BNT CEO Sahin looking confident. End of October prediction for BNT/Pfizer vaccine? "We're now end of Oct, beginning of Nov; that means it won't be long now till the first so-called read-out". 🤞 (My translation, watching tape from Fri night live interview) tagesspiegel.de/wissen/antrag-…
...*If* the effectiveness & safety data look good, Sahin ⬆️ expects lodging an application for FDA approval by mid-November; the process to clear pre-phase 3 data has already begun in Europe. First batches have been produced, but haven't cleared quality control yet.
...Ideally, Sahin said, antibodies would completely stop any of the virus getting into the cells, but you have to assume some virus will make it past them. That's when you need T-cells to step in & kill the virus, & make any disease milder. So a good vaccine needs to induce both
...Sahin said BNT developed 20 candidates at the outset: they picked 4 of those to go into the 1st clinical trial. 2 of them, b1 & b2, induced particularly good immune response, so they compared them to each other. Their immune response was similar, but b2 was better tolerated.
...I'd said a few days ago that I thought the BTN/Pfizer could be fully recruited this week. Sounds like it is, or as good as. Sahin said 44,000 participants had been injected with vaccine or placebo & they'll have 2 months' worth of safety data for half of them by mid-November.
...Interviewers pushing on the implications of moving this fast. Sahin said "We left nothing out". He said it usually takes months for regulators to green light a clinical trial, but they were in almost weekly contact so when it got to that decision point, it only took days.
..Sahin described EMA process (European Medicines Agency).They feed in data as soon as they get it & EMA assesses it "in real time".Q: will boosters be needed every 6 months, every year? A: Don't know.Based on what's known about immunity after infection, hopes for at least a year
...Interviewer asked him to tell the truth: has he been vaccinated? He said no, it would be against the rules, but as soon as he's allowed, he will...
...Now asking him about challenges of the cold chain logistics (the BNT/Pfizer vaccine has to be kept at minus 80 degrees, lasts at least 5 days after it's in a normal fridge). He gave a totally Germany-focused answer: eg maybe you'd always need to get it at a university hospital
...They're doing more tests to see if it could last for longer than 5 days in a normal fridge.
...Asked about political interference: Sahin said neither BNT (Germany) nor Pfizer (USA) can make a major decision alone & that provides protection against political interference. Asked about China: he said the Chinese regulator is being as diligent with them as EMA & FDA...
...Final question was, could the vaccine fail? Sahin said it's now out of their control, & he doesn't yet know the results of the trial, but he's optimistic - we'll know, he said, "in 2 weeks". / fin
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