Valneva Covid-19 vaccine: French pharma begins its first UK clinical trials

Summary

  • Valneva clinical trials to start from today in the UK
  • The potential Covid-19 vaccine is being developed in Livingston, West Lothian
  • The initial testing of the vaccine will be done on 150 Brits
  • The early phase 1 and 2 trials will identify the efficacy and safety of the vaccine and its immune response against SARS-COV-2 virus

For the latest Covid-19 vaccine candidate VLA2001, manufactured by French biotech firm Valneva and being developed in Livingston, West Lothian, clinical trial will start in the United Kingdom. Biotech firm Valneva SE said the UK government has already ordered at least 60 million doses.

 

Clinical trials

The initial testing of Valneva’s vaccine candidate VLA2001 will be done on 150 Brits who have volunteered for the trial. It will take place at four testing sites of National Institute for Health Research -- Southampton, Newcastle, Bristol, and Birmingham.

The early phase 1 and 2 trials will identify the efficacy and safety of the vaccine and its immune response against SARS-COV-2 virus.

If these trials are successful, clinical trials will be carried out on a larger scale consisting of over 4,000 UK volunteers, which will be scheduled for April. Two doses regimen of the vaccine will be given to the volunteers. The later stage trial will be conducted in two groups: 1. Participants between the age of 18-65 years and 2. Participants above 65 years of age.

The UK government is expected to finance the clinical studies and is also mulling to fund its Scottish facility.

(Image source: ©Kalkine Group 2020)

The vaccine candidate

VLA2001 is a Vero-cell based, highly purified inactivated vaccine candidate that is being developed to fight against the coronavirus and is being developed using the technology Valneva had earlier used to manufacture Japanese Encephalitis Vaccine.

The VLA2001 vaccine would work by inactivating the virus particles of SARS-CoV-2 with high S-protein density and a combination of two adjuvants - alum and CpG 1018. This is expected to produce a strong immune response and generate neutralizing antibodies.

The French vaccine company Valneva focuses on prevention against diseases with major unfulfilled needs.

The portfolio of the company comprises two commercial vaccines for travelers: IXIARO®/JESPECT® and DUKORAL®. The former is used for the prevention of Japanese encephalitis and the latter is used for the prevention of cholera.

Valneva has its operations scattered in various regions such as Austria, Canada, Sweden, France, the UK, and the US with a workforce of over 500 employees. At present, the company is trying to develop various vaccines, which includes unique vaccines against chikungunya, Covid-19, and Lyme disease.

(Image source: ©Kalkine Group 2020)

 

Journey of Valvena’s VLA2001

22 April 2020

  • The Valneva reveals that it is developing a vaccine named VLA2001 to combat SARS-CoV-2, the coronavirus.
  • Valneva would be leveraging its well-established platform that it has been using to develop IXIARO®, the vaccine approved for prevention of Japanese encephalitis.
  • The company also mentioned that it was collaborating with Dynavax to evaluate the potential use of its CpG 1018 adjuvant as part of the VLA2001 vaccine.
  • The clinical studies of the vaccine were expected to commence by the end of 2020. The regulatory approval would be reached potentially in the H2 2021, the company said.

20 July 2020

  • Valneva SE made an announcement that it will be participating in the Covid-19 vaccine response program of the UK government.
  • The French company stated that it had reached an agreement in principle with the UK government to provide up to 100 million doses of VLA2001.
  • The UK government was expected to make a contribution to its clinical studies costs.

14 September 2020

  • Valneva SE disclosed that it had entered into a vaccine partnership with the UK government for the development of VLA2001.
  • The agreement stated that on the successful development of the vaccine, Valneva would provide 60 million doses to the UK government in H2 2021.
  • The agreement specifies that options of procuring 40 million doses in 2022 and 30-90 million doses in 2023-2025 is available with the Government of UK.
  • These options could result in a revenue of almost €900 million.

 

How many vaccine candidates have started their trials in the UK?

Valneva’s promising vaccine is the fifth to enter clinical trials in the UK. The other four vaccine candidates that have already started or are in the mid-way of their clinical trials are:

  • Oxford/AstraZeneca
  • Imperial College London
  • Novavax
  • Janssen

 

How many doses of potential Covid-19 vaccine have been secured by the UK?

The UK government has developed a portfolio of seven different vaccine candidates in total, securing an early access to 357 million doses as of now.

(Source: Office of National Statistics, UK Government)

Interesting Read: AstraZeneca (LON: AZN) UK Vaccine Trial Withdraw Sub-Group

The UK had registered itself as the first western country to both procure and authorise 40 million doses of the Pfizer/BioNTech Covid-19 vaccine, which would be enough to vaccinate one-third of its population. The mass inoculation programme in the UK started on 8 December.

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