Due to an editing error, a story about the National Vaccine Injury Compensation Program (Consumer News, Jan. 29) incorrectly said that diphtheria is also called whooping cough. Pertussis is known as whooping cough. (Published 2/5/91)

The morning after Lorraine Lopez was vaccinated against diphtheria, also known as whooping cough, she awoke screaming, vomiting and feverish. Five days later, after she suffered a major seizure, her mother rushed her to the hospital. Several weeks later, the doctors told her parents that their formerly healthy infant was brain damaged and severely retarded.

Today, Lopez, who lives with her family in Pueblo, Colo., is 20 but has the mental faculties of a 3-month-old, her age at the time of her diphtheria-pertussis-tetanus (DPT) shot. She wears diapers, eats baby food and cannot stand or walk.

Last month, her mother was awarded a lifetime annuity for her care equal to annual payments ranging from $38,000 to $55,638 -- the lifetime equivalent of more than $1 million. The award was made by a little-known federal program designed to compensate those injured or killed by DPT or other mandatory vaccines.

Known as the National Vaccine Injury Compensation Program, the no-fault program was created by Congress in 1986 to provide a more efficient and less costly alternative to civil lawsuits. The first phase of the program was originally set to end last fall. But after a last minute torrent of claims, which some congressional supporters attributed to a lack of publicity about the program by federal health officials, President Bush granted an extension until Jan. 31. Those claiming injuries related to childhood vaccines -- DPT, polio or measles, mumps and rubella -- administered before Oct. 1, 1988, have until Thursday to file a claim.

The program is the first federal no-fault system for handling claims arising from injuries caused by vaccines and could be the prototype for handling claims for future vaccines, such as one for AIDS.

Under the terms of the program, claimants alleging vaccine-related injury need not prove fault by those who manufactured or administered the vaccine, only that injury occurred within a certain time specified by law or was caused by the vaccine. Lawyers for the Department of Health and Human Services in essence serve as defense lawyers and can challenge the claim, but the process is far less adversarial than a typical civil suit and the standard of proof is less stringent.

The impetus for the program was a spate of news reports in the early 1980s about children who had suffered neurological damage after receiving DPT shots. Pediatricians were concerned as prices for the vaccine skyrocketed while the number of DPT manufacturers dwindled. Vaccine manufacturers said that mounting lawsuits filed by parents claiming their children were injured made insurers reluctant to sell them liability coverage.

Alarmed by the specter of an inadequate vaccine supply, Congress passed the National Childhood Vaccine Injury Compensation Act, which was backed by an unusual coalition of vaccine manufacturers, pediatricians and parents' groups. The aim was to funnel lawsuits out of the overburdened court system and into a simpler, federally funded compensation program, thereby lowering manufacturers' insurance costs and preserving vaccine supplies.

By most measures, the program has succeeded so far. Lawsuits against DPT manufacturers have declined from their 1986 peak of 255 to 47 in 1990, according to the Centers for Disease Control. DPT prices have stabilized since the law's passage, and worries about adequate vaccine supplies have abated.

The program has also been lauded for its efficiency and civility by families and their lawyers. "Under this system, it's very fast. There's no drug company to send its investigators into your neighborhood and ask everyone what you're up to, no long trials that go on for days and days," said Michael R. Hugo, chairman of the Vaccine Litigation Group for the Association of Trial Lawyers of America. Cases are typically disposed of in one-day hearings at the U.S. Court of Claims conducted by special masters, who are lawyers appointed to decide the cases.

But some worry that the program may be a victim of its own success. Since last fall, the program has been overwhelmed by more than 3,000 claims, many more than predicted. Assuming that at least half are found to have merit, the program does not have enough money to pay for them, according to officials at the claims court and HHS. And if the $400 million compensation program runs out of funds, thousands of families could be forced to seek recourse in the courts.

"The gut issue is how in the world to pay for over 3,000 claims," said Stephan E. Lawton, outgoing chairman of the Advisory Commission on Childhood Vaccines, which oversees the compensation program. "This is going to be . . . something Congress will have a tough time wrestling with."

But in the current tight budget climate, additional funds of $1 billion or more from Congress are universally regarded as remote. One possible solution is to use money from a fund intended to pay for vaccine-related injuries occurring after Oct. 1, 1988, Lawton said. Revenues for the trust fund come from a tax on childhood vaccines.

Raiding the vaccine tax trust fund to pay for pre-1988 claims would probably run into opposition from vaccine manufacturers and some members of Congress, however, because of concerns that the large number of old claims could bankrupt the fund.

Other possibilities, which would likely arouse opposition from parents, are to cap awards or to restrict the kinds of injuries for which awards may be granted, Lawton said.

Under current law, no limit is placed on the overall size of an injury award, although there are caps on certain categories of expenses. Death benefits are capped at $250,000; there is a $30,000 ceiling on attorney's fees, costs, lost wages and payments for pain and suffering. Awards for pre-1988 injuries have averaged about $1.2 million, according to HHS. So far, the program has paid out $74 million in 145 cases, according to Claims Court Chief Special Master Gary J. Golkiewicz.

If a family is not granted an award by the compensation system or decides to decline an award, it may bring a civil suit in state or federal court instead. So far, according to the Court of Claims, no one has declined an award.

Celina Lopez, Lorraine's mother, filed a lawsuit against several vaccine manufacturers in 1986. She withdrew the suit last year, three years before the case would likely have gone to trial, and opted instead to file a claim under the federal program. In less than a year, she received an award that was smaller than she might have received from a jury. Lopez said that while she had mixed feelings about the award, she was impressed by the contrast between the legal system and the compensation program. "It was like night and day," she said. "Even the hearing was very pleasant."

There is growing skepticism in the medical community about whether the pertussis vaccine causes brain damage. At the time the program was created, there was a scientific consensus that it could cause brain damage, although there was disagreement about how often this occurred. The most widely accepted estimate of the risk of permanent brain damage was one in 330,000 vaccine doses, based on a large-scale British study conducted in the late 1970s. But several groups of experts, including one convened by the CDC in 1989, have reevaluated the study and concluded that it lacked the statistical power to decide this question.

"What has happened is a movement away from {the pertussis-brain damage connection} as an accepted fact, where people were arguing about frequency, to {the view that} it hasn't been proven and if it does occur, it's very rare," said Walter A. Orenstein, director of CDC's Division of Immunization. CDC's Immunization Practices Advisory Committee, which will issue final recommendations later this year, "tentatively feels pertussis vaccine is not proven to cause brain damage," he added. A committee reviewing the issue for the American Academy of Pediatrics has also found scant evidence. HHS officials say they will consider these and other findings in determining if changes in the program are needed.

One hope for resolving the issue lies with a new, safer DPT vaccine that both parents' groups and pediatricians favor as having fewer side effects. Lederle Praxis Biologicals and Connaught Laboratories Inc., which manufacture vaccines, have asked the Food and Drug Administration to approve a new pertussis vaccine that has been used in Japan for the past decade.

In the meantime, public health experts and vaccine manufacturers have been watching the compensation program with keen interest as a possible model for other vaccines under development. Last year, a group that included pharmaceutical manufacturers and government policy-makers recommended that a no-fault compensation program be established for AIDS vaccines, some of which may soon begin large-scale tests in people.

Sarah Glazer is a Washington writer.

How to File a Claim

Anyone claiming injury from polio, DPT or measles-mumps-rubella vaccines must file a petition with the U.S. Claims Court, 717 Madison Place NW, Washington, D.C. 20005. The petition must contain complete medical records and sworn statements to support the claim of a vaccine-related injury. If there is not time to gather the necessary records by the Jan. 31 deadline, the Court will accept a letter by that date stating that the additional records required by law will be provided as soon as possible.

Information is also available from Dissatisfied Parents Together (DPT), 128 Branch Rd., Vienna, Va. 22180. 703-938-DPT3.