Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential risk of the Medicines & Healthcare products Regulatory Agency being given temporary authorisation allowing patients the covid-19 vaccine before that vaccine undergoes the full licensing process.

All vaccines will undergo a thorough assessment of quality, safety and efficacy before being licensed. The preferred route to enable deployment of a new vaccine for COVID-19 is through the usual marketing authorisation (product licensing) process. If a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and efficacy, becomes available, we will seek to license that vaccine through the usual route. Until the end of December 2020, European Union legislation requires biotechnological medicines, which would include candidate COVID-19 vaccines, to be authorised via the European Medicines Agency, and a marketing authorisation granted by them would automatically be valid in the United Kingdom. From January 2021, the UK’s licensing authority Medicines and Healthcare products Regulatory Agency will have new powers to license all medicines, including vaccines. Any temporary authorisation of the supply of an unlicensed vaccine would be by exception and the timing of this would depend on the public health need. Following vaccine deployment, safety will be proactively and continuously monitored.