@Pharma_Pro @SteveFDA @US_FDA Agree, Daniel. But, isn't there a history of BLAs/NDAs being approved for drugs meant to treat large population without AdCom mtngs/over-ruling AdCom vote? I am asking for issuing EUA for the 2 vaccines asap with only FDA review so that they could be started to be given asap..1/
@Pharma_Pro @SteveFDA @US_FDA ...and still have the AdCom meeting on the 10th Dec (to decide whether to keep or revoke the EUA) as well as in say 6 months to determine if the EUA should be kept/revoked based on real-world safety and effectiveness data, and even prior to a BLA, which is rarely revoked..2/
@Pharma_Pro @SteveFDA @US_FDA ...Considering what we are going to expect massive 4th #COVID19 wave during Christmas period due to mass get together during Thanksgiving, it is even more important that especially healthcare workers and the elderly are vaccinated a day after Thanksgiving. ..3/
@Pharma_Pro @SteveFDA @US_FDA ...Not many would be vaccinated between now and Dec 10th so the risk of say what happened in 1976 with the swine flu vaccine is low. As you know active EUAs are very frequently reviewed with every submission of real-world data so there is plenty of opportunities to revoke EUAs 3/
@Pharma_Pro @SteveFDA @US_FDA @threadreaderapp please unroll
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