New Vaccine May Help Allay Fears
A new pertussis vaccine that could be given as a booster to children at 18 months and again at school age may be available later this year, according to the vaccine’s manufacturer.
The alternative vaccine would be significant because of the controversy that has dogged the current DPT shot.
Lederle Laboratories, manufacturer of the new vaccine, called Acel-imune, has requested that the Food and Drug Administration approve the new shot because it is a better vaccine, not because the one in use is unsafe, says Craig Engesser, a Lederle spokesman. (Lederle is one of three U.S. companies that makes the current DPT vaccine.)
“We’ve always stood behind our current product,” Engesser says. “We’re not necessarily moving to provide (the new vaccine) to calm fears. We’re doing it because it is an improved product and is an advancement in science. The higher comfort level that parents will have, hopefully, from this vaccine is secondary to that.”
Lederle is awaiting final FDA approval to use the vaccine for the fourth and fifth booster shots a child receives at 18 months and between ages 4 and 6. In January, an independent panel of medical experts recommended to FDA officials that Acel-imune be approved, a step that must precede formal approval.
The vaccine already in use would be continued for children at 2, 4 and 6 months of age, but Lederle is moving ahead with studies to determine if Acel-imune is safe and effective for infants, Engesser says.
“Our goal is to make it available for all five doses. But we’re several years from that,” he adds.
The new vaccine combines the diphtheria and tetanus components now in use with a new pertussis component. The pertussis component in current vaccines consists of whole dead bacteria. The new pertussis component, in use in Japan for several years, consists of only pieces of the dead pertussis bacteria.
The idea is to inject pieces of the bacteria that induce immunity while removing pieces of bacteria that can cause side effects, says Dr. Richard Johnston.
“I think, in the not-too-distant future, we’ll have that vaccine,” Johnston says. “But we need to know that it is protective.”
According to Engesser, 16 million doses of the pertussis vaccine have been distributed in Japan since the early 1980s: “It’s got an excellent, very positive, record in Japan.
“Children who receive it either at 18 months or 5 years had less reactivity at the injection site; less redness, tenderness, swelling; less fever and were less fretful. And the vaccine is as effective (at preventing disease) as the earlier one.”
