On July 9, 2018, a Federal district court approved a stipulation between the Informed Consent Action Network (ICAN) – an anti-vaccine organization – and the United States Government regarding a Freedom of Information Act (FOIA) complaint filed by the anti-vaccine ICAN.
What does this mean?
As part of the National Childhood Vaccine Injury Act of 1986 (NCVIA), the act that created the National Vaccine Injury Compensation Program (NVICP or VICP), the Department of Health and Human Services (HHS) was required to report to two Congressional Committees on its vaccines related activities. As the Act explains, and as quoted in the stipulation,
(a) General rule
In the administration of this part and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall—
(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and promote the refinement of such vaccines, and
(2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.
Within 2 years after December 22, 1987, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) of this section during the preceding 2-year period.
On August 25, 2017, the stipulation tells us that the anti-vaccine ICAN submitted an FOIA request for any reports submitted. After not getting a quick enough answer, they filed a complaint with a federal district court under the Freedom of Information Act provisions (on April 12, 2018).
On June 27, 2018, the HHS sent them a message saying that “the [Department]’s searches for records did not locate any records responsive to your request,” and detailing how they searched. The parties filed the stipulation attached, which acknowledges that the response fills the FOIA request.
What it likely means is that HHS did not file the reports it was supposed to file with Congress. If the anti-vaccine ICAN wants to lobby for filing such reports, more power to them. These reports should be filed.
What this does not mean
The stipulation does not mean that HHS did not work on vaccine safety, or that there is not abundant research on the topic.
Multiple Institute of Medicine reports – now the National Academy of Science – looked at vaccines. These detailed reports summarize a large body of studies and draw conclusions based on this ongoing data. HHS commissions these reports. In July 2014, a large report on vaccine safety commissioned by HHS was also completed.
Four different federal committees within HHS look at vaccine safety from different directions.
- The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviews vaccines before license – in addition to the FDA’s official review.
- The Advisory Committee on Immunization Practices which recommends vaccines continues to examine safety data related to vaccines. Each meeting of the committee hears lengthy presentations of the large studies done on various vaccines.
- The National Vaccine Advisory Committee (NVAC).
- The Advisory Committee on Childhood Vaccines.
All of these committees have independent experts and slots for consumer representatives among their members. To give one example of their work, the NVAC creates standards for best practices related to vaccines. These include a requirement to check indications and report adverse events. The American Academy of Pediatrics endorses these standards, shares them, and offers guidance on implementation.
Four monitoring system – one passive, three active, oversee vaccine safety:
- VAERS – the Vaccine Adverse Events Reporting System – is a passive reporting system designed to catch safety signals, where anyone can submit a report with no verification needed.
- The Vaccine Safety Datalink, a collaboration of the CDC and large healthcare organizations, allows for active monitoring and studies of over 9 million people.
- PRISM, a collaboration between FDA and provider organizations, also allows for active monitoring and studies.
- The CDC’s Clinical Immunization Safety Assessment (CISA) project allows for studies of especially vulnerable populations, and for consultation with individual providers facing adverse events or potentially at-risk patients.
All these HHS units are actively engaged in working on vaccine safety.
In a letter responding to a previous set of claims from the anti-vaccine ICAN, Dr. Melinda Wharton from HHS corrected many of the organization’s misunderstandings on vaccine safety studies.
In short, while the HHS should have submitted the required reports, it has done and continued to do abundant work related to vaccine safety. Anyone claiming based on the stipulation that HHS is not working to assure and improve vaccines safety or that there are no studies either misunderstands or lacks knowledge about what HHS is doing, or is being dishonest.
Update 2019 April 28
In an investigative article, journalist Jackie Kucinich found out what happened to the reports HHS did not provide.
At a March 2019 hearing of the Senate Committee on Health, Education, Labor and Pensions, Chairman Lamar Alexander (R-TN) said the reports were actually required within two years of the law’s implementation, not every two years. And, Alexander said, “the HELP Committee has two reports from the Department submitted to Congress dated May 4, 1988, and July 21, 1989.’
- This article was first published in July 2018. It has been updated to add some information about further investigations into HHS’s role in updating Congress about vaccines. Apparently, Del Bigtree and his anti-vaccine ICAN was misinformed.
- This article was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.