Medicine:VLA2001
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | Killed/Inactivated |
| Clinical data | |
| Other names | Valneva COVID-19 vaccine |
| Routes of administration | Intramuscular |
| ATC code |
|
VLA2001[1], also known as the Valneva COVID-19 vaccine, is a COVID-19 vaccine candidate developed by French biotechnology company Valneva SE in collaboration with American company Dynavax Technologies.[2]
Technology
It is an whole-virus inactivated vaccine, grown in culture using the Vero cell line and inactivated with BPL. It also contains two adjuvants, alum and CpG 1018. It uses the same manufacturing technology as Valneva’s Ixiaro vaccine for Japanese encephalitis.[1]
Development
Phase I/II
VLA2001 is currently undergoing a Phase I/II trial with 150 participants in the United Kingdom.[3][4] The trial was expected to be complete by 15 February 2021, with full reporting completed by August 2021. The trials are being supported by the UK National Institute for Health Research and four British universities.[5]
Phase III
On 21 April 2021, VLA2001 commenced Phase III trials with approximately 4,000 volunteers.[6]
Deployment
In September 2020, Valneva reached an agreement with Dynavax to help manufacture up to 100 million doses of vaccine in 2021 at its facility in Livingston, Scotland, and to provide up to 190 million doses over a 5-year period to the UK government.[7] Due to government support, Valneva will progress immediately into Phase III trials and develop production capacity before the full evaluation of the Phase I/II trial, rather than the traditional slower sequential approach which has lower financial risk.[8]
References
- ↑ 1.0 1.1 "VLA2001 COVID-19 Vaccine". 31 December 2020. https://www.precisionvaccinations.com/vaccines/vla2001-covid-19-vaccine.
- ↑ "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine – Valneva" (in en-US). https://valneva.com/press-release/valneva-and-dynavax-announce-commercial-supply-agreement-for-inactivated-adjuvanted-covid-19-vaccine/.
- ↑ "Covid: Clinical trials begin for Valneva vaccine". BBC News. 16 December 2020. https://www.bbc.co.uk/news/uk-scotland-edinburgh-east-fife-55316690.
- ↑ "Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate". 16 December 2020. https://valneva.com/press-release/valneva-initiates-phase-1-2-clinical-study-of-inactivated-adjuvanted-covid-19-vaccine-candidate/.
- ↑ Clinical trial number NCT04671017 for "Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults" at ClinicalTrials.gov
- ↑ "Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001". Valneva. 21 April 2021. https://valneva.com/press-release/valneva-initiates-phase-3-clinical-trial-for-its-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/.
- ↑ Technologies, Dynavax. "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine" (in en). https://www.prnewswire.com/news-releases/valneva-and-dynavax-announce-commercial-supply-agreement-for-inactivated-adjuvanted-covid-19-vaccine-301129818.html.
- ↑ "Q&A with Valneva: UK Government scales up Covid-19 manufacturing". 6 August 2020. https://www.pharmaceutical-technology.com/features/valneva-manufacturing-uk-government-covid19/.
External links
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