Study Hails 3 Whooping Cough Vaccines : Health: In clinical trials, they proved to be more effective and safer than the one in use. FDA promises to give them ‘priority review.’
WASHINGTON — Researchers have found that three experimental vaccines protect children against whooping cough more effectively and safely than the vaccine currently in use and officials said Thursday that this should mean accelerated approval of the vaccines for use in the United States.
Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said that in clinical trials the new vaccines protected 84% of Swedish and Italian children against whooping cough, compared with 36% of Italians and 48% of Swedes who were given the conventional vaccine.
More than that, Fauci said, parents who worry about the swelling, fever and general “fussiness” that frequently result from today’s vaccine could expect “significantly less” in the way of side effects from the new vaccines.
Fauci said that he is working with drug manufacturers and the Food and Drug Administration to ensure that the new vaccines become available as soon as possible.
The FDA said that applications for the new vaccines would be given a “priority review,” which means that they could be approved in a minimum of six months. So far the FDA has not received any applications but at least one drug company--North American Vaccine in Beltsville, Md.--said that it will apply in the next few weeks.
In the meantime, FDA officials cautioned parents to continue to have their children immunized with the current vaccine. They said that children who begin their immunization program with the old vaccine will be able to switch safely to the new.
“We are very worried that people will hold off and wait until the [new] vaccine is approved,” said Donald McLearn, an FDA spokesman.
Unlike the current vaccine, which uses entire cells of dead bacteria that cause whooping cough, the new vaccines use only partial cells.
*
Fauci said that the current whole-cell vaccine is 90% effective in the United States, where--unlike Italy and Sweden--children are required to be vaccinated against whooping cough before entering kindergarten. But the new vaccines, he said, “promise to become the new gold standard in immunization.”
American children typically receive the whooping cough vaccination as part of a diphtheria-tetanus-pertussis shot at 2, 4 and 6 months of age. They receive booster shots at 12 and 18 months and immediately before entering kindergarten.
The federal Centers for Disease Control and Prevention in Atlanta said that provisional data showed 4,698 cases of pertussis (the scientific name for whooping cough) in the United States in 1994, with eight deaths. The World Health Organization estimates that there are 50 million cases annually and 350,000 deaths related to whooping cough worldwide.
Fauci said that most whooping cough cases in the United States are among improperly immunized children. Some parents of children who suffer moderate or severe side effects from the current pertussis vaccine do not complete the necessary rounds of shots, he said.
Before the pertussis vaccine was developed in 1947, there were 200,000 cases of the disease annually and 12,000 deaths.
Whooping cough is a highly contagious respiratory disease that starts with a runny nose, sneezing, slight fever and dry, irritating cough. If the disease is untreated with antibiotics, the patient can develop episodes of short, rapid coughs followed by quick, deep breaths, or “whoops.”
The whoops can cause vomiting, an inability to breathe and brain injury from lack of oxygen.
More to Read
Sign up for Essential California
The most important California stories and recommendations in your inbox every morning.
You may occasionally receive promotional content from the Los Angeles Times.