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Phase 1 will include healthcare personnel (HCP), other essential workers, high risk adults, and adults over 65. Phase 1 has 3 tiers: 1a (highest priority), 1b and 1c.
FDA summarized recent VRBPAC meeting. VRBPAC members agreed that current FDA guidance is the absolute minimum to issue EUA. Some members recommended longer safety follow-up, and continuation of trials with placebo group as long as feasible. 2/
Process overview: the Covid-19 Work Group will review phase 3 efficacy/safety data and present policy options to ACIP. An emergency meeting will occur when FDA authorizes a vaccine, and ACIP will vote on recommendation. It could be more targeted than FDA indication. 2/9
👉Moderna reviewed published phase 1 results. Their phase 3 has enrolled 13K (18% nonwhite).