Vaccination: Licensing

(asked on 15th September 2020) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that any vaccine approved for product license is safe for use.


Answered by
Nadine Dorries Portrait
Nadine Dorries
This question was answered on 23rd September 2020

All vaccines will undergo a thorough assessment of quality, safety and efficacy before being licenced. 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 the Medicines and Healthcare products Regulatory Agency will have new powers to license all medicines, including vaccines. Following vaccine deployment, safety will be proactively and continuously monitored.

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