Here's the thrust of his memo wrt regulatory path moving forward.
The path forward for CBER/OVRR/OBPV
I want to outline a path forward. Our general approach in CBER will be to direct vaccine regulation towards evidence based medicine. This means: we will take swift action regarding this new safety concern, we will not be granting marketing authorization to vaccines in pregnant women based on unproven surrogate endpoints (any prior promises will be null and void), and we will demand pre-market randomized trials assessing clinical endpoints for most new products. Pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting), and not merely generate antibody titers. Immunogenicity will no longer be used to expand indicated populations — these populations should be included in premarket RCTs.
We will revise the annual flu vaccine framework, which is an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods. We will re-appraise safety and be honest in vaccine labels. I look forward to hearing your thoughts on how to do this better.
Additionally, at FDA, we have not been focused on understanding the benefits and harms of giving multiple vaccines at the same time. This is a concern shared by many Americans. The FDA’s standard has been to require randomized studies too small to draw any conclusions from — creating a false sense of efficacy and safety.
OVRR and OBPV staff will be tasked with writing guidelines to reflect these changes, and the mission of CBER will change to reflect this worldview. Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it. Vaccines will be treated like all other medication classes — no better or worse than AAV vectors, monoclonal antibodies, or anti-sense oligonucleotides.
Insofar as vaccines have third party benefits, and many do, these will be judged just like drugs may have third party benefits — a person who takes an appropriate psychiatric medicine may be a better parent or spouse — but this requires data and cannot be assumed. I have seen no evidence that COVID-19 vaccines, which do not halt transmission, benefit third parties. I have no doubt that MMR vaccines do provide third party benefits when administered to high enough fractions of society.
Having said this, I remain open to vigorous discussions and debate on these topics, as I have always been. I am open minded to modifications or alterations. As you can imagine, I believe these debates should be private, internal to FDA, until they are ready to be made public. I don’t endorse selective reporting of our meetings and documents. Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor and CC my deputy Katherine Szarama.
For those who choose to remain in CBER, I look forward to working with you, learning from you, discussing with you, and interacting with you on our shared mission: to elevate vaccine science to 21st century evidence based medicine.