Washington Post: “A dozen former leaders of the Food and Drug Administration warned Wednesday that plans for a stricter approach to vaccine approvals risk undermining the nation’s ability to fight infectious diseases and could threaten the health of vulnerable Americans. In the New England Journal of Medicine, [subscription req’d – title is A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA], the former FDA commissioners wrote that they were “deeply concerned” with plans the nation’s top vaccine regulator, Vinay Prasad, laid out Friday in a leaked internal email. They argued that his approach represents a major shift that could delay the arrival of vaccines better matched for evolving viruses, make it potentially prohibitively expensive for new shots to come to market, and slow expanded approval of vaccines for more people.

Quote from the leaked FDA email authored by Vinay Prasad MD MPH CBER Director, CMSO US FDA – “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…”

See also CIDRAP – FDA official proposes ‘impossible’ standards for vaccine testing that could curtail access to immunizations