Novavax's Nuvaxovid™ Receives Positive CHMP Opinion for Clearance of Full Marketing Authorization for COVID Prevention in the EU
Tuesday, May 30, 2023
Novavax, Inc. (Nasdaq: NVAX ), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that Nuvaxovid ™ (NVX-CoV2373) has been recommended for full marketing authorization (MA) for use as a primary series in individuals aged 12 years and older and as a booster in individuals aged 18 years and more for the prevention of COVID-19 in the European Union (EU) following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The European Commission will review the CHMP recommendation and is expected to take a final decision on MA.
"The CHMP's positive opinion on the marketing authorization of our COVID vaccine brings us closer to full authorization and will allow us to obtain an updated vaccine in time for the fall," said John C. Jacobs , Chairman and Chief Executive Officer of Novavax.
Novavax has demonstrated the efficacy and safety of Nuvaxovid as a primary series, as well as the immunogenicity and safety of the vaccine as a booster vaccine in persons aged 12 years and older in the phase trial 3 PREVENT-19, phase 2 trials and real data.
Novavax's COVID vaccine is licensed in more than 40 markets worldwide. In the EU, Nuvaxovid has received conditional approval for a two-dose primary series in adults and adolescents , and for a booster dose in adults .
Trade name in the United States
The trade name Nuvaxovid™ has not yet been approved by the United States Food and Drug Administration (FDA).
Use of the Novavax COVID-19 vaccine with adjuvant in the United States
The Novavax COVID-19 vaccine with adjuvant has not been approved or licensed by the United States FDA, but has been authorized for emergency use by the FDA, under an authorization for use of (EUA) to prevent coronavirus disease 2019 (COVID-19) as a primary series in people aged 12 years and older. The Novavax COVID-19 vaccine with adjuvant is also authorized to administer a first booster dose at least six months after the end of the primary vaccination course with a COVID-19 vaccine authorized or approved for people aged 18 years. and more for which an FDA-cleared bivalent mRNA COVID-19 booster vaccine is not accessible or clinically appropriate,
Emergency use of this product is authorized only for the duration of the declaration that there are circumstances justifying the authorization of an emergency use of the medical product under section 564(b)( 1) of the FD&C Act, unless the declaration terminates or the authorization is revoked sooner.
Authorized use
Novavax COVID-19 vaccine with adjuvant is authorized under Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 ( COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people aged 12 years and older. The Novavax COVID-19 vaccine with adjuvant is also authorized to administer a first booster dose at least six months after the end of the primary vaccination course with a COVID-19 vaccine authorized or approved for people aged 18 years. and more for which an FDA-cleared bivalent mRNA COVID-19 booster vaccine is not accessible or clinically appropriate,
IMPORTANT SAFETY INFORMATION Contraindications
Novavax
COVID-19 Vaccine with Adjuvant should not be given to people with a known history of severe allergic reaction (e.g. anaphylaxis) to any component of Novavax COVID-19 Vaccine with Adjuvant. COVID-19 with adjuvant.
Warnings and Precautions
Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions should be immediately available if an acute anaphylactic reaction occurs following administration of Novavax COVID-19 adjuvanted vaccine. Monitor individuals receiving Novavax COVID-19 Vaccine with Adjuvant for immediate adverse reactions according to Centers for Disease Control and Prevention (CDC) guidelines .
Myocarditis and Pericarditis : Data from clinical trials provide evidence of increased risks of myocarditis and pericarditis following administration of Novavax COVID-19 vaccine with adjuvant (see EUA's full prescribing information). The CDC has published considerations for post-vaccination myocarditis and pericarditis, including for vaccinating people with a history of myocarditis or pericarditis ( https://www.cdc.gov/vaccines/covid-19/clinical -considerations/interim-considerations-us.html#myocarditis-pericarditis ).
Syncope (fainting): May occur in association with the administration of injectable vaccines. Procedures should be in place to prevent injury from fainting.
Impaired Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to the Novavax COVID-19 vaccine with adjuvant.
Limitations of vaccine efficacy: The Novavax COVID-19 vaccine, with adjuvant, may not protect all vaccine recipients.
Adverse reactions
Adverse reactions reported in clinical trials following administration of Novavax COVID-19 vaccine with adjuvant include: injection site pain/tenderness, fatigue/malaise, muscle aches, headache, joint pain, nausea /vomiting, injection site redness, injection site swelling, fever, chills, injection site pruritus, hypersensitivity reactions, lymphadenopathy-related reactions, myocarditis and pericarditis.
Cases of myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of Novavax COVID-19 vaccine, with adjuvant, outside of clinical trials.
Other side effects, some of which may be serious, may become apparent with more widespread use of the Novavax adjuvanted COVID-19 vaccine.
Reporting of Adverse Events and Vaccine Administration Errors
The immunization service provider registered with the Federal COVID-19 Immunization Program is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
vaccine administration errors, whether or not associated with an adverse event,
serious adverse events (regardless of their attribution to vaccination),
cases of myocarditis,
cases of pericarditis,
cases of multi-system inflammatory syndrome (MIS) in adults and children, and
cases of COVID-19 resulting in hospitalization or death.
Complete and submit VAERS reports online: For additional assistance with VAERS reports, call 1-800-822-7967. Reports should include the words “Novavax COVID-19 Vaccine, Adjuvanted EUA” in the description section of the report.
Whenever possible, report adverse events to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: www.NovavaxMedInfo.com, Fax : 1-888- 988-8809, Tel. : 1-844-NOVAVAX (1-844-668-2829).
Click here to view the Novavax COVID-19 Vaccine Adjuvant Fact Sheet for Vaccination Providers and full EUA prescribing information.
Click here to view the Fact Sheet for Beneficiaries and Caregivers .
About Nuvaxovid™ (NVX-CoV2373)
NVX-CoV2373 is a protein-based vaccine made by creating copies of the Spike protein from SARS-CoV-2 that causes COVID. Using Novavax's unique recombinant nanoparticle technology, the non-infectious Spike protein serves as an antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation stored at 2-8°C, allowing use of existing vaccine supply and cold chain channels.
About the PREVENT-19 Phase 3 Trial
Novavax's COVID-19 (PREVENT-19) PRE-fusion Protein Subunit Vaccine Efficacy Trial is a randomized, placebo-controlled, blinded Phase 3 trial in the United States and in Mexico to evaluate the efficacy and safety of NVX-CoV2373 as a primary series and as a booster in adults and adolescents to prevent SARS-CoV-2 infection. As a primary series, the primary endpoint was first onset of symptomatic COVID-19 (mild, moderate, or severe) confirmed by polymerase chain reaction (PCR) and occurring at least seven days after the second dose in 29,960 adult participants who were 18 years of age or older at the start of the study and had not violated the protocol prior to illness. The main criterion for secondary evaluation is prevention against moderate or severe COVID-19, symptomatic and confirmed by PCR. The full results of the trial have been published inle New England Journal of Medicine.
The pediatric expansion of the trial involved 2,247 adolescents aged 12 to 17 in the United States. The results of this expansion were announced in February 2022 . The adult booster trial evaluated a single booster dose of the vaccine in adult participants approximately six months after their first two-dose vaccination series. The results of the expansion were announced in October 2022 .
About Matrix-M™ Adjuvant
Added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it stronger, broader and longer lasting. Matrix-M adjuvant stimulates entry of antigen presenting cells at the injection site and enhances antigen presentation in local lymph nodes.
About Novavax
Novavax, Inc. (Nasdaq: NVAX ) drives better health by discovering, developing and commercializing innovative vaccines to protect people against serious infectious diseases. Novavax, a global company based in Gaithersburg , MD, in the United States, offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance immune response. Focused on the world's most pressing health issues, Novavax is currently evaluating vaccines against COVID or influenza. The company is also evaluating a combined COVID and flu vaccine. For more information, visit novavax.com and LinkedIn .
Forward-Looking Statements Statements
herein regarding Novavax's future, business plans and prospects, ongoing development of NVX-CoV2373, regulatory strategy and approval pathways in relation to NVX-CoV2373 and its vaccines COVID-19 based on variants, scope, timing and outcome of future regulatory filings and actions, clearances in Europeand the additional worldwide authorizations relating to NVX-CoV2373 for use in adults and adolescents, and as a reminder, the evolving COVID-19 pandemic, the potential impact and scope of Novavax and NVX-CoV2373 in access to vaccines, population protection, safety, security, intended use and expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the challenges of satisfying, alone or with partners, various product safety, efficacy and characterization requirements, including those related to process qualification and test validation, necessary to satisfy applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax's ability to pursue anticipated regulatory pathways; unforeseen difficulties or delays in the conduct of clinical trials; difficulties in meeting contractual requirements under agreements with multiple commercial, governmental and other entities;2022 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place undue reliance on the forward-looking statements contained in this press release. We encourage you to read our SEC filings, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date of this document and we undertake no obligation to update or revise them. Our business is subject to various important risks and uncertainties, including those mentioned above. Investors, potential investors and other stakeholders should carefully consider these risks and uncertainties.
Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com
Médias
Ali Chartan
240-720-7804
media@novavax.com
