Novavax Phase 3 COVID-19 Omicron Trial Results(nvax 二阶)

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Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster

Nov 8, 2022

The Novavax BA.1 vaccine candidate met its primary strain-change endpoint allowing for development of variant vaccines, if necessary
Novavax' prototype vaccine induced broad immune response against original Wuhan, BA.1, and BA.5 strains
The trial showed no benefit for a bivalent vaccine utilizing Novavax' recombinant protein/adjuvant technology

GAITHERSBURG, Md., Nov. 8, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced topline results from its Phase 3 Boosting Trial for the SARS-CoV-2 rS Variant Vaccines (COVID-19) showing that the Company's BA.1 vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint. The data demonstrate that the BA.1 vaccine candidate neutralizing responses in those not previously exposed to COVID-19 were greater than those of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if necessary (see chart 1).

Additionally, data show no benefit for the Novavax bivalent vaccine candidate compared to the BA.1 vaccine candidate or prototype vaccine in the overall trial population. Immunoglobulin G (IgG) antibody responses against BA.1 and prototype strains showed similar responses across the three vaccine groups (prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype + BA.1 vaccine candidate [n=277]).* Importantly, for the BA.5 strain (which is structurally similar to BA.1), pseudoneutralization responses demonstrated that there was no benefit for the BA.1 or bivalent vaccine candidates compared to the prototype vaccine.**

Overall, the data demonstrated that the prototype vaccine induced a broad immune response against original prototype, BA.1, and BA.5 strains. The prototype vaccine induced robust IgG responses to both BA.1 and the matched prototype strain.* Pseudoneutralization responses against BA.5 for the prototype vaccine were comparable to those induced by the more closely matched BA.1 vaccine and bivalent vaccine candidates.*

"Today's results show that use of our prototype vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains. This is a hallmark of our vaccine technology and shows the suitability of our current prototype vaccine as a booster even as the COVID-19 landscape continues to evolve," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "Our vaccine, which provides broad immune response even in the face of evolving variants, presents a potential strategy to protect against COVID-19 now and into the future."

When given as a second booster dose (fourth dose), all three vaccine formulations were similarly well-tolerated, consistent with the well-established safety profile of the prototype vaccine. The most common local solicited symptom was pain/tenderness (BA.1 69%, prototype 71%, bivalent 65%). The most common systemic solicited symptoms were fatigue and malaise (BA.1 45%, prototype 41%, bivalent 45%), headache (BA.1 38%, prototype 35%, bivalent 36%), muscle pain (BA.1 25%, prototype 24%, bivalent 24%), and joint pain (BA.1 10%, prototype 11%, bivalent 6%), with the majority of reactions being mild or moderate.

Chart 1: Geometric Mean Ratio of BA.1 wild-type Neutralizing Responses (Day 14) Study Arm in Participants Not Previously Infected

	Group Comparisons
Neutralizing antibodies for BA.1	BA.1 vaccine to prototype vaccine	Bivalent vaccine to prototype vaccine	Bivalent vaccine to BA.1 vaccine
Geometric Mean Ratio (GMR)	1.6	1.2	0.7
GMR 95% Confidence Interval	1.31, 2.03	0.94, 1.44	0.57, 0.89

*IgG responses are not statistically significant.
**Fit-for-purpose analysis being confirmed with validated assay.

About the Phase 3 Omicron Trial
Novavax' Phase 3 Omicron trial is a two-part, observer blinded, randomized trial to evaluate Omicron subvariant vaccine candidates. NVX-CoV2515 (BA.1) and bivalent (NVX-CoV2373 + Omicron subvariant NVX-CoV2515) vaccine candidates were compared to NVX-CoV2373 in adults aged 18 to 64 previously vaccinated with three doses of mRNA vaccines. All formulations include the Matrix-M™ adjuvant to enhance and broaden the immune response. The trial is evaluating the reactogenicity and immune responses to all three formulations. The trial's primary endpoints include measures of immune response, and its secondary endpoints include additional measurements of immune responses and safety measures. The trial plans to enroll 2,090 adults aged 18 to 64 across 19 sites in Australia。

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