My testimony to FDA’s vaccine advisory committee: Time for a reset
Beyond the curve: Dr. Peter Lurie's COVID-19 blog
This installment of Beyond the Curve reproduces the testimony Dr. Peter Lurie will deliver today before the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee.
I am Peter Lurie, President of the non-profit Center for Science in the Public Interest and an Associate Commissioner at FDA from 2014 to 2017. I have no conflicts of interest to disclose.
This meeting represents a potential turning point in assuring that the scientific method and the principle of transparency take center stage in any discussion of COVID-19 vaccine candidates. Until now, the process of developing these products has been inappropriately politicized with an eye on the election calendar rather than the deliberate timeframes that science requires.
Now is the time for a reset. This committee has a unique opportunity to set a new tone for vaccine deliberations going forward. In so doing, the following principles should be honored:
- Agency transparency: Advisory Committee meetings are one of the few opportunities for the agency to obtain meaningful outside expert and public input. The Committee must assure that FDA honors its commitment to hold an Advisory Committee meeting on particular products before issuing Emergency Use Authorizations (EUAs). The Committee should also pressure the agency to provide more detail on the reasons for clinical holds on vaccine trials (and other products).
- Corporate transparency: While some companies have released their clinical trial protocols, others have not and, in general, companies have not provided detailed statistical analysis plans or stopping rules. This Committee should also insist that companies granted EUAs commit to rapid submission of a Biologics Licensing Application (BLA).
- Appropriately high efficacy standards: The legal standard for an EUA is that it is “reasonable to believe” that the vaccine “may be effective.” This standard is lower than the conventional standard for product approval which is “substantial evidence [of effectiveness].” These EUA terms are not defined in statute and FDA has been inconsistent in its interpretations during the course of this pandemic, often accepting data considerably weaker than it has in previous emergencies. When a vaccine candidate comes before this Committee, I urge it to interpret these terms rigorously. A vaccine that is only minimally effective is one for which any efficacy can be overwhelmed by behavioral disinhibition as people, assuming themselves to be protected, lower their guards and reduce mask-wearing or social distancing.
- High safety standards: Even if a trial is terminated early because the product is effective, it is critical that sponsors continue to follow subjects for up to a year to monitor for late-occurring adverse events and to establish whether immunity wanes. In addition, this Committee should seek clarity on the sample size calculations underlying the agency’s efforts to exclude vaccine-induced enhanced respiratory disease, as described in the EUA guidance.
- High ethical standards: This Committee should demand that informed consent forms and Institutional Review Board (IRB) minutes be made public. It should assure that subjects are receiving proper counseling on how to avoid infection with SARS-CoV-2 and that vaccines proved safe and effective are provided to control patients in ongoing and subsequent trials.
The politicization of vaccines in this pandemic has already undermined public trust, contributing to an alarming rise in vaccine hesitancy. A vaccine that is not accepted is an ineffective vaccine. The only antidotes to public mistrust are transparency and scientific rigor. I urge this Committee to be their staunchest advocate.
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