Valneva’s inactivated COVID-19 vaccine candidate, VLA2001

Specialty vaccine company Valneva has developed the COVID-19 vaccine candidate VLA2001. As of April 2022, it is the only inactivated vaccine candidate against COVID-19 in clinical development in Europe.

 

About the vaccine candidate VLA2001

  • Inactivated
  • Adjuvanted with Alum and CpG 1018
  • Whole virus candidate
  • Using the manufacturing platform of Valneva’s commercial Japanese encephalitis (JE) vaccine

 

Conditional Marketing Authorization from the UK MHRA and Emergency Use Authorization from Bahraini NHRA granted

On April 14, 2022, VLA2001 was granted Conditional Marketing Authorization (CMA) by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom for primary immunization in adults 18 to 50 years of age. This follows the emergency use authorization that was granted by the Bahraini NHRA in March 2022. Valneva signed an advance purchase agreement with the Kingdom of Bahrain in December 2021 and made first shipments of VLA2001 to Bahrain at the end of March 2022.

 

Rolling submission with EMA ongoing

Rolling submission for initial approval of the VLA2001 vaccine candidate with the European Medicines Agency (EMA) is ongoing.  

 

Positive Phase 3 results

Positive Phase 3 results of a randomized, observer-blind controlled immunogenicity trial Cov-Compare comparing the vaccine candidate VLA2001 to an active comparator vaccine (Press Release)

~3000 participants aged 30 and over
~1000 participants aged 18-29 years

  • Superior neutralizing antibody titer levels compared to the active comparator vaccine
  • Neutralizing antibody seroconversion rate above 95% (Non-inferiority compared to active comparator vaccine)
  • Generally well tolerated (significantly better tolerability profile than AZD1222)
  • Complete absence of severe COVID-19 cases despite circulating variants
  • VLA2001 induced broad T-cell responses against S, M, and N proteins

 

Read more about the vaccine candidate VLA2001 here: https://valneva.com/research-development/covid-19-vla2001/