A new whooping cough vaccine licensed by FDA last Dec. 17 may cause fewer side effects in children.
"This vaccine may be very useful in getting more children protected," said James Mason, M.D., head of the Public Health Service and director of the National Vaccine Program. "Important as it has been in preventing a difficult and sometimes fatal disease, the old pertussis or whooping cough vaccine has caused more complaints of sore arms, fever, and occasionally more severe effects than most of the other childhood vaccines. As a result, some children never get their full series of shots."
The most common side effects reported in clinical trials of the new vaccine--brand name Acel-Imune--included tendemess, redness and swelling at the injection site, fever, drowsiness, fretfulness, and vomiting.
With diphtheria and tetanus components in addition to the pertussis vaccine, Acel-Imune is licensed for the fourth and fifth DTP shots; the old pertussis vaccine will continue to be used for the first three shots that constitute primary immunization. The new pertussis vaccine appears as effective as the old one in older children, and research is under way to determine its effectiveness in primary immunization in infants.
Whooping cough is so contagious it infects up to 90 percent of exposed household members who are not immune. Routine U.S. vaccination has brought a drop in case reports from 120,000 with 1,100 deaths in 1950 to an annual average in recent years of 3,500 with 10 deaths. However, in the wake of the largest U.S. measles outbreak in 20 years, with more than 27,600 cases and 89 deaths reported in 1990, the federal government is emphasizing early childhood immunizations. (See "A Responsibility to Remember: Childhood Vaccines" in the September 1990 FDA Consumer.)
The old pertussis vaccine is made from the whole pertussis organism, while the new one is made from only part of the organism and, thus, is called acellular. Availability of an acellular vaccine is a significant step forward in infectious disease control, said Gerald Quinnan, M.D., acting director of FDA's Center for Biologics, which evaluated and licensed Acel-Imune.
Takeda Chemical Industries Ltd. of Osaka, Japan, produces Acel-Imune's pertussis component, and Lederle Laboratories of Wayne, N.J., makes the diphtheria and tetanus portions and will distribute the product in the United States.
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