Global Vaccine Safety and the FDA
A recent announcement from the Food and Drug Administration (FDA) raises some interesting questions about the ways in which we track vaccine safety. The FDA’s Center for Biologics Evaluation and Research has declared its intention to launch a new program titled the “Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) initiative.” The aim of this new program is to ensure the safety of vaccines manufactured worldwide by doing the following:
- Ensuring the safety of vaccinated people by helping developing countries to create “at least a minimal capacity for vaccine safety activities”
- Enhancing capacity for vaccine safety assessment in countries that manufacture and use either new or prequalified vaccines
- Encouraging “international collaboration, training and information exchange.”
On the face of it, this effort sounds like something vaccine safety advocates could definitely get behind. And indeed, it could be that the GRUVSS initiative finally launches a healthy tradition of demanding safety from all vaccine developers.
However, we at the VaccineXchange are skeptical, to say the least. And this is why:
- The program is to be run by the FDA, which has a long history of failing to adequately ensure vaccine safety. A report released in 2007 by the FDA’s own Subcommittee on Science and Technology noted that the FDA cannot regulate “the development of medical products based on ‘new science’”; that it “does not have the capacity to ensure the safety of food for the nation”; and that “there is insufficient capacity in modeling, risk assessment and analysis.” The Subcommittee concluded that “the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” These deficiencies, according to the Subcommittee, stem from an increase in the demands upon the FDA, as well as a lack of a similar increase in resources. This means that “the scientific demands on the Agency far exceed its capacity to respond;” a situation that results in “significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public.” How can we expect an agency that is failing to ensure vaccine safety within the U.S. to succeed in ensuring vaccine safety around the world?
- One of the stated purposes of the GRUVSS initiative is to improve U.S. public health by gathering information about adverse events around the world, particularly information about vaccines that are licensed in other countries before they enter the U.S. This sounds great, but in practice, what does this mean? At the moment, adverse events in the U.S. are tracked via VAERS, a system that nobody is mandated to report to and that appears to have few resources devoted to it. Assuming that this system is effective and efficient (which we highly doubt), it will still be useless unless there is extensive outreach in the U.S. as well as other countries to educate doctors and patients about this resource. The only such guide to outreach appears to be a “working session on vaccine pharmacovigilance … to provide tools to assist countries in implementing a systems perspective to pharmacovigilance.” There is no information on what these tools are, but more problematically, this whole program appears to be attempting to export FDA systems that everyone acknowledges are far from perfect.
- In line with the above, one of the outreach programs mentioned is a two-day seminar on “Pharmacovigilance: the study of Adverse Drug Reactions and Related Problems” which focuses on the methods used by FDA scientists “to assess post-marketing safety data and inform subsequent regulatory actions taken for vaccines and other biologics.” This seminar is more about analyzing data than actually gaining any, and also appears to suggest that the methods used by the FDA are incredibly successful and therefore a good basis for other countries to evaluate safety data. However, as we already know, the FDA is not a very efficient or effective agency when it comes to vaccine safety. Do we really want to export their practices?
- Lastly, the whole program is also going to consult with the Bill and Melinda Gates Foundation on improving global vaccine safety. We are skeptical as to how effective this is going to be in actually improving safety, given that the Gates Foundation is extremely pro-vaccine and also appears to be very much influenced by the pharmaceutical industry.
This last point, in particular, raises questions about the true purpose of the GRUVSS initiative. It seems plausible that the initiative is actually an attempt to control information about vaccine safety. After all, a global program like this may make it easier to prevent information about high rates of adverse reactions to vaccines from becoming public knowledge before government agencies have a chance to act. It would also make it easier to suppress data if necessary to continue selling more and more vaccines.
We hope these are just groundless fears, and that this is actually a program to monitor the reality of unsafe vaccines. However, based on the track records of the organizations involved, we really cannot help assuming the worst.