Hello, everyone, and how are you today? We are doing just fine, thank you. Clear, blue skies and comfortable temperatures are enveloping the Pharmalot campus, where our short person is, once again, hunched over a laptop in pursuit of some learning, while our official mascot is being walked about the neighborhood. This gives us time to fire up the coffee kettle and brew a cup of stimulation — our choice today is coconut. We have also gathered a few items of interest to help you get started this morning. We hope all goes well today and that you conquer the world. Meanwhile, do stay in touch. We enjoy your tips and feedback. …
A Food and Drug Administration advisory committee is meeting Thursday to consider whether the agency should authorize emergency use of the Covid-19 vaccine developed by Pfizer (PFE) and BioNTech (BNTX) that appeared to be highly efficacious in a Phase 3 clinical trial, STAT notes. If the panel recommends emergency use, and if the FDA follows the advice, the rollout of Covid-19 vaccine will begin within a few days in the U.S. Earlier this week, the U.K. started using the vaccine and Canada’s drug regulator approved emergency use. (Live updates will be here.)
Johnson & Johnson (JNJ) is cutting the size of its pivotal U.S. Covid-19 vaccine trial — the only major study testing a single dose of a Covid vaccine — from 60,000 to 40,000 volunteers, STAT reports. The change is being made possible by the fact that Covid-19 is so pervasive across the country. The more virus there is in the U.S., the more likely it is that participants will be exposed to it, meaning researchers will be able to reach conclusions based on a smaller trial.
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