Peter Roderick: Transparency in approving covid-19 vaccines

Transparency is generally regarded as essential for public trust in medicines, and likely to lead to better decision-making. Yet lack of transparency has been a hallmark of the regulation of medicines. Modest improvements have been made over the last decade, but the spotlight is being shone again on how the regulatory system operates as approvals are being given or considered for several covid-19 vaccines.

In the US, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held live-streamed public meetings to discuss the issue generally on 22 October 2020, and specifically for the Pfizer/BioNTech vaccine, with an FDA analysis, on 10 December ahead of the FDA’s decision. That meeting voted 17/4, and one abstention, in favour of emergency use approval, which was issued the next day. A further meeting is scheduled pre-licensure for the Moderna vaccine on 17 December. As the FDA head, Stephen M. Hahn has said, “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines”.

Comparing this with the UK is like comparing chalk with cheese. Vaccine approvals in the UK are given on behalf of ministers. The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care. It performs the Secretary of State’s duties in licensing medicines under a framework agreement with the Department, but has no separate legal status. A temporary authorisation for the Pfizer/BioNTech vaccine was announced on 2 December. Three documents, including authorisation conditions, were posted on the MHRA webpages, but these do not include any analysis, evidence submitted by the companies such as clinical study reports, or the pharmacovigilance plan. MHRA’s public assessment report was published on 15 December.

Approval was given “with advice from the Commission on Human Medicines.” The Commission has a statutory duty to advise ministers on the safety, efficacy and quality of medicines. No public meetings were held by the Commission or its expert sub-groups. The Commission’s advice to ministers has not been published. The sub-groups’ advice to the Commission has not been published. Scant “summary” minutes of private meetings of the Commission and expert advisory groups have been published. Commission minutes are usually prefaced with a statement that “Information is being withheld, under Section 43 of the Freedom of Information Act 2000, on the grounds that information regarding the issue under consideration and advice from the CHM remains confidential at the date of this summary and will remain so until a final decision has been taken. There is no overriding public interest to release such information in advance of the regulatory process being completed (sic).”  

But no Commission minutes have been published for any of its meetings since 30 July 2020. Under the heading “Update from the Covid-19 Expert Working Group”, the summary minute of that meeting merely states that “The Commission agreed with the conclusion of the EWG minutes.” According to the Commission’s website, there is no such body as the Covid-19 Expert Working Group, but there’s a COVID-19 Therapeutics Expert Working Group, a COVID-19 Vaccines Safety Surveillance Methodologies Expert Working Group and a COVID-19 Vaccines Benefit Risk Expert Working Group. No minutes of meetings are published for any of these working groups. We now know from the MHRA assessment report that the Benefit Risk EWG gave advice to the Commission on five occasions between 11 September and 30 November 2020.  

Moreover, declarations of interests of the members of the Commission and its sub-groups have not been updated since 2018. No declarations of interest have been published for the three covid-19 working groups.

The secrecy around SAGE in the spring should not now be repeated for vaccines. Kindly show, not just tell. The advice of the Commission and its sub-groups on covid-19 vaccines must be published, along with the evidence submitted by the companies and the pharmacovigilance plan, and, in time, safety reports. Clinical study reports, usually redacted, are made available generally by the European Medicines Agency, both reactively and proactively. The MHRA’s practice post-Brexit is unknown. The Freedom of Information Act will apply, but proactive publication of the reports by the MHRA is necessary now. Fuller and timely publication of meeting minutes that provide meaningful information, and of declarations of interest, is also necessary. More widely, the Medicines and Medical Devices Bill currently going through Parliament is an obvious opportunity to establish the MHRA as a statutory regulator free from direct ministerial control and to set out transparency and public dialogue obligations. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases in the US, apologised for his comment that the UK “did not do [vaccine approval] as carefully” as the FDA: perhaps he was being polite.  

Peter Roderick is a Principal Research Associate in the Population Health Sciences Institute at Newcastle University, UK 

Competing interests: None declared