Valneva COVID-19 vaccine is a

COVID-19 vaccine A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an e ...

developed by French biotechnology company

Valneva SE __NOTOC__ Valneva SE is a French biotech company headquartered in Saint-Herblain, France, developing and commercializing vaccines for infectious diseases. It has manufacturing sites in Livingston, Scotland; Solna, Sweden, and Vienna, Austria, wit ...

in collaboration with the American biopharmaceutical company Dynavax Technologies. In April 2022, the United Kingdom

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

(MHRA) approved the vaccine, being the first in the world to do so. It was approved for medical use in the European Union in June 2022.

Technology

It is a

whole inactivated virus An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in microbiological culture, culture and then killed to destroy disease-producing capacity. In contrast, atte ...

vaccine, grown in culture using the

Vero cell Vero cells are a lineage of cells used in cell cultures. The 'Vero' lineage was isolated from kidney epithelial cells extracted from an African green monkey (''Chlorocebus'' sp.; formerly called ''Cercopithecus aethiops'', this group of monkeys ha ...

line and inactivated with BPL. It also contains two

adjuvants In pharmacology, an adjuvant is a drug or other substance, or a combination of substances, that is used to increase the efficacy or potency of certain drugs. Specifically, the term can refer to: * Adjuvant therapy in cancer management * Analgesi ...

alum An alum () is a type of chemical compound, usually a hydrated double salt, double sulfate salt (chemistry), salt of aluminium with the general chemical formula, formula , where is a valence (chemistry), monovalent cation such as potassium or a ...

and CpG 1018. It uses the same manufacturing technology as Valneva's Ixiaro vaccine for

Japanese encephalitis Japanese encephalitis (JE) is an infection of the brain caused by the Japanese encephalitis virus (JEV). While most infections result in little or no symptoms, occasional inflammation of the brain occurs. In these cases, symptoms may include he ...

History

Clinical trials

Valneva COVID-19 vaccine completed phase I/II trial with 153 participants in the United Kingdom. The trials were supported by the UK

National Institute for Health Research The National Institute for Health and Care Research (NIHR) is the British government’s major funder of clinical, public health, social care and translational research. With a budget of over £1.2 billion in 2020–21, its mission is to "impr ...

and four British universities. In April 2021, Valneva COVID-19 vaccine commenced

phase III trials The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

with approximately 4,000 participants. In August 2021, New Zealand was chosen for trialing on 300 adult volunteers, due to low case numbers and slow vaccine rollout. Positive results for the phase III trials were reported in October 2021.

Society and culture

Legal status

;United Kingdom In April 2022, Valneva COVID-19 vaccine was approved by the United Kingdom's

(MHRA). ;United Arab Emirates In May 2022, the company announced that Valneva COVID-19 vaccine was granted emergency use authorization from the United Arab Emirates (UAE). ;European Union In May 2022, the European Union's drug regulator, the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

(EMA), accepted Valneva's filing of a marketing authorization for Valneva COVID-19 vaccine. In June 2022, the EMA announced that it would propose to authorize COVID-19 Vaccine (inactivated, adjuvanted) Valneva in the EU, primarily for vaccination of people aged 18 to 50 years. It was approved for medical use in the European Union in June 2022.

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 Livingston may refer to: Businesses * Livingston Energy Flight, an Italian airline (2003–2010) * Livingston Compagnia Aerea, an Italian airline (2011–2014), also known as Livingston Airline * Livingston International, a North American custom ...

, Scotland, and to provide up to 190 million doses over a 5-year period to the UK government. Due to government support, Valneva progressed 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. In September 2021, Valneva announced that the UK government had cancelled the vaccine order. The cancellation reason was not officially given, but seems to be related to difficulties getting building materials due to

Brexit Brexit (; a portmanteau of "British exit") was the withdrawal of the United Kingdom (UK) from the European Union (EU) at 23:00 GMT on 31 January 2020 (00:00 1 February 2020 CET).The UK also left the European Atomic Energy Community (EAEC or ...

and not vaccine quality. In November 2021, the

European Commission The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...

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. Valneva COVID-19 vaccine was granted a marketing authorization in the European Union following a notification by the EMA on 23 June 2022. The EU's medicines regulator has recommended the vaccine primarily for vaccination of 18 to 50 year olds.

References

External links

* * * {{DEFAULTSORT:Valneva Covid-19 Vaccine Clinical trials French COVID-19 vaccines Inactivated vaccines