Good morning, I am Theresa Wrangham, the Executive Director for the National Vaccine Information Center and I thank the commission for the opportunity to offer public comment.
For 30 years NVIC has been the oldest and largest parent led charitable non-profit organization representing public vaccine safety concerns and informed consent protections in the public health system. As an independent clearinghouse for information on diseases and vaccines, NVIC does not advocate for or against the use of vaccines. We support the availability of all preventive health care options, including vaccines, and the right of consumers to make educated, voluntary health care choices.
During last week’s meeting of the National Vaccine Advisory Committee there was a great deal of discussion on strategies to increase the uptake of vaccines in pregnant women and the question of whether or not an unborn child would be covered by the Vaccine Injury Compensation Program for vaccine injuries sustained prior to birth was raised. Dr. Evans responded that pregnant women would be covered for injuries they sustained, but that there have been no injury claims to date filed with regard to vaccine injury sustained in utero and that it may take Congressional action to extend injury compensation to unborn children harmed by vaccines. We would ask this committee to task its new working group to investigate and respond to that question and consider recommending compensation be extended to unborn children when harmed by vaccines received by pregnant mothers.
We would again thank this commission for its thoughtful process on expanding the vaccine injury table in light of the recent findings of the Institute of Medicine (IOM) in this regard. However, as the commission is aware, the IOM report was unable to make causal determinations for 85% of the adverse events under the IOM’s review due to the lack of quality science. The IOM’s acknowledgment of this lack of science underscores the urgent need for ongoing independent vaccine safety research. We would again request that this commission make recommendations to close these acknowledged research gaps, as is their purview under the legal mandate for safer childhood vaccines. This research is not only urgently needed, but would also have the effect of decreasing the number of cases dismissed or treated as litigative risk and make the claims process less adversarial and more expeditious.
The ACCV discussed such a recommendation at its last meeting, but the discussion seemed to become sidetracked on how such research would be funded. We would observe that there is no requirement for ACCV recommendations to identify funding in order to fulfill the charge for ongoing vaccine safety research. There was a suggestion during the last meeting of the ACCV that the vaccine injury trust fund could fund such research. We would remind the commission that those funds were intended to compensate those injured by vaccines. Given the ongoing expansion of the vaccine schedule, fast-tracking of vaccines for licensure and acknowledged vaccine gaps, these funds must continue to serve the injured, as it must also be acknowledged that there is equal likelihood that the vaccine injury table will also expand, as most recently demonstrated by the IOM findings. We would ask that any recommendation for on-going research made by the commission also seek to protect the original intent of the injury compensation trust fund.
In closing, we would ask that presentations made to the commission be made available to the public, prior to the meeting and or via webinar to enable members of the public attending via teleconference to follow the presentations made during the meeting.
Again, we thank the committee for the opportunity to comment today.