To ask the Secretary of State for Health and Social Care, with reference to the covid-19 vaccine candidates for which the Government has provided funding, what the safety criteria are for each of those vaccine candidate trials; to what extent each of those safety criteria are required to be met in order that those vaccine candidate trials can be deemed by the Government to have achieved satisfactory outcomes; and by (a) what methods and (b) what number of people (i) in which locations and (ii) over what time periods those assessments on whether those safety criteria have been met are being made.
30 November 2020
There is broad agreement between international regulators on both the safety and the efficacy criteria that would be required for approval and authorisation of a COVID-19 vaccine. These criteria will apply to all COVID-19 vaccine candidates, irrespective of whether they receive funding from the United Kingdom Government.
The Medicines and Healthcare products Regulatory Agency (MHRA) will perform the assessment of the quality, safety and efficacy data submitted by developers of COVID-19 vaccines and will seek the advice of its independent expert advisors on the Commission on Human Medicines.
No approval will be given for any COVID-19 vaccine without robust evidence of efficacy and safety. The MHRA has teams of assessors available to review the submissions.
To expedite the review of COVID-19 vaccine applications, developers of COVID-19 vaccines can submit their Marketing Authorisation Applications in the form of a rolling submissions and do not need to wait to have a complete data package before submission.
The time taken for MHRA’s review will depend on what data will be submitted and when.