Interesante resumen de la llamada de ayer:
Refer to the following that Sarel Oberholster, SA Author, summarized the Cantor Global Healthcare Conference 2021 today
1. We are preventing COVID illness. Greg.
2. Grown from 150 personnel to over 1200 and still growing.
3. Covid virus here to stay, particularly infectious & virulent, expected to continue to evolve.
4. Vaccination rates globally still very low, still pandemic.
5. Clear ongoing need for revaccination.
6. Mentions the importance of the unique Novavax adjuvant Matrix M which give Novavax a commercial edge and is underappreciated.
7. The Novavax platform goes beyond just COVID.
8. Glen," We don't have a dose limiting toxicity", we could increase dose until we could no longer increase immune response and still had no safety issues, in achieving the maximum efficacy. We can operate in this maximum efficacy/maximum immune response space but the "mRNA can't do this" as pushing up the mRNA dose has safety issues.
9. The full length spike protein and adjuvant technology "no-one makes it as well as we do" and that is why the Novavax vaccine works so well against variants while still being safe, over the long haul this is going to prove a real winner.
10. Broadly protective immune response technology with the vaccine showing the immune system the full length spike protein and allowing the immune system to still "see" unchanged portions of the spike protein even when the virus is mutating.
11. Release assays caused the delays but have been resolved and validated. Process of testing those assays against final product in preparation for final CMC packages. Interactive conversations with regulators across the globe. Now have "alignment" which he indicates is not "approval" but as close to approval one can get before submission. It should facilitate early approvals.
12. Filings now shortened from "next couple of months" to "next month or so" where all filings will happen in a condensed period of time. FDA EUA application may be the later stage one but it will be EUA.
13. Quality control systems had to be built from scratch, is done, but it added to delays. Testing the lots now.
14. The UK trail was done with 50l scale material and the US trial was done with 2000l scale material with highly consistent vaccine performance and data. Commercial product will be comparable to trial product.
15. Confident that they can boost on top of someone else's vaccine and get a better immunogenicity profile. Also expects a lower reactogenicity (better safety profile).
16. Expect data on 12-18's by end of year.
Reactogenicity. In clinical trials, the term reactogenicity refers to the property of a vaccine of being able to produce common, "expected" adverse reactions, especially excessive immunological responses and associated signs and symptoms, including fever and sore arm at the injection site. Other manifestations of reactogenicity typically identified in such trials include bruising, redness, induration, and swelling.