Rise and shine, everyone, another busy day is on the way. We can tell, in part, because our short person is hunched over a lap top for another round of remote learning and our official mascot is ceaselessly bounding about the grounds in search of squirrels and chipmunks. As for us, we are brewing cups of stimulation and foraging for items of interest, a never-ending process. Speaking of which, here are a few tidbits to help you along. As always, we hope your day is productive and enjoyable. Stay in touch and stay safe. …
The White House cast aside its objections and endorsed Food and Drug Administration plans for assessing whether a Covid-19 vaccine should be given to the public, making it likely that a shot will not be cleared until after the election, The Wall Street Journal reports. The FDA issued the guidelines soon afterward on Tuesday afternoon. The guidelines call for a two-month observation period to see whether people who got the vaccine had suffered negative side effects.
Meanwhile, dozens of leading medical experts are urging the FDA to adopt a stricter standard for tracking the safety of vaccine clinical trial participants, STAT reports. The FDA guidance says the agency will review Phase 3 data that includes a median follow-up of at least two months after a vaccination regimen to assess safety. But in a letter to the FDA, the academics and scientists argue that is not a high enough bar, because it would allow for fewer than two months of observation of some trial participants.
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