Large-scale Coronavirus Vaccine Manufacturing Begins In Scotland
28th January 2021
Speciality vaccine company Valneva has started commercial manufacturing of its promising COVID-19 vaccine candidate in Livingston, West Lothian, Scotland.
Valneva begins large-scale vaccine manufacturing at its Livingston site in West Lothian.
up to 60 million jabs due to be manufactured by the end of 2021 if the vaccine is approved
UK government investment will support 100 new jobs at the site, a doubling of the workforce
his follows a multi-million-pound joint investment in the facility by the UK government last year as part of an agreement in principle to secure early access to Valneva's vaccine by the end of 2021. 60 million doses have already been secured for the UK, with an option to acquire a further 130 million if the vaccine is proven to be safe, effective and suitable.
This investment will now support 100 new highly-skilled jobs for scientists and technicians at the Livingston facility - doubling the workforce, putting Scotland at the forefront of the UK's fight against COVID-19, and boosting the UK's resilience in dealing with current and future pandemics by establishing a permanent vaccine manufacturing base.
Valneva's coronavirus vaccine candidate is currently in phase I/II trials and will still need to meet the necessary safety and effectiveness standards and receive regulatory approval before it is rolled out at the end of the year. However, if it is approved, manufacturing at risk now will mean that the UK can roll the vaccine out across the country quicker.
Business Secretary Kwasi Kwarteng said:Thanks to the UK Vaccine Taskforce, we have ordered up to 60 million jabs of Valneva's promising vaccine if it proves to be safe, effective and suitable in its clinical trials this year.
By starting manufacturing, we will have a running start at rolling these out as quickly as possible to protect the British public if it receives regulatory approval.
This facility in Scotland, backed by millions from the Government, will help us beat coronavirus and boost our resilience against future pandemics.
The new facility establishes a permanent UK capability to manufacture inactivated viral vaccines - one of the most proven, widely used types which is also used for flu, polio and rabies jabs.
If the vaccine proves successful and receives regulatory approval following a rigorous assessment of available data, the Livingston facility will have the capacity to produce up to 250 million doses annually for shipment across the UK and around the world.
Scottish Secretary, Alister Jack said:It's incredibly exciting that a potential new COVID-19 vaccine will be manufactured right here in Scotland, at the Valneva plant in Livingston.
This big step forward is a testament to the talent and hard work of all the Valneva staff who have worked so far to get to this stage.
The UK government has invested millions into developing the Valneva vaccine, which is also supporting hundreds of highly skilled jobs in Scotland.
Chief Executive Officer of Valneva Thomas Lingelbach said:We are extremely pleased to have achieved these 2 important milestones in such a short period of time. Our team in Scotland have done an amazing job to get manufacturing started so quickly.
I would like to thank the UK Vaccines Taskforce and National Institute for Health Research who have played vital roles in the rapid recruitment and enrolment of the volunteers for the clinical study. We believe that our vaccine, assuming successful development, can make a major contribution in the UK and beyond.
UK Health Secretary Matt Hancock said:We’ve already secured 60 million doses of the Valneva vaccine which, if approved, will be another vital tool in our fight against this virus.> The start of manufacturing in West Lothian today puts Scottish expertise right at the heart of the UK vaccine programme.
Set to deliver millions more jabs across all four nations, this is yet another fantastic example of the strength of our Union, as we work together as one United Kingdom to tackle the virus.
Interim Chair of the UK government’s Vaccines Taskforce Clive Dix said:I am thrilled that manufacturing has begun in Livingston as a result of the excellent work being done by Valneva in conjunction with the Vaccines Taskforce.
If approved this new vaccine will be a crucial part of our efforts to tackle coronavirus - not just in the UK but around the world.
Through the Vaccines Taskforce, the UK has secured early access to 367 million doses of seven of the most promising vaccines so far. To date, the UK government has invested over £230 million into manufacturing a successful vaccine.
The UK was the first country in the world to procure, authorise and then deploy both the Oxford/AstraZeneca and Pfizer/BioNTech vaccines.
Production of the Oxford University/AstraZeneca vaccine started last autumn where the bulk of the vaccine for the UK is being made in Oxfordshire and Staffordshire, with filling into vials taking place in North Wales.
In total, more than 7.1 million people across the UK have now had a least one dose of the vaccine.
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Valvena
January 28, 2021
Vaccine production initiated to optimize timeline for potential deliveries
Phase 1/2 clinical study now fully enrolled; initial data read out expected in April 2021
Saint-Herblain (France), January 28, 2021 - Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it has commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies, in order to optimize the timeline for potential deliveries of the vaccine. The Phase 1/2 clinical study is now fully enrolled and is expected to report initial results in April 2021.
VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. A total of 150 healthy adults aged 18 to 55 years have been recruited for the Phase 1/2 study which commenced mid December 2020[1].
Thomas Lingelbach, Chief Executive Officer of Valneva, said, "We are extremely pleased to have achieved these two important milestones in such a short period of time. Our team in Scotland have done an amazing job to get manufacturing started so quickly. I would like to thank the UK Vaccines Taskforce and National Institute for Health Research who have played vital roles in the rapid recruitment and enrollment of the volunteers for the clinical study. We believe that our vaccine, assuming successful development, can make a major contribution in the UK and beyond."
In September 2020, Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its COVID-19 vaccine VLA2001[2]. Under this partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. Valneva also announced in January 2021[3] it is in advanced discussions with the European Commission for the supply of up to 60 million doses of VLA2001.
About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease
SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused over 2 million reported deaths globally. It has been declared a pandemic by the World Health Organization (WHO).
About VLA2001
VLA2001 is Valneva’s vaccine candidate against the SARS-CoV-2 virus. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine and received positive CHMP on December 10, 2020. VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius).
About VLA2001-201
VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years have been recruited. The study, which included an open-label dose-escalation phase, is now fully enrolled and is expected to report initial results in April 2021. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated.
About Valneva SE
Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees.
Valneva web site
