Covid Scotland: What is the Valneva vaccine? Is it made in Livingston? Why has the UK Government axed its supply agreement?
French vaccine maker Valneva has announced that the UK Government has severed its supply agreement for a new Scottish-produced coronavirus vaccine.
Some 100 million doses of the Valneva vaccine were put on order after the UK increased its request by 40 million in February.
The UK Government served notice over allegations of a breach of the agreement, but Valneva, which is manufacturing the jab at a site in Scotland, said it "strenuously" denies the allegations.
Here’s what we know so far.
What is the Valneva vaccine?
French pharmaceutical and medicines company Valneva has been producing a Covid-19 vaccine in partnership with the UK’s Department of Health and Social Care (DHSC).
Its vaccine, known as VLA2001, is described by Valneva as ‘the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against Covid-19 in Europe’.
The VLA2001 Valneva vaccine is designed to be used as a Covid vaccine, but has also been mooted as a potential candidate for booster vaccines to limit the impact of coronavirus variants such as the Delta variant.
It contains whole, inactive SARS-CoV-2 with a high amount of the virus’ spike protein and two adjuvants in the form of aluminium salt (alum) and
VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and cytosine phosphoguanine (CpgG 1018).
While alum has been used in as a vaccine adjuvant for centuries, CpG 1018 is used in vaccines such as the HEPISLAV-B Hepatitis B vaccine as an adjuvant believed to boost antibody production.
Where is the Valneva vaccine being produced?
Valneva’s VLA2001 vaccine is currently in production at the company’s UK production site in Livingston, West Lothian.
Despite the UK Government’s unexpected withdrawal from the agreement, the company says it will be continuing its vaccine development plan.
The vaccine is currently being used in Phase 3 clinical trials with Public Health England, with results set to be announced in October.
Valneva said it will use these results as part of ‘rolling submission’ for vaccine approval with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which it commenced on 23 August 2021.
It hopes to see initial approval for VLA2001 from MHRA in late 2021.
Why has the UK Government withdrawn from the Valneva vaccine supply agreement?
According to Valneva’s statement issued on its website on Monday (13 September), the UK Government has terminated its Supply Agreement with the company for its potential VLA2001 Covid-19 vaccine.
It said that the UK Government alleges that the company has breached supply agreement obligations.
Valneva “strenuously denies” this allegation.
The company’s partnership with the UK Government was first announced in September 2020, with the Supply Agreement allowing the government to purchase up to 190 million doses through 2025.
On 1 February 2021, the UK Government announced that it had bought a further 40 million doses of Valneva’s VLA2001 vaccine, 100 million in total, to “bolster long-term vaccine production in Scotland”.
It claimed the deal to “boost Scotland vaccine production powerhouse at Valneva’s site in West Lothian, supporting 100 highly-skilled jobs.”
The then UK Health Secretary, Matt Hancock, said at the time that the Valneva vaccine “showcases the best of Scottish expertise right at the heart of our UK vaccine endeavour, demonstrating the strength of our union and what the UK can achieve when it works together.”
Writing on its website today (13 September), Valneva said: "Valneva SE, a specialty vaccine company, today announced that it has received a termination notice from the UK Government (HMG) in relation to the Supply Agreement for its COVID-19 vaccine candidate, VLA2001.
"The contract provides HMG with the right to terminate. HMG has alleged that the company is in breach of its obligations under the supply agreement, but the company strenuously denies this."
The company added: “Valneva has worked tirelessly, and to its best efforts, on the collaboration with Her Majesty’s Government (HMG) including investing significant resources and effort to respond to HMG’s requests for variant-derived vaccines.
"Valneva continues to be committed to the development of VLA2001 and will increase its efforts with other potential customers to ensure that its inactivated vaccine can be used in the fight against the pandemic.”
Additional reporting by PA