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Msg  107221 of 116392  at  1/15/2021 10:13:42 AM  by

willix


Trial Participants on Placebo: What does Novavax say?

   After hearing from many of you on what was communicated on this subject, here is a recap of what I heard:
 
 "They expressed hope that 2373 would get an EUA prior to us being offered the Moderna shot."
 
 "When I become eligible for the vaccine, which should be approx Feb 1 (65 - 75 yrs) am a to call the clinic and they will un-blind me. If I am in the placebo group I will be offered the vaccine. They emphasized that they want to keep me in the trial. Otherwise, if I drop out my data will be deleted from the study."
 
"If you become eligible for the shot, we will ask you to wait for 6 months and then we will un-blind you and give you the Novavax vaccine if you are on placebo."
 
If you become eligible for the other vaccines, we will un-blind you and schedule you to come in to get the actual vaccine if you are on placebo.
 
If you become eligible, we ask that you wait for 35 days, at which time we will un-blind you and give you 2373 at that time if you are on placebo.  You would then come in on the 21st day and get your second dose.
 
"If approved in GB, approval would be imminent in the US. At that point, the placebo arm will be “probably” be offered the vaccine That’s what I was told by the attending."
 
And lastly, here is what Novavax communicated to me:
We're talking to the FDA.  As soon as something is decided, we will let all participants know, but we don't know when that will be.
 
     I believe that they really don't have a clue, can't make any plans for anything, don't want to risk rubbing them the wrong way, and are just going about their business with the trial as planned.  I think that since they were so late getting started, they determined that waiting for the FDA or whatever group is making this decision has shown no clarity and it was not in Novavax's interest to delay the trial any further.  I think the chances are most likely that the UK trial and likely EUA from there being the basis for the EUA application and approval here will make the decision mute and they will be able to convert everyone who has received the placebo to get the actual vaccine before the general public if that fits into the Biden administration distribution plan.  Whether that is by the end of February or as soon as the UK trial announces their read out or EUA, or the US decision makers finally make a decision in advance of a US approval is anybody's guess.  In my opinion that deciding group needs to convert the trial to a monitoring trial though as soon as the UK EUA is granted, as at that point the ethics of the keeping the placebo group off the vaccine vanish.  
 

 


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