Novavax prototype seedlings can be used as a booster

Novavax, Inc.
(NASDAQ: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation severe infectious disease vaccines, announced on November 9 the top-line results of its Phase 3 Enhancement Trial of the SARS-CoV-2 rS variant (COVID-19), indicating that the company's BA.
1 vaccine candidate (NVX-CoV2515) met its primary strain endpoint
。 These data suggest that BA.
1 candidate vaccines are more capable of neutralizing and responding in people not exposed to the novel coronavirus (NVX-CoV2373), allowing them to switch to new variants if necessary (see Figure 1).

In addition, the data showed no benefit
of Novavax bivalent candidate compared with BA.
1 candidate or prototype vaccine in the entire trial population.
The response of immunoglobulin G (IgG) antibodies to BA.
1 and prototype strains showed similar responses
in three vector groups (prototype [N=273], BA.
1 candidate [N=279] and bivalent-prototype + BA.
1 candidate [N=277]).
*Importantly, for BA.
5 strains (structurally similar to BA.
1), the pseudo-neutralization response showed no benefit
of BA.
1 or bivalent candidate compared to the prototype vaccine.
**

Overall, the data suggest that the prototype vaccine elicited a broad immune response
against the original prototype, BA.
1 and BA.
5 strains.
The prototype vector induces a strong IgG response
to BA.
1 and matching prototype strains.
*The pseudo-neutralization response to BA.
5 prototype seedlings was comparable
to that induced by more closely matched BA.
1 and bivalent candidates.
*

Gregory M.
Glenn, MD, President of R&D at Novavax, said: "Today's results suggest that using our prototype as a booster can induce cross-reactive responses to various variants and potentially prevent future strains
.
This is a hallmark of our seedling technology and shows the suitability of our current prototype as a booster, even as the coronavirus pandemic
continues.
Our vaccines, which provide a broad immune response even as virus variants continue to evolve, offer a potential strategy
to protect current and future protection from COVID.
"

When administered as a second booster dose (total fourth dose), all three doses were equally well tolerated, consistent with the established safety
profile of the prototype vaccine.
The most common local causing symptom was pain/pain sensation (BA.
1 69%, prototype 71%, bivalent 65%)
.
The most common systemic symptoms were fatigue and restlessness (BA.
1 45%, prototype disease 41%, bivalent disease 45%), headache (BA.
1 epidemic 38%, prototype disease 35%, bivalent disease 36%), muscle pain (BA.
1 epidemic 25%, prototype disease 24%, bivalent disease 24%) and joint pain (BA.
1 epidemic 10%, prototype disease 11%, bivalent disease vaccine 6%), most of the reactions were mild or moderate.

*The IgG response was not statistically significant
.

**Coordinated use analysis has been confirmed
by validation analysis.

About the Phase 3 Omicron trial

Novavax's Phase 3 Omicron trial is a two-part blinded randomized trial of observers to evaluate Omicron subvariant candidates
.
NVX-CoV2515 (BA.
1) and bivalent vaccine (NVX-CoV2373 + Omicron subvariant NVX-CoV2515) vaccine candidates were compared
with NVX-CoV2373 in adults aged 18 to 64 years who had previously received three doses of mRNA vaccine.
All formulations include Matrix-M™ adjuvants to enhance and expand the immune response
.
The trial is evaluating regenerative genicity and immune response
to all three formulations.
The primary endpoint of the trial included measures of immune response, followed by additional measures of immune response and safety measures
.
The pilot plans to recruit 2,090 adults
aged 18 to 64 at 19 research centres in Australia.

About NVX-CoV2373

NVX-CoV2373 is a protein-based epidemic that was engineered from the genetic sequence of the first SARS-CoV-2, the virus that causes the disease
.
The seedlings were created using Novavax recombinant nanoparticle technology to generate antigens derived from the coronavirus spike protein, while also formulated using Novavax's patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate the production of high levels of neutralizing antibodies
.
NVX-CoV2373 contains purified protein antigens, does not replicate, and does not cause new coronary pneumonia
.

The vaccine is packaged in a 10-dose vial as a ready-to-use liquid formulation
.
The vaccination protocol requires two intramuscular injections of 0.
5 ml (5 μg antigen and 50 μg Matrix-M adjuvant)
21 days apart.
The seedlings are stored at temperatures between 2-8 degrees Celsius and can use existing seedling supplies and cold chain channels
.
The use of infected seedlings should follow official recommendations
.

Novavax has established partnerships
for the production, commercialization and distribution of the vaccine worldwide.
The existing license leverages Novavax's manufacturing partnership with the Serum Institute of India, the world's largest manufacturer
of epidemic seedlings by volume.
This will then be complemented by data from other manufacturing plants throughout Novavax's global supply chain
.

About Matrix-M Adjuvant Novavax's patented saponin-based Matrix-M™™ adjuvant, which enhances antigen presentation in regional lymph nodes by stimulating antigen-presenting cells into the injection site, enhances immune response, has been shown to be effective and generally well tolerated
.