This guest post has been written by Dr. Dorit Reiss, Professor of Law at the University of California Hastings College of Law. Dr. Reiss is a regular contributor to various blogs and law journals, where she utilizing her legal expertise to examine the social policies of immunization.
Regulating Vaccine Safety, by Dr. Dorit Reiss
According to yesterday’s news reports, long-time vaccine critic Robert F. Kennedy, Jr. met with President-elect Donald Trump.
Following their meeting Kennedy reported that an offer was made to lead a new commission on vaccine safety and scientific integrity. As one would imagine, this has caused concern for immunization advocates and elation among anti-vaccine activists. It is, at this point, unclear whether Kennedy’s statements are true, as a Trump spokesperson issued an email statement that Forbes reported as follows:
“The President-elect enjoyed his discussion with Robert Kennedy Jr. on a range of issues and appreciates his thoughts and ideas. The President-elect is exploring the possibility of forming a commission on Autism, which affects so many families; however no decisions have been made at this time. The President-elect looks forward to continuing the discussion about all aspects of Autism with many groups and individuals.”
While Trump’s intentions in meeting with Kennedy may still be unclear, this is a good opportunity for us to review the specific ways in which vaccine safety is regulated here in the U.S., and the oversight committees that monitor vaccines pre and post licensure.
To begin, it is safe to say that vaccine safety is heavily regulated in the United States, with multiple systems overseeing the vaccine enterprise.
It would be hard to hide a problem if one existed. Further scrutiny reveals that vaccines are very safe and that when problems occur, they are quickly discovered and addressed. It is important to also note that many of the same vaccines used in the U.S. are also studied and used in other countries. Even if the U.S. apparatus was completely flawed, it would be hard to hide any dangers in this age of global communications, intra-government collaboration and oversight.
Vaccine Regulation in the United States
The U.S. is a regulatory state and vaccines are no exception. The vaccine licensing process goes through multiple stages of vaccine testing and approval, as depicted in the CDC infographic pictured at right.
However, before a vaccine can even begin the clinical trial phase in humans, a request must be submitted to the FDA in the form of an Investigational New Drug application, which requires toxicology and animal data. (For more details on this regulation, you can refer to the resource here.)
This is followed by clinical testing, which is also heavily regulated as can be seen in a review of these references here and here.
While the FDA is underfunded and understaffed, and may not have the ability to constantly monitor all trials, companies know that FDA monitoring is to be expected and they must assume their trials will be reviewed.
Furthermore, once the clinical trials are complete, there is an additional layer of review. The sponsor and FDA present the results of the clinical trials to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). Most members of this committee are not part of the FDA; instead the committee is comprised of consumer representatives, as well as experts in relevant fields, many of whom work in universities or hospitals. The current roster for the Committee can be found here. The committee is further governed by the Federal Advisory Committee Act (FACA), which requires pre-announced public meetings.
After the licensing process is complete, there are several monitoring systems in place.
This includes the Vaccine Adverse Events Reporting System (VAERS), which allows independent parties to report an event or injury that happened after vaccination that is believed to be caused by the vaccine. Since anyone can report anything, whether it was actually caused by vaccines or not, including things based on internet rumors,VAERS isn’t necessarily a good gauge of the frequency of vaccine harms. However, where it is helpful is in identifying possible problems and patterns of possible injury.
Another system is the Vaccine Safety Datalink, a collaboration of the CDC and large health care organizations, that conducts additional studies.
Still other mechanisms exist, as detailed by Every Child by Two here. They include The Center for Biologics Evaluation and Research, which receives results of tests and samples of specific vaccine lots before a lot is approved for release. Also included is The Clinical Immunization Safety Assessment Network, which is described by Every Child by Two as follows:
“a national network of six medical research centers with expertise in immunization safety conducting clinical research on immunization associated health risks. CISA was established in 2001 as a collaborative project between the Immunization Safety Office, six medical research centers, and America’s Health Insurance Plans.”
Experts in vaccinology and vaccine safety from the six academic medical centers convene a monthly call, during which a complex vaccine safety issue is addressed in a structured format. An investigator presents a case, which includes the history of present illness (the adverse event reported following vaccination), and detailed physical and diagnostic (laboratory and other) findings. A summary of a literature review on this subject and the Vaccine Adverse Event Reporting System (VAERS) data are also presented. The experts discuss the findings and formulate a general assessment and plan. When appropriate, these conclusions are shared with the concerned provider.”
Once a vaccine is licensed and approved by the FDA, another advisory committee conducts a thorough view of the evidence to assure safety, effectiveness and cost-effectiveness of the vaccine before it is ever recommended to the public. This committee is known as the Advisory Committee on Immunization Practices (ACIP), which is made up of panel of experts and includes a consumer representative. ACIP meetings are also subject to the rules of FACA, which means meetings are announced ahead of time and open to the public. A quick look at the ACIP’s recommendations shows how thorough they are in their deliberations.
In addition, there is still another federal advisory committee – the National Vaccine Advisory Committee (NVAC) – which makes vaccine related recommendations, often related to research priorities and safety to the Assistant Secretary of Health, who also serves as the director of the National Vaccine Program Office. NVAC members are not government employees, but rather represent a diverse cross-section of medical, public health and consumer representatives. The NVAC regularly seeks input from individuals and organizations who traditionally oppose universal vaccination.
In other words, there are numerous committees already involved in overseeing and ensuring vaccine safety, and the overlap ensures that it would be impossible to hide a valid concern.
In addition to the U.S. government mechanisms created to monitor vaccine safety, studies are constantly being conducted in universities and in private settings both in the United States and abroad. It is hard to believe that if a problem were left undiscovered by one of the many U.S. oversight committees detailed above, research would not reveal the problem in some other way.
There is an abundance of evidence that shows that vaccines are very, very safe.
A recent review that started with over 20,000 articles concluded that:
“Evidence was found for an association of several serious AEs [adverse events] with vaccines; however, these events were extremely rare: absolute risk is low.”
Vaccine critics like to make their case that vaccines are not safe by pointing out the compensation that has been awarded to people who claim a vaccine caused them harm. But even if we use this measure favored by vaccine critics, the rate of compensation by the National Vaccine Injury Compensation Program, the no-fault program set up to compensate those harmed by vaccines, remains at less than one compensation per million doses. It should be noted that most of this compensation is made through settlements, and settlements don’t show causation. In fact, the government routinely denies causation in these settlements.
From every direction you look, vaccines harms are very rare.
When a vaccine safety problem arises, it is transparently discussed and treated seriously. For example, when an early rotavirus vaccine was associated with a rare but serious intestinal complication in the late 1990s, at a rate of 1 per 10,000, the vaccine was quickly removed from the market. The issue was discovered via the systems we now have in place and was clearly revealed on the CDC’s website.
There have even been concerns that vaccines could somehow cause autism, SIDS and other disorders. While these ideas continue to be perpetuated by vaccine critics, there has been an abundance of research surrounding these concerns and no evidence showing any relation to vaccines.
Effectiveness problems are similarly addressed publicly. For example, the Advisory Committee on Immunization Practices recently reviewed data regarding the low effectiveness of the live attenuated influenza vaccine (LAIV), more commonly known as the Flumist vaccine. After reviewing efficacy data from past seasons, the Committee chose to retract their recommendation of the vaccine until further studies could ensure an appropriate level of effectiveness. The issue was not one of safety, but it serves as an example of how vaccines are closely monitored and problems openly and transparently addressed.
Vaccine safety is heavily and closely monitored here in the U.S. and abroad. Neither the structure of our current safety monitoring systems, nor the results, suggest that there is need for concern regarding the oversight mechanisms in place.
Vaccine safety is important to everyone and should remain a high priority. But there is no reason to spend additional financial and personnel resources to create complex new structures when the existing oversight committees consist of fully qualified individuals and independent experts who are successfully fulfilling their duties to ensure that the vaccines given to infants, children, adolescents and adults in the U.S. remain both safe and effective.