Danke für die Mitschrift @meikel123 #9544!
Aktuelle Einschätzung seitens Biontech (Stand 10.05.2021): Sollte viele Fragen zur Wirkung und möglichen Anpassungen des aktuellen Comirnaty Version gegen Mutanten klären! Zusammengefasst: 1. hohe Wirksamkeit gegen alle bekannten Mutationen (auch Nachweise aus dem Feld - Israel & Qatar 2. Anpassung aktuelle Comirnaty Version aktuell nicht notwendig. Falls notwendig, wäre nur eine Minimalanpassung der eigentlichen "Mustervorlage" des Impfstoffs nötig, die keinen Einfluss auf die Produktion hätte, da schnell und einfach umsetzbar!
"Operator
Your next question comes from Tazeen Ahmad from Bank of America.
Tazeen Ahmad
For me, I wanted to just ask a little bit more about the booster. Ugur, are you thinking that the booster for the original formulation that you have manufactured for the Wuhan variant would be sufficient for future protection? Or do you think that the rate of change of each of the variants would necessitate any kind of change to the actual vaccine itself? And is it the latter? If you do have to modify the vaccine, how in any way does that change your rate of production plans for the need of boosters starting, let's say, next year and beyond?
Ugur Sahin
At the moment, we don't see a need for changing our vaccine. As you know, we have done – in the last six months, we've evaluated more than 30 different variants and evaluated immune responses, antibody response induced with the virus type vaccine for neutralization and we see for the most variants almost equal neutralization. We have in the meantime also real world data for the activity of our vaccines. For example, against the UK variants that are more than 90%. In the Israel real world data, almost 90%. From real world data from Qatar – and we have also seen last Friday a publication showing you real world data from Qatar showing that our vaccine is able also to prevent infection, PCR confirmed infection with a 75% of effectiveness.
We have also seen in our laboratory experiments that increasing the neutralization antibody titer, besides also an also an increase of neutralizing antibody titer and almost normal neutralization antibody titers against, for example, South African variant. So, at the moment, we don't see any reason to adapt our vaccine, but we are working on establishing a process and the regulatory framework by executing a blueprint [indiscernible] to ensure that.
And potential change to a new variant would only impact as far as we can see at the moment just the DNA template without changing any other process, the manufacturing process appears to be absolutely robust for all kinds of variants. So, that means once we have a decision for a new variant, we can just change the DNA template, and without losing any production capacity, come up with supply of the new variant vaccine." |