Government Response

The Government responded to this petition on Tuesday 20th December 2022

The Government is confident that the approval processes of the medicines regulator are robust. It is a matter for the COVID-19 public inquiry whether it wishes to pursue any of these issues.

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.

The R174 authorisations of the Pfizer, AstraZeneca and Moderna vaccines were replaced by marketing authorisations (MAs) in December 2020, June and March 2021. Initially these were conditional MAs with specific obligations on the marketing authorisation holders to provide longer term data. The MA of Comirnaty has now been converted to a full MA as there are no outstanding specific obligations.

Bivalent Boosters

The approved bivalent booster vaccines met the MHRA’s expected standards of safety, quality and effectiveness. The decisions were endorsed by the CHM after a careful review of the evidence.

Neutralising antibodies prevent the SARS-COv-2 virus entering the body’s cells. A neutralising antibody response has been shown to correlate with vaccine efficacy, allowing an estimate of effectiveness over a shorter period.

The clinical study of the Moderna bivalent booster was not designed to compare the efficacy of the original and bivalent boosters. The results of the study showed that both the original Spikevax vaccine and the updated bivalent vaccine elicited a significant immune response against the ancestral strain and Omicron. While the immune response against the ancestral strain did not differ much between the vaccines, the bivalent vaccine triggered a superior antibody response against Omicron BA.1.

The Pfizer bivalent Original/Omicron BA.4-5 vaccine and the Original/Omicron BA.1 bivalent vaccine have the same composition, apart from containing mRNA which matches different, but closely related, Omicron subvariants. The MHRA’s decision to approve the Pfizer BA.4-5 booster was based on all available evidence on the original Pfizer/BioNTech COVID-19 vaccine and its adapted vaccines. This included extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent original/Omicron BA.1 vaccine and safety data from an on-going clinical trial of the bivalent original/Omicron BA.4-5 vaccine.

MHRA Funding and Operational Independence

MHRA retains operational independence and the pharmaceutical industry does not play any part in the independent decisions made by MHRA. Fees charged to the regulated industry funds MHRA’s medicines regulation work according to the full cost recovery rules as set out in His Majesty’s Treasury’s Managing Public Money.

The majority of the MHRA’s income comes from the pharmaceutical industry through fees, e.g., all Marketing Authorisation applicants have to pay a fee. For further information, click here: https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-21-june-2021/freedom-of-information-request-on-whether-the-mhra-receives-funding-from-the-bill-and-melinda-gates-foundation-foi-21-624

MHRA staff members are required to make annual conflict of interest declarations, and immediately declare any financial or other interests as and when they arise. Staff members cannot hold direct financial interests in the pharmaceutical and healthcare (medical devices) industries.

Department of Health and Social Care