Novavax COVID-19 Vaccine (Nuvaxovid, CovoVax, NVX-CoV2373) 2023
Novavax COVID-19 vaccine (Nuvaxovid™, CovoVax™, NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of the SARS-CoV-2 beta coronavirus. The COVID-19 (SARS-CoV-2 rS [Recombinant, adjuvanted)) the vaccine was created using Novavax's proprietary nanoparticle technology, Matrix-M™, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response and helping an immunized person make antibodies against the coronavirus.
Novavax Inc.'s vaccines are genetically engineered using three-dimensional nanostructures of recombinant proteins critical to disease pathogenesis. The COVID-19 vaccine creates an engineered baculovirus containing a modified coronavirus spike protein gene. The baculovirus then infects a culture of Sf9 moth cells, which generate the spike protein and display it on their cell membranes. Next, the spike proteins are harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins.
On Dec. 17, 2021, the World Health Organization (WHO) granted Emergency Use Listing for Novavax's NVX‑CoV2373 vaccine manufactured and marketed by Serum Institute of India Pvt. Ltd. (SII) named CovoVax. In addition, as of Jun. 13, 2022, the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) issued updated interim policy recommendations. On Nov. 29, 2022, the WHO issued an updated EUL for the Nuvaxovid™ COVID-19 vaccine as a primary series of two doses in adolescents aged 12 through 17 and as a booster in adults.
Novavax's COVID-19 vaccine (Nuvaxovid) was authorized by the European Medicines Agency (EMA) and European Commission (EC) for adults on Dec. 20, 2021 - E.U. study number: EudraCT number, 2020-004123-16. On Jun. 16, 2022, the EMA published clinical data EMEA/H/C/005808/0000. The EMA's human medicines committee (CHMP) recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid developed by Novavax CZ, a.s., to include adolescents aged 12 to 17 years. On Jul. 5, 2022, the EC approved the expanded conditional marketing authorization. On Dec. 7, Canada issued a similar primary-series, two-dose authorization.
As of 2023, NVX-CoV2373 vaccines had received authorizations for adults from more than 43 countries, including the U.S. Novavax COVID-19 vaccine brands include Nuvaxovid, CovoVax, NVX-CoV2373, TAK-019 - (non-USA) Trademark filing #90813423. A global listing of NVX‑CoV2373 studies is available at this link. NNVX-CoV2373's Drugbank Accession Number: DB15810; UNII: UK9AK2IN1P. "No human fetal-derived cell lines or tissue, including HEK293 cells, are used to develop, manufacture, or produce NVX-CoV2373," a Novavax spokesperson told Religion News Service on Feb. 8, 2022.
On Feb. 13, 2023, Novavax confirmed a new agreement with the U.S. government will maintain the U.S. public's access to Novavax's vaccines and support the development of smaller dose vials, strain selection in line with new recommendations, and a smooth transition to the commercial market.
See the Summary of Product Characteristics with Package Leaflet, Prescribing Information, and Important Safety Information, adverse event reporting instructions, or request additional information; please visit www.NovavaxCovidVaccine.com. In addition, the global information about the Novavax COVID-19 Vaccine varies by country and is searchable on this weblink. And at NovavaxMedInfo.com.
Maryland-based Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company located at 21 Firstfield Road, Gaithersburg, MD 20878, that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.
NVX-CoV2373 U.S. Authorizations
Novavax, Inc. announced on Feb. 13, 2023, a modification to its existing agreement with the U.S. Department of Health and Human Services (HHS) to deliver up to 1.5 million doses of the Novavax COVID-19 Vaccine. The U.S. Food and Drug Administration (FDA) publishes Fact Sheets for Healthcare Providers, RECIPIENTS, and CAREGIVERS. Novavax, Inc. Filip Dubovsky, MD, MPH Executive Vice President & Chief Medical Officer, presented to the Vaccines and Related Biological Products Advisory Committee on Jan. 26, 2023 - Novavax Vaccine Regimens Addressing COVID-19.
On Oct. 19, 2022, Novavax, Inc. announced that the Novavax COVID-19 Vaccine had received a EUA from the U.S. FDA to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to adults for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to adults who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The FDA confirmed on Aug. 19, 2022, that the Novavax COVID-19 Vaccine was available under EUA to prevent COVID-19 in individuals 12 years of age and older. The CDC approved this EUA on August 22, 2022. Previously, Novavax, Inc. announced on Aug. 15, 2022, that it submitted an application to the U.S. FDA for EUA of its protein-based COVID-19 Vaccine as a homologous and heterologous booster in adults aged 18 and older. As of Aug. 8, 2022, Novavax received U.S. FDA EUA and CDC recommendations for NVX-CoV2373, marking the first protein-based COVID-19 vaccine authorized in the U.S. for adults. According to data from the U.S. CDC, about 332,000 doses of Novavax's COVID-19 vaccine have been distributed in the USA as of August 4, 2022, and more than 2,300 people have been fully vaccinated.
Previously, the U.S. CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices (ACIP) recommendation on Jul. 19, 2022, that Novavax’s COVID-19 vaccine be used as another primary series option for adults (18+ yrs). The ACIP conducted a digital review meeting led by Dr. Grace Lee, the presentations are posted on this CDC weblink. Filip Dubovsky, MD, MPH, with Novavax, Inc., presented this vaccine information.
The FDA issued an EUA on Jul. 13, 2022, for the Novavax COVID-19 Vaccine. On July 11, 2022, Novavax announced an agreement with the U.S. HHS, in collaboration with the Department of Defense, to secure an initial 3.2 million doses of Novavax's COVID-19 vaccine should it receive a U.S. FDA EUA and a recommendation from the CDC. Novavax's vaccine would become available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
Novavax announced on Jul 1, 2022, that clinical data generated to date demonstrate that this prototype vaccine offers broad immune responses, including against circulating variants, such as the Omicron BA.4/5.
Novavax, Inc. participated in the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, which resulted in a 19-2 vote to recommend the inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the U.S. beginning in the Fall of 2022. During the meeting, Novavax highlighted data showing that the structural features of Novavax's protein-based COVID-19 vaccine, enhanced by the Matrix-M™ adjuvant, displayed epitopes across both the original strain and emerging variants contributing to the generation of broadly cross-reacting antibodies. In addition, additional data from Phase 2 and Phase 3 trials and in vitro data on neutralizing antibodies and receptor inhibition from trial participants show cross-reactivity with all variants tested, particularly following booster doses.
On Jun. 7, 2022, the VRBPAC's twenty-two members voted 21 yes, with one abstaining, to endorse the protein-based Novavax COVID-19 vaccine authorization. The FDA VRBPAC digital meeting will review various authorization presentations.
Nuvaxovid™ Authorizations
Delivered over 100 million doses of Nuvaxovid, Novavax's COVID-19 vaccine, globally to date. Nuvaxovid is the first protein-based COVID-19 vaccine granted authorization from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and is offered per the Joint Committee on Vaccination and Immunisation advice. The MHRA granted Conditional Marketing Authorization (CMA) for Nuvaxovid's use as a two-dose primary series vaccine for active immunization to prevent COVID-19. On Nov. 9, 2022, Novavax announced the MHRA expanded the CMA for Nuvaxovid as a homologous and heterologous booster dose after the primary series of Nuvaxovid (six months) or of an mRNA or adenoviral vector vaccine for active immunization to prevent COVID-19 in adults aged 18 and older. On Nov. 29, 2022, the WHO issued an updated EUL for Nuvaxovid™ as a primary series of two doses for people aged 12 through 17 and as a booster in adults. The Nuvaxovid label expanded in adult booster and adolescent primary series
Nuvaxovid™ has manufacturing sites in the Czech Republic, Australia, Canada, Japan, and South Korea's S.K. bioscience. On Jul. 19, 2022, Novavax signed agreements with SK bioscience to manufacture and supply a version of the Novavax COVID-19 vaccine. In 2021, Novavax licensed and transferred its manufacturing technologies and supplies the Matrix-M™ adjuvant to enable Takeda to manufacture the vaccine at its Hikari facility in Japan.
CovoVax™ Authorizations
Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SSI) confirmed the CovoVax™ vaccine was authorized in Indonesia on Dec. 1, 2021. India's Drugs Controller General of India (DCGI) issued its authorization on Dec. 28, 2021. And the DCGI granted authorization for the Novavax co-brand vaccine for adolescents aged ≥12 to <18 years in India on Mar. 22, 2022. On May 2, 2022, the Standing Technical Sub-Committee of the NTAGI authorized Covovax for those aged 12+ years. And media in India reported that SII reduced the price of Covovax to private hospitals from Rs 900 to Rs 225, excluding taxes. On Jun. 28, 2022, ANI reported the Drugs Controller General of India approved Covovax for restricted use for children aged 7-11 years. On Sept. 13, 2022, the companies confirmed that CovoVax was authorized in South Africa. On Jan. 9, 2023, local media reported Covovax may obtain approval as a booster in India.
NVX-CoV2373 SARS-CoV-2 Variants
On January 21, 2023, a peer-reviewed study published by Nature found data showing that after a third dose of NVX-CoV2373, we observed high titers against Omicron BA.1 (GMT: 1,197) and BA.4/BA.5 (GMT: 582), with responses similar in magnitude to those triggered by three doses of an mRNA vaccine. These data are of particular relevance as BA.4/BA.5 is dominating in multiple locations and highlights the potential utility of the NVX-CoV2373 vaccine as a booster in resource-limited environments.
NVX-CoV2373 Availability
As of 2023, over 94 million doses of NVX-CoV2373 had been delivered globally. The Company previously announced regulatory filings for its vaccine in the U.K., Austria, Australia, Canada, Cyprus, Estonia, European Commission, Indonesia, The Philippines, Croatia, New Zealand, Singapore, South Korea, UAE, Japan, Finland, South Africa, France, Germany, Israel, India, Ireland, Germany, Switzerland, the Netherlands, Taiwan, Thailand, Switzerland, Portugal, and Singapore. Global information about the Novavax COVID-19 Vaccine is found on this weblink.
NVX-CoV2373 Adolescents
As of Sept. 16, 2022, Taiwan, Swiss, USA, Japan, Israel, India, Australia, New Zealand, South Korea, and the U.K. had authorized adolescents aged 12 through 17 to receive the Nuvaxovid vaccine.
NVX-CoV2373 Booster Authorizations
The Korean Ministry of Food and Drug Safety approved Nuvaxovid on Jan. 18, 2023, as a heterologous and homologous booster for active immunization to prevent COVID-19 in adults. Novavax announced in January 2023 that Nuvaxovid was recommended for expanded authorization in the European Union, Swissmedic, New Zealand's Medsafe, Japan, Australia, Spain, Italy, and Canada as a heterologous and homologous booster dose in adults aged 18 and older.
NVX-CoV2373 Side Effects
Filip Dubovsky, M.D., MPH, with Novavax, Inc., presented heart health (Post-Authorization Myocarditis / Pericarditis) information - 1,072,074 doses administered worldwide as of June 30, 2022; a Broad search safety database yielded 68 potential reports; Reports often had limited information; Brighton Collaborative Case definition used to evaluate reports: 1 met the definitive case definition of myocarditis, 6 met the probable case definition of myocarditis, 10 met the probable case definition of pericarditis.
The EMA updated the label for Novavax's COVID-19 vaccine (NVX-CoV2373) to include the risk of severe allergic reactions on Jul. 14, 2022. The EMA reported that Nuvaxovid had a total of 964 cases of suspected side effects spontaneously reported from EU/EEA countries; none of these reported a fatal as of May 15, 2022. The WHO says Nuvaxovid is contraindicated in persons with hypersensitivity to the active substance or to any excipients. Appropriate medical treatment and supervision should be available in an anaphylactic reaction.
Visit https://www.novavaxcovidvaccine.com for adverse reaction reporting instructions. Also, read more about the side effects on the FDA's Fact Sheet for Recipients and Caregivers.
Novavax Influenza Vaccines
Novavax's COVID-Influenza Combination Vaccine (CIC), formerly known as the COVID-NanoFlu™ combination vaccine candidate, combines NanoFlu™ and NVX-CoV2373. On October 13, 2022, the Company announced the CIC vaccine formulations generated robust antibody responses against both SARS-CoV-2 and influenza antigens, and antibody responses were modeled using a Design of Experiments approach to help optimize future dose selection. On Dec. 30, 2022, a Phase 2 trial for CIC and influenza stand-alone vaccine candidates launched. The dose-confirming trial will evaluate the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80.
Novavax News 2023
February 28, 2023 - Novavax reaffirmed intent to deliver an updated mono- or bivalent strain vaccine for the 2023 fall vaccination season, consistent with public health recommendations. And achieved revenues in the fourth quarter of 2022 of $357 million and the full year 2022 of $2.0 billion.
February 23, 2023 - The U.S. CDC Advisory Committee on Immunization Practices meeting affirmed Novavax COVID-19 vaccine authorizations and availability.
January 5, 2023 - Spanish, Italian, and French Authorities Expand the Use of Novavax COVID-19 Vaccine.
December 30, 2022 - Novavax Announces a Phase 2 Clinical Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates.
November 8, 2022 - "Today's results show that the use of our prototype vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains. This is a hallmark of our vaccine technology and shows the suitability of our current prototype vaccine as a booster even as the COVID-19 landscape continues to evolve," said Gregory M. Glenn, M.D., President of Research and Development, Novavax.
September 2, 2022 - Swissmedic expanded its temporary authorization of the Nuvaxovid™ vaccine in adolescents and as a heterologous and homologous booster dose for adults.
July 28, 2022 - U.S. CDC: Recommendations for the Novavax COVID-19 Vaccine Primary Series in Adults 18 and Older - Clinician Outreach and Communication Activity presentation.
July 13, 2022 - Novavax's vaccine became the first protein-based COVID-19 vaccine authorized in the U.S.
June 13, 2022 - The WHO's SAGE recommended the Novaxax vaccine for people aged 18 and above.
May 9, 2022 - The Company confirmed continued label expansion, including primary, booster, and adolescent authorizations and new shipments of Nuvaxovid™ into the European Union, Canada, South Korea, Australia, Thailand, Singapore, and New Zealand.
April 8, 2022 - Novavax, Inc., and Serum Institute of India Pvt. Ltd. announced that Thailand's FDA granted a EUA for Novavax's vaccine under the brand name Covovax™.
March 1, 2022 - Australia confirmed that Nuvaxovid (Novavax) could be used as a booster in an individual aged 18 years.
February 9, 2022 - S.K. bioscience announced that the first recombinant protein-based COVID-19 vaccine was authorized in South Korea.
July 7, 2020 - Novavax, Inc. announced that it had been selected to participate in Operation Warp Speed and awarded $1.6 billion by the U.S. federal government.
May 11, 2020 - Novavax, Inc. announced that the Coalition for Epidemic Preparedness Innovations would invest up to $384 million of additional funding on top of the $4 million it invested in March 2022.
April 8, 2020 - Novavax, Inc announced it had identified a coronavirus vaccine candidate, NVX-CoV2373. The clinical development plan combines a Phase 1/Phase 2 approaches to allow rapid advancement.
Novavax Clinical Trials
The NVX-CoV2373 vaccine continues to be evaluated in multiple clinical trials.
On October 3, 2022, a peer-reviewed journal of Clinical Investigation published a study that found the protein-based vaccine NVX-CoV2373 induces robust T-cell immunity capable of recognizing SARS-CoV-2 antigens and supporting humoral immune responses. And on Oct. 25, 2022, a non-peer-reviewed study reported that after the third dose of NVX-CoV2373, titers against Omicron BA.1 (GMT: 1,197) and BA.4/BA.5 (GMT: 582), with responses similar in magnitude to those triggered by three doses of an mRNA vaccine. And on Nov. 8, 2022, the Company reported the Novavax BA.1 vaccine candidate (NVX-CoV2515) met its primary strain-change endpoint allowing for the development of variant vaccines, if necessary; Novavax' prototype vaccine induced a broad immune response against the original Wuhan, BA.1, and BA.5 strains; and the phase 3 trial showed no benefit for a bivalent vaccine utilizing Novavax' recombinant protein/adjuvant technology.
