Novavax
American biotechnology company
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| May 2025 | Novavax received FDA approval for its COVID-19 vaccine for adults 65 years or over and high-risk individuals 12 years or over. |
| January 2025 | Novavax announced four new preclinical programs in infectious diseases, including shingles, clostridioides difficile, and vesicular stomatitis virus. |
| 2024 | A new vaccine formulation was developed containing a recombinant spike protein from lineage JN.1 for the 2024-2025 period. |
| 2024 | Novavax made a deal with Sanofi for Sanofi to take over commercialization responsibilities for NVX-CoV2373 in most countries starting in 2025. |
| December 2024 | Novavax sold its Czech manufacturing facility to Novo Nordisk for $200 million. |
| October 2024 | Novavax announced a $1.2 billion partnership with Sanofi, allowing Sanofi to use Novavax's Matrix-M adjuvant for other products. |
| October 2024 | The CHMP gave a positive opinion to update the composition of Nuvaxovid to target the SARS-CoV-2 JN.1 variant for the 2024/2025 vaccination campaign. |
| October 2024 | The CHMP gave a positive opinion to update Nuvaxovid's composition to target the SARS-CoV-2 JN.1 variant for the 2024/2025 vaccination campaign. |
| August 2024 | The FDA granted emergency use authorization for an updated Novavax COVID-19 vaccine with a monovalent component corresponding to the Omicron variant JN.1 strain of SARS-CoV-2. |
| January 2024 | Vaccine authorized in Brazil. |
| January 2024 | The Novavax COVID-19 vaccine was authorized in Brazil. |
| 2023 | Novavax developed an updated vaccine version specifically targeting the Omicron variant, incorporating a recombinant spike protein from lineage XBB.1.5. |
| October 2023 | The FDA amended the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted to include the 2023–2024 Formula and removed authorization for the original monovalent version. |
| July 2023 | Novavax received full Marketing Authorization from the European Commission for Nuvaxovid, allowing use as a primary series for individuals 12 and older and as a booster for adults 18 and older. |
| 2022 | The vaccine was developed with updated formulations to provide coverage against the Omicron variant. |
| August 2022 | CDC recommended the Novavax COVID-19 vaccine for adolescents aged 12–17 years. |
| August 2022 | The FDA granted Emergency Use Authorization for the Novavax COVID-19 vaccine in people aged 12–17 years. |
| July 2022 | CDC recommended the Novavax COVID-19 vaccine as a two-dose primary series for adults age 18 and older. |
| July 2022 | The FDA authorized NVX-CoV2373 for emergency use as a primary immunization in adults, becoming the fourth COVID-19 vaccine authorized in the US. |
| July 2022 | The vaccine received emergency use authorization from multiple global health authorities, including the WHO and regulatory bodies in various countries, enabling broader distribution. |
| July 13 2022 | US Food and Drug Administration issued emergency use authorization for Novavax COVID-19 Vaccine for individuals 18 years and older. |
| June 2022 | A US Food and Drug Administration (FDA) advisory committee voted 21-0 with one abstention to recommend authorization of Novavax's vaccine for use in adults. |
| June 26 2022 | Novavax COVID-19 vaccine administered 216,000 doses in the European Union/European Economic Area (EU/EEA) since its authorization. |
| February 2022 | Health Canada authorized Nuvaxovid for COVID-19 prevention in adults 18 years and older. |
| February 2022 | Novavax received approval for its COVID-19 vaccine Nuvaxovid in Canada, expanding its global vaccine authorization. |
| January 31 2022 | Novavax applied to the FDA for Emergency Use Authorization for NVX-CoV2373. |
| January 20 2022 | Australia's Therapeutic Goods Administration granted provisional approval for Novavax's COVID-19 vaccine NUVAXOVID, the first protein COVID-19 vaccine approved in the country. |
| 2021 | Novavax conducted vaccine trials with 5,000 volunteers at the Thackray Museum of Medicine in Leeds. |
| December 2021 | The European Commission granted a conditional marketing authorization for the Novavax COVID-19 vaccine to be sold under the brand name Nuvaxovid across the EU. |
| December 2021 | Novavax reported its phase III trial results, demonstrating 90.4% overall efficacy against different SARS-CoV-2 variants and 100% efficacy against moderate-to-severe disease following the second vaccine dose. |
| December 17 2021 | World Health Organization added Novavax's Covovax vaccine to the list of approved coronavirus vaccines for emergency use in the Covax programme. |
| November 2021 | The EMA received an application for conditional marketing authorization for the Novavax COVID-19 vaccine. |
| November 2021 | Novavax was reported to be producing its vaccine in Poland through Mabion SA, a Contract Development and Manufacturing Organisation (CDMO). |
| November 1 2021 | Novavax and Serum Institute of India received emergency use authorization from Indonesia for their recombinant nanoparticle protein-based COVID-19 vaccine. |
| September 6 2021 | Novavax and Takeda Pharmaceutical Company announced that the Japanese government will purchase 150 million doses of vaccine candidate TAK-019, pending regulatory approval. |
| June 2021 | Novavax initiated the development of updated vaccine formulations to provide coverage against emerging COVID-19 variants, demonstrating adaptive vaccine development strategies. |
| June 2021 | Novavax submitted its COVID-19 vaccine for regulatory review, marking a significant milestone in the vaccine's development process. |
| June 2021 | Novavax reported positive results from Phase 3 clinical trials of their COVID-19 vaccine, demonstrating high efficacy against original SARS-CoV-2 strains. |
| May 2021 | Post-hoc analysis of the Novavax vaccine trial revealed a cross-protective vaccine efficacy of 51.0% against the Beta variant for HIV-negative participants. |
| May 2021 | Novavax expanded its phase III clinical trial to include a pediatric component, enrolling 3,000 adolescents aged 12-17 across up to 75 sites in the United States. |
| May 2021 | Serum Institute of India began production of the Novavax COVID-19 vaccine candidate branded as Covovax in India after receiving government permission. |
| May 22 2021 | Novavax and Moderna announced a deal with the South Korean government to manufacture COVID-19 vaccines. Novavax also began co-developing the vaccine with CEPI in India under the brand name Covovax. |
| May 22 2021 | Novavax and Moderna announced a deal with the South Korean government to manufacture COVID-19 vaccines. CEPI granted Novavax up to $399 million to support vaccine development. |
| March 2021 | Novavax conducted a preliminary randomized, placebo-controlled study with 2684 participants to test the vaccine's efficacy against COVID-19, with the Beta variant being predominant. |
| February 2021 | The European Medicines Agency (EMA) started a rolling review of the Novavax COVID-19 vaccine (NVX‑CoV2373). |
| February 2021 | Novavax partnered with Takeda to manufacture the vaccine in Japan, where it is known as TAK-019. |
| January 2021 | Novavax reported interim trial results from South Africa, showing a lower vaccine effectiveness rate of around 50-60% against the Beta COVID-19 variant (lineage B.1.351). |
| January 2021 | Novavax reported preliminary results from the UK trial, showing the vaccine candidate was more than 89% effective. |
| 2020 | Novavax signed an agreement with Serum Institute of India for mass scale production of COVID-19 vaccine for developing and low-income countries. |
| 2020 | Novavax reported plans to manufacture its COVID-19 vaccine in Spain. |
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