Novavax Nuvaxovid™ COVID-19 Vaccine Granted Expanded Conditional Advertising and marketing Authorization within the European Union for Use as a Booster for Adults Aged 18 and Older

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  • Nuvaxovid™ is now approved within the EU to be used in adults aged 18 and older as a booster no matter earlier vaccine historical past

GAITHERSBURG, Md., Sept. 12, 2022 /PRNewswire/ — Novavax, Inc. ( Nasdaq: NVAX), a biotechnology firm devoted to creating and commercializing next-generation vaccines for severe infectious illnesses, right this moment introduced that the European Fee (EC) has accredited the expanded conditional advertising and marketing authorization (CMA) of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine within the European Union (EU) as a homologous and heterologous booster for energetic immunization to stop coronavirus illness 2019 (COVID-19) attributable to the extreme acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for adults aged 18 and older. The approval follows the advice made by the European Medicines Company’s Committee for Medicinal Merchandise for Human Use on September 1, 2022.

“We’re happy to supply the primary protein-based vaccine as each a main sequence and booster within the European Union,” mentioned Stanley C. Erck, President and Chief Govt Officer, Novavax. “As we proceed to discover greatest practices for managing COVID-19 long run, we have now ongoing trials additional exploring Nuvaxovid’s efficacy and security as a booster and preclinical information has indicated that our vaccine induces immune response in opposition to Omicron variants, together with BA.4/5.”

The expanded CMA was primarily based on information from Novavax’ Part 2 trial carried out in Australia, from a separate Part 2 trial carried out in South Africa, and from the UK-sponsored COV-BOOST trial. As a part of the Part 2 trials, a single booster dose of Nuvaxovid was administered to wholesome grownup individuals roughly six months after their main two-dose vaccination sequence of Nuvaxovid. The third dose produced elevated immune responses corresponding to or exceeding ranges related to safety in Part 3 medical trials. Within the COV-BOOST trial, Nuvaxovid induced a strong antibody response when used as a heterologous third booster dose.

Within the Novavax-sponsored trials, following the booster, native and systemic reactions had been typically short-lived with a median period of roughly two days. The incidence of Grade 3 or greater occasions remained comparatively low. Security reporting of reactogenicity occasions confirmed an growing incidence throughout all three doses of Nuvaxovid, reflecting the elevated immunogenicity seen with a 3rd dose. Medically attended adversarial occasions (AE), doubtlessly immune-mediated medical situations, and extreme AEs occurred occasionally following the booster dose and had been balanced between vaccine and placebo teams.

Nuvaxovid has additionally been approved in Japan, Australia, and New Zealand as a booster in adults aged 18 and older and is actively beneath overview in different markets.

The EC beforehand granted CMA for Nuvaxovid to stop COVID-19 in adults aged 18 and older in December 2021. Moreover, the EC granted expanded CMA for Nuvaxovid to stop COVID-19 in adolescents aged 12 by way of 17 in July 2022.

Commerce Title within the U.S.
The commerce title Nuvaxovid™ has not but been accredited by the U.S. Meals and Drug Administration.

Necessary Security Data

  • Nuvaxovid is contraindicated in individuals who’ve a hypersensitivity to the energetic substance, or to any of the excipients.
  • Occasions of anaphylaxis have been reported with administration of COVID-19 vaccines. Acceptable medical remedy and supervision needs to be obtainable in case of an anaphylactic response following the administration of the vaccine. Shut remark for at the least quarter-hour is advisable and a second dose of the vaccine shouldn’t be given to those that have skilled anaphylaxis to the primary dose of Nuvaxovid.
  • Nervousness-related reactions, together with vasovagal reactions (syncope), hyperventilation, or stress‐associated reactions might happen in affiliation with vaccination as a psychogenic response to the needle injection. It can be crucial that precautions are in place to keep away from damage from fainting.
  • Vaccination needs to be postponed in people affected by an acute extreme febrile sickness or acute an infection. The presence of a minor an infection and/or low-grade fever shouldn’t delay vaccination.
  • Nuvaxovid needs to be given with warning in people receiving anticoagulant remedy or these with thrombocytopenia or any coagulation dysfunction (similar to haemophilia) as a result of bleeding or bruising might happen following an intramuscular administration in these people.
  • The efficacy of Nuvaxovid could also be decrease in immunosuppressed people.
  • Administration of Nuvaxovid in being pregnant ought to solely be thought of when the potential advantages outweigh any potential dangers for the mom and foetus.
  • The results with Nuvaxovid might briefly have an effect on the flexibility to drive or use machines.
  • People will not be totally protected till seven days after their second dose. As with all vaccines, vaccination with Nuvaxovid might not shield all vaccine recipients.
  • The most typical adversarial reactions noticed throughout medical research had been headache, nausea or vomiting, myalgia, arthralgia, injection website tenderness/ache, fatigue, and malaise.

For extra info on Nuvaxovid, together with the Abstract of Product Traits with Package deal Leaflet, adversarial occasion reporting directions, or to request further info, please go to the next web sites:

About Nuvaxovid™ (NVX-CoV2373)

Nuvaxovid 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 know-how 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. Nuvaxovid incorporates purified protein antigen and may neither replicate, nor can it trigger COVID-19.

Nuvaxovid 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 needs to be in accordance with official suggestions.

Novavax has established partnerships for the manufacture, commercialization, and distribution of Nuvaxovid worldwide. Current authorizations leverage Novavax’ manufacturing partnership with Serum Institute of India, the world’s largest vaccine producer by quantity. They may later be supplemented with information from further manufacturing websites all through Novavax’ international provide chain.

Concerning the Novavax COVID-19 vaccine (NVX-CoV2373) Part 3 Trials

The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Part 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 individuals 18 years of age and over in 119 places in the U.S. and Mexico. The first endpoint for PREVENT-19 was the primary incidence of PCR-confirmed symptomatic (delicate, average or extreme) COVID-19 with onset at the least seven days after the second dose in serologically unfavorable (to SARS-CoV-2) grownup individuals at baseline. The statistical success criterion included a decrease certain of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic average or extreme COVID-19. Each endpoints had been assessed at the 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 strong antibody response after the second dose in each research. Full outcomes of the trial had been revealed within the New England Journal of Medication (NEJM). 

The pediatric growth of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to judge the security, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent individuals 12 to 17 years of age in 73 places in america, in contrast with placebo. Within the pediatric trial, the vaccine achieved its main effectiveness endpoint (non-inferiority of the neutralizing antibody response in comparison with younger grownup individuals 18 by way of 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 greater in adolescents than in adults in opposition to all variants studied.

Moreover, a trial carried out within the U.Okay. with 14,039 individuals 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 primarily based on the primary incidence of PCR-confirmed symptomatic (delicate, average or extreme) COVID-19 with onset at the least seven days after the second examine vaccination in serologically unfavorable (to SARS-CoV-2) grownup individuals 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 by way of the invention, growth, and commercialization of revolutionary vaccines to stop severe infectious illnesses. The corporate’s proprietary recombinant know-how platform harnesses the ability and velocity of genetic engineering to effectively produce extremely immunogenic nanoparticles designed to deal with 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 World Well being Group. The vaccine is presently beneath overview by a number of regulatory companies worldwide, together with for extra indications and populations similar to adolescents and as a booster. Along with its COVID-19 vaccine, Novavax can also be presently evaluating its COVID-19-Influenza Mixture vaccine candidate in a Part 1/2 medical trial, its quadrivalent influenza investigational vaccine candidate, and can also be evaluating an Omicron strain-based vaccine (NVX-CoV2515) in addition to a bivalent format Omicron-based / authentic 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.

Ahead-Wanting 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 growth of NVX-CoV2373,  together with an Omicron pressure primarily based vaccine and bivalent Omicron-based / authentic pressure primarily based vaccine, a COVID-seasonal influenza mixture 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’ international provide chain, further worldwide authorizations of NVX-CoV2373 to be used in adults and adolescents, and as a booster, the potential affect and attain of Novavax and NVX-CoV2373 in addressing vaccine entry, controlling the pandemic and defending populations, the efficacy, security meant utilization, 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 embrace, 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; 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; unanticipated challenges or delays in conducting medical trials; challenges assembly contractual necessities beneath agreements with a number of business, governmental, and different entities; and people different threat components recognized within the “Danger Components” and “Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations” sections of Novavax’ Annual Report on Kind 10-Okay for the yr ended December 31, 2021 and subsequent Quarterly Experiences 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’re 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 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. Traders, potential buyers, and others ought to give cautious consideration to those dangers and uncertainties.

Contacts:
Traders
Erika Schultz | 240-268-2022
[email protected]

Media
Ali Chartan or Giovanna Chandler | 202-709-5563
[email protected]

SOURCE Novavax, Inc.

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