Hahn said the FDA is looking at the manufacturing data, specifically the quality around manufacturing, the clinical data that shows whether the vaccine is safe and effective and the data surrounding adverse effects. The U.S. Food and Drug Administration (FDA) is set to meet on December 10 to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the Europe... [Full Article...]
A study published on Monday by agency researchers identified 106 infections among 7,389 archived blood samples drawn from individuals in nine different states between December 13, 2019, and January 17, 2020. "Remember when the 14-day quarantine was set up, it was very early in the pandemic when we had less information", says Michael Osterholm, a member of the Biden COVID-19 advisory board. [Full Article...]
Dr Varon , who had been working his 252nd consecutive day on the Covid ward, said that despite the pain and heartache he has been witnessing during his work, he has surprised himself by how he has coped. "When you are an elderly individual, it's more hard because you are alone", he said. "Some of them try to escape", he said. "We actually had somebody who tried to escape through a window the ot... [Full Article...]
Experts caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed. Panel member Dr. Beth Bell of the University of Washington highlighted that on average, one person is dying of COVID-19 per minute in the USA right now. [Full Article...]
Six Ontario schools are now closed and 14 per cent (or 671 of 4,828 sites) have a reported case. Ford says he is seeking information on how much of what vaccine the province will receive and a clear delivery date. Toronto is reporting more than 300 fewer cases than the 727 reported a day earlier. The health unit has also reported two probable cases that are under investigation. [Full Article...]
The agency said on Tuesday it would decide by December 29 whether to provisionally authorise the vaccine from US drugmaker Pfizer and its German partner BioNTech . German MEP Pieter Liese weighed in to insist individual EU member states could have authorised the vaccine but had chosen to wait for the European Medicines Agency (EMA) to examine more information rather than follow the "hasty" ... [Full Article...]
Speaking in the Commons, Mr Hancock said: "We can afford to let up a little, we just can't afford to let up a lot". It means people could have greater freedoms in tiers from Wednesday, he said. These regular moves help to bring down the tiered system of restrictions. "I want this massive diagnostics capacity to be core to how we treat people in the NHS so that we help people to stay healthy in ... [Full Article...]
That's when the woman's mother and sister intervened, beating the man with a golf club and stabbing him, a sheriff's department news release says. South Pasadena officers responded to a home on Five Oaks Drive around 10am after receiving a call about a domestic violence incident. [Full Article...]