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  • 00:00What we through what we've learned in the last 20 minutes or so. So we have just received the Food and Drug Administration staff report on the Pfizer violent CAC vaccine. And what we're finally seeing is the actual nitty gritty details of the findings of the trial. Of course everybody is hearing 95 percent efficacy rate which is great news. In fact what they don't give a specific number what they give is a range. And they say that that on average they're thinking about 95 percent. In fact it could be over 97 percent effective more significantly than that. There are things like they are getting fewer adverse events in older people. Very unexpected. Normally older people are more vulnerable. So you would see more harm in those kind of people. And not only that we're now seeing some evidence about what might happen after just one shot. Michelle is the Federal Drug Administration is it politicized right now or is it a political. Well the Food and Drug Administration has been very very definitive that they are not going to allow any politics to come into play in this particular IBEX. Not only that they are saying they're sticking with the way they do it to the political dismay of some folks for example requiring this advisory committee hearing. Right. What we're talking about now is the FDA staff report that in two days we're going to have an outside panel of experts weighing in on this entire report. Some people are saying why do we need outsiders. Let's just get it done. It looks great. There's no terrible side effects that we're seeing. The efficacy is very high. Why do we need to have other people weighing in. Why are you taking our time to look at the UK. They've done it. Let's go. And the FDA is saying not only that we're not going to cut any corners here we're going to do it all correctly. We're not going to approve this. We're going to issue an emergency use authorization which means we're going to allow people to use it. If we find safe but you don't actually have full approval and we can pull out at any point if something bad happens. So they are sticking to every little bureaucratic detail here. They're just doing it at unbelievable hyper speed. OK. Michelle so let's fast forward and get a sense of what this means for Thursday's meeting and beyond. What are you looking for to determine their reticence to push forward with an accelerated plan of rollout beyond just emergency use. Well in terms of we're going to start rolling it out when an emergency use comes right the panel is expected to recommend for approval or or for authorization. On Thursday we're expecting you go forward. We're not. I we're going to get through the weekend without a decision from the FDA. So on Monday I think most people are thinking we're going to start seeing some distribution. What they're looking for in this document. Right. Ninety two pages. Ninety two pages is the executive summary. There's tens of thousands of pages of the trial. What they're looking for is any indication it did anybody have an unexpected side effect. Did anybody you know develop some kind of multiple sclerosis some kind of a cancer or some kind of a heart attack. Did anything happen that could potentially be harmful caused by the vaccine. And they're going to dig into every single possible risk that they found in this trial of over 40000 people to see if there's any indication here.
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Pfizer Vaccine Safe and Effective, FDA Staff Concludes

  • Bloomberg Surveillance

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December 8th, 2020, 1:54 PM GMT+0000

Pfizer and BioNTech's vaccine is highly effective in preventing Covid-19 and there are no safety concerns that would prevent the shot from being granted an emergency-use authorization, according to a U.S. Food and Drug Administration staff report. Bloomberg's Michelle Cortez has the latest on "Bloomberg Surveillance." (Source: Bloomberg)


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