{"id":49247,"date":"2020-12-17T16:51:31","date_gmt":"2020-12-17T15:51:31","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=49247"},"modified":"2020-12-17T16:51:31","modified_gmt":"2020-12-17T15:51:31","slug":"peter-roderick-transparency-in-approving-covid-19-vaccines","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2020\/12\/17\/peter-roderick-transparency-in-approving-covid-19-vaccines\/","title":{"rendered":"Peter Roderick: Transparency in approving covid-19 vaccines"},"content":{"rendered":"<p><span style=\"font-weight: 400\">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.<\/span><\/p>\n<p><span style=\"font-weight: 400\">In the US, the Food and Drug Administration\u2019s Vaccines and Related Biological Products Advisory Committee (VRBPAC) held live-streamed public meetings to discuss the issue generally on <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=1XTiL9rUpkg&amp;feature=youtu.be\"><span style=\"font-weight: 400\">22 October 2020<\/span><\/a><span style=\"font-weight: 400\">, and specifically for the Pfizer\/BioNTech vaccine, with an <\/span><a href=\"https:\/\/www.fda.gov\/media\/144245\/download\"><span style=\"font-weight: 400\">FDA analysis<\/span><\/a><span style=\"font-weight: 400\">, on <\/span><a href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement\"><span style=\"font-weight: 400\">10 December<\/span><\/a><span style=\"font-weight: 400\"> ahead of the FDA\u2019s decision. That meeting voted 17\/4, and one abstention, <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=owveMJBTc2I&amp;feature=youtu.be\"><span style=\"font-weight: 400\">in favour<\/span><\/a><span style=\"font-weight: 400\"> of emergency use approval, which was issued <\/span><a href=\"https:\/\/www.fda.gov\/media\/144412\/download\"><span style=\"font-weight: 400\">the next day<\/span><\/a><span style=\"font-weight: 400\">.<\/span><span style=\"font-weight: 400\"> A further meeting is scheduled pre-licensure for the Moderna vaccine on <\/span><a href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement\"><span style=\"font-weight: 400\">17 December<\/span><\/a><span style=\"font-weight: 400\">. <\/span><span style=\"font-weight: 400\">As the FDA head, Stephen M. Hahn <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine\"><span style=\"font-weight: 400\">has said<\/span><\/a><span style=\"font-weight: 400\">, \u201cThe FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines\u201d.<\/span><\/p>\n<p><span style=\"font-weight: 400\">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\u2019s duties in licensing medicines under a <\/span><a href=\"https:\/\/www.gov.uk\/government\/publications\/dh-and-mhra-framework-agreement\"><span style=\"font-weight: 400\">framework agreement<\/span><\/a><span style=\"font-weight: 400\"> with the Department, but has no separate legal status. A temporary authorisation for the Pfizer\/BioNTech vaccine was announced on <\/span><a href=\"https:\/\/www.gov.uk\/government\/news\/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine\"><span style=\"font-weight: 400\">2 December<\/span><\/a><span style=\"font-weight: 400\">. Three documents, including authorisation conditions, were posted on the <\/span><a href=\"https:\/\/www.gov.uk\/government\/publications\/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19\"><span style=\"font-weight: 400\">MHRA webpages<\/span><\/a><span style=\"font-weight: 400\">, but these do not include any analysis, evidence submitted by the companies such as clinical study reports, or the pharmacovigilance plan. MHRA\u2019s public assessment report was published on 15 December.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Approval was given \u201cwith advice from the <\/span><a href=\"https:\/\/www.gov.uk\/government\/news\/uk-medicines-regulator-gives-approval-for-first-uk-covid-19-vaccine\"><span style=\"font-weight: 400\">Commission on Human Medicines.<\/span><\/a><span style=\"font-weight: 400\">\u201d The Commission has a <\/span><a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2012\/1916\/regulation\/10\"><span style=\"font-weight: 400\">statutory duty<\/span><\/a><span style=\"font-weight: 400\"> 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\u2019s advice to ministers has not been published. The sub-groups\u2019 advice to the Commission has not been published. Scant <\/span><a href=\"https:\/\/app.box.com\/s\/jv487awvqzzsrdql0o34h9gg350ceyd4\"><span style=\"font-weight: 400\">&#8220;summary&#8221; minutes<\/span><\/a><span style=\"font-weight: 400\"> of private meetings of the Commission and expert advisory groups have been published. Commission minutes are usually prefaced with a statement that \u201cInformation 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 (<\/span><i><span style=\"font-weight: 400\">sic<\/span><\/i><span style=\"font-weight: 400\">).\u201d\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">But no Commission minutes have been published for any of its meetings since 30 July 2020. Under the heading &#8220;Update from the Covid-19 Expert Working Group&#8221;, the summary minute of that meeting merely states that \u201cThe Commission agreed with the conclusion of the EWG minutes.\u201d According to the Commission\u2019s website, there is no such body as <\/span><i><span style=\"font-weight: 400\">the<\/span><\/i><span style=\"font-weight: 400\"> Covid-19 Expert Working Group, but there\u2019s 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.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Moreover, declarations of interests of the members of the Commission and its sub-groups have not been updated <\/span><a href=\"https:\/\/www.gov.uk\/government\/publications\/human-medicines-regulations-2012-advisory-bodies-annual-report-2018\"><span style=\"font-weight: 400\">since 2018<\/span><\/a><span style=\"font-weight: 400\">. No declarations of interest have been published for the three covid-19 working groups.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The <\/span><a href=\"https:\/\/www.theguardian.com\/uk-news\/2020\/apr\/14\/no-10-secrecy-around-sage-coronavirus-advisory-group\"><span style=\"font-weight: 400\">secrecy around SAGE<\/span><\/a><span style=\"font-weight: 400\"> 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\u2019s 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 <\/span><a href=\"https:\/\/services.parliament.uk\/bills\/2019-21\/medicinesandmedicaldevices.html\"><span style=\"font-weight: 400\">Medicines and Medical Devices Bill<\/span><\/a><span style=\"font-weight: 400\"> 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, <\/span><a href=\"https:\/\/www.bbc.co.uk\/news\/world-us-canada-55177948\"><span style=\"font-weight: 400\">apologised<\/span><\/a><span style=\"font-weight: 400\"> for his comment that the UK \u201cdid not do [vaccine approval] as carefully\u201d as the FDA: perhaps he was being polite.\u00a0\u00a0<\/span><\/p>\n<p><em><span style=\"font-weight: 400\"><strong>Peter Roderick<\/strong> is a Principal Research Associate in the Population Health Sciences Institute at Newcastle University, UK\u00a0<\/span><\/em><\/p>\n<p><em><strong>Competing interests<\/strong>: None declared<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2020\/12\/17\/peter-roderick-transparency-in-approving-covid-19-vaccines\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":66,"featured_media":49248,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[223],"tags":[],"class_list":["post-49247","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-guest-bloggers"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Peter Roderick: Transparency in approving covid-19 vaccines - The BMJ<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/bmj\/2020\/12\/17\/peter-roderick-transparency-in-approving-covid-19-vaccines\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Peter Roderick: Transparency in approving covid-19 vaccines - The BMJ\" \/>\n<meta property=\"og:description\" content=\"Transparency is generally regarded as essential for public trust in medicines, and likely to lead to better decision-making. 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The workers are among the first to receive the vaccine across the country, and Michigan Medicine received 1,950 initial doses of the vaccine. 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