On 01/15/2013, the Institute of Medicine issued a report The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies. The report was based on a 12-month evaluation by an IOM committee of the scientific evidence supporting the federally recommended child vaccine schedule. The Committee made recommendations about the feasibility of conducting research to evaluate the health outcomes of vaccinated and unvaccinated children and those following an alternative vaccine schedule.
Good News and Bad News
There is good news and bad news in this report. Good news: the committee repeatedly pointed out the astonishing lack of quality scientific studies to support the safety of the CDC-recommended numbers of doses and timing of vaccinations for children 0 to 6 years old in the child vaccine schedule. The committee confirmed there are large knowledge gaps, especially about children with increased biological susceptibility to suffering vaccine reactions and injuries.
Bad news: The committee’s recommendation is that the CDC should conduct future vaccine safety studies using closed patient databases like the Vaccine Safety Datalink (VSD), which unfortunately prevent independent replication of the findings. For more than two decades, NVIC has called for independent vaccine safety research by investigators without industry or government conflicts of interest.
NVIC’s Press Release: Call for Transparency
NVIC issued a press release that calls for transparency, independence and replication in future vaccine safety research to examine the safety of the child vaccine schedule. The outstanding question every parent wants to answered remains: When will the real vaccine safety science conducted by researchers without industry or government conflicts of interest begin?
NVIC PRESS RELEASE
National Vaccine Information Center Supports Three of Five Recommendations of New IOM Report on U.S. Childhood Immunization Schedule Safety and Calls for Transparency
WASHINGTON–(BUSINESS WIRE)–The non-profit National Vaccine Information Center (NVIC.org) supports three out of five recommendations made by an IOM committee asked by federal health officials to make recommendations for Sudying the safety of the current U.S. child vaccine schedule. NVIC is calling for transparency, independence and replication in future research to assess the safety of federal vaccine policies, including evaluating health outcomes of vaccinated and unvaccinated children and those using alternative vaccine schedules.
“Replication is the gold standard in science because it prevents fraud in science. Transparency is important to public trust in science”
“In the full report, the IOM Committee has done a good job outlining core parental concerns about the safety of the federally recommended child vaccine schedule and identifying large knowledge gaps that cause parents to ask doctors questions they can’t answer,” said Barbara Loe Fisher, NVIC Co-founder and President. “The most shocking part of this report is that the committee could only identify fewer than 40 studies published in the past 10 years that address the 0-6 year old child vaccine schedule.”
NVIC supports the IOM Committee’s first three recommendations (4-1, 5-1, 6-1) calling for federal health officials to:
- Assess evidence about public confidence in the federally recommended child vaccine schedule to improve communication between doctors and the public;
- Define potential vaccine adverse health outcomes and populations biologically at increased susceptibility for suffering vaccine reactions and injury; and
- Make evaluating the safety of the child vaccine schedule a scientific research priority.
NVIC does not agree with the last two committee recommendations (6-2 and 6-3) suggesting that prospective clinical trials, including cohort trials, are not useful for examining the safety of the child vaccine schedule. NVIC also strongly opposes the committee recommendation that future vaccine safety research be conducted by DHHS and its corporate partners exclusively using existing closed database systems, such as the Vaccine Safety Datalink (VSD).
“Replication is the gold standard in science because it prevents fraud in science. Transparency is important to public trust in science,” said Fisher. “It is a conflict of interest for federal health agencies, which are developing and patenting new vaccines, regulating, making policy for and promoting mandating of vaccines, to also be in charge of conducting research into the safety of federal vaccine policies. Using closed patient databases, such as the VSD, prevents independent replication of vaccine safety conclusions made by DHHS officials collaborating with HMO’s and pharmaceutical corporations in public-private partnerships.”
Frequently citing a lack of enough quality scientific studies in the report, the IOM committee was unable to determine whether the numbers of doses and timing of federally recommended vaccines children receive in the first six years of life are – or are not – associated with health problems in premature infants or the development of chronic brain and immune system disorders in children, including:
- learning disorders;
- communication disorders;
- developmental disorders;
- intellectual disability;
- attention deficit disorder;
- disruptive behavior disorder;
- tics and Tourette’s syndrome;
- febrile seizures and
In its report, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies, the committee said, “No studies have compared the differences in health outcomes that some stakeholders questioned between entirely unimmunized populations of children and fully immunized children. Experts who addressed the committee pointed not to a body of evidence that had been overlooked but rather to the fact that existing research has not been designed to test the entire immunization schedule.”
NVIC has been calling for bench science investigating the biological mechanisms for vaccine injury and death and evaluation of long-term health outcomes for vaccinated and unvaccinated children for the past two decades. NVIC’s co-founders worked with Congress to secure vaccine safety informing, recording and reporting provisions in the National Vaccine Injury Act of 1986 and presented a parent stakeholder statement to this IOM Committee outlining public concerns about the safety of the current child vaccine schedule. NVIC is a 501C3 charity founded in 1982 and dedicated to preventing vaccine injuries and deaths through public education and defending the informed consent ethic.
Contacts: National Vaccine Information Center Barbara Loe Fisher, 703-938-0342
TLB suggests you visit NVIC.org for more articles concerning vaccine safety.
Click here “immunization” to read the original NVIC press release.
See original NVIC article here: http://www.nvic.org/NVIC-Vaccine-News/January-2013/IOM-Issues-Report-on-Safety-of-the-Child-Vaccine-S.aspx