Valneva COVID-19 vaccine

Valneva COVID-19 vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeInactivated
Clinical data
Other namesVLA2001, VLA2101
Routes of
administration		Intramuscular
ATC code
  • None

Valneva COVID-19 vaccine, also known as the VLA2001 (Original Wuhan variant based)[1] and VLA2101 (other non-disclosed variant based), is a COVID-19 vaccine candidate developed by French biotechnology company Valneva SE in collaboration with American company Dynavax Technologies.[2]

Technology

It is a 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]

Clinical trials

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]

On 21 April 2021, VLA2001 commenced Phase III trials with approximately 4,000 volunteers.[6] In August 2021, New Zealand has been chosen for trialing on 300 adult volunteers due to low case numbers and slow vaccine rollout.[7]

Clinical trials listed by the US National Library of Medicine

  • NCT04671017 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.
  • NCT04864561 Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE).
  • NCT04956224 Immunogenicity of VLA2101 Compared to VLA2001.

Economics

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.[8] 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.[9]

In September 2021, Valneva announced that the UK government had cancelled the vaccine order.[10] The cancellation reason was not officially given, but seems to be related to difficulties getting building materials due to Brexit [11] and not vaccine quality.

On 10 November 2021 the European Commission approved a contract with Valneva providing the possibility to purchase almost 27 million doses of its vaccine in 2022. This also includes the possibility to adapt the vaccine to new variants as well as the order of an additional 33 million vaccine doses in 2023. [12]

References

  1. 1 2 "VLA2001 COVID-19 Vaccine". Precision Vaccinations. 31 December 2020. Retrieved 11 January 2021.
  2. ↑ "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine – Valneva". Retrieved 27 April 2021.
  3. ↑ "Covid: Clinical trials begin for Valneva vaccine". BBC News. 16 December 2020. Retrieved 11 January 2021.
  4. ↑ "Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate". Valneva SE. 16 December 2020. Retrieved 18 December 2020.
  5. ↑ 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
  6. ↑ "Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001". Valneva. 21 April 2021. Retrieved 22 April 2021.
  7. ↑ Stewart, Ella (17 August 2021). "New Zealand to trial new Covid-19 vaccine". RNZ. Retrieved 17 August 2021.{{cite web}}: CS1 maint: url-status (link)
  8. ↑ Technologies, Dynavax. "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine". www.prnewswire.com. Retrieved 27 April 2021.
  9. ↑ Nawrat A (6 August 2020). "Q&A with Valneva: UK Government scales up Covid-19 manufacturing". Pharmaceutical Technology. Retrieved 11 January 2021.
  10. ↑ "UK scraps Covid-19 vaccine deal with French firm Valneva". BBC News. 13 September 2021.
  11. ↑ https://www.bloomberg.com/news/articles/2021-11-24/u-k-threw-covid-vaccine-maker-under-bus-over-contract-ceo-says
  12. ↑ "Coronavirus: Commission approves contract with Valneva to secure a new potential vaccine". European Commission. 10 November 2021. Retrieved 15 November 2021.{{cite web}}: CS1 maint: url-status (link)
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