Dr June Raine, Chief Executive of the MHRA discusses how COVID-19 vaccines are approved. 

Vaccines are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) following a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on Human Medicines, which reviews in depth all of the data to ensure the vaccines meet the required standards of safety, quality and effectiveness.

The MHRA has carried out a “rolling review” of data for each of the vaccines approved in the UK. A “rolling review” is one of the tools the regulator has at its disposal to enhance development of novel medicines. The vaccine candidate is reviewed on a rolling basis, meaning that the MHRA begins an independent assessment of the vaccine using information submitted by the vaccine developer during development. The MHRA will then accept and consider new evidence when it becomes available until the application is sufficient to warrant authorisation. It ensures that the MHRA is able to review data in real time under a rolling review process, to help speed up the approval timeline of potential vaccines. 

The decision to approve the supply of the vaccines was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic.