http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsc1202.htm
By Susan J. Landers, AMNews staff. Dec. 2, 2002. Additional information
Washington -- The Food and Drug Administration sought public opinion on whether to proceed with a trial to vaccinate young children with the smallpox vaccine and the public responded.
Within a few days of the FDA's Oct. 31 notice in the Federal Register, hundreds of people -- physicians, mothers, fathers and preschool operators among them -- voiced opinions.
Many implore the FDA not to test the vaccine, which is known to have serious side effects, on children. "Children's bodies and minds are still fragile and growing," writes one woman. "Please do not place young children in jeopardy by testing this vaccine on them."
But others offer a different opinion: "Government should proceed with these tests. Smallpox vaccines should be made available to everyone."
The FDA is proposing to test the vaccine on 40 children ages 2 to 5, a population that had routinely received the smallpox vaccine until it was discontinued in the early 1970s.
The trial would test the safety and immune response to the smallpox vaccine, Dryvax, used at full strength and also diluted at a one-to-five ratio.
The CDC says for every 1 million smallpox vaccinations given, 1 person would likely die. |
Although he didn't weigh in with an opinion to the FDA, Samuel Katz, MD, professor of pediatrics at Duke University, Durham, N.D., favors proceeding with the trial. "I think it's very appropriate that any new vaccines that will be licensed for widespread use be tested on children."
Children may respond differently than adults as they might to any other pharmaceutical product, he said.
Even though the vaccine is the same one used 30 years ago, the diluent used to prepare the dry vaccine is different, Dr. Katz pointed out. The trial would also include a more diluted form of the vaccine, making it an agent that should be tested in children to determine whether it causes any unusual reactions and to find out if it produces the appropriate response. The diluted version has already been tested in adults and found to be safe and to have produced the desired result -- a raised blister that scabs over.
"I think it would be unethical not to test children," said Dr. Katz.
Several physician groups, including the AMA and the Infectious Diseases Society of America, where Dr. Katz serves as a liaison to the Centers for Disease Control and Prevention, have advised against initiating a broad vaccination campaign before there is any evidence that the disease has made an appearance.
Potential adverse reactions from the smallpox vaccine range from fever to tissue necrosis and extensive lesions to encephalitis. A likely death rate of one per 1 million vaccinations was established by the CDC.
Many predict that the vaccine carries even more dangers to today's population, which includes many whose immune systems are suppressed because they have received organ transplants, are taking cancer drugs or have HIV.
Children vaccinated for smallpox would have to stay out of school or day care for the next 30 days. |
Eczema, which seems more prevalent among children today than in the 1960s, also places children at greater risk from eczema vaccinata, a rampant infection that can be contracted either from the vaccine itself or from someone recently vaccinated.
Because of the risk of person-to-person transmission, children who receive the vaccine would be excluded from day care or school for at least 30 days following vaccination, according to the protocol.
The vaccination would be administered to children via five skin scratches with a bifurcated needle, in contrast with the 10 to 15 scratches received by adults. The vaccination site would then be covered with a semi-occlusive dressing.
If any children should develop severe adverse events, treatment would be provided with vaccinia immune globulin and cidofovir. The latter drug, noted the protocol, has been approved by the FDA but not to combat adverse smallpox vaccine events.
The final determination on whether to proceed with the trial will be made by Dept. of Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan, MD, PhD.
Public comments collected by the FDA on smallpox vaccine for children (http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm)
Copyright 2002 American Medical Association. All
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