Provision of Human Challenge Studies

42 NEW ROAD
E1 2AX
GB

Companies House number: 02326557

£16,331,538

No

No

• Services Agreement - [REDACTED].pdf
• Signed contract

This contract is for research and experimental development services. The benefits of the contract do not accrue exclusively to HMG but to the scientific and academic communities more widely. It is excluded from the requirements of the Public Contracts Regulations 2015 by application of regulation 14.
The contractor was identified by a selection process that concluded that hVIVO was the only contractor capable of delivering the authority's requirements in the time required. The authority considered and approached a number of alternative suppliers; however, none indicated that it had taken or had any intention to take any steps towards developing the capability to deliver human challenge studies relating to SARS-CoV-2 in the near future. The closest alternative to hVIVO would delay the commencement of the characterisation study by a period of between 6 and 12 months, potentially prolonging the public health and economic consequences of the pandemic.
Having conducted technical and market analysis, the authority concluded that hVIVO is the only potential provider technically capable to deliver good manufacturing practice (GMP) virus, a characterisation study of that virus and the subsequent vaccine challenge studies with the required number of participants within the Authority's required timeframe. hVIVO is the only company to have publicly committed to conducting commercial human challenge studies relating to SARS-CoV-2 and the only organisation capable of delivering GMP virus in time for the characterisation study to commence in January 2021.
The contracting authority requires the characterisation study to commence in January 2021 because the resultant vaccine challenge studies are a crucial element of its strategy to bring about an end to the public health and economic consequences of the Covid-19 pandemic. January 2021 is the earliest date that a suitable facility and approved study protocol will be available to commence a characterisation study in order to enable vaccine challenge studies to commence in May 2021. It is an essential requirement, therefore, that the contractor is capable of delivering GMP virus and delivering a characterisation study before then.