UPDATE: HRSA has rescheduled this meeting of the ACCV. Visit HRSA's website for information about when the next ACCV meeting will be held.
ACCV Considering Vaccinated/Unvaccinated Health Outcomes Workgroup
Posted: 2/23/2022 8:34:35 PM | with 2 comments
During the December 2021 meeting of the Advisory Commission on Childhood Vaccines (ACCV), member Karen Kain repeated concerns relating to the safety of the childhood schedule that she has voiced since her appointment to the Commission in 2019. More specifically, she noted the long standing need for a study comparing health outcomes among vaccinated and unvaccinated children.
Lorrin, Ms. Kain’s daughter, was injured at six weeks old by a DPT vaccine in 1994. Ms. Kain’s vaccine injury claim was conceded by the federal government and her family received compensation from the federal Vaccination Injury Compensation Program (VICP) to care for Lorrin until her death in 2009.1 Ms. Kain serves on the ACCV as a consumer representative in the capacity of a parent of a vaccine injured child.2
Feasibility of a Study on Vaccinated/Unvaccinated Health Outcomes
During the ACCV’s upcoming Mar. 3 meeting, Ms. Kain will present a workgroup proposal to assess epidemiological research to investigate potential health outcome differences among vaccinated and unvaccinated children and potentially make research recommendations for the ACCV’s consideration.
The foundation for the workgroup proposal is likely to be based in part on a 2013 report, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence and Future Studies published by the Institute of Medicine (IOM), which was renamed the National Academy of Medicine in 2015 and is part of the National Academies of Science. The report 3 confirmed that as of 2013, no study had looked at the safety of the federally recommended early childhood vaccination schedule (birth to six years old) as a whole and suggested that the CDC’s Vaccine Safety Datalink (VSD) was the most appropriate database for conducting a health outcomes study investigating vaccine safety issues of concern to the public.4
Subsequent to the IOM’s 2013 report, the CDC responded to the IOM’s recommendations in their 2016 White Paper on Studying the Safety of the Childhood Schedule for the Vaccine Safety Datalink. The white paper agreed that it is feasible to use the VSD to conduct safety research on the childhood vaccine schedule.5
Public Trust in CDC’s Vaccine Safety Datalink (VSD)
Ms. Kain asked questions of the CDC’s representative during the December 2021 ACCV about whether the CDC had conducted using the VSD since the publishing of their 2016 white paper. The CDC’s representative responded that some were in progress and that he believed that four of the outcome priorities from the white paper had been published.6
Additionally, she also noted public trust issues with the VSD’s data-sharing program, and shared some of the findings from the IOM’s 2005 report, Vaccine Safety Research, Data Access AND Public Trust7 with the commission.
The 2005 IOM Committee report addressed the VDS’s lack of transparency, pointing out that the CDC’s data-sharing program didn’t meet the traditional definition of a data sharing program, and that change was needed for the program to be considered a truly publicly accessible data sharing program.8 Notably, the report stated that independent researchers should be given access to VSD data for the purpose of analyzing and replicating vaccine safety studies published by the CDC based on VSD data, as well as be able to formulate alternative hypotheses.9
The 2005 IOM Committee report also recommended that the government seek legal advice on the applicability of existing federal law relating to the public’s access to research data and the quality of data collected or supported by the federal government,10 commenting that the public’s trust was dependent on perception of the independence and fairness of VSD research priorities and approval of VSD data-sharing proposals.11
NVIC’s president and co-founder Barbara Loe Fisher made a presentation at an August 2004 public meeting of the IOM Committee of the Review of the National Immunization Program’s Procedures and Data Sharing Program. She outlined NVIC’s concerns about lack of transparency by federal agencies regarding vaccine risks and lack of public access to the VSD data by independent researchers, which has led to public distrust of vaccine safety studies published by the government.12
However, the CDC’s 2016 white paper did not address the IOM’s 2005 VSD data-sharing concerns and was solely focused on responding to the IOM’s 2013 report.13
Advocating for Independent Vaccine Safety Research
As part of IOM’s examination of evidence for the safety of the federally recommended early childhood vaccination schedule, NVIC was invited to provide a public perspective on the safety of the schedule and the feasibility of conducting studies comparing total health outcomes in vaccinated and unvaccinated children. The statement by NVIC’s Barbara Loe Fisher at a February 2012 IOM Committee meeting outlined several possible designs for comparing the total health outcomes of vaccinated and unvaccinated children, while also noting that there were two questions that the public urgently wanted answered:14
- “Is inflexible implementation of one-size-fits-all vaccine policies using an expanded vaccine schedule compromising the health of a growing minorityof children, who are biologically susceptible to developing chronic brain and immune system dysfunction after vaccination?
- Is the increased use of multiple vaccines to prevent almost all experience with acute infectious disease during infancy and childhood contributing to better long term health on an individual and population basis or is the a priori assumption that more vaccination is better producing unintended consequences?"
Since 1982, NVIC has advocated for independent oversight of vaccine safety monitoring and research and her statement at the 2012 IOM Committee meeting detailed much of that history.15 Yet, the impact of the childhood schedule on total health outcomes has remained largely unaddressed and it is unclear which of the IOM’s recommendations to improve the fairness and transparency of the VSD data-sharing program have been implemented by the CDC. After the IOM’s 2013 report was published, NVIC issued a press release 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. 16
What YOU Can Do!
The IOM’s 2005 report affirmed that the independence and transparency of VSD research activities is important to ensure the public’s trust in its use as a research tool to address vaccine safety issues like the safety of the childhood vaccination schedule.17
Should the ACCV form a workgroup to make VSD related research recommendations, it is urgent that the workgroup also examine VSD transparency issues and recommendations made by the IOM’s 2005 report on the CDC’s VSD data-sharing program. Use of the VSD to answer vaccine safety questions cannot be limited to government agencies and their partners and must allow for equal access by external independent researchers to confirm research findings or to propose alternate hypotheses, as dictated by the scientific method18 and recommended by the IOM 17 years ago.19
The ACCV will provide an opportunity for public comment, and anyone may sign up to provide an oral and/or submit a written public comment. Links have not yet been published on the ACCV’s website to register for public comment, and this link should be checked often prior to the meeting to sign up or submit your written public comment.
NVIC encourages the public to voice their concerns about the independence and transparency of the CDC’s VSD Data-Sharing Program and support high quality independent research into the safety of the federally recommended childhood vaccination schedule.
1 Kain, K. A Unique Life Fully Lived: A Personal Journey of Love, Hope, and Courage. Mascot Books Apr. 1, 2014.
2 U.S. Health Resources & Services Administration. Advisory Commission on Childhood Vaccines Roster. December 2021.
3 Institute of Medicine. Summary of Methodological Issues. In: The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. National Academies Press 2013; Pg 134.
4 Institute of Medicine. Health Outcomes. In: The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies. National Academies Press 2013; Pg 5.
5 U.S. Centers for Disease Control. White Paper on Studying the Safety of the Childhood Schedule for the Vaccine Safety Datalink. 2016.
6 U.S. Health Resources & Services Administration (HRSA). ACCV December 2021 Webinar Recording. Jan. 20 ,2022.
7 Institute of Medicine. Vaccine Safety, Research, Data Access AND Public Trust. National Academies Press 2005.
8 Institute of Medicine. Limitations of the Vaccine Safety Datelink and the Need for Collaboration. In: Vaccine Safety Research, Data Access, AND Public Trust. National Academies Press 2005; Pg 5.
9 Institute of Medicine. Recommendation 3.4: Independent Researcher Access. In: Vaccine Safety Research, Data Access, AND Public Trust. National Academies Press 2005; Pg 9.
10 Institute of Medicine. The Shelby Amendment And The Information Quality Act. In: Vaccine Safety Research, Data Access, AND Public Trust. National Academies Press 2005; pgs 31-32.
11 Institute of Medicine. Contextual Issues. In: Vaccine Safety Research, Data Access, AND Public Trust. National Academies Press 2005; Pg 4.
12 Fisher BL. Institute of Medicine Committee Meeting – NVIC Statement on the National Immunization Program’s Procedures and Data Sharing Program. National Vaccine Information Center Aug. 23, 2004.
13 U.S. Centers for Disease Control. White Paper on Studying the Safety of the Childhood Schedule for the Vaccine Safety Datalink. 2016.
14 Fisher, BL. Public Perspective - Institute of Medicine Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. National Vaccine Information Center Feb. 9, 2012.
15 Fisher, BL. Public Perspective - Institute of Medicine Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. National Vaccine Information Center Feb. 9, 2012.
16 NVIC. National Vaccine Information Center Supports Three of Five Recommendations of New IOM Report on US Childhood Immunization Schedule Safety and Calls for Transparency. Jan. 16, 2013.
17 Institute of Medicine. Contextual Issues. In: Vaccine Safety Research, Data Access, AND Public Trust. National Academies Press 2005; Pg 4.
18 Editors, Encyclopaedia Britannica. Scientific Method. Encyclopedia Britannica Accessed Feb. 21, 2022.
19 Institute of Medicine. Contextual Issues. In: Vaccine Safety Research, Data Access, AND Public Trust. National Academies Press 2005; Pg 4.
Posted: 2/23/2022 8:34:35 PM | with 2 comments