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November 11, 2021

EC to procure 60 million doses of Valneva’s Covid-19 vaccine

The EU Member States can secure nearly 27 million doses of VLA2001 next year on obtaining EMA approval.

The European Commission (EC) has approved an agreement to purchase up to 60 million doses of the Valneva inactivated vaccine candidate VLA2001 for Covid-19 over a period of two years.

VLA2001 has inactivated whole SARS-CoV-2 virus particles with a greater density of S-protein, along with alum and Dynavax Technologies’ CpG 1018 adjuvant.

The vaccine could potentially be used for active immunisation of at-risk populations for Covid-19 prevention.

The latest contract would permit all Member States of the EU to procure nearly 27 million vaccine doses next year.

It also includes an option for the Member States to acquire up to 33 million extra doses in 2023 and to adapt the shot against novel variant strains of SARS-CoV-2.

The company plans to commence supply of the vaccine doses in April next year on securing approval from the human medicines committee (CHMP) of the European Medicines Agency (EMA).

The rolling review of the vaccine is anticipated to begin in the coming days.

Valneva chief medical officer Dr Juan Carlos Jaramillo had said last month that the company could secure a contract manufacturing organisation in Europe if additional capacity is needed for producing its Covid-19 vaccine.

The company’s deal with the EC is expected to conclude after a final analysis that includes volumes needed by each of the Member States.

Last month, Valneva reported favourable data from the Phase III trial of the vaccine.

Valneva CEO Thomas Lingelbach said: “Our Phase III results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could make an important contribution to the global fight against the Covid-19 pandemic.”

The latest agreement is EC’s eighth contract with a pharmaceutical firm to buy Covid-19 vaccines.

Earlier, the Commission entered agreements with AstraZeneca, Janssen Pharmaceuticals, Sanofi and GSK, CureVac, Pfizer and BioNTech, Novavax and Moderna.

In a separate development, the EMA has commenced the assessment of Moderna’s application seeking expansion of authorisation to use its Covid-19 vaccine, Spikevax, in children aged between six and 11 years.

Currently, the vaccine is authorised to immunise individuals aged 12 years and above against Covid-19.

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