Valneva’s inactivated COVID-19 vaccine candidate, VLA2001
To help fight the pandemic, specialty vaccine company Valneva has developed VLA2001. As of April 2021, it is the only inactivated vaccine candidate in clinical trials against COVID-19 in clinical development in Europe.
About the vaccine candidate VLA2001
- Adjuvanted with Alum and CpG 1018
- Whole virus candidate
- Vero-cell based
- Using the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine
Rolling submission with the MHRA in the UK commenced
In August 2021, Valneva commenced rolling submission, for initial approval of VLA2001 with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).
Valneva completed recruitment for Pivotal Phase 3 trial Cov-Compare
Over 4,000 volunteers have been recruited in the United Kingdom (Press release) for the Phase 3 immunogenicity trial “Cov-Compare”, which compares VLA2001 against AstraZeneca’s conditionally approved vaccine, Vaxzevria (Press release). Topline data are expected early in fourth quarter 2021.
Valneva completed recruitment of Elderly Participants in Further Phase 3 Trial
In parallel to the Phase 3 trial conducted in the UK, Valneva has initiated a Phase 3 trial in New Zealand, VLA2001-304, to generate data in the elderly and to potentially enable variant-bridging through immune-comparability (Press Release). In September 2021, Valneva completed recruitment of the initial cohort of 300 elderly participants aged 56 years and older with the objective to generate further safety and immunogenicity data for this age group. The cohort size has been increased to 300, from 150, in consultation with the European Medicines Agency (“EMA”). Topline data from this cohort will read out in early 2022, and it is expected that the data will support additional regulatory submissions.
Valneva participates in the world’s first COVID-19 vaccine booster trial in the UK
Valneva is participating in a UK government-funded clinical trial looking at different COVID-19 ‘booster’ vaccines. The Cov-Boost trial, led by University Hospital Southampton NHS Foundation Trust, will look at seven different COVID-19 vaccines, including VLA2001, as potential boosters.
Read more about VLA2001 here: https://valneva.com/research-development/covid-19-vla2001/