Launch a Public Inquiry into the approval process for covid-19 vaccines

We want the Government to launch a Public Inquiry to investigate the MHRA's process for approving covid-19 vaccines.

This should consider all aspects of the approval process, including how approval was expedited and the drivers for expedition, and any potential conflicts of interests.

The MHRA are primarily funded by fees from the pharmaceutical industry.

An expedited rolling review was used to grant temporary authorisations for the use of covid-19 vaccines.

Initial covid-19 vaccines were approved based on efficacy reducing illness from covid-19, whereas bivalent boosters have been approved based on immune response. Moderna Bivalent booster was approved despite lower efficacy than the original vaccine, and Pfizer BA.4-5 booster was approved using BA.1 data.

Public Assessment Reports for bivalent boosters have only been published months after the boosters were approved.

Public Inquiry

On 28 June 2022 the Prime Minister published the Terms of Reference (ToR) for the UK COVID-19 Public Inquiry.

The ToR set out that the Inquiry will look at the development, delivery and impact of therapeutics and vaccines. The Inquiry is independent of the Government, the Department of Health and Social Care cannot comment on when, or to what extent, the Inquiry will focus upon vaccines.

An exercise to listen to experiences of the pandemic has been launched and any person or organisation are encouraged to visit the COVID-19 Inquiry website for further details.

Approval Process for COVID Vaccines

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised Pfizer, AstraZeneca and Moderna COVID-19 vaccines under Regulation 174 (R174) of the Human Medicines Regulations 2012 between November 2020 and January 2021. R174 is a temporary authorisation for supply of an unlicensed medicine in response to certain public health threats, such as a pandemic. Once data shows that benefits outweigh the risks R174 is triggered by the government.

The three vaccines were assessed via an expedited rolling review. This allowed MHRA to review data as it became available and meant good progress had been made before the last submission of data was received. Each vaccine’s data package was reviewed by MHRA teams of scientists and clinicians who rigorously evaluate the quality, safety and effectiveness of the vaccines.

The data was scrutinised by the COVID-19 Vaccines Benefit Risk Expert Working Group (VBR EWG). This was established to advise MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM), on the benefits and risks of COVID vaccines. The CHM critically reviewed the data before advising the UK government on the safety, quality and effectiveness of the vaccines. No vaccine would be authorised for supply in the UK unless the expected standards were met.