Drugs / MIVALSECOVATEIN
MIVALSECOVATEIN
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05925127 | Oct 2023 → May 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 2/3 | NCT05975060 | Sep → Nov 2023 | COVID-19 | Novavax | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT05973006 | Aug 2023 → Apr 2024 | COVID-19 | Novavax | Completed | No outcome recorded |
| Phase 41 trial · 1 met primary | ||||||
| Phase 4 | NCT05767606 | Mar → Jul 2023 | COVID-19, pneumococcal infection | Medical University of Vienna | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2024-04-01 | Novavax | Results Novavax Presents Data on Updated COVID-19 Vaccine and Progress to Date on its COVID-19-Influenza Combination Vaccine Candidate at World Vaccine Congress 2024 novavax.com ↗
New data from Novavax's ongoing research on its updated XBB.1.5 COVID-19 vaccine in participants who previously received an mRNA vaccine showed robust neutralizing antibody titers for the XBB.1.5 subvariant as well as for the currently circulating JN.1 subvariant. |
| 2024-02-28 | Novavax | Regulatory Novavax’s Protein-based Non-mRNA COVID-19 Vaccine Available Now as Additional Dose for Individuals Aged 65 and Older Following U.S. CDC Advisory Committee Recommendation novavax.com ↗ |
| 2024-01-24 | Novavax | Regulatory Novavax’s Updated COVID-19 Vaccine▼ Authorized in the United Kingdom novavax.com ↗
“Today’s MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year,” said John C. Jacobs, President and Chief Executive Officer, Novavax. |
| 2023-12-18 | Novavax | Regulatory Novavax's Updated COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan novavax.com ↗
the Taiwan Food and Drug Administration has granted emergency use authorization for Nuvaxovid ™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older. |
| 2023-12-05 | Novavax | Regulatory Novavax's Updated COVID-19 Vaccine Now Authorized in Canada novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M ™ adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. |
| 2023-11-29 | SK Bioscience Co., Ltd. | Regulatory Novavax’s Updated COVID-19 Vaccine Receives Emergency Use Authorization in the Republic of Korea skbioscience.com ↗
This marks the fourth approval of Novavax´s updated COVID-19 vaccine globally, following approvals in the U.S., the EU, and by the WHO, and it is the first approval in Asia. |
| 2023-11-29 | Novavax | Regulatory Novavax’s Updated COVID-19 Vaccine Receives Emergency Use Authorization in the Republic of Korea novavax.com ↗
Novavax ’s partner, SK bioscience, today announced that Novavax’s updated COVID-19 vaccine (NVX-CoV2601) has received Emergency Use Authorization from the Ministry of Food and Drug Safety in the Republic of Korea. |
| 2023-11-28 | Novavax | Regulatory Novavax's Updated Protein-based COVID-19 Vaccine Now an Option for All 194 Member States of the World Health Organization novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older. |
| 2023-10-31 | Novavax | Regulatory Novavax's Updated Nuvaxovid™ COVID-19 Vaccine Receives Positive CHMP Opinion in the EU novavax.com ↗
Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M ™ adjuvant, today announced that the Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) has been recommended for approval for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older in the European Union by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. |
| 2023-10-31 | Novavax | Regulatory Novavax's Updated COVID-19 Vaccine Now Approved in the EU novavax.com ↗
today announced the European Commission has granted approval for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. |
| 2023-10-20 | SK Bioscience Co., Ltd. | Regulatory Updated Novavax COVID-19 Vaccine Is Submitted for Emergency Use Authorization in the Republic of Korea skbioscience.com ↗ |
| 2023-10-03 | Novavax | Regulatory Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. novavax.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MIVALSECOVATEIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068266 ↗ |
| Known as | Mivalsecovateina | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068266 ↗ |
| Known as | Mivalsecovateine | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068266 ↗ |
| Known as | NVX-CoV2601 | “The co-administration of the Omicron-adapted COVID-19 vaccine from Novavax (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine (PCV20) has not been previously investigated.” PMID 39756693 ↗ Jan 20253“The Novavax COVID-19 vaccine, NVX-CoV2601, contains XBB.1.5 recombinant spike protein” PMID 39824198 ↗ Jan 2025 |
| Modality | Vaccine | “the Omicron-adapted COVID-19 vaccine from Novavax (NVX-CoV2601)” PMID 39756693 ↗ Jan 2025 |
| Route | Intramuscular | “one IM injection on Day 0” NCT05925127 ↗ |