, including the tax that funds the federal vaccine compensation program.
Kessler said parents will notice one drawback: Existing pertussis vaccines could be combined into one shot with another vaccine that fights infant meningitis. Connaught is working to combine Tripedia with that so-called Hib vaccine.
For now, that means babies will get an extra shot, ``but I think many pediatricians would argue the safety profile may be worth that extra injection,'' Kessler said.
LENGTH: Medium: 67 linesby CNB