Dose Data News Today

To apply for authorization. there was an add layer as you mentioned, which is that they were encouraged to apply for authorization which gives a sense that the regulators have seen something encouraging in the date. a the only thing we heard until today, late last night, was that the two doses in children between amings of 2 and 5 did not seem to be generating a strong immune response. so i dont know if the regulators are saying were very encouraged that a third dose will be enough to generate t...

Two-dose vaccine ages -- for the higher range, 2 to 5 or 2 to 4, didnt show much antibody production or didnt show much increase in boosted immunity. totally safe. they found it was totally safe which is why theyre willing to give an authorization right now, but whats interesting to me is why move forward until theyve seen data that its protective? >> yeah. that is the big question. i think for up until just recently i think the thinking was lets wait to see what that third dose data sort of sho...

Much of an immune response, it is safe so we should get started on getting shots into kids arms. one quote from the "washington post" on this. we know two doses isnt enough and we get that, says one of the people familiar with the situation. the idea is, lets go ahead and start the review of two doses. if the data holds up in the submission, you could start kids on their primary baseline months earlier than if you dont do anything until the third dose data comes in. what do you think of that? >>...

Pfizer to submit their two dose data to them for authorization, they said in part this afternoon that the fda felt it was their responsibility as a public health agency to act with urgency and have all available options including they provide us with initial data on two doses from the on going study, their goal was to understand if two dose was provide sufficient protection. remember, we had press release information already in december from pfizer that said, you know, there two dose regimen in ...

Needed. the surge in omicron cases also brought on a flood of new data that led them to their decision today. >> makes sense for us to wait until we have the data from evaluation of a third dose before taking action. >> pfizer and its research partner bion tech issued this statement given that the study is advancing at rapid pace, the companies will wait for the three dose data as pfizer and bion tech continue to believe it may provide a higher level of protection in this age group. the companie...

In reviewing that data, the fda made a determination that they would rather see true efficacy numbers an effectiveness. they may actually not just need to rely on this but look at actual cases to determine whether or not they want to move forward with an authorization or approve this request for expansion of their data. >> so is it as simple they know two doses are not cutting it and they need to make sure that they can test that three dose dozen? >> they have a lot of pushback for even approval...

(0) DGAP-News: Immunic, Inc. / Key word(s): Study results Immunic, Inc. Announces EMPhASIS Interim Analysis of 10 mg Cohort Confirms IMU-838s Dose Response in Relapsing-Remitting Multiple Sclerosis and Supports Phase 3 Dose Selection 15.04.2021 / 12:30 The issuer is solely responsible for the content of this announcement. Immunic, Inc. Announces EMPhASIS Interim Analysis of 10 mg Cohort Confirms IMU-838s Dose Response in Relapsing-Remitting Multiple Sclerosis and Supports Phase 3 Dose Select...