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Valneva COVID-19 vaccine - Wikipedia

From Wikipedia, the free encyclopedia

Vaccine against COVID-19

Pharmaceutical compound

Valneva COVID-19 vaccine (VLA2001) is a COVID-19 vaccine developed by European specialty vaccine company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.^[7]^[8]^[9]

In April 2022, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine, being the first in the world to do so. It was authorized for medical use in the European Union in June 2022.^[3] It was authorized for medical use in the European Union in June 2022.^[2]

It is a whole whole inactivated virus vaccine,^[8] grown in culture using the Vero cell line and inactivated with β-propiolactone (BPL). It also contains two adjuvants: alum and CpG 1018.^[10] It uses the same manufacturing technology as Valneva's IXIARO® vaccine for Japanese encephalitis.^[1]

Valneva COVID-19 vaccine completed phase I/II trial with 153 participants in the United Kingdom.^[11]^[12] The trials were supported by the UK National Institute for Health Research and four British universities.^[13]

In April 2021, Valneva COVID-19 vaccine commenced phase III trials with approximately 4,000 participants.^[14] In August 2021, New Zealand was chosen for trialing on 300 adult volunteers, due to low case numbers and slow vaccine rollout.^[15] Positive results for the phase III trials were reported in October 2021.^[16]

Society and culture[edit]

United Kingdom

In April 2022, Valneva COVID-19 vaccine was approved by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA).^[4]^[3]

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).^[17]

European Union

In May 2022, the European Union's drug regulator, the European Medicines Agency (EMA), accepted Valneva's filing of a marketing authorization for Valneva COVID-19 vaccine.^[18]

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.^[19]^[20] It was authorized for medical use in the European Union in June 2022.^[2]

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, Scotland, and to provide up to 190 million doses over a 5-year period to the UK government.^[21] 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.^[22]

In September 2021, Valneva announced that the UK government had cancelled the vaccine order.^[23] The cancellation reason was not officially given, but seems to be related to difficulties getting building materials due to Brexit^[24] and not vaccine quality.

In November 2021, the European Commission 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.^[25]

Valneva COVID-19 vaccine was granted a marketing authorization in the European Union in June 2022.^[2] In October 2023, the authorization was withdrawn for commercial reasons at the request Valneva Austria GmbH.^[26]

^ ^a ^b "VLA2001 COVID-19 Vaccine". Precision Vaccinations. 31 December 2020. Archived from the original on 13 January 2021. Retrieved 11 January 2021.
^ ^a ^b ^c ^d ^e "COVID-19 Vaccine (inactivated, adjuvanted) Valneva EPAR". European Medicines Agency (EMA). 20 June 2022. Archived from the original on 28 June 2022. Retrieved 28 June 2022.
^ ^a ^b ^c "Regulatory approval of COVID-19 Vaccine Valneva". Medicines and Healthcare products Regulatory Agency (MHRA). Archived from the original on 14 April 2022. Retrieved 14 April 2022.
^ ^a ^b "Press release: Valneva COVID-19 vaccine approved by MHRA". Medicines and Healthcare products Regulatory Agency (MHRA) (Press release). 14 April 2022. Archived from the original on 14 June 2022. Retrieved 4 June 2022.
^ "COVID-19 Vaccine (inactivated, adjuvanted) Valneva Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
^ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF). Archived (PDF) from the original on 9 October 2024. Retrieved 24 September 2024.
^ "Dynavax Technologies Corp". Reuters. Archived from the original on 4 June 2022. Retrieved 4 June 2022.
^ ^a ^b Hotez PJ, Bottazzi ME (January 2022). "Whole Inactivated Virus and Protein-Based COVID-19 Vaccines". Annual Review of Medicine. 73 (1): 55–64. doi:10.1146/annurev-med-042420-113212. PMID 34637324. S2CID 238747462.
^ "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine" (Press release). Valneva. Archived from the original on 7 April 2021. Retrieved 27 April 2021.
^ "Vaccine Valneva Summary of Product Characteristics" (PDF). Archived (PDF) from the original on 28 June 2022. Retrieved 4 June 2022.
^ "Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate". Valneva SE (Press release). 16 December 2020. Archived from the original on 17 January 2021. Retrieved 18 December 2020.
^ "Valneva Reports Positive Phase 1/2 Data For Its Adjuvanted COVID-19 Vaccine Candidate VLA2001". Valneva SE (Press release). 6 April 2021. Archived from the original on 11 May 2022. Retrieved 8 June 2022.
^ Clinical trial number NCT04671017 for "Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults" at ClinicalTrials.gov
^ "Valneva Initiates Phase 3 Clinical Trial for its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001" (Press release). Valneva. 21 April 2021. Archived from the original on 21 April 2021. Retrieved 22 April 2021.
^ Stewart E (17 August 2021). "New Zealand to trial new Covid-19 vaccine". RNZ. Archived from the original on 19 August 2021. Retrieved 17 August 2021.
^ "Valneva Reports Positive Phase III Results". Valneva SE (Press release). 18 October 2021. Archived from the original on 8 June 2022. Retrieved 8 June 2022.
^ "Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine" (Press release). Valneva. 16 May 2022. Retrieved 4 June 2022 – via Bloomberg News.
^ "EU's drug regulator accepts Valneva's COVID-19 vaccine marketing authorization filing". Reuters. 19 May 2022. Archived from the original on 4 June 2022. Retrieved 4 June 2022. The European Union's medicine regulator accepted Valneva's filing of marketing authorization application for its inactivated COVID-19 vaccine candidate, the French company said on Thursday.
^ "EMA recommends Valneva's COVID-19 vaccine for authorisation in the EU". European Medicines Agency (EMA) (Press release). 23 June 2022. Archived from the original on 28 June 2022. Retrieved 28 June 2022.
^ "EMA recommends new Valneva Covid-19 vaccine for use". The Brussels Times. Archived from the original on 28 June 2022. Retrieved 24 June 2022.
^ "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine" (Press release). Dynavax Technologies. Archived from the original on 22 April 2021. Retrieved 27 April 2021 – via PR Newswire.
^ Nawrat A (6 August 2020). "Q&A with Valneva: UK Government scales up Covid-19 manufacturing". Pharmaceutical Technology. Archived from the original on 26 January 2021. Retrieved 11 January 2021.
^ "UK scraps Covid-19 vaccine deal with French firm Valneva". BBC News. 13 September 2021. Archived from the original on 14 September 2021. Retrieved 14 September 2021.
^ "U.K. Threw Covid Vaccine Maker Under Bus over Contract, Valneva CEO Says". Bloomberg. 24 November 2021. Archived from the original on 3 February 2022. Retrieved 3 February 2022.
^ "Coronavirus: Commission approves contract with Valneva to secure a new potential vaccine". European Commission (Press release). 10 November 2021. Archived from the original on 25 August 2020. Retrieved 15 November 2021.
^ "Public Statement - COVID-19 Vaccine (inactivated, adjuvanted) Valneva (SARS-CoV-2 virus, strain Wuhan hCoV-19/Italy/INMI1-isl/2020, inactivated)" (PDF). www.ema.europa.eu. European Medicines Agency. 2023.

Clinical trial number NCT04671017 for "Dose Finding Study to Evaluate The Safety, Tolerability and Immunogenicity of an Inactiviated, Adjuvanted SARS-CoV-2 Virus Vaccine Candidate Against Covid-19 in Healthy Subjects" at ClinicalTrials.gov
Clinical trial number NCT04864561 for "Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE)" at ClinicalTrials.gov
Clinical trial number NCT04956224 for "Safety and Immunogenicity of VLA2001 Adults Aged ≥56 Years " at ClinicalTrials.gov
COVID-19 Vaccine (inactivated, adjuvanted) Valneva Safety Updates from the European Medicines Agency