It is not often one gets to witness history, but I count myself lucky that I did while I monitored the Sept. 10-11, 2013 meeting of the National Vaccine Advisory Committee (NVAC). During that meeting I read a statement to clarify the historic record on behalf of NVIC co-founders Barbara Loe Fisher and Kathi Williams.
The September 2013 meeting marked the 25th year Anniversary of NVAC and the Vaccines for Children program. Special guest Tim Westmoreland was invited to address1 the NVAC about the history of why Congress created the federal Vaccine Injury Compensation Program (VICP) and the federal vaccine advisory committees under the National Childhood Vaccine Injury Act of 1986.2
A Crisis of Public Trust in DPT Vaccine Safety
In the early 1980’s Mr. Westmoreland served as Counsel to the House Subcommittee on Health and the Environment.3 In his statements to NVAC, Mr. Westmoreland said his comments were his own but attributed the “perfect storm” that compelled Congress to create a federal vaccine injury compensation program in 1986 to (1) short falls and rationing of vaccines; (2) publicized vaccine injuries of children and public concern about vaccine safety; and (3) vaccine industry withdrawal from the marketplace. He added that “the crisis was always vaccine injury compensation.”
And herein lies a valuable history lesson.
NVIC Founders Worked With Congress in 1980’s
When I heard these comments during the meeting, I notified NVIC President Barbara Loe Fisher and NVIC Vice President Kathi Williams because, as co-founders of Dissatisfied Parents Together (DPT) in 1982, they worked with parents of DPT vaccine injured children and Congress and secured vaccine safety informing, recording and reporting provisions in the 1986 Vaccine Injury Act. To clarify the public record about NVIC’s standing and involvement in creation of the 1986 law, they wrote a statement for me to give on their behalf during the NVAC public comment period at the end of the day.
Read NVIC’s statement to NVAC
In their statement, Barbara and Kathi described how DPT vaccine injury lawsuits in the early 1980’s prompted pharmaceutical companies and medical trade groups to press Congress for liability protection. They also stated that parents of vaccine injured children were told by congressional staffers on both sides of the aisle that legislation giving liability protection to vaccine manufacturers was going to be passed to “protect the vaccine supply” – with or without the participation of parents of vaccine injured children.
It was only through the efforts of parents of DPT vaccine injured children, including co-founders of Dissatisfied Parents Together (DPT) which opened the National Vaccine Information Center in 1989, that vaccine safety informing, reporting and recording provisions were secured in the 1986 law that also created a no-fault Vaccine Injury Compensation Program (VICP). The original 1986 legislation allowed petitioners to pursue civil litigation if they were turned down for compensation in the U.S. Federal Court of Claims. However, in 2011 the U.S. Supreme Court declared vaccines to be “unavoidably unsafe” and effectively shielded drug companies from all vaccine injury lawsuits.4
ACCV: Nearly $3 Billion in Compensation but Claim Dismissals High
There has been nearly $3 billion in federal compensation awarded to children and adults for vaccine injuries and deaths since the VICP began making awards in 1989. At the September meeting of the Advisory Commission for Childhood Vaccines (ACCV) the Division of Vaccine Injury Compensation (DVIC) reported that fiscal year 2013 was likely to exceed totals for compensated claims of previous years – over $216 million as of August 13. Reportedly, two large claims, one for $48 million and another for $40 million, will likely settle prior to the DVIC’s fiscal year end of September 30th. While the VICP approaches record compensations, their average dismissal rate from 2008 to 2013 is over 80 percent.5
GBS Recommended for Addition to Vaccine Injury Table
The DVIC also requested that the ACCV add Guillian-Barre’ Syndrome (GBS) related to influenza vaccinations in their recommendations to expand the Vaccine Injury Table (VIT)6 along with previously ACCV approved recommendations based on the recent findings by Institute of Medicine to the Secretary of DHHS.
GBS is an immune mediated neurological disorder that affects the nervous system and causes paralysis. The VICP has compensated just over 90 percent of adjudicated GBS/flu shot cases and the ACCV voted to include GBS as an influenza vaccine related injury in their recommendations to the DHHS Secretary.
Influenza vaccine injury is the leading vaccine injury claim submitted to the VICP.
Influenza and Healthy People 2020 Goals
‘Tis the season and as I reported earlier this year,7 adults are increasingly being pressured by doctors and public health officials to comply with the federally recommended adult vaccination schedule.8 DHHS officials set adult flu shot coverage targets based on Healthy People 2020 Goals. The objective of Healthy People in terms of vaccination is to increase vaccine uptake rates and reduce infectious diseases for which vaccines are licensed and recommended by federal health officials. 9 These goals were designed to be aspirational but are now being treated by CDC officials as hard targets that must be reached within certain time limits.
Though influenza vaccine injuries and deaths are now leading compensation awards in the VICP, and effectiveness of the vaccine is variable, influenza vaccine uptake targets among children and adults are relentlessly pursued. CDC’s Dr. Anne Schuchat briefed the NVAC on Healthy People 2020 Goals for influenza vaccine:
- 70% of children age 6 months to 17 years;
- 70% for adults 18 and over;
- 90% for Health Care Providers (HCP)
- TBA for Pregnant women – waiting for data to set goal
The “Horrors of HPV Vaccine Coverage”
With the exception of HPV vaccine coverage, Dr. Schuchat also briefed the NVAC on other vaccination coverage objectives related to the Healthy People 2020 goals. She presented data that demonstrated vaccine coverage goals of 90% or more had been mostly reached for DTaP, hep B, MMR, polio, varicella and HiB vaccines. 10
However, Dr. Schuchat was not happy with HPV vaccine coverage in the U.S., which she said was experiencing a “pathetic plateau.” She stated during the NVAC meeting that the “horrors of HPV vaccine coverage” would be presented in greater detail to the NVAC in a separate presentation that was largely the same information we reported in August.11
HPV vaccine coverage is not a Healthy People 2020 goal.
Healthy People 2020 Extends Reach
New to Healthy People 2020 vaccine coverage goals for children 19-35 months are hep B birth dose (85%), rotavirus (80%) and hep A (85%), so it is likely that there will be more publicity generated by public health officials and medical trade groups to promote use of these vaccines. Currently coverage is estimated to be approximately 70% for hep B and rotavirus and 55% for hep A.
The Unvaccinated and Measles
There has been increased media coverage about “pockets” and “clusters” of unvaccinated individuals where measles cases are occurring among communities of vaccinated children and adults. Within the Healthy People 2020 goals there is a tracking measure to sustain levels of unvaccinated children ages 19 to 35 months at less than one percent. Data used for this measure is from the National Immunization Survey, which showed that for 2012 that rate is 0.8 percent. Should it reach 1 percent, a tracking goal will be put into place.
With all the media focus on 159 cases reported in the U.S. by the end of August, Dr. Schuchat noted that measles incidence in the U.S. is still well below 1 case per million. In fact, in her presentation the incidence was noted as 0.18 per million and showed that all states had at least a 92 percent MMR vaccine coverage rate.
For more information on measles, view or read an analysis published by NVIC in September with more than 80 references on reported measles outbreaks in the U.S. Please forward this analysis to your friends to increase public awareness about measles and measles vaccine.
Making Exemptions Harder to Get in the Works
With Healthy People goals being used as hard measurement for the success of CDC operated public health programs, it is doubtful that anyone reading this post will be surprised to learn that the NVAC is struggling to find creative ways to change the behavior of those who refuse vaccines and to neutralize the concerns of the numbers of parents and health care professionals growing more hesitant to comply with expanding vaccine schedules.
A new working group has been formed in NVAC to examine vaccine hesitancy and suggest ways to change behaviors. If our experience in advocating for protection of vaccine exemptions at the state level is any example of what to expect, this federal working group is likely to recommend further restriction of vaccine exemptions and government-operated behavior modification programs for those declining one or more federally recommended vaccines.
When recommendations of this nature have been made in the past by the NVAC, they hit with lightening speed in terms of affecting vaccine mandates at the state level.12 Time will tell, but we anticipate that the fight to preserve vaccine choice and exemptions at a state level will become more aggressive in 2014.
Be Ready to Act
Be ready to act to protect vaccine exemptions in your state by signing up to use NVIC’s Advocacy Portal. You will receive real-time email alerts about legislative efforts to expand, eliminate or restrict vaccine exemptions in your state. NVIC’s Advocacy Portal makes it easy to contact your legislator by smart phone or computer and make your voice heard. This informed consent issue affects every individual’s ability to voluntarily decide whether or not to accept or decline the use of one or more vaccines.
Please forward our articles, brochures and website address to your friends and family and encourage them to support informed consent to medical and vaccine risk-taking.
6 DVIC Presentation to the ACCV to add GBS to the VIT, ACCV September 2013 meeting, Sept. 5, 2013
7 Wrangham, T. NVIC Newsletter – CDC Launches Media Campaigns to Increase Vaccine Use. Aug. 20, 2013
9 Healthy People Immunization and Infectious Diseases Overview. HealthyPeople.gov, accessed Oct. 10, 2013.
11 Wrangham, T. NVIC Newsletter – CDC Launches Media Campaigns to Increase Vaccine Use. Aug. 20, 2013
12 Wrangham, T. NVIC Newsletter - NVAC Says: Mandate Flu Shots for Health Care Workers – Feb. 21, 2012
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