GAITHERSBURG, Md., Oct. 19, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology firm devoted to growing and commercializing next-generation vaccines for severe infectious ailments, in the present day introduced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has acquired emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to supply a first booster dose no less than six months after completion of main vaccination with a licensed or authorised COVID-19 vaccine to people 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine shouldn’t be accessible or clinically applicable, and to people 18 years of age and older who elect to obtain the Novavax COVID-19 Vaccine, Adjuvanted as a result of they’d in any other case not obtain a booster dose of a COVID-19 vaccine.
“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” mentioned Stanley C. Erck, President and Chief Executive Officer, Novavax. “According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults.”
The FDA EUA resolution was based mostly on information from the Phase 3 Prevent-19 scientific trial and from the U.Okay.-sponsored COV-BOOST trial. In the Phase 3 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to wholesome grownup members aged 18 and older roughly eight or 11 months after their main collection. Following a booster dose, antibody ranges elevated considerably relative to pre-boost ranges, rising above ranges related to safety within the Phase 3 trials. Neutralizing antibodies additionally elevated by 34- to 27-fold in comparison with pre-boost ranges when boosted at eight or 11 months. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted elevated antibody titers when used as a third dose following preliminary dosing with one other licensed COVID-19 vaccine (heterologous boosting).
In the trial, following the booster, native and systemic reactions had a median length of roughly two days. The incidence of Grade 3 or greater occasions remained comparatively low. Safety reporting of reactogenicity occasions confirmed an growing incidence throughout all three doses of the Novavax COVID-19 Vaccine, Adjuvanted, typically seen with elevated immunogenicity. Among members 18 years of age and older, solicited opposed reactions following administration of a booster dose of the Novavax COVID-19 Vaccine, Adjuvanted have been injection web site ache/tenderness (81.1%), fatigue/malaise (63.4%), muscle ache (63.0%), headache (52.9%), joint ache (30.3%), nausea/vomiting (14.7%), injection web site swelling (8.4%), injection web site redness (6.3%), and fever (6.3%).
The subsequent step for the vaccine is a coverage suggestion for use as a first booster from the Centers for Disease Control and Prevention (CDC). Doses of the Novavax COVID-19 Vaccine, Adjuvanted can be found for use within the U.S. pending this ultimate step and may be positioned on Vaccines.gov.
Novavax’ vaccine can be out there for use as a booster in adults aged 18 and older within the European Union, Japan, Australia, New Zealand, Switzerland, and Israel. In addition, a variety of nations have coverage suggestions permitting use of the vaccine as a heterologous or homologous booster dose. In the U.S., the FDA granted EUA for a two-dose main collection in adults aged 18 and older in July and for adolescents aged 12 by way of 17 in August. Following these EUA’s, the CDC really useful the vaccine for use as a main collection for each age teams.
This undertaking has been supported partly with federal funds from the Department of Health and Human Services (HHS); the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), by way of the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) below contract quantity MCDC2011-001.
Use of the Novavax COVID-19 Vaccine, Adjuvanted within the U.S.
The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been authorised or licensed by the US Food and Drug Administration (FDA), however has been licensed for emergency use by FDA, below an Emergency Use Authorization (EUA) to stop Coronavirus Disease 2019 (COVID-19) as a main collection people 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine can be licensed to supply a first booster dose no less than 6 months after completion of main vaccination with a licensed or authorised COVID-19 vaccine to people 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine shouldn’t be accessible or clinically applicable, and to people 18 years of age and older who elect to obtain the Novavax COVID-19 Vaccine, Adjuvanted as a result of they’d in any other case not obtain a booster dose of a COVID-19 vaccine.
The emergency use of this product is barely licensed for the length of the declaration that circumstances exist justifying the authorization of emergency use of the medical product below Section 564(b)(1) of the FD&C Act except the declaration is terminated or authorization revoked sooner.
Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is permitted for use below an Emergency Use Authorization (EUA) to supply a two-dose main collection for energetic immunization to stop coronavirus illness 2019 (COVID-19) brought on by extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people 12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted vaccine can be licensed to supply a first booster dose no less than 6 months after completion of main vaccination with a licensed or authorised COVID-19 vaccine to people 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine shouldn’t be accessible or clinically applicable, and to people 18 years of age and older who elect to obtain the Novavax COVID-19 Vaccine, Adjuvanted as a result of they’d in any other case not obtain a booster dose of a COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to people with a recognized historical past of a extreme allergic response (e.g., anaphylaxis) to any element of the Novavax COVID-19 Vaccine, Adjuvanted.
Warnings and Precautions
Management of Acute Allergic Reactions: Appropriate medical therapy to handle rapid allergic reactions should be instantly out there 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 prevalence of rapid opposed reactions based on the Centers for Disease Control (CDC) and Prevention tips.
Myocarditis and Pericarditis: Clinical trials information present proof for elevated dangers of myocarditis and pericarditis following administration of the Novavax COVID-19 Vaccine, Adjuvanted (see Full EUA Prescribing Information). The CDC has printed issues associated to myocarditis and pericarditis after vaccination, together with for vaccination of people with a historical past of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis).
Syncope (fainting): May happen in affiliation with administration of injectable vaccines. Procedures needs to be in place to keep away from harm 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 shield all vaccine recipients.
Adverse Reactions
Adverse reactions reported in scientific trials following administration of the Novavax COVID-19 Vaccine, Adjuvanted embrace injection web site ache/tenderness, fatigue/malaise, muscle ache, headache, joint ache, nausea/vomiting, injection web site redness, injection web site swelling, fever, chills, injection web site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis, and pericarditis.
Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted exterior of scientific trials.
Additional opposed reactions, a few of which can be severe, could turn into obvious with extra widespread use of the Novavax COVID-19 Vaccine, Adjuvanted.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination supplier enrolled within the federal COVID-19 Vaccination Program is accountable for necessary reporting of the next to the Vaccine Adverse Event Reporting System (VAERS):
- vaccine administration errors whether or not or not related to an opposed occasion,
- severe opposed occasions (regardless of attribution to vaccination),
- instances of myocarditis,
- instances of pericarditis,
- instances of Multisystem Inflammatory Syndrome (MIS), in adults and youngsters, and
- instances of COVID-19 that ends in hospitalization or demise.
Complete and submit studies to VAERS on-line: For additional help with reporting to VAERS, name 1-800-822-7967. The studies ought to embrace the phrases “Novavax COVID-19 Vaccine, Adjuvanted EUA” within the description part of the report.
To the extent possible, report opposed occasions to Novavax, Inc. utilizing the next contact data or by offering a copy of the VAERS type to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 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 (Vaccination Providers) and EUA Full Prescribing Information.
Please click on to see the Fact Sheet for Recipients and Caregivers.
About NVX-CoV2373 (Novavax’ COVID-19 Vaccine, Adjuvanted)
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. NVX-CoV2373 accommodates purified protein antigen and may neither replicate, nor can it trigger COVID-19.
NVX-CoV2373 is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination routine calls for two 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 present vaccine provide and chilly chain channels. Use of the vaccine needs to be in accordance with official suggestions.
The PREVENT-19 trial of NVX-CoV2373 is being carried out with help from the U.S. authorities, together with the Department of Defense, BARDA, a part of the Administration for Strategic Preparedness and Response, and the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health at HHS. BARDA is offering as much as $1.75 billion below a Department of Defense settlement (quantity MCDC2011-001). JPEO-CBRND can be offering funding of as much as $45.7 million below a separate settlement. To date, the U.S. authorities has agreed to order 3.2 million doses of NVX-CoV2373 below these present agreements. Novavax and the U.S. authorities will decide the timing, pricing, and quantities for supply of any further NVX-CoV2373 doses. Novavax intends to pursue further U.S. procurement of each NVX-CoV2373 doses and different potential formulations.
Novavax has established partnerships for the manufacture, commercialization, and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine producer by quantity. They are being supplemented with information from further manufacturing websites all through Novavax’ international 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 progressive vaccines to stop severe infectious ailments. The firm’s proprietary recombinant expertise platform harnesses the facility 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 acquired authorization from a number of regulatory authorities globally, together with the U.S. FDA, the European Commission, and the World Health Organization. The vaccine is presently below overview by a number of regulatory businesses worldwide, together with for further populations and indications such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax can be presently evaluating its COVID-19-Influenza Combination (CIC) vaccine candidate in a Phase 1/2 scientific trial, its quadrivalent influenza investigational vaccine candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as properly as a bivalent format 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.
Forward-Looking 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 further doses of NVX-CoV2373 and different potential formulations, the timing of scientific trial outcomes, the continuing improvement of NVX-CoV2373, NVX-CoV2515 and bivalent Omicron-based / authentic pressure based mostly vaccine, a CIC investigational vaccine candidate, the scope, timing and final result of future regulatory filings and actions, together with potential suggestions and authorizations from the CDC, Novavax’ plans to complement present authorizations with information from the extra manufacturing websites in Novavax’ international provide chain, further worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID-19 pandemic, 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, 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 would 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 scientific trials; 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 industrial, governmental, and different entities; and people different threat elements 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 12 months ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We warning buyers to not place appreciable reliance on forward-looking statements contained on this press launch. You are inspired to learn our filings with the SEC, out there 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 business is topic to substantial dangers and uncertainties, together with these referenced above. Investors, potential buyers, and others ought to give cautious consideration to those dangers and uncertainties.
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