- Homologous boosting with the prototype Novavax COVID-19 vaccine induced strong antibody titers for Omicron BA.1, BA.2, and BA.5
- Study 307 (Lot Consistency) achieved its main endpoint, exhibiting that three vaccine tons induced a comparable immune response thereby demonstrating the consistency of the manufacturing course of
- A sturdy immunogenicity response was noticed following main vaccination in addition to boosting which matched the degrees beforehand related to safety
GAITHERSBURG, Md., Oct. 12, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology firm devoted to growing and commercializing next-generation vaccines for severe infectious ailments, at present introduced information from the Phase 3 PREVENT-19 trial and Study 307 (Lot Consistency) on the World Vaccine Congress Europe 2022. PREVENT-19 information in each adults aged 18 and older and adolescents aged 12 by way of 17 confirmed the prototype Novavax COVID-19 vaccine (NVX-CoV2373) achieved its pre-specified immunologic endpoint. Study 307 (Lot Consistency) met its main endpoint, exhibiting that three a number of the Novavax COVID-19 vaccine examined as a heterologous booster induced constant immune responses in beforehand vaccinated adults aged 18 to 49.
“These data further demonstrate the consistent immunogenicity and safety profile of the Novavax COVID-19 vaccine as a booster, regardless of previous vaccine history,” mentioned Gregory M. Glenn, M.D., President of Research and Development, Novavax. “These data are an early indication that our vaccine may be effective against variants such as Omicron. We have ongoing trials further exploring the Novavax COVID-19 vaccine’s potential as an effective booster against these variants, including BA.4/5, and look forward to sharing these data.”
PREVENT-19 grownup and adolescent homologous boosting
In the PREVENT-19 trial, a single homologous booster dose was given to pick grownup members aged 18 and older, roughly eight or 11 months after their main collection. Following a booster dose, extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) anti-spike (anti-S) Immunoglobulin G (IgG; a sort of antibody) ranges elevated considerably relative to pre-boost ranges, rising above the extent correlated with 95% vaccine efficacy in a current USG examine. Neutralizing antibodies towards the prototype pressure additionally elevated by 34- to 27-fold in comparison with pre-boost ranges when boosted at eight or 11 months. Boosting additionally elevated IgG and human angiotensin changing enzyme 2 (hACE2) receptor inhibition antibody ranges towards Omicron BA.1, BA.2, and BA.5 variants, with ranges which are similar to these noticed in Phase 3 efficacy research.
In the pediatric growth of PREVENT-19 which evaluated boosting in adolescents aged 12 by way of 17, a single homologous booster dose was evaluated for anti-S IgG, hACE2 receptor inhibition and neutralization antibody responses. Following boosting, neutralizing titers have been 2.7-fold larger than these seen with main vaccination, and a big enhance was noticed for antibody towards Omicron BA.1, BA.2, and BA.5.
In each adults and adolescents, a 3rd dose of the Novavax COVID-19 vaccine decreased the antigenic distance between SARS-CoV-2 variant and prototype virus strains, suggesting profit for the prevention of COVID-19 towards modern variants similar to Omicron. Additionally, in each adults and adolescents, booster doses have been effectively tolerated, with principally delicate to average reactogenicity that was of brief length.
Study 307 (Lot Consistency) grownup homologous and heterologous boosting
Study 307 (Lot Consistency) achieved its main endpoint, exhibiting that three a number of the Novavax COVID-19 vaccine induced constant immune responses in adults aged 18 to 49. Further, anti-S IgG titers have been throughout the vary beforehand discovered to correlate with excessive efficacy within the PREVENT-19 Phase 3 trial. Safety was additionally constant throughout tons, with no severe associated treatment-emergent opposed occasions (AE). These findings verify a constant vaccine manufacturing course of.
Further, heterologous boosting responses have been constant throughout members who obtained main vaccines from Moderna, Pfizer, or Johnson & Johnson, with IgG ranges approximating ranges noticed in PREVENT-19.
About PREVENT-19
PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to guage the efficacy, security, and immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960 members 18 years of age and over in 119 areas within the U.S. and Mexico. The main endpoint for PREVENT-19 was the primary incidence of PCR-confirmed symptomatic (delicate, average, or extreme) COVID-19 with onset not less than seven days after the second dose in serologically damaging (to SARS-CoV-2) grownup members at baseline. The statistical success criterion included a decrease sure of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic average or extreme COVID-19. Both endpoints have been assessed not less than seven days after the second examine vaccination in volunteers who had not been beforehand contaminated with SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy total. It was usually well-tolerated and elicited a strong antibody response after the second dose in each research. Full outcomes of the trial have been printed within the New England Journal of Medicine.
The pediatric growth of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to guage the protection, effectiveness, and efficacy of NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent members 12 to 17 years of age in 73 areas within the U.S., in contrast with placebo. In the pediatric trial, the vaccine achieved its main effectiveness endpoint (non-inferiority of the neutralizing antibody response in comparison with younger grownup members 18 by way of 25 years of age from PREVENT-19) and demonstrated 80% efficacy total at a time when the Delta variant of concern was the predominant circulating pressure within the U.S. Additionally, immune responses have been about two-to-three-fold larger in adolescents than in adults towards all variants studied.
About Study 307 (Lot Consistency)
Study 307 (Lot Consistency) evaluated three totally different a number of the Novavax COVID-19 vaccine in roughly 900 adults aged 18 by way of 49, who obtained an preliminary main collection of the Novavax COVID-19 vaccine or different approved or accredited vaccines and a subset who had additionally obtained a booster shot with a certified or accredited COVID-19 vaccine not less than six months prior. Participants have been boosted with a single dose of the Novavax COVID-19 vaccine. Immunogenicity and security have been assessed, together with a comparability of IgG ranges based mostly on the vaccine that was used for the first collection. The examine achieved its main endpoint, exhibiting that three a number of the Novavax COVID-19 vaccine examined induced constant immune responses. Further, anti-S IgG titers have been throughout the vary beforehand discovered to correlate with excessive efficacy within the PREVENT-19 Phase 3 trial. Safety was additionally constant throughout tons, with no severe associated treatment-emergent AEs. These findings verify a constant vaccine manufacturing course of.
About the Novavax COVID-19 vaccine (NVX-CoV2373)
The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the primary pressure of SARS-CoV-2, the virus that causes COVID-19 illness. The vaccine was created utilizing Novavax’ recombinant nanoparticle expertise to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to boost the immune response and stimulate excessive ranges of neutralizing antibodies. The Novavax COVID-19 vaccine accommodates purified protein antigen and can neither replicate, nor can it trigger COVID-19.
The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination routine calls for 2 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days aside. The vaccine is saved at 2°- 8° Celsius, enabling using current vaccine provide and chilly chain channels. Use of the vaccine must be in accordance with official suggestions.
Novavax has established partnerships for the manufacture, commercialization, and distribution of the vaccine worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine producer by quantity. They will later be supplemented with information from further manufacturing websites all through Novavax’ world provide chain.
About Matrix-M™ Adjuvant
Novavax’ patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated impact by stimulating the entry of antigen-presenting cells into the injection web site and enhancing antigen presentation in native lymph nodes, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology firm that promotes improved well being globally by way of the invention, improvement, and commercialization of revolutionary vaccines to stop severe infectious ailments. The firm’s proprietary recombinant expertise platform harnesses the ability and velocity of genetic engineering to effectively produce extremely immunogenic nanoparticles designed to handle pressing world well being wants. The Novavax COVID-19 vaccine has obtained authorization from a number of regulatory authorities globally, together with the U.S. Food and Drug Administration, the European Commission, and the World Health Organization. The vaccine is presently underneath evaluation by a number of regulatory companies worldwide, together with for extra populations and indications similar to adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax can be presently evaluating its COVID-19-Influenza Combination vaccine candidate in a Phase 1/2 medical trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) in addition to a bivalent format Omicron-based / unique strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to boost the immune response and stimulate excessive ranges of neutralizing antibodies.
For extra info, go to www.novavax.com and join with us on LinkedIn.
Forward-Looking Statements
Statements herein referring to the way forward for Novavax, its working plans and prospects, its partnerships, the timing of medical trial outcomes, the continuing improvement of NVX-CoV2373, together with NVX-CoV2515 and bivalent Omicron-based / unique pressure based mostly vaccine, a COVID-seasonal influenza mixture investigational vaccine candidate, its quadrivalent influenza investigational vaccine candidate, the scope, timing and end result of future regulatory filings and actions, together with Novavax’ plans to complement current authorizations with information from the extra manufacturing websites in Novavax’ world provide chain, further worldwide authorizations of NVX-CoV2373 to be used in adults and adolescents, and as a booster, the potential influence and attain of Novavax and NVX-CoV2373 in addressing vaccine entry, controlling the pandemic and defending populations, the efficacy, security, meant utilization, and anticipated administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are topic to quite a few dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such statements. These dangers and uncertainties embrace, with out limitation, challenges satisfying, alone or along with companions, varied security, efficacy, and product characterization necessities, together with these associated to course of qualification and assay validation, essential to fulfill relevant regulatory authorities; unanticipated challenges or delays in conducting medical trials; problem acquiring scarce uncooked supplies and provides; useful resource constraints, together with human capital and manufacturing capability, on the flexibility of Novavax to pursue deliberate regulatory pathways; challenges assembly contractual necessities underneath agreements with a number of business, governmental, and different entities; and these different threat components recognized within the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report on Form 10-Okay for the yr ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We warning traders to not place appreciable reliance on forward-looking statements contained on this press launch. You are inspired to learn our filings with the SEC, obtainable at www.sec.gov and www.novavax.com, for a dialogue of those and different dangers and uncertainties. The forward-looking statements on this press launch communicate solely as of the date of this doc, and we undertake no obligation to replace or revise any of the statements. Our business is topic to substantial dangers and uncertainties, together with these referenced above. Investors, potential traders, and others ought to give cautious consideration to those dangers and uncertainties.
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