Hello, everyone, and how are you today? We are doing just fine, thank you, now that the Pharmalot campus has settled down. The short person is hunched over the laptop and the official mascot has finally withdrawn to the official snoozing corner. This means we are free to pursue the important tasks — brewing cups of stimulation (our choice today is blueberry) and foraging for items of interest. Speaking of which, here are a few tidbits. We hope your day goes well and you survive any tumult. Meanwhile, stay in touch and stay safe. …
Food and Drug Administration staff said that data on the Pfizer (PFE) Covid-19 vaccine were in line with its guidance on emergency use authorization, raising hopes it could soon be available to Americans aged 16 and older, Reuters says. The comments were made in documents released ahead of a meeting on Thursday of an FDA advisory panel to discuss whether the vaccine, which was developed with BioNTech (BNTX), should be authorized for emergency use. The FDA is expected to decide whether to authorize the vaccine within days or weeks.
Before the Pfizer Covid-19 vaccine proved highly successful in clinical trials last month, the company offered the Trump administration the chance to lock in supplies beyond the 100 million doses the drug maker agreed to sell the government as part of a $1.95 billion deal over the summer. But the administration never made the deal, The New York Times reports, a choice that now raises questions about whether the U.S. allowed other countries to take its place in line.
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May I observe that todays’ last line clarifies yesterday comment? Oh, those PDUFA dates: “Pandemic-related travel restrictions have hampered inspections and, in some cases, have caused the agency to miss its Prescription Drug User Fee Act (PDUFA) action dates.”