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COVID-19 VACCINE:

NVX-CoV2373 Recombinant glycoprotein

researcher:
Novavax + Emergent BioSolutions + FUJIFILM Diosynth Biotechnologies + Serum Institute of India + Takeda
https://novavax.com/
(USA)
vaccine type: Protein subunit
Distribution updates
Nov 09Novavax announced that the U.S.FDA has granted Fast Track Designation for NVX-CoV2373 the company's COVID-19 vaccine (by novavax.com)
May 27Novavax aims to produce 1 billion doses of its vaccine in 2021 after Praha Vaccines acquisition (by novavax.com)
May 25Novavax aims to produce 100M doses by the end of 2020, and 1B doses by the end of 2021 (by forbes.com)
Human Testing updates (clinical trials)

PHASE 1

 

started May 6 2020

with 131 healthy volunteers aged 18-59

trial location: Australia

results: expected in July 2020

» clinical trial details

PHASE 2

 

started August 17 2020

with 2904 healthy volunteers aged 18-64

trial location: South Africa

» clinical trial details

PHASE 3 (UK)

 

started September 23 2020

with 15000 healthy volunteers aged 18+

trial location: United Kingdom

» clinical trial details

PHASE 3 (USA/Mexico)

 

started November 2020

with 30000 healthy volunteers aged 18+

trial location: Usa and Mexico

» clinical trial details

Feb 22Novavax announced the enrollment of PREVENT-19 its Phase 3 study in the US and Mexico to evaluate safety and efficacy of the vaccine (by novavax.com)
Dec 28Novavax announced the start of its vaccine's Phase 3 study in the USA and Mexico (by novavax.com)
Dec 28Novavax's vaccine Phase 3 trial has begun enrolling approx. 30000 people around 115 sites in US and Mexico (by nih.gov)
Oct 27Novavax announced updates on its Phase 3 clinical devolopment program of NVX-CoV2373 (by novavax.com)
Oct 14Novavax's vaccine Phase 3 trial begins in Leeds with over 600 people who have signed up to the NHS Vaccine Registry (by leeds.ac.uk)
Sep 28Novavax's vaccine will be administered to anyone aged 18-84 at the Royal Free Hospital in London (by royalfree.nhs.uk)
Sep 24Novavax has started its first Phase 3 study in the UK to evaluate the efficacy and safety of its vaccine (by novavax.com)
Sep 02Novavax published Phase 1 data of its vaccine in The New England Journal of Medicine (by novavax.com)
Aug 24Novavax expands Phase 2 clinical trial on the age range of the Phase 1 portion by including older adults (by novavax.com)
Aug 17Novavax started today a Phase 2b clinical trial in South Africa to evaluate the efficacy of its vaccine (by novavax.com)
Aug 04NVX-CoV2373's data from its Phase 1/2 clinical trials showed the vaccine was well tollerated (by novavax.com)
May 26Nucleus Network has begun Phase 1/2 trial in Australia on behalf of Novavax with funding from CEPI (by medicalalley.org)
May 25Novavax today announced enrollment of the first participants in a Phase 1/2 clinical trials (by novavax.com)
Apr 09Vaccine developed by Novavax will start human clinical trials in May (by clinicaltrialsarena.com)
Animal Testing updates (pre-clinical trials)
start date: February 2020
Aug 19NVX-CoV2373 vaccine protects cynomolgus macaque upper and lower airways against SARS-CoV-2 (by biorxiv.org)
Jun 30Novavax's NVX-CoV2373 elicits immunogenicity in baboons and protection in mice (by biorxiv.org)
Jun 09Novavax's vaccine has produced the highest levels of neutralizing titers in non-human primates (by biocentury.com)
Apr 08Animal studies suggest that Novavax's vaccine is effective in blocking the virus (by endpts.com)
Feb 26Novavax has produced and assessed multiple vaccine candidates in animal models (by novavax.com)
early development updates
Feb 04Novavax announced the start of the rolling review process for authorization of its vaccine by multiple regulatory agencies (by novavax.com)



funding:
Coalition for Epidemic Preparedness (CEPI) + DoD $ 60 million + Operation Warp Speed $1.6 billion
Jul 09Novavax has been awarded $1.6B from Operation Warp Speed to complete clinical development (by novavax.com)
Jun 10DoD has agreed to fund up to $60m to support Novavax in the further development of the vaccine (by novavax.com)
May 11Novavax is set to complete Phase 2 testing thanks to additional $384 plus million from CEPI (by biocentury.com)
Apr 08Novavax received US$4 million funding from the CEPI institution (by marketwatch.com)
partnerships:
Feb 26Novavax and Takeda have finalized license agreement for Novavax's vaccine in Japan with Takeda already dosed the first participants in a Phase 1/2 clinical trial (by novavax.com)
Sep 30ABEC will be supporting SII by delivering bioreactors for the manufacturing of Novavax COVID-19 vaccine (by businesswire.com)
Sep 25Endo's subsidiary Par Sterile Products has entered into an agreement with Novavax to produce NVX-CoV2373 final dug product (by investor.endo.com)
Sep 15Novavax announced today a manufacturing agreement with SIIPL for producing up to 2B doses annually (by novavax.com)
Aug 13Novavax and SK bioscience announced an agreement for the antigen component of NVX-CoV2373 (by novavax.com)
Aug 06Novavax signed a supply and license agreement with SII for its vaccine (by seruminstitute.com)
Aug 06Novavax supply deal with SII will support min 1B doses of its vaccine for India and poor countries (by novavax.com)
Jul 23Novavax and FDB announced agreement to manufacture bulk drug substance for NVX-CoV2373 (by novavax.com)
Jun 03AGC Biologics will partner with Novavax manufacturing the adjuvant component of the vaccine (by agcbio.com)
Mar 10Emergent BioSolutions signs development and manufacturing agreement with Novavax (by emergentbiosolutions.com)



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