It’s one of the most dangerous side effects of a vaccine: Autism. But a recent FDA panel has asked the agency to reconsider its approval of a vaccine that is meant to protect children up to age 11 against flu viruses.
The parents of children who have autism have been pushing for years for parents to be allowed to bypass the FDA approval process and seek medical care from alternatives to mainstream medical providers. These alternatives are not necessarily better than getting vaccinated but do have an upside for the children, the parents maintain. One of these alternative providers, Riverkeeper, the parent advocacy group, advocates for some of these risks of vaccinations, and has lobbied against the labeling of some vaccines for autism, for example.
The panelists said that they wouldn’t suggest rejecting the vaccine outright but that they wanted greater data on the risks that came with the vaccine. For example, they said the agency should change how it designates which vaccines are preservative-free. Right now, thimerosal, which is found in vaccines made of live viruses, is on the FDA’s list of pediatric vaccines, but thimerosal is not safe for children aged 3 to 11.
“You are asking us to think twice, thrice, about vaccines for any level of access,” Dr. Daniel Jernigan, a member of the panel and a pediatrician from Boston, told his colleagues. “It is not a happy place for any of us.”
“We just need to wait and get the data,” said Roni Stiger, another panelist and the director of pediatric epidemiology at the CDC.
The vaccine in question is FluMist, a mist that is more easily administered than a traditional injection and is meant to be used outside the doctor’s office. In its current form, it is effective for children ages 6 to 23 months.
The panelists voted 7-4 that the risk/benefit analysis of FluMist was too lopsided in favor of the vaccine. Four of the panelists voted that the age range shouldn’t be limited to only 3 to 11 years old and that they would recommend the vaccine for anyone who wants to receive it.
However, the panelists decided that they would not recommend removing the preservative from the vaccine for everyone, but would recommend doing so for 4- to 7-year-olds. The panel has also recommended a study to determine what happens to a child after receiving a vaccine containing thimerosal.
A CDC spokeswoman said that the CDC is still reviewing the vote and evaluating the study recommendation.
“While this is encouraging, CDC is still far from solving the question of whether all routine flu vaccinations for this age group should be approved and recommended,” said the spokeswoman. “We will continue to evaluate all evidence related to influenza vaccination.”
This article was written by Susan Crawford, producer of “Frontline’s,” “Frontline Presents,” and a Pulitzer Prize-winning investigative reporter who has written books about the financial crisis, Iran’s nuclear program, and the war on terror. She is a J-School instructor and a co-host of National Public Radio’s “Tell Me More.” She can be reached at [email protected].