My comment to the FDA's Vaccines and Related Biological Products Advisory Committee meeting on the J&J vaccine EUA
The public can comment on the FDA’s committee meeting tomorrow (February 26th) to discuss the Emergency use Authorization for the Johnson & Johnson / Janssen vaccine candidate. Members of the public can submit comments via an online system here or via the mail. Attached is my letter. The main theme is transparency. The online system submission form sets a limit of 5,000 characters but this ended up being around 6,500 so it was submitted as an attachment.
To the VRBP Advisory Committee:
I am writing to request the FDA exhibit full transparency and show their cost-benefit calculations which justified such a long delay in approving the J&J/Janssen vaccine. Taxpayers deserve decisions that are made on the basis of rational cost-benefit analysis informed by the best science and data available. There is an incredible fog around key decisions that have greatly affected Americans during the COVID-19 pandemic - such as the FDA's decisions that made it hard for at-home tests to be approved, HHS & FDA decisions not to pursue or support human challenge trials, and the FDA's deadly decision to delay approvals of life-saving vaccines, most shockingly the AstraZeneca vaccine. With 2,000 - 3,000 Americans dying every day and millions of Americans desperate for life-saving vaccines (as evidenced by long lines across the country) it is only fair that taxpayers know the reasons for the FDA’s delays.
In a relentless pursuit of safety the FDA has ironically ignored the greatest safety concern to the American people - the SARS-CoV2 virus, and many have died needlessly as a result. Beyond normal expected utility based utilitarian calculations, the proactionary principle(s), developed by philosopher Max More and extended by Steve Fuller and others provide a good blueprint for conducting rational cost benefit analysis. It is my belief that the procedures the FDA have used to decide if and when to approve this vaccine have not utilized even the most rudimentary cost-benefit analyses, and lives have been lost as a result. I am open to changing my mind, however, if the FDA can produce a cost-benefit calculation that informed their decision making.
The interim Phase III collection period for the Janssen vaccine ended January 22 and they submitted their EUA application on February 4th. The American people have had to wait 22+ days for the EUA to be granted. Between February 4th - 26th, around 52,500 Americans will have lost their lives to COVID-19 (extrapolating the death rate forward 2 days from February 24th). In that time, countless others will have suffered under the ravages of the disease and the numerous sequela of “long COVID”. Even among those who have been lucky enough not to have their bodies invaded by the virus, most have suffered brutal economic and psychological effects from the pandemic.
As economist Tyler Cowen points out, it is a fallacy to think that manufacturing is the main bottleneck to getting life-saving vaccines to American people. Millions of doses of both the Pfizer and Moderna vaccines were available when the FDA finally approved them, showing that FDA approval was a larger constraint than manufacturing. While J&J may not have as many vaccines produced by February 26th as Moderna & Pfizer did at their EUA, if an expectation of an earlier EUA had been set by the FDA the company would have had a stronger incentive to ramp up production. It is incorrect to view the manufacturing and approval as independent - both are linked, with the timeframe set for one affecting the timeframe for the other. In economic terms, the elasticity of manufacturing to demand is not zero. Production of J&J's vaccine began long ago so they could provide vaccines for their Phase I/IIa trial which began on July 22, 2020. While the company has faced production setbacks, a GSA report (GAO-21-265) estimates they will have 2 million doses available on February 26th.
The government of South Africa announced on February 10th that they would start administering the J&J vaccine to frontline health care workers. Now imagine if the FDA had made the J&J vaccine available just two weeks prior and assume that 2 million doses could therefore be distributed two weeks earlier as a result. At the current monthly rate of deaths, the average american has a 1/9,410 chance of dying from COVID-19 every 2 weeks. The risk of dying from the J&J vaccine, by contrast, based on the Phase I/II data and our prior knowledge about similar vaccines, is at most 1/1,000,000 (likely an overestimate). Assuming the vaccine is 100% effective at preventing death from COVID-19 (a safe assumption based on the current science), delivery of 2 million J&J vaccines 2 weeks earlier could save 212 lives and reduce suffering in many more. However, this number is obviously an underestimate because the vaccines will be distributed to the elderly and those with pre-existing conditions first, who have a 10x - 100x higher chance of dying from COVID-19 than the average American. So, the true number of lives that would have been saved is in the ballpark range 2,120-20,120.
The FDA's decision to delay approval of the AstraZeneca vaccine by demanding additional American Phase III trial participants represents an even more egregious decision which surely cost thousands of Americans their lives. To be respectful of the purpose of the meeting at hand, however, I have restricted my discussion here to the J&J vaccine alone.
I ask that the FDA produce a cost-benefit analysis and clearly explain the reasons for the following decisions:
The reason the FDA did not allow the J&J vaccine to be made available via the FDA’s Expanded Access Program after excellent Phase I/II safety & immunogenicity data was published The Lancet on January 13th, 2021. (side note: see this article in STAT)
The reason the FDA did not recommend and/or advocate that those with a high risk of dying from COVID-19 obtain the J&J vaccine via the Right-to-Try pathway prior to EUA.
The reason the FDA, in October, created a requirement for a median 2 month follow up period in Phase III trials.
The reason the FDA decided not to recommend J&J use challenge trials to demonstrate the efficacy of their vaccine in a faster manner.
The reason the FDA decided not to allow pre-distribution of the J&J vaccine prior to EUA to speed up distribution.
The reason the FDA did not implement rolling reviews for the J&J vaccine.
The reason the FDA decided it needed 22 days to review J&J’s EUA application.
For each point, a cost-benefit calculation should be provided including a list of costs and benefits to the action vs the opposite action, ideally expressed in terms of quality-adjusted life years (QALYs) saved or lost.
Finally, I ask that in their communications and messaging the FDA focus on the efficacy of the J&J vaccine against hospitalization and death, especially against the South African variant, so Americans are informed first and foremost about the most important benefits of this vaccine.
Daniel C. Elton, Ph.D.