Novavax Pronounces Expanded Settlement with SK bioscience to Manufacture COVID-19 Vaccine Containing Omicron Variant and Manufacture the Novavax COVID-19 Vaccine in Prefilled Syringes
GAITHERSBURG, Md., July 19, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology firm devoted to growing and commercializing next-generation vaccines for critical infectious ailments, has signed agreements with its associate, SK bioscience, for the manufacturing and provide of a model of the Novavax COVID-19 vaccine (NVX-CoV2373) containing Omicron variant and for the manufacture of the vaccine in prefilled syringes.
The businesses signed an settlement for the expertise switch of Novavax’ proprietary COVID-19 variant antigen supplies in order that SK bioscience can manufacture the drug substance focusing on COVID-19 variants together with the Omicron BA.5 subvariant.
“Non-clinical knowledge generated up to now reveal that our COVID-19 vaccine gives broad immune responses together with towards circulating variants, comparable to Omicron BA.5,” mentioned Stanley C. Erck, President and Chief Government Officer, Novavax. “We’re accelerating our scientific program evaluating an Omicron BA.5 part to our vaccine and look ahead to persevering with to work with SK bioscience as an vital manufacturing associate.”
As well as, the businesses have signed an settlement to fabricate and provide the Novavax COVID-19 vaccine in a prefilled syringe. SK bioscience will start work to allow the manufacturing course of for business provide of the vaccine in prefilled syringes in 2023.
Presently, SK bioscience manufactures drug substance for the vaccine. Novavax and SK bioscience even have a collaboration and licensing settlement below which SK bioscience completely commercializes the Novavax COVID-19 vaccine in South Korea, and with Novavax, collectively commercializes the vaccine in Vietnam and Thailand.
Approved Use within the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted is allowed to be used below an Emergency Use Authorization (EUA) to offer a two-dose major sequence for lively immunization to stop coronavirus illness 2019 (COVID-19) brought on by extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people 18 years of age and older.
IMPORTANT SAFETY INFORMATION
Contraindications
Don’t administer the Novavax COVID-19 Vaccine, Adjuvanted to people with a identified historical past of a extreme allergic response (e.g., anaphylaxis) to any part of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and Precautions
Administration of Acute Allergic Reactions: Applicable medical remedy to handle rapid allergic reactions should be instantly accessible within the occasion an acute anaphylactic response happens following administration of the Novavax COVID-19 Vaccine, Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the incidence of rapid hostile reactions in line with the Centers for Disease Control (CDC) and Prevention guidelines.
Myocarditis and Pericarditis: Medical trials knowledge present proof for elevated dangers of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Info).
Syncope (fainting): Could happen in affiliation with administration of injectable vaccines. Procedures ought to be in place to keep away from damage from fainting.
Altered Immunocompetence: Immunocompromised individuals, together with people receiving immunosuppressant remedy, could have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted could not defend all vaccine recipients.
Antagonistic Reactions
Antagonistic reactions reported in scientific trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted embody injection website ache/tenderness, fatigue/malaise, muscle ache, headache, joint ache, nausea/vomiting, injection website redness, injection website swelling, fever, chills, injection website pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis.
Myocarditis, pericarditis, and anaphylaxis have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted exterior of scientific trials.
Further hostile reactions, a few of which can be critical, could change into obvious with extra widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.
Reporting Antagonistic Occasions and Vaccine Administration Errors
The vaccination supplier enrolled within the federal COVID-19 Vaccination Program is answerable for necessary reporting of the next to the Vaccine Antagonistic Occasion Reporting System (VAERS):
- vaccine administration errors whether or not or not related to an hostile occasion,
- critical hostile occasions (no matter attribution to vaccination),
- instances of Multisystem Inflammatory Syndrome (MIS), and
- instances of COVID-19 that ends in hospitalization or dying.
Full and submit experiences to VAERS on-line: https://vaers.hhs.gov/reportevent.html. For additional help with reporting to VAERS, name 1-800-822-7967. The experiences ought to embody the phrases “Novavax COVID-19 Vaccine, Adjuvanted EUA” within the description part of the report.
To the extent possible, report hostile occasions to Novavax, Inc. utilizing the next contact data or by offering a replica of the VAERS type to Novavax, Inc. Web site: www.NovavaxMedInfo.com, Fax Quantity: 1-888-988-8809, Phone Quantity: 1-844-NOVAVAX (1-844-668-2829).
Please click on to see the Novavax COVID-19 Vaccine, Adjuvanted Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and EUA Full Prescribing Information.
Concerning 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 reinforce the immune response and stimulate excessive ranges of neutralizing antibodies. The Novavax COVID-19 vaccine accommodates purified protein antigen and may neither replicate, nor can it trigger COVID-19.
The Novavax COVID-19 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 the usage of present vaccine provide and chilly chain channels. Use of the vaccine ought to be in accordance with official suggestions.
Novavax has established partnerships for the manufacture, commercialization, and distribution of its COVID-19 vaccine worldwide. Present authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine producer by quantity. They are going to later be supplemented with knowledge from further manufacturing websites all through Novavax’ international provide chain.
The Novavax COVID-19 vaccine and the PREVENT-19 trial have been supported partially with federal funds from the U.S. authorities, together with the Division of Well being and Human Providers (HHS); Workplace of the Assistant Secretary for Preparedness and Response; Biomedical Superior Analysis and Growth Authority (BARDA), via the Division of Protection Joint Program Government Workplace for Chemical, Organic, Radiological and Nuclear Protection (JPEO-CBRND); and the Nationwide Institute of Allergy and Infectious Illnesses, a part of the Nationwide Institutes of Well being at HHS. BARDA is offering as much as $1.75 billion below a Division of Protection settlement (# MCDC2011-001). The Division of Protection Joint Program Government Workplace for Chemical, Organic, Radiological and Nuclear Protection can be offering funding of as much as $45.7 million below a separate settlement. Up to now, the U.S. authorities has agreed to order 3.2 million doses of Novavax’ vaccine below these present agreements ought to it obtain a suggestion from the CDC. Novavax and the U.S. authorities will decide the timing, pricing, and quantities for supply of any further doses. Novavax intends to pursue further U.S. procurement of each its COVID-19 vaccine doses and different potential formulations.
Concerning the Novavax COVID-19 vaccine (NVX-CoV2373) Section 3 Trials
The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Section 3 trials.
PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to judge the efficacy, security, and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 members 18 years of age and over in 119 areas in the U.S. and Mexico. The first endpoint for PREVENT-19 was the primary incidence of PCR-confirmed symptomatic (gentle, reasonable, or extreme) COVID-19 with onset at the very least seven days after the second dose in serologically unfavorable (to SARS-CoV-2) grownup members at baseline. The statistical success criterion included a decrease certain of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic reasonable or extreme COVID-19. Each endpoints had been assessed at the very least seven days after the second examine vaccination in volunteers who had not been beforehand contaminated with SARS-CoV-2. Within the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy general. It was typically well-tolerated and elicited a sturdy antibody response after the second dose in each research. Full outcomes of the trial had been revealed within the New England Journal of Medicine (NEJM).
The pediatric enlargement of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to judge the protection, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent members 12 to 17 years of age in 73 areas in america, in contrast with placebo. Within the pediatric trial, the vaccine achieved its major effectiveness endpoint (non-inferiority of the neutralizing antibody response in comparison with younger grownup members 18 via 25 years of age from PREVENT-19) and demonstrated 80% efficacy general at a time when the Delta variant of concern was the predominant circulating pressure within the U.S. Moreover, immune responses had been about two-to-three-fold increased in adolescents than in adults towards all variants studied.
Moreover, a trial carried out within the U.Ok. with 14,039 members aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded examine and achieved general efficacy of 89.7%. The first endpoint was based mostly on the primary incidence of PCR-confirmed symptomatic (gentle, reasonable, or extreme) COVID-19 with onset at the very least seven days after the second examine vaccination in serologically unfavorable (to SARS-CoV-2) grownup members at baseline. Full outcomes of the trial had been revealed in NEJM.
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 website 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 via the invention, growth, and commercialization of revolutionary vaccines to stop critical infectious ailments. The corporate’s proprietary recombinant expertise platform harnesses the ability and velocity of genetic engineering to effectively produce extremely immunogenic nanoparticles designed to handle pressing international well being wants. The Novavax COVID-19 vaccine, has obtained authorization from a number of regulatory authorities globally, together with the U.S., EC, and the WHO. The vaccine is at present below evaluate by a number of regulatory businesses worldwide, together with for added indications and populations comparable to adolescents and as a booster. Along with its COVID-19 vaccine, Novavax can be at present evaluating a COVID-seasonal influenza mixture vaccine candidate in a Section 1/2 scientific trial, which mixes NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and can be evaluating an Omicron strain-based vaccine (NVX-CoV2515) in addition to a bivalent Omicron-based / authentic strain-based vaccine. These vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant to reinforce the immune response and stimulate excessive ranges of neutralizing antibodies.
For extra data, go to www.novavax.com and join with us on LinkedIn.
*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated throughout a managed part 3 trial carried out throughout the 2019-2020 influenza season.
Ahead-Trying Statements
Statements herein referring to the way forward for Novavax, its working plans and prospects, its partnerships, the potential for subsequent orders from the U.S. authorities for added doses of NVX-CoV2373 and different potential formulations, the timing of scientific trial outcomes, the continuing growth of NVX-CoV2373, together with an Omicron pressure based mostly vaccine and bivalent Omicron-based / authentic pressure based mostly vaccine, a COVID-seasonal influenza investigational vaccine candidate, the scope, timing and end result of future regulatory filings and actions, together with Novavax’ plans to complement present authorizations with knowledge from the extra manufacturing websites in Novavax’ international 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 and supposed utilization of NVX-CoV2373, and the 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 embody, with out limitation, challenges satisfying, alone or along with companions, numerous security, efficacy, and product characterization necessities, together with these associated to course of qualification and assay validation, essential to fulfill relevant regulatory authorities; issue 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; unanticipated challenges or delays in conducting scientific trials; challenges assembly contractual necessities below agreements with a number of business, governmental, and different entities; and people different threat elements recognized within the “Danger Elements” and “Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations” sections of Novavax’ Annual Report on Kind 10-Ok for the 12 months ended December 31, 2021 and subsequent Quarterly Stories on Kind 10-Q, as filed with the Securities and Change Fee (SEC). We warning buyers to not place appreciable reliance on forward-looking statements contained on this press launch. You might be inspired to learn our filings with the SEC, accessible 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 converse solely as of the date of this doc, and we undertake no obligation to replace or revise any of the statements. Our enterprise is topic to substantial dangers and uncertainties, together with these referenced above. Buyers, potential buyers, and others ought to give cautious consideration to those dangers and uncertainties.
Contacts:
Buyers
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ir@novavax.com
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SOURCE Novavax, Inc.
