Zu Deiner Frage bzgl. Omicron, hier Informationen aus dem Transcript:
...For Booster vaccinations, we believe waning immunity and the emergence of variance will fuel an ongoing need for booster doses, and we're building a body of evidence that our vaccine, which induces broad immune responses to variants, including Omicron will be an important option for boosters. Existing data demonstrates that 2373 is capable of boosting a homologous and heterologous primary vaccination series with a favorable tolerability profile. In pediatric populations, we believe 2373's overall product profile positions our vaccine as a desirable future alternative in a rollout of pediatric vaccines globally.
...Turning to Slide 14. So I want to talk about the data generated from Novavax led trials and others, demonstrating 2373 strong potential as a booster. Our Phase II study in the U.S. and Australia has recently shown that a third dose induces strong and functional immune responses, including against new emerged variants such as Omicron. I'll discuss these data in more detail on the following slide. In the CoV-Boost study run by the University of Southampton, showed that 2373 is suitable for use following primary vaccination with mRNA or viral vector vaccines. This builds the case that 2373 can be used as a booster on top of other primary vaccine regimens. And further, we have additional ongoing booster studies through which we expect to generate important data in 2022. This includes our PREVENT-19 Phase III study, which we believe could be label-enabling for both homologous and heterologous boosting indications. And as we expect strong demand for boosters to continue globally, pursuing label indications and policy recommendations for 2373 as a booster will remain a top priority in the first half of 2022.
...And after a third dose at 6 months, there's a significant increase in IgG against all variants, including Omicron, several fold above what was associated with strong efficacy after 2 doses.
...Moving to Slide 16. So additional data from our Phase II U.S., Australia trial showed that we induced robust functional immunity as measured by hACE2 receptor binding blocking antibodies, which is a stringent functional measure of immune responses. After 2 doses, we observed immune responses against all variants. And after a booster at 6 months, we see 100% seroconversion against all variants with the magnitude of immune responses greater than the peak observed after 2 doses, where we saw high levels of efficacy in Phase III trials. These data present an encouraging picture for 2373 use against Omicron and other circulating variants.
...Let's turn to Slide 17. In addition to primary boosting -- primary vaccination and boosting, we believe 2373 can play a major role in the pediatric segment globally. In our PREVENT-19 Phase III pediatric expansion. We evaluated 2373 in adolescents age 12 to 17 and initial findings from the study demonstrated functional immune response after 2 doses that are 2.4 to 4x higher than in adults including against the Delta and Omicron variants. We believe these initial findings will support 2373's future use in pediatric population, and we believe it will provide broad cross protection for adolescents during continued viral evolution. We expect to submit the adolescent data to global regulatory agencies in this quarter.
...We initiated development of an Omicron-specific vaccine last month within days of the variant being identified and began GMP manufacturer that same month. Our response to the Omicron variant demonstrates a hallmark of our vaccine, our ability to rapidly develop and scale a strain change, if and when one is needed. We expect to initiate clinical studies in this quarter, and we believe that developing the vaccine through a strained change approach may create a pathway to licensure. While we will be prepared to switch to a variant-strained vaccine based on Omicron, it's too early to say whether that's the right approach or whether 2373 generates a sufficiently broad protective response and simply use 2373 as a boost for the foreseeable future. Over time, data will help us answer that question.
www.sec.gov/Archives/edgar/data/1000694/...22428d1_ex99-1.htm