Sumary of Pfizer applies for emergency coronavirus vaccine approval in U.S.:
- Regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until after a long, hard winter..
- and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study..
- Pfizer says final results show coronavirus vaccine is 95% effective, no safety concerns The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete..
- 2:09 Coronavirus vaccine distribution challenges Coronavirus vaccine distribution challenges – Nov 10, 2020 Friday filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready..
- About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week..
- Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot..
- On the safety side, the companies cites results from 38,000 study participants who’ve been tracked for two months after their second dose..
- That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict..
- They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom..
- For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?.
- EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL If there an emergency green light, “that vaccine is still deemed investigational..
- That why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers…