The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Arlinda Anna Lee - Canaccord Genuity Corp., Research Division - Analyst
: Congratulations on the impressive efficacy, and thank you for the tremendous effort to get here so quickly. I had a few questions about 162 and
then also 311. I guess I'm curious on the dose guidance. The 1.3 billion doses from -- for next year, does -- that guidance doesn't seem to have
changed. So I'm wondering if the Marburg facility is included in that?
And then on the logistics of delivery, there's some debate in the U.S. about allocations. And I'm curious when you deliver the 100 million doses to
the U.S., are you delivering to the sites per -- based on where they tell you to go or how does that work?
And then on 4-1BB with the conditional activity, I am wondering, one, how did you decide on the expansion cohorts? And if that conditional activity
is something that you're planning to work into some of your other programs as well?
Question: Arlinda Anna Lee - Canaccord Genuity Corp., Research Division - Analyst
: Okay. Thank you. And then on the logistics of delivery, I'm just curious about how you're going to deliver it to the U.S.? And whether you're going
to give it to the sites, in particular, as U.S. direct, or how does that work?
Question: Zhiqiang Shu - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: And I want to add my congrats as well to the team. It's definitely a critical moment for mRNA and for BioNTech.
A few questions on the COVID-19 vaccine. So the first one is I'd like to know what was the initial rationale for the protocol change from 32 cases to
62 cases for the first interim analysis? And then secondly, I assume that once you reach the final efficacy analysis, you would unblind the trial. I
wonder how would you reassure fair assessment of long-term protection and safety once you unblind the trial?
And then also, I'd like to understand the -- for booking sales, I remember -- I recall, there are a few countries that you would take the sales -- book
the sales for a few European countries. Would you disclose those countries at this time?
And then finally, for the oncology, I have a quick question on BNT111 plus PD-1 study that -- you mentioned in your press release that you would
conduct additional trials for registration. Can you provide more color on that? Why do you think that will be the case? And then for -- can you
remind us the -- to randomize the arms for the -- for that trial, BNT111 plus PD-1?
Question: Zhiqiang Shu - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst
: Great. And then one question. I asked about the assessment of long-term protection if the trial is unblinded. Can you comment on that as well?
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