VACCINE TESTING ON KIDS BLOCKED
08 Apr 2003
Source: Los Angeles Times, April 8, 2003
Vaccine Testing on Kids Blocked
U.S. turns down a Harbor-UCLA smallpox proposal for 2- to 5-year-olds.
By Charles Ornstein, Times Staff Writer
Top federal health officials have blocked a controversial study proposed by Harbor-UCLA Medical Center that would have tested the safety of smallpox vaccine in 2- to 5-year-old children, researchers said Monday.
After sharp criticism from patient advocates, the U.S. Department of Health and Human Services and the Food and Drug Administration determined that "there is no justification for this particular clinical investigation to proceed," according to a Jan. 24 letter sent to the Torrance hospital.
The research was designed to determine whether diluted doses of the vaccine, which is harvested from calves' bellies, could be used in children without compromising its effectiveness. The study, which would have involved 40 children in California and Ohio, had been supported by the federally funded National Institute of Allergy and Infectious Diseases.
In their January letter, federal officials noted that research was not necessary because bioterrorism preparedness plans do not call for children to receive the diluted vaccine.
But Dr. Joel Ward, director of the UCLA Center for Vaccine Research at Harbor-UCLA, said the study was "too controversial."
The public "was profoundly against giving the vaccine to children, and the secretary of health decided that this was not worth pursuing."
A Harbor-UCLA board that reviews research proposals involving human subjects disagreed about whether the benefits outweighed the risks. The board requested that the federal government step in and make a decision, as the law provides.
The research was to have been conducted at Harbor-UCLA and Cincinnati Children's Hospital Medical Center. Kaiser Permanente was to have been one of the sources of participants in Southern California.
Hundreds of people -- including academics and doctors -- submitted comments to the FDA criticizing the research.
"The vaccine has tremendous, very serious, life-threatening risks attached to it," said Vera Sharav, president and founder of the Alliance for Human Research Protection, one of the staunchest critics. "There's no justification for exposing healthy little children to that kind of risk, by any standards. They should be the last ones to be put at risk."
About one or two people per million who received the smallpox vaccine decades ago died of side effects. As many as 52 people per million suffered life-threatening complications, including encephalitis, while an additional 1,000 per million suffered reactions such as serious rashes.
The federal government has launched a three-phase vaccination program for adults to prepare for possible release of the smallpox virus by terrorists. In the first stage, now underway, health authorities are vaccinating hospital emergency workers and public health personnel likely to treat infected patients first. Ward said he accepts the government's decision, but he is concerned about the implications for future research.
"Research should not be a political contest," he said. "I hope that the government would not in the future take this tack of testing the waters of public acceptability, or science would be greatly crippled."