Gracias por darnos los bienos dias de esta forma :)
Gracias por darnos los bienos dias de esta forma :)
Resultados de 10mg y booster de 5mg para fin de año, imagino que podría ser en cualquier momento.
Now that the enrollment stage of Stage one part of the study, testing a 10-microgram dose of the parent strain is about to complete, we do expect to have our efficacy readout by year-end when we have accrued a significant number of cases -- a sufficient number of cases.
In parallel, the enrollment of Stage two of the study, testing a bivalent formulation of five-microgram parent strain and five-microgram beta strain has started this month. Let's now turn on the booster study at the lower part of the slide. It will assess the immune response in adults previously immunized with the vaccine using either mRNA, protein or adenovector technologies.
The first arm of the study is testing a five-microgram dose parent strain, and we do expect key data to also be available by year-end. As previously mentioned our aspiration is to develop a practical universal booster vaccine. They are more stable at normal refrigeration temperature and agnostic to which vaccine technology was previously used in the primary series.
El precio, sobre 10€ la dosis:
It will be a sort of EUR10. No change there. Now it's up to the Phase III readout that's coming pretty soon.
Sobre el combo gripe/covid
No de momento. Porque dice que no se ahorran visitas, que se hace todo en la misma. (Pero se ha visto que la del covid pierde eficacia, habría que ver en ya vacunados). Y porque hacen falta mejores vacunas de gripe. (Suena un poco a excusa pero no tiene sentido que no lo intenten al menos).
So your question is about the flu COVID-19 combination interest need versus clinical profile? For any combination, and you know that we know commissions fairly well as we are the worldwide leader of perfect combinations. We're always looking at what's the need for it, what problems are we trying to solve versus clinical benefit. In terms of need, we always look at what's the convenience. On convenience, you know that today, in most of the countries in the world, in one single visit, you can receive COVID-19 boosters and flu in the same visit. So you're not saving any visit.
Now on the second part is from a clinical profile perspective, what are we looking for? And as we've shared before, and as shown by the success of our growth of influenza differentiated vaccines, clearly, people are looking at superior influenza vaccines. So that's the bar to reach in terms of both safety and efficacy. So as I mentioned today in the presentation, that's something we're going to look at. Are we able with Flumarin to reach that clinical safety and efficacy bar and then we'll move on. But there's a lot to go there. We are very confident with the flu strategy we have in place, and we are looking forward to share it with you on December
Parece que el 1 de diciembre hay algo donde hablarán de vacunas. ¿Igual tienen resultados de covid para entonces?
Una pregunta más que interesante, ya que la vacuna viene en dos viales separados. Esto es un punto que debería destacar NVAX muy mucho. Y en la respuesta incide en que no hacen esto del covid para tener ingresos sino para ayudar...
First for Thomas. If I understand correctly, your recombinant COVID vaccine is presented in two vials, one for the antigen and one for the adjuvant. Therefore, don't you think that this presentation could seriously slow down the use of your vaccine being in a pandemic or booster -- or primary vaccination or booster, sorry? And do you plan to improve this presentation, if not already done, to have, for example, ready-to-use syringe?
So indeed, so COVID-19, the situation is evolving, and we are supplying and where we are needed. So we are trying to be relevant. What does that mean concretely? It means that the product we are developing is developed with our partners in Europe and North America. The express demand has clearly been about booster doses, not primary vaccination doses. And of course, back to your question, Jean-Jacques.
In terms of presentation, of course, all our partners know very well, but this is a vial of antigen and a vial of adjuvants that are premixed at bedside level. So that's very clear. It didn't prevent them at all, as I mentioned previously to place orders so that we can move forward in 2022 as soon as we have our Phase III readout. But I remind everyone again that as I mentioned initially, our contribution and our engagement in COVID-19 is not about the financial, it's about having an impact on the pandemic.
Creo que es uno de las mayores riesgos para Novavax.
O eso o el mismo día que anuncien sacan los datos a la vez Sanofi.....
Tengo ganas de entrarle pero se ha puesto cara, para mi estrategia, y me da miedo un nuevo barrido hacia abajo como acostumbrna a hacer antes de good news.
Certificados de GMP tanto de la MHRA como de la EMA para Novavax CZ y planta Fuji Diosynth UK.
1.200M de capacidad adicionales a los 2.000M del SII. Volamos cerca de los 4.000M de capacidad productiva.
Unce upon a time.....20 mesos ago
Una cosa es que la planta tenga el visto bueno para producir y otra este el producto final esté validado.
Hasta que no entreguen nueva documentación de otras plantas no estaremos seguros de que la validación está completada en esas.