- Submission to New Zealand's Medsafe marks the primary protein-primarily based COVID-19 vaccine submitted for authorization to regulatory authorities in New Zealand
- All modules required for regulatory review of Novavax vaccine, together with CMC information, at the moment are complete for Medsafe
GAITHERSBURG, Md., Nov. three, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to establishing and commercializing subsequent-generation vaccines for critical infectious ailments, today introduced the business has filed for provisional approval of the vaccine to the new Zealand medicines and clinical gadgets defense Authority (Medsafe).
"latest submission marks Novavax' persevered development in bringing the first protein-based mostly COVID-19 vaccine in line with phase three data to the global group," talked about Stanley C. Erck, President and Chief govt Officer, Novavax. "We stay laser-concentrated on delivering our vaccine, which is constructed on a proven, smartly-understood vaccine platform, and thank the executive of recent Zealand for their ongoing partnership and self belief in our COVID-19 vaccine application."
Novavax has now achieved the submission to Medsafe of all modules required for the regulatory assessment of NVX-CoV2373, a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The chemistry, manufacturing and controls (CMC) module submitted to Medsafe, in addition to other regulatory corporations international, leverage Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the area's biggest vaccine manufacturer by way of quantity. it'll later be supplemented with statistics from additional manufacturing sites in Novavax' international give chain.
The submission comprises medical statistics from evade-19, a pivotal phase 3 trial of 30,000 members within the U.S. and Mexico that established 100% coverage against moderate and severe sickness and ninety.four% efficacy typical. scientific data from a pivotal section 3 trial of 15,000 members in the U.ok. were additionally previously submitted to Medsafe, during which NVX-CoV2373 confirmed efficacy of 96.four% towards the usual virus stress, 86.3% in opposition t the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 established a good security and tolerability profile.
Novavax these days announced regulatory filings for its vaccine in the uk, Australia, and Canada, and the completion of all information and modules within the European Union. The business also expects to finished an extra supplemental submitting for its vaccine for Emergency Use list with the area health corporation almost immediately. Novavax expects to submit the complete package to the U.S. FDA by means of the conclusion of the yr.
This submission turned into facilitated by means of the enterprise's native partner, Biocelect Pty. Ltd., as sponsor.
about the NVX-CoV2373 section 3 trialsNVX-CoV2373 is being evaluated in two pivotal phase three trials: a trial in the U.k. that tested efficacy of 96.four% against the usual virus strain, 86.3% towards the Alpha (B.1.1.7) variant and 89.7% efficacy universal; and the steer clear of-19 trial within the U.S. and Mexico that confirmed a hundred% protection in opposition t moderate and severe sickness and 90.four% efficacy usual. It changed into generally well-tolerated and elicited a sturdy antibody response.
NVX-CoV2373 is a protein-primarily based vaccine candidate engineered from the genetic sequence of the first pressure of SARS-CoV-2, the virus that explanations COVID-19 disease. NVX-CoV2373 changed into created the use of Novavax' recombinant nanoparticle know-how to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to increase the immune response and stimulate high tiers of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and might neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a able-to-use liquid formula in a vial containing ten doses. The vaccination routine requires two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days aside. The vaccine is saved at 2°- eight° Celsius, enabling using present vaccine provide and bloodless chain channels.
About Matrix-M™ AdjuvantNovavax' patented saponin-based Matrix-M™ adjuvant has proven a potent and well-tolerated effect with the aid of stimulating the entry of antigen-featuring cells into the injection site and adorning antigen presentation in native lymph nodes, boosting immune response.
About NovavaxNovavax, Inc. (Nasdaq: NVAX) is a biotechnology enterprise that promotes more suitable health globally through the discovery, development and commercialization of imaginitive vaccines to steer clear of severe infectious illnesses. The enterprise's proprietary recombinant expertise platform combines the vigor and pace of genetic engineering to effectively produce highly immunogenic nanoparticles designed to handle pressing international fitness wants. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that explanations COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all simple aims in its pivotal section three medical trial in older adults. both vaccine candidates contain Novavax' proprietary saponin-primarily based Matrix-M™ adjuvant to enhance the immune response and stimulate high stages of neutralizing antibodies.
For extra tips, visit www.novavax.com and fix with us on Twitter and LinkedIn.
forward-searching StatementsStatements herein relating to the way forward for Novavax, its operating plans and prospects, its partnerships, the continuing development of NVX-CoV2373 and other Novavax vaccine product candidates, and the scope, timing and result of future regulatory filings are forward-looking statements. Novavax cautions that these ahead-looking statements are subject to numerous risks and uncertainties that may trigger exact results to vary materially from those expressed or implied via such statements. These risks and uncertainties consist of challenges gratifying, by myself or along with companions, quite a lot of safeguard, efficacy, and product characterization necessities, including those related to manner qualification and assay validation, quintessential to satisfy applicable regulatory authorities; issue acquiring scarce raw substances and resources; useful resource constraints, including human capital and manufacturin g means, on the capacity of Novavax to pursue deliberate regulatory pathways; challenges meeting contractual requirements below agreements with varied business, governmental, and different entities; and people different risk elements recognized in the "possibility components" and "administration's dialogue and analysis of economic condition and results of Operations" sections of Novavax' Annual report on form 10-k for the year ended December 31, 2020 and subsequent Quarterly reports on form 10-Q, as filed with the Securities and trade commission (SEC). We warning investors no longer to location appreciable reliance on ahead-looking statements contained during this press release. you're inspired to read our filings with the SEC, accessible at www.sec.gov and www.novavax.com, for a dialogue of these and different hazards and uncertainties. The ahead-searching statements in this press liberate speak best as of the date of this doc, and we undertake no obligation to update or revise any of the statements. Our company is discipline to monstrous risks and uncertainties, including these referenced above. investors, abilities investors, and others should supply cautious consideration to these dangers and uncertainties.
Contacts:
InvestorsNovavax, Inc.Erika Schultz | 240-268-2022ir@novavax.com
Solebury TroutAlexandra Roy | 617-221-9197aroy@soleburytrout.com
MediaAlison Chartan | 240-720-7804Laura Keenan Lindsey | 202-709-7521media@novavax.com
View normal content material to down load multimedia:https://www.prnewswire.com/news-releases/novavax-data-covid-19-vaccine-for-provisional-approval-in-new-zealand-301415357.html
supply Novavax, Inc.
0 Comments