|Friday, February 15, 2008|
Federal health officials are reviewing whether routine immunizations contributed to the deaths of as many as three North Idaho babies this fall, a spokesman for the Centers for Disease Control and Prevention said this week.
The agency has requested autopsy reports and medical records for at least two children and could seek them for a third Kootenai County infant, all of whom died in September and October, apparently within days of receiving recommended vaccines.
There's no clear link between the vaccines and the deaths, which were classified as Sudden Infant Death Syndrome, or SIDS, said Curtis Allen, a spokesman for the CDC. "There is nothing so far to indicate that there is a particular problem other than these children died in the same city," Allen said.
But the mother of one of the children said it's no coincidence that her 4-month-old son died within days of receiving injections to prevent serious childhood illnesses, including diphtheria, tetanus, pertussis, hepatitis B, polio, rotavirus and invasive pneumococcal disease.
"My baby was so healthy," said Shelly Walker, 39, of Hayden. "He was extremely full of life, energy and vitality."
Nevertheless, early on the morning of Sept. 15, less than three days after Vance Vernon Walker received a round of vaccines at Lakeside Pediatric and Adolescent Medicine in Coeur d'Alene, his mother awoke to a nightmare.
"It was about 5:15 a.m. I woke up and thought, 'He's not making any noise!' " Walker recalled. "I went to pick him up and then I screamed."
Her 16 1/2-pound boy was warm and his lips were still pink, but he wasn't moving. Blood was crusted beneath his eyes, and his clothes and toys were covered with a bloody froth.
As her husband, Brian, 46, called 911, Walker worked frantically to resuscitate their child. But in the emergency room at Kootenai Medical Center, doctors said Vance had been dead for several hours.
"I grabbed my baby in my arms and held him up and I screamed, 'How in the hell did this happen?' " Walker said. "Was it the vaccines?"
Medical officials from the CDC and the federal Food and Drug Administration are working to answer that question for the Walkers and for families of two other babies who died within six weeks of each other.
Two of the deaths have been logged in the voluntary Vaccine Adverse Event Reporting System –VAERS – jointly operated by the CDC and FDA, agency officials said. But Dr. Robert West, the Kootenai County coroner, confirmed that three infants died this fall within days of immunization.
Parents of the other babies could not be reached for comment.
Autopsies failed to detect any specific vaccine reactions, West said, forcing a determination of SIDS – a "diagnosis of exclusion," he noted.
He said he welcomes the federal review. "It is a little bit unusual but not totally unheard of," West said. "It deserves the investigative clout of the CDC."
Walker confirmed that her son's death was one of the Idaho cases reported to VAERS. The other reported child likely was also under the care of the Coeur d'Alene pediatric group, Allen said. That raises the possibility the children received vaccines from the same batch.
If the CDC receives three reports of deaths or 10 reports of serious non-fatal injuries related to the same lot of a vaccine, it launches a review, Allen said.
In Vance Walker's case, the immunizations included a dose of Pediarix, a combined vaccine that contains DTaP, hepatitis B and inactivated polio vaccines. His mother's records indicate the lot number of the vaccine manufactured by GlaxoSmithKline was AC21B124B.
He also received a dose of Prevnar, lot number B54007C, a vaccine manufactured by Wyeth Pharmaceuticals.
Allen, of the CDC, said it would be up to the medical practice to decide whether to suspend use of the vaccine. Dr. Brian Hickok, the pediatrician for Walker's son, did not return calls about the issue. A representative for the medical practice declined to comment.
Those two vaccines are the most likely to be implicated in any adverse events, said David Terzian, a Virginia lawyer who specializes in vaccine injury cases. Terzian said the Walkers have a good chance of receiving compensation for their son's death through a federal program because it occurred so soon after immunization, well within the 72 hours required by federal rules.
Information provided by drug manufacturers and attached to the vaccines reports low numbers of associated deaths. In 14 clinical trials of Pediarix, five deaths were reported among 8,088 recipients of the vaccine, including two cases of SIDS.
In a study of more than 34,000 children in which about half received Prevnar and half received a control vaccine, a dozen deaths, including five SIDS deaths, occurred in the Prevnar group. By contrast, 21 deaths occurred in the control group, including four SIDS deaths, according to manufacturer data.
Immunization specialists acknowledge that any death following vaccination is a tragedy. But they emphasize that far more children died or fell ill in the era before vaccinations.
"For the most part, disease is always going to be more risky than getting a vaccine," said Nicole Pender, health educator for the immunization program at the Washington state Department of Health.
That is no comfort to Shelly Walker. She hopes her experience inspires parents to educate themselves about the risks of vaccines and prompts them to monitor any reaction, however slight. She plans to file a claim through the National Vaccine Injury Compensation Program, which provides a maximum of $250,000 after a vaccine-related death.
In return, all records related to her son's injury and death will be sealed by the drug manufacturers. Walker is optimistic that they'll use the data to improve product safety so other families won't experience her tragedy.
"My hope is they're compiling data and statistics to make things better," she said. "I'm trying to believe in the inherent goodness of something here."