Novavax NVX-CoV2373 COVID-19 Vaccine Description
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)) 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. 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. As of Jun. 13, 2022, the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) issued updated interim policy recommendations. 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 Oct. 3, 2022, a study published by the peer-review Journal of Clinical Investigation 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.
As of November 2022, NVX-CoV2373 vaccines had received authorizations for adults from more than 43 countries, including the U.S. and from the WHO. 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. 18, 2022.
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. 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 Vaccine Price
As of November 2022, the Novavax COVID-19 vaccine price in the USA was sponsored by the U.S. CMS and Medicare during the Public Health Emergency. CMS identified specific code(s) for each COVID-19 product and particular administration codes (91304, 0041A, 0042A) for payment.
Reuters reported that Denmark announced it would buy 280,000 doses of Novavax's Nuvaxovid™ COVID-19 vaccine for roughly $20.9 per dose as part of a European Union pending agreement. Additional vaccine price and discount information is posted at InstantRx™.
NVX-CoV2373 U.S. FDA Authorizations
The U.S. FDA's Fact Sheets for Healthcare Providers, RECIPIENTS, and CAREGIVERS. On Oct. 19, 2022, Novavax, Inc. announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), had received 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 U.S. FDA confirmed on Aug. 19, 2022, that the Novavax COVID-19 Vaccine, Adjuvanted is 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. 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, according to data from the U.S. CDC. 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 U.S. FDA Vaccines and Related Biological Products Advisory Committee's 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. Additional data from Phase 2 and Phase 3 trials, as well as 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 FDA's Vaccine Committee's twenty-two members voted 21 yes, with one abstaining, to endorse the protein-based Novavax COVID-19 vaccine authorization. The FDA staff makes all final authorization or approval decisions. Novavax issued a statement on Jun. 3, 2022, 'the data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). Furthermore, in the post-crossover portions of our studies, the cases we have seen are all within the expected rate. And, 'Based on our interpretation of all the clinical data supporting NVX-CoV2373, including over 50,000 participants in clinical trials, we believe there is insufficient evidence to establish a causal relationship. We will continue to monitor all adverse events, including myocarditis and pericarditis.'
On Jun. 7, 2022, the FDA VRBPAC digital meeting will review various authorization presentations. "Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease."
Nuvaxovid U.K. Authorizations
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 caused by the SARS-CoV-2 coronavirus in adults aged 18 and older in February 2022 and in adolescents aged 12 through 17 in August 2022.
On Nov. 9, 2022, Novavax announced that the U.K.'s 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.
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 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 June 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. Reuters reported on On November 22, 2022, SSI had a 300 million dose commitment to GAVI for Covovax, with options for 750 million additional doses. Novavax terminated the agreement due to Gavi’s failure to purchase the contracted COVID-19 vaccines before the end of 2022.
One dose (0.5 mL) contains 5 micrograms of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M1. Adjuvant Matrix-M1 containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract.
NVX-CoV2373 SARS-CoV-2 Variants
As of November 2022, the U.S. NIH's OpenData Portal reported in vitro Therapeutic Activity against the Omicron variant and sublineages. But, the breaking nature of these releases should be interpreted with caution. During the U.S. FDA Vaccines and Related Biological Products Advisory Committee Meeting on Jun. 28, 2022, Novavax's Gregory M. Glenn, M.D. President, R&D, presented 'Structural features of our recombinant trimeric spike protein vaccine leads to broadly cross-neutralizing antibodies. Novavax technology induces cross-reactive immunity driven by recognition of conserved epitopes on Novavax recombinant spike protein, and the adjuvant enhances the breadth and duration of an immune response.
On Jul. 17, 2022, a non-peer-reviewed study found showed that after two Novavax vaccine doses, Omicron sub-lineages BA.1 and BA.4 were resistant to neutralization by 72% (21/29) and 59% (17/29) of samples. However, after the third dose of NVX-CoV2373, observed high titers against Omicron BA.1 (GMT: 1,197) and BA.4 (GMT: 582), similar in magnitude to those triggered by three doses of an mRNA vaccine.
And Novavax announced on Feb. 10, 2022, data from the pediatric expansion of phase 3 PREVENT-19 study showed in post hoc analyses robust immune responses in adolescents, including IgG responses against Spike proteins of several variants (including Alpha, Beta, Delta, Gamma, Mu, and Omicron) that were 2-3-fold higher than in adults, with 100% seroconversion against all variants following a 2-dose series of vaccinations. Adolescent functional immune responses (hACE2 receptor inhibition) against these variants were 2.4-4-fold higher than in adults against all evaluated variants.
As of November 2022, over 94 million doses of NVX-CoV2373 had been delivered globally. About 216,000 doses of Nuvaxovid were administered to adults in the EU/EEA from authorization to Jun. 26, 2022. In the U.S., the government's website offers local availability information.
Reuters reported Novavax delivered a written notice to Gavi, the Vaccine Alliance, on November 21, 2022, terminating an agreement for the sale of the company's COVID-19 vaccine to low- and middle-income countries
Nuvaxovid COVID-19 vaccines are available for use in the United Kingdom as of Sept. 27, 2022. Nuvaxovid is the first protein-based COVID-19 vaccine granted authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) and will be offered per advice from the Joint Committee on Vaccination and Immunisation.
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 at this weblink.
The company says the vaccine use in adolescents is the same as in adults, with two injections given in a muscle three weeks apart. The HUMMINGBIRD study, for children 6 months to 11 years old, is testing the investigational NVX-CoV2373 vaccine.
As of Sept. 16, 2022, Taiwan, Swiss, USA, Japan, Israel, India, Australia, New Zealand, South Korea, and the U.K. Medicines and Healthcare Products Regulatory Agency had authorized adolescents aged 12 through 17 to receive the Nuvaxovid vaccine.
NVX-CoV2373 Booster Authorizations
Novavax announced on Oct. 10, 2022, that SK bioscience had submitted a Post Approval Change Application to the Korean Ministry of Food and Drug Safety for Nuvaxovid for use as a heterologous and homologous booster for active immunization to prevent COVID-19 in adults. In September 2022, the Korean CDC advised the companies that Nuvaxovid can be used off-label as a booster in adults aged 18 and older.
Novavax announced in 2022 that Nuvaxovid was recommended for expanded conditional marketing authorization in the European Union, Swissmedic, New Zealand's Medsafe, Japan, Australia, and Canada had granted expanded provisional approval for Nuvaxovid™ as a heterologous and homologous booster dose in adults aged 18 and older.
On Nov. 8, 2022, Novavax announced topline results from its Phase 3 Boosting Trial for the SARS-CoV-2 rS Variant Vaccines (COVID-19), showing that the Company's BA.1 vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint. The data demonstrate that the BA.1 vaccine candidate neutralizing responses in those not previously exposed to COVID-19 were greater than those of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if necessary.
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; 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. This EMA update is a warning commonly included for commercially available vaccines, including COVID-19 vaccines. However, Novavax’s clinical development program reported no severe allergic reactions, and therefore, this risk was not listed in the initial product label. With the broader deployment of doses, Novavax received (2) reports of anaphylaxis (allergic reaction) that met a probable/definite case definition. Because anaphylaxis can occur with all vaccines and based on these cases, Novavax and the EMA agreed to update the label accordingly: A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid.
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 who have a hypersensitivity to the active substance or to any of the excipients. Appropriate medical treatment and supervision should be available in an anaphylactic reaction.
Visit https://www.novavaxcovidvaccine.com for adverse reaction reporting instructions. Read more about the side effects on the FDA's Fact Sheet for Recipients and Caregivers.
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 for the manufacturing and supply of a version of the Novavax COVID-19 vaccine (NVX-CoV2373) containing the Omicron variant and for the manufacture of the vaccine in prefilled syringes. Currently, SK bioscience manufactures drug substances for the vaccine. Novavax and SK bioscience also have a collaboration and licensing agreement under which SK bioscience exclusively commercializes the Novavax COVID-19 vaccine in South Korea, and Novavax jointly commercializes the vaccine in Vietnam and Thailand.
In 2021, Novavax licensed and transferred its manufacturing technologies and is supplying the Matrix-M™ adjuvant to enable Takeda to manufacture the vaccine at its Hikari facility in Japan.
On Jul. 7, 2020, Novavax was awarded $1.6 billion by the U.S. federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial, establish large-scale manufacturing, and deliver 100 million doses of NVX‑CoV2373. And the Coalition for Epidemic Preparedness Innovations has provided critical support to Novavax, including the commitment of approximately $400 million to advance early clinical development and manufacturing scale-up around the globe.
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. These dose insights will inform the Phase 2 confirmation trial to begin by the end of 2022. On April 20, 2022, the company announced initial results from the CIC Phase 1/2 clinical trial demonstrated that formulating the combination vaccine is feasible, well-tolerated, and immunogenic.
Novavax Inc. Financial
November 8, 2022 - Total revenue for the third quarter of 2022 was $735 million, compared to $179 million for the comparable period in 2021. The third quarter of 2022 total revenue includes $628 million of revenue comprised of $626 million of product sales from NVX-CoV2373 based on the sale of 35 million doses sold by Novavax and $2 million of royalties, milestone, and adjuvant sales to our license partners. Grant revenue of $106 million in the third quarter of 2022 compared to $135 million in the prior year resulted from a decrease in activity under our agreements with the Coalition for Epidemic Preparedness Innovations.
August 8, 2022 - The company announced Total Revenue for the second quarter of 2022 was $186 million, compared to $298 million for the comparable period in 2021. The second quarter of 2022 total revenue includes $78 million of revenue comprised of $55 million of product sales from NVX-CoV2373 based on three million doses sold by Novavax and $23 million of royalties, milestones, and adjuvant sales to our license partners.
May 9, 2022 - Novavax, Inc. announced its first quarter of 2022 total revenue includes $605 million comprised of $586 million of product sales from NVX-CoV2373 based on 31 million doses sold by Novavax and $19 million of royalties and adjuvant sales to license partners. Grant revenue of $99 million in the first quarter of 2022 compared to $447 million in the prior year.
Novavax News 2020 - 2022
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.
October 27, 2022 - The AMA published: Novavax booster, COVID vaccines in pregnancy, and boosters for kids.
October 10, 2022 - Stanley Erck delivered an Opening Statement at the European Parliament – COVI Committee Hearing.
September 27, 2022 - "With U.K. data showing that people infected with both COVID-19 and the flu are more than five times as likely to die compared to someone with no infection, it is more important than ever to consider any vaccine offered to you by the National Health Service," said Stanley C. Erck, President and CEO 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.
September 1, 2022 - "This (EU) recommendation is a critical step towards being able to offer the first protein-based COVID-19 vaccine registered for use as both a primary series and booster regardless of previous vaccine history in the EU," said Stanley C. Erck, President, and Chief Executive Officer, Novavax.
August 26, 2022 - The AMA published: What doctors wish patients knew about the Novavax COVID-19 vaccine.
August 19, 2022 - "Having more vaccine options for use in both adults and adolescents, like the Novavax COVID-19 Vaccine, Adjuvanted will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of COVID-19 with the start of fall and the back-to-school season," said Stanley C. Erck, President, and CEO, Novavax.
August 17, 2022 - Stanley C. Erck, Novavax, stated: “The US-India ties are even stronger than before and aligned in values and vision. Novavax and Serum Institute of India are committed to growing these partnerships to leverage our collective dedication, ingenuity, and expertise to protect the health of people everywhere.”
August 15, 2022 - "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations," said Stanley C. Erck, President, and CEO, Novavax.
August 12, 2022 - Novavax's partner SK bioscience will provide the first protein-based COVID-19 vaccine approved for use in adolescents aged 12 through 17 years in South Korea.
August 8, 2022 - Novavax adjusted guidance for 2022 to account for several evolving market dynamics. 'We remain confident in our vaccine as a strong additional choice. Its competitive product profile includes our vaccine’s efficacy, well-tolerated safety profile, durability of protection, and ability to address both current and future variant strains. In Q3, we are already making tremendous progress. We have shipped over 23 million doses since the beginning of July, and while in some cases delivery timing may be pushed into 2023, we do not expect total contracted demand to change under the majority of our Advance Purchase Agreements.'
August 4, 2022 - "We are excited to begin the Hummingbird trial to study Nuvaxovid's efficacy in children as young as six months through age 11," said Stanley C. Erck, President, and CEO, of Novavax.
August 1, 2022 - The AMA published a video discussion: Sandra Fryhofer, MD, AMA’s liaison and member of ACIP’s COVID-19 Vaccine Workgroup.
July 29, 2022 - Novavax announced the submission of a request to the WHO to expand the Emergency Use Listing of Nuvaxovid™ for active immunization to prevent COVID-19 in adolescents aged 12 through 17.
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 26, 2022 - The Company announced Australia and Japan authorized adolescents aged 12 through 17 to receive the Nuvaxovid vaccine.
July 13, 2022 - Novavax's vaccine became the first protein-based COVID-19 vaccine authorized in the U.S.
June 23, 2022 - The Taiwan Food and Drug Administration granted emergency use authorization for the Novavax COVID-19 Nuvaxovid™ vaccine for adults.
June 13, 2022 - The WHO stated: that SAGE has recommended its use for people aged 18 and above.
June 13, 2022 - Novavax, Inc. announced that the Australian Therapeutic Goods Administration granted provisional registration of the Nuvaxovid™ vaccine as a booster for adults.
June 7, 2022 - Novavax announced its COVID-19 vaccine received positive votes from U.S. FDA Vaccines and Related Biological Products Advisory Committee.
June 2, 2022 - Novavax announced the submission of a request to the Medicines and Healthcare products Regulatory Agency in the U.K. to expand the conditional marketing authorization of the Nuvaxovid™ COVID-19 vaccine as a homologous and heterologous booster dose for individuals aged 18 and over.
May 27, 2022 - Inoculations began at Juntendo University Hospital in Tokyo. The Novavax COVID-19 vaccine is the fourth to be used in Japan.
May 20, 2022 - Novavax announced the submission of a request to the EMA to expand the conditional marketing authorization of the Nuvaxovid™ COVID-19 vaccine in the European Union as a homologous and heterologous booster dose for individuals aged 18 and over. This request for expanded CMA is supported by data from Novavax's Phase 2 clinical trial conducted in Australia.
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 20, 2022 - Novavax, Inc. announced initial results from the Phase 1/2 clinical trial of the COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax' COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC trial demonstrated that formulating the combination vaccine is feasible, well-tolerated, and immunogenic.
April 13, 2022 - Novavax, Inc. announced that Swissmedic had granted Novavax conditional marketing authorization for Nuvaxovid.
April 8, 2022 - Novavax, Inc., and Serum Institute of India Pvt. Ltd. announced that Thailand's FDA granted EUA for Novavax's vaccine under the brand name Covovax™.
March 22, 2022 - Novavax and Serum Institute of India Pvt. Ltd. announced that the Drugs Controller General of India granted EUA for Novavax's COVID-19 vaccine for adolescents aged ≥12 to <18 years in India.
March 1, 2022 - Australia confirmed that Nuvaxovid (Novavax) could be used as a booster in an individual aged 18 years.
February 23, 2022 - Novavax, Inc. announced the first doses of Nuvaxovid™ COVID-19 Vaccine have begun shipping to E.U. member states.
February 10, 2022 - Novavax, Inc. announced that NVX-CoV2373 achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S.
February 9, 2022 - S.K. bioscience (CEO Jae-Yong Ahn) announced that the first recombinant protein-based COVID-19 vaccine was authorized in South Korea.
August 4, 2021 - Novavax, Inc. announced that it had reached an agreement with the European Commission to purchase up to 200 million doses of NVX-CoV2373.
July 7, 2020 - Novavax, Inc. announced that it has been selected to participate in Operation Warp Speed and has been 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 approach to allow rapid advancement.
March 10, 2020 - CEPI provides an initial $4 million to accelerate vaccine development to prepare for Phase 1 clinical study.
Novavax Clinical Trials
The NVX-CoV2373 vaccine continues to be evaluated in multiple clinical trials.
Full results from the PREVENT-19 pivotal Phase 3 clinical trial of NVX-CoV2373 have been published in the New England Journal of Medicine: on December 15, 2021. And it achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. The study enrolled 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S.
On August 5, 2021, the Company confirmed the final analysis from PREVENT-19 U.S. and Mexico Phase 3 trial: Achieved primary efficacy endpoint with an overall efficacy of 90.4% against mild, moderate, and severe disease; Demonstrated 100% protection against moderate and severe disease; Demonstrated 91.0% efficacy among high-risk populations; Demonstrated 92.6% efficacy against Variants of Concern/Variants of Interest (VoC/VoI) and 100% efficacy against variants not considered VoC/VoI.