@ducky has kindly again shared summaries from her COVID-19 reading this week! https://covidbc.webfoot.com/2025/05/24/2025-05-24-general/
Highlights:
the [FDA] anticipates requiring large randomized controlled trials with the controls getting a placebo for all vaccines — even for just updating the strains used in previously approved vaccines. (Yes, giving some participants an ineffective treatment when an effective treatment is known is highly unethical.)
This modern globalized life, with high velocity human transportation, requires guardrails not necessary at a plod. Influenza and SARS-CoV-2 simply recombine and mutate too frequently to do studies with 12-month endpoints, and the policy announcement she cites says they will
demand robust, gold-standard data on persons at low risk
which, if they choose, could be taken to mean longitudinal studies
1/