Novavax COVID-19 Vaccine (Nuvaxovid™) Description 2022
Novavax COVID-19 vaccine (Nuvaxovid™, CovoVax™, NVX-CoV2373) (SARS-CoV-2 rS [Recombinant, adjuvanted)) is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 beta coronavirus. The COVID-19 vaccine was created using Novavax's proprietary nanoparticle technology, Matrix-M, an adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.
Novavax Inc.'s vaccine candidates 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.
Novavax's patented saponin-based 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 virus.
On Aug. 4, 2020, Novavax announced the Phase 1 data from its Phase 1/2 clinical trial found the recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older was last updated on Oct. 28, 2020. Cellular immune responses were measured in a subset of participants, and NVX‑CoV2373 induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a).
On Jan. 28, 2021, NVX‑CoV2373 became the first protein-based vaccine candidate to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom (U.K.) and South Africa. In addition, the Company announced the vaccine's efficacy of 96.4% against mild, moderate, and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the U.K.
On Dec. 17, 2021, the World Health Organization (WHO) granted Emergency Use Listing for the NVX‑CoV2373 vaccine manufactured and marketed by Serum Institute of India Pvt. Ltd. (SII) named CovoVax. Novavax's COVID-19 vaccine Nuvaxovid was endorsed by the European Medicines Agency, and European Commission granted conditional marketing authorization on Dec. 20, 2021 - E.U. study number: EudraCT number, 2020-004123-16.
Then, the NEJM published a paper on Feb 10, 2022, concluding a phase 3 clinical trial: NVX-CoV2373 was safe and effective for preventing Covid-19. Most breakthrough cases were caused by contemporary variant strains. A pivotal Phase 3 clinical trial conducted in the UK published on Feb. 28, 2022, found a high level of efficacy for NVX-CoV2373 was maintained over 6-months of surveillance. Additionally, the analysis showed vaccine efficacy of 82.5% (95% CI: 75.0, 87.7) in protection against all COVID-19 infections, both symptomatic and asymptomatic, as measured by PCR+ or anti-N seroconversion.
A non-peer-reviewed head-to-head comparison published on March 21, 2022, shows that the mRNA COVID-19 vaccines made by Pfizer and Moderna outperform those produced by Jansen (Johnson & Johnson) and Novavax. The data also provide a finely detailed picture of each vaccine's immune protection.
Novavax COVID-19 vaccine brands include Nuvaxovid, CovoVax, NVX-CoV2373, TAK-019 - 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 February 18, 2022.
See the full 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 at this weblink.
Maryland-based Novavax, Inc. (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. The Company confirmed sales from NVX-CoV2373 included 31 million doses sold by Novavax in the first quarter of 2022.
Novavax COVID-19 Vaccine Variant Protection (Omicron BA.2)
As of May 12, 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. And Novavax announced on Feb. 10, 2022, data from the pediatric expansion of the 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.
Novavax COVID-19 Vaccine Authorizations For 2022
As of May 16, 2022, Novavax's vaccine has received various authorizations in over 170 countries, including in the EU, and is Listed by the World Health Organization (WHO), as its 10th authorization. The Company announced regulatory filings for its vaccine in the U.K., Austria, Australia, Cyprus, Estonia, European Commission, Indonesia, The Philippines, Croatia, New Zealand, Canada, India, Ireland, Singapore, South Korea, UAE, Japan, Finland, South Africa, France, Germany, Israel, Germany, Switzerland, the Netherlands, Taiwan, Thailand, Switzerland, Portugal, and Singapore. Global information about the Novavax COVID-19 Vaccine's availability is found at this weblink.
Previously, Novavax completed the submission of the final data package for the NVX-CoV2373 vaccine to the U.S. FDA on Jan. 31, 2022. The FDA's Vaccines and Related Biological Products Advisory Committee review is scheduled for June 7, 2022.
CovoVax™ Vaccine in 2021 - 2022
Novavax, Inc. and Serum Institute of India Pvt. Ltd. confirmed the CovoVax vaccine was authorized in Indonesia on Dec. 1, 2021, and Listed by the WHO on Dec. 17, 2021. India's the 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.
Nuvaxovid™ Vaccine in 2021 - 2022
Novavax announced on May 4, 2022, the submission of a request to the MHRA in Great Britain (England, Scotland, and Wales) to expand the authorization of the Nuvaxovid COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years.
On March 1, 2022, the Australian Technical Advisory Group on Immunisation issued guidance on using Novaxva as a booster for patients aged 18 and over ‘if no other COVID-19 vaccine is considered suitable. And Nuvaxovid is the only protein-based COVID-19 vaccine granted authorization from Health Canada.
On April 18, 2022, Takeda announced that it had received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid (TAK-019) for adults. Takeda Pharmaceutical Company Limited (TSE:4502 / NYSE: TAK) confirmed on February 3, 2022; it is partnering with Novavax in Japan for the development, manufacturing, and commercialization of TAK-019, their COVID-19 vaccine candidate, utilizing Takeda’s Hikari manufacturing site in Japan. Takeda also entered into an agreement with the Government of Japan’s MHLW to purchase 150 million doses of TAK-019. Distribution of the first doses in Japan is planned for early 2022, subject to regulatory approval. On December 15, 2021, the companies submitted an approval application for TAK-019 to the MHLW.
On November 30, 2021, the EMA started evaluating an application for Novavax's Nuvaxovid EMEA/H/C/005808 in adolescents aged 12 to 17. The European Commission granted CMA for Nuvaxovid to prevent COVID-19 in people 18 years of age and older in December 2021. Doses of Nuvaxovid began shipping to EU member states shortly after that. In addition, on March 15, 2021, the Company filed European Medicines Agency P/0126/2021 for use in Europe. If granted, Nuvaxovid COVID-19 Vaccine would be the first protein-based option for adolescents aged 12-17 years in Europe.
Novavax COVID-Influenza Combination Vaccine
Novavax's COVID-Influenza Combination Vaccine (CIC), formerly known as the COVID-NanoFlu™ combination vaccine candidate, combines NanoFlu™ and NVX-CoV2373. 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. Both protein-based vaccines used in the trial were formulated with the patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Both vaccines previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials. These results were previously published in The Lancet in September 2021.
On June 14, 2021, the Company announced a non-peer-reviewed manuscript, "safety, Immunogenicity, and Efficacy of a COVID-19 Vaccine (NVX-CoV2373) Co-administered With Seasonal Influenza Vaccines," available at medRxiv.org. This statement reinforces the U.S. CDC's interim clinical considerations that COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without timing. On December 21, 2021, the WHO's SAGE stated: Coadministration of an inactivated seasonal influenza vaccine and any dose of NVX-CoV2373 is acceptable.
Novavax COVID-19 Vaccine Indication
Nuvaxovid NVX-CoV2373 is a vaccine candidate indicated as a SARS-CoV-2 coronavirus vaccine to prevent COVID-19. NVX-CoV2373 demonstrated efficient binding with receptors targeted by the virus in preclinical trials, a critical aspect for effective vaccine protection. The journal Nature published an article on November 8, 2021: How protein-based COVID vaccines could change the pandemic.
The WHO's SAGE interim recommendations published on December 21, 2021, include but are not limited to the following: Use of the vaccine in specific populations, including persons with comorbidities, breastfeeding women, and those living with human immunodeficiency virus; Use of NVX-CoV2373 vaccine in pregnant women if the benefits of vaccination to the pregnant woman outweigh the potential risks; and Coadministration of an inactivated seasonal influenza vaccine and any dose of NVX-CoV2373 is acceptable.
Novavax COVID-19 Vaccine Pediatric Plans
Novavax announced on May 4-6, 2022, the submission of variations to the Australian Therapeutic Goods Agency, New Zealand's Medsafe, and Great Britain to expand the provisional approval of its Nuvaxovid for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years.
The Drugs Controller General of India approved NVX-CoV2373 for restricted use in an emergency for adolescents aged 12 through 17 years in India. SK bioscience also recently submitted a regulatory filing for adolescent vaccine authorization to the South Korean Ministry of Food and Drug Safety. And in Thailand and Japan on April 18, 2022.
Novavax initiated the administration of the first booster doses of NVX-CoV2373 in the pediatric expansion of the PREVENT-19 pivotal Phase 3 clinical trial on April 22, 2022, evaluating the third dose among participants aged 12 through 17. On February 10, 2022, the PREVENT-19 pediatric study expansion in adolescents aged 12 through 17 achieved a primary effectiveness endpoint demonstrating comparability to the adult population; Trial demonstrated 82% clinical efficacy against Delta variant; Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied; the Vaccine was well-tolerated with no safety signals identified. On May 3, 2021, the Company announced the pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373. The other arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety, and immunogenicity of NVX-CoV2373 in up to 3,000 adolescents aged 12-17 across up to 75 sites in the USA.
Novavax COVID-19 Vaccine Dosage and Boosters
Novavax evaluated two intramuscular immunizations of 5 and 25 μg NVX Cov2373, with and without its Matrix-M adjuvant, in a Phase I trial. On December 21, 2021, the Company announced that the first booster doses of NVX-CoV2373 had been administered to extend the Company's PREVENT-19 pivotal Phase 3 clinical trial.
Novavax confirmed on March 25, 2022, participating in an ongoing Phase 1/2 trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to assess homologous and heterologous boosting regimens in participants who received a primary series of a COVID-19 vaccine. The trial is being conducted at approximately ten clinical research sites. Participants will be followed for 12 months, with full results expected in 2023. Novavax' COVID-19 vaccine is also being evaluated in an observer-blinded Phase 3 study in the United Arab Emirates to assess homologous versus heterologous boosting of participants who have already been immunized with Sinopharm's COVID-19 vaccine.
The WHO Strategic Advisory Group of Experts on Immunization recommended on December 21, 2021, the primary two-dose vaccination series of NVX-CoV2373 in persons aged 18 and older, and an additional third dose of NVX-CoV2373 administered to immunocompromised persons. On December 22, 2021, Novavax confirmed a third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after a booster dose.
Novavax COVID-19 Vaccine Side Effects
On April 28, 2022, the EMA reported that Nuvaxovid had 294 cases of suspected side effects reported from EU/EEA countries; none of these cases reported a fatal outcome. By the same date, about 178,000 doses of Nuvaxovid had been administered in the EU/EEA. The WHO says Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance or to any of the excipients. Events of anaphylaxis have been reported with the administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in an anaphylactic reaction.
On December 22, 2021, the Company announced that local and systemic reactions were generally short-lived following the booster dose, with a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose. Visit https://www.novavaxcovidvaccine.com for adverse reaction reporting instructions.
Novavax COVID-19 Vaccine Cost
Reuters reported that Denmark announced it would buy 280,000 doses of Novavax's COVID-19 vaccine for roughly $20.9 per dose as part of a European Union pending agreement.
Novavax COVID-19 Vaccine Payment in the U.S.
During the COVID-19 public health emergency, the U.S. government pays for COVID-19 vaccines. CMS identified specific code(s) for each COVID-19 product and particular administration codes (91304, 0041A, 0042A) for payment.
Novavax Inc. (Nasdaq: NVAX) Financial News 2021 - 2022
May 9, 2022 - Novavax, Inc. announced its first quarter of 2022 total revenue includes $605 million of revenue 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. Reiterating the full year 2022 total revenue guidance of between $4 and $5 billion.
February 28, 2022 - Novavax, Inc. (NASDAQ: NVAX) announced its financial results and operational highlights for the twelve months ended December 31, 2021 - revenue for the fourth quarter and full-year ended 2021 were $222 million and $1.1 billion, respectively, compared to $280 million and $476 million for the comparable periods in 2020 - Full-year 2022 total revenue guidance of between $4 billion and $5 billion.
February 5, 2022 - Seeking Alpha reported that NVAX's partnership with SII will help to ensure FY2022 delivery of at least 1.8 billion vaccine doses. As a result, 'we expect a massive upwards re-rating for NVAX's future revenues, as more realize the benefit of its protein-based vaccine.'
January 7, 2022 - Novavax, Inc. announced that it had executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of the NVX-CoV2373 COVID-19 vaccine candidate. As part of the agreement, Australia will have the option to purchase up to an additional 10 million doses.
Novavax COVID-19 Vaccine News: 2020 - 2022
May 14, 2022 - CNA reported Taiwan's FDA Director Wu Xiumei confirmed that Novavax submitted an application for emergency use authorization.
May 13, 2022 - Novavax’s Nuvaxovid COVID-19 vaccine will be offered at Singapore’s first Joint Testing and Vaccination Centre and at Public Health Preparedness Clinics in late May 2022.
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.
May 6, 2022 - Deliveries of Novavax’s COVID-19 vaccine arrived in Singapore this week.
May 3, 2022 - Portugal media reported the Novavax vaccine is available/indicated for certain people.
April 29, 2022 - Novavax, Inc. announced that the U.S. FDA would review the NVX-CoV2373 COVID-19 Vaccine at a meeting on June 7, 2022.
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 18, 2022 - Gary Dubin, M.D., President of the Global Vaccine Business Unit, Takeda. “We are proud to contribute to the development of Nuvaxovid and manufacture the vaccine at our Hikari facilities, continuing our commitment to the COVID-19 public health response in Japan.”
April 18, 2022 - Novavax, Inc. offered its first look at data from its COVID-19 influenza combination vaccine and seasonal influenza vaccine clinical trials at the World Vaccine Congress on April 18 - 21, 2022.
April 18, 2022 - Toronto Public Health is offering Novavax vaccines to adults starting April 21, 2022.
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 emergency use authorization for Novavax's protein-based vaccine under the brand name Covovax™.
March 31, 2022 - Novavax, Inc. announced the submission of its request to expand the conditional marketing authorization of the Nuvaxovid™ COVID-19 Vaccine in the EU to adolescents aged 12 through 17 years.
March 31, 2022 - Health Canada announced it had distributed 1 million Novavax vaccine doses.
March 25, 2022 - Novavax, Inc. announced that NVX-CoV2373 is included in two clinical trials to evaluate its vaccine's safety, immunogenicity, and reactogenicity as a booster dose.
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 17, 2022 - The EU Medicines Agency Tweeted: Nuvaxovid has been rolled out across Europe over the past weeks. Anyone who has not received any dose of a COVID19 vaccine should get vaccinated as soon as possible with one of the five options now available.
March 8, 2022 - The Company announced the first doses of Novavax’ COVID-19 vaccine would be available to New Zealanders beginning the week of March 14, 2022.
March 6, 2022 - Local media reported India's Drugs Controller General of India granted permission for Covovax vaccine phase 3 clinical trials as a booster dose.
March 2, 2022 - Yale Medicine published: Comparing the COVID-19 Vaccines: How Are They Different?
March 1, 2022 - Australia confirmed Nuvaxovid (Novavax) can be used as a booster in an individual aged 18 years and above if no other COVID-19 vaccine is considered suitable for that individual.
March 1, 2022 - Local media reported Novavax's Nuvaxovid is the fourth vaccine to be approved by Medsafe. Pfizer/BioNTech, AstraZeneca, and Janssen are all approved for use in New Zealand.
February 23, 2022 - Novavax, Inc. announced the first doses of Nuvaxovid™ COVID-19 Vaccine have begun shipping to EU member states. Nuvaxovid is the first protein-based COVID-19 vaccine authorized for use in Europe.
February 15, 2022 - GAVI published: What is the Novavax vaccine, and why does the world need another type of COVID-19 vaccine?
February 14, 2022 - The Company announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional marketing authorization of NVX-CoV2373 for use in adults.
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 - SK bioscience (CEO Jae-Yong Ahn) announced that the first recombinant protein-based COVID-19 vaccine authorized in South Korea and developed by Novavax, Inc., Nuvaxovid, began to be shipped from SK’s vaccine manufacturing plant, L -House in Andong on the morning of the 9th. The initial volumes to be distributed for domestic use are about 2 million doses.
February 3, 2022 - Reuters reported Germany's expert panel on vaccine use recommended Novavax's COVID-19 vaccine for people over 18 years of age.
February 3, 2022 - Novavax, Inc. announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorization for Nuvaxovid™ COVID-19 Vaccine for adults in Great Britain.
January 31, 2022 - Novavax, Inc. announced that it has submitted a request to the U.S FDA for a EUA for NVX-CoV2373 for the immunization of individuals 18 years of age and older against the SARS-CoV-2 betacoronavirus.
January 28, 2022 - Novavax, Inc. and Israel's Ministry of Health today announced an advanced purchase agreement of NVX-CoV2373.
January 25, 2022 - Reuters reported Germany expects to receive 3.8 million doses of Novavax's Nuvaxovid vaccine in the late first quarter of 2022.
January 24, 2022 - New Zealand media reported Medsafe is unable to finalize its assessment of the Novavax Covid-19 vaccine.
January 22, 2022 - Media in Sydney reported: 'Desperately waiting': The Australians who need Novavax vaccine for medical reasons.
January 20, 2022 - Novavax, Inc. announced that Australia's Therapeutic Goods Administration had granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) Novavax' COVID-19 vaccine. The vaccine will be supplied to Australia under the brand name Nuvaxovid.
January 14, 2022 - France's HAS considers the Nuvaxovid® vaccine from Novavax to represent an effective alternative and has positioned it in the country's vaccine strategy.
January 12, 2022 - Novavax, Inc. and its partner SK bioscience, Co. Limited announced that South Korea's Ministry of Food and Drug Safety approved a Biologics License Application from SK bioscience for Nuvaxovid™ COVID-19 Vaccine. SK bioscience has an advance purchase agreement with the South Korean government to supply 40 million doses of Nuvaxoid.
January 10, 2022 - Yale Medicine published news article: Comparing the COVID-19 Vaccines: How Are They Different?
January 6, 2022 - Belgium-based Ardena announced it will be expanding capacity for purification and fractionation of GMP manufacturing for Novavax at its site in Södertälje, Sweden.
January 4, 2022 - Local media reported Mia Kontio, a virologist at the Institute for Health and Welfare, it is not known when Novavax's jabs could start arriving in Finland.
December 31, 2021 - The Company announced it has completed the submission of the final data package, including the complete chemistry, manufacturing, and controls module, to fulfill the prerequisites for the EUA application request to the U.S. FDA for the NVX-CoV2373 vaccine.
December 28, 2021 - Novavax, Inc., and Serum Institute of India Pvt. Ltd. announced that the Drugs Controller General of India has granted emergency use authorization for the brand name Covovax™.
December 23, 2021 - Novavax, Inc. and SK bioscience, Co. Limited (SK Group) announced the expansion of collaboration and license agreements for the NVX-CoV2373 vaccine.
December 23, 2021 - The Gezondheidsraad confirmed the Novavax vaccine was suitable for people who do not want an mRNA vaccination.
December 22, 2021 - Science.org published an article: Novavax's long-awaited COVID-19 vaccine authorizations offer an alternative to mRNA.
December 22, 2021 - Novavax, Inc. announced initial data evaluating the immune response of NVX-CoV2373 against the Omicron variant, as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.
December 21, 2021 - The Company announced that the first booster doses of NVX-CoV2373 have been administered to extend the Company's PREVENT-19 pivotal Phase 3 clinical trial. All PREVENT-19 trial participants are now eligible to receive a third booster dose of NVX-CoV2373.
December 21, 2021 - Novavax, Inc. announced that the WHO Strategic Advisory Group of Experts on Immunization had published its interim recommendations for the use of NVX-CoV2373.
December 20, 2021 - Novavax, Inc. announced that the European Medicines Agency (EMA) has recommended granting conditional marketing authorization for the Novavax COVID-19 vaccine to prevent COVID-19 in people from 18 years of age and older. NVX-CoV2373 will be marketed in the European Union as Nuvaxovid.
December 17, 2021 - The Company announced the WHO had Listed the Covovax vaccine version, produced by the Serum Institute of India.
November 19, 2021 - Reuters reported Serum Institute of India had been authorized by the Indian government to export millions of CovoVax vaccines to Indonesia.
November 17, 2021 - Novavax, Inc. and Serum Institute of India Pvt. Ltd. announced that the Philippine Food and Drug Administration had granted a EUA for Novavax's COVID-19 vaccine.
November 16, 2021 - Alcami announced today that they had signed a master laboratory services agreement with Novavax. With the execution of the agreement, Novavax has immediately secured full-time equivalent resources to provide analytical testing support for its recombinant nanoparticle protein-based COVID-19 vaccine candidate.
November 15, 2021 - Novavax, Inc. and S.K. bioscience, Co. Limited confirmed the submission of a Biologics License Application for Novavax's COVID-19 vaccine to South Korea's Ministry of Food and Drug Safety, the final review stage for authorization in Korea.
November 8, 2021 - The journal Nature published an article: How protein-based COVID vaccines could change the pandemic.
October 20, 2021 - In response to a recent news article citing anonymous sources, Novavax confirms our confidence in our ability to deliver our high-quality vaccine. Further, we underscore our ongoing commitment to the stringent standards of production and manufacturing for our recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.
October 19, 2021 - Novavax confirmed topline immunogenicity and reactogenicity data from Comparing COVID-19 Vaccine Schedule Combinations – Stage 2 (Com-COV2), a Phase 2 clinical study conducted by the University of Oxford, were presented at the World Vaccine Congress taking place in Barcelona.
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.
June 30, 2021 - Novavax, Inc. announced the publication of results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candidate conducted in the United Kingdom in the New England Journal of Medicine. The final analysis confirmed an overall efficacy of 89.7%.
June 14, 2021 - Novavax, Inc. announced data from the first coadministration study of a SARS-CoV-2 vaccine candidate [Novavax, NVX-CoV2373] and an approved influenza vaccine [Seqirus, adjuvanted, trivalent seasonal influenza vaccine or a cell-based, quadrivalent seasonal influenza vaccine), suggest simultaneous vaccination may be a viable immunization strategy. In addition, the protection afforded by the candidate vaccine was consistent with the main study at 87.5% and 89.8%, respectively.
August 6, 2020 - Novavax announced a license agreement with Serum Institute of India Private Limited to develop and commercialize NVX‑CoV2373 in low- and middle-income countries and India. This agreement excludes major upper-middle and high-income countries, for which Novavax continues to retain rights.
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 to complete late-stage clinical development and deliver 100 million doses of NVX‑CoV2373.
May 11, 2020 - Novavax, Inc. announced that the Coalition for Epidemic Preparedness Innovations (CEPI) would invest up to $384 million of additional funding, on top of $4 million it invested in March, to advance the clinical development of NVX-CoV2373, NNovavax'coronavirus vaccine candidate against SARS-CoV-2.
April 8, 2020 - Novavax, Inc announced it had identified a coronavirus vaccine candidate, NVX-CoV2373. The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach to allow rapid advancement during the current coronavirus pandemic.
March 10, 2020 - CEPI provides an initial $4 million to accelerate vaccine development to prepare for Phase 1 clinical study.
Novavax COVID-19 Vaccine (Nuvaxovid, Covovax, NVX-CoV2373) 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: 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 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.