The FDA should condition any vaccine approval on open trial data
That is why the FDA should condition any vaccine approval on increased transparency on the part of manufacturers. Pharmaceutical companies should be required to release detailed information, including machine-readable data, regarding their vaccine clinical trial designs, implementation and results for scientific scrutiny.
It is encouraging that a handful of companies are claiming 90 percent effectiveness or greater for their covid-19 vaccine candidates, but we are concerned that without full transparency for clinical trial data, public confidence in the safety and effectiveness of an eventual vaccine will be undermined, meaning fewer people will be willing to take a vaccine.
While Johnson & Johnson has committed to sharing participant-level data, results, protocols and other trial documents for its vaccine candidate, others have thus far made only their trial protocols public. That includes Pfizer/BioNTech and Moderna, both of which have already applied for emergency-use authorization from the FDA for their experimental vaccines, as well as AstraZeneca, which is expected to follow suit. If those authorizations are granted, significant data from the clinical trials will not be available on the FDA website, as they would be for a product receiving standard FDA approval.
Protocol data does help to bring a level of transparency around a study’s design, participant enrollment criteria and other factors, but such data doesn’t show the results of the clinical trial on the participants. Nor does it include demographic data and other characteristics of those enrolled in the trial. Sharing this data in a manner that protects participant privacy is critical not only in assessing the results, but also in informing and improving future clinical trials and studies.
The FDA’s track record for enforcing transparency around covid-19-related emergency authorizations is concerning. A recent report from the Government Accountability Office pointed out that in the cases of four covid-19 therapeutics, the FDA has not always made the evidence to support its authorization decisions transparent. GAO recommended that the FDA identify “ways to uniformly disclose information from its scientific review of safety and effectiveness data — similar to the agency’s public disclosure of such data supporting the approval of new drugs and biologics — when it issues an [emergency-use authorization] for a therapeutic or vaccine.” Notably, the GAO stated that increasing transparency “could help increase the public’s confidence” in the FDA’s decisions.
To the FDA’s credit, the agency has made its requirements for clearance of covid-19 vaccines publicly available and has committed to reporting company summaries of data as well as its own assessments of the data. Pfizer will also publicly present all safety and efficacy data that it submits to the FDA’s independent advisory committee overseeing vaccines.
But none of that is a substitute for making data on vaccine trials fully available. Companies’ desire for secrecy must not be allowed to override the need for transparency in public health.
As capable and thorough as the FDA’s scientists are, having more people scrutinizing the anonymized data can only be a good thing. To do that, the FDA and vaccine-makers must make participant-level trial data, along with trial protocols and other documents necessary to understand these data, accessible to the public. While publication of these materials in a peer-reviewed scientific journal will also be important, that process could take months, and these data need to be available for review as soon as possible.
The FDA has a real opportunity now to build public trust and strengthen the government’s response to the pandemic. Of the roughly 40 percent who say they are unlikely to be vaccinated, about half say they might reconsider once others get the vaccine and more information becomes available. In other words, more transparency can ensure that these much-needed vaccines will be administered not only across the country but also throughout the world.
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