The Politics-Covid Nexus
Figure 1 – How do citizens perceive their government’s handling of the pandemic?
Treatments in Clinical Trials
Bridging the Gap
- ^ Anna Leach, Seán Clarke, and Ashley Kirk, “Covid cases and deaths today: coronavirus UK map,” The Guardian, 14 October 2020, available online at https://www.theguardian.com/world/2020/oct/14/covid-cases-and-deaths-today-coronavirus-uk-map
- ^ Loveday Morris and Luisa Beck, “Germany, once seen as an example in the Covid fight, battles to contain spike in infections,” The Washington Post, 9 October 2020, available online https://www.washingtonpost.com/world/germany-once-seen-as-an-example-in-the-coronavirus-fight-battles-to-contain-infections/2020/10/09/487dac46-09a6-11eb-8719-0df159d14794_story.html
- ^ https://yougov.co.uk/topics/international/articles-reports/2020/03/17/perception-government-handling-covid-19
- ^ Johnson & Johnson’s phase III trial is currently paused and AstraZeneca’s US phase III trial remains paused in the US; however, such occurrences are not uncommon.
- ^ Randomised Evaluation Of Covid-19 Therapy (RECOVERY), p. 6, available online at https://www.recoverytrial.net/files/recovery-protocol-v9-1-2020-09-18.pdf
- ^ https://www.recoverytrial.net/
- ^ RECOVERY, “Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19,” RECOVERY website, 16 June 2020, available online at https://www.recoverytrial.net/news/low-cost-dexamethasone-reduces-death-by-up-to-one-third-in-hospitalised-patients-with-severe-respiratory-complications-of-covid-19
- ^ See announcements on the RECOVERY websites: “No clinical benefit from use of hydroxychloroquine in hospitalised patients with COVID-19,” 5 June 2020, available online at https://www.recoverytrial.net/news/statement-from-the-chief-investigators-of-the-randomised-evaluation-of-covid-19-therapy-recovery-trial-on-hydroxychloroquine-5-june-2020-no-clinical-benefit-from-use-of-hydroxychloroquine-in-hospitalised-patients-with-covid-19 and “ Lopinavir-ritonavir is not an effective treatment for patients hospitalised with COVID-19,” 5 October 2020, available online at https://www.recoverytrial.net/news/lopinavir-ritonavir-is-not-an-effective-treatment-for-patients-hospitalised-with-covid-19
- ^ See https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1
- ^ Gilead press release, “European Commission Grants Conditional Marketing Authorization for Gilead’s Veklury® (remdesivir) for the Treatment of COVID-19,” Gilead website, 3 July 2020, available online at https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/european-commission-grants-conditional-marketing-authorization-for-gileads-veklury-remdesivir-for-the-treatment-of-covid19
- ^ The US FDA has not been consistent with respect to what safety and efficacy data are required for EUA. For more, see Comment by GlobalData Healthcare, “Eli Lilly’s and Regeneron’s EUA talk trigger prudence on available Covid-19 data,” Clinical Trials Arena, 12 October 2020, available online at https://www.clinicaltrialsarena.com/comment/eli-lilly-regeneron-eua-covid-data/
- ^ Donato Paulo Mancini and Clive Cookson, “Remdesivir has little effect on Covid-19 mortality, WHO study says,” Financial Times, 16 October 2020, available online at https://www.ft.com/content/ee9b611f-2b4b-4572-afe1-b0b804d17a94?accessToken=zwAAAXUxLNSYkdPum2EfK0tFctOv4bC4BNF6lA.MEQCIAC_wFqTgNplMFlmA-uvIVspxIx0_Qc1tKJfDOEsbANAAiAJ5d5-eVBGJ8poSsHtDUpXZ-683GZo5sYGMfpjXBwP_A&sharetype=gift?token=3b524c3d-41af-4b5a-a4ab-497ceba9ac7f
- ^ James Gallagher, “Coronavirus cure: what progress are we making on cures?” BBC, 2 September 2020, available online at https://www.bbc.co.uk/news/health-52354520
- ^ Ibid.
- ^ Astra Zeneca, “Calquence showed promising clinical improvement in majority of 19 hospitalised covid-19 patients,” company website, 5 June 2020, available online at https://www.astrazeneca.com/media-centre/press-releases/2020/calquence-showed-promising-clinical-improvement-in-majority-of-19-hospitalised-covid-19-patients.html
- ^ Selina McKee,” AZ’ Calquence shows promise for Covid-19 disease,” Pharma Times, 8 June 2020, available online at http://www.pharmatimes.com/news/az_calquence_shows_promise_for_covid-19_1341849
- ^ Lilly Investors, “LY-CoV555 in the Covid-19 outpatient setting,” company website, 16 September 2020, available online at https://investor.lilly.com/news-releases/news-release-details/lilly-announces-proof-concept-data-neutralizing-antibody-ly
- ^ Owen Dyer, “Covid-19: Eli Lilly pauses antibody trial for safety reasons,” BMJ 2020;371:m3985, 14 October 2020, available online at https://www.bmj.com/content/371/bmj.m3985
- ^ https://www.lilly.com/news/stories/statement-activ3-clinical-trial-nih-covid19 Lilly’s statement regarding NIH’s ACTIV-3's clinical trial, Lilly website, 26 October 2020, available online at
- ^ Lucy Parsons, “Eli Lilly’s COVID-19 antibody trial paused due to safety issue,” PMLiVE, 13 October 2020, available online at https://www.pmlive.com/pharma_news/eli_lillys_covid-19_antibody_trial_paused_due_to_safety_issue_1353071
- ^ Kyle Blankenship, “Eli Lilly, Amgen join forces to scale production of Covid-19 antibody cocktails,” Fierce Pharma, 17 September 2020, available online at https://www.fiercepharma.com/manufacturing/eli-lilly-amgen-join-forces-to-scale-production-covid-19-antibody-cocktails
- ^ REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.
- ^ Tim McDonnell, “A ‘bridge to a vaccine’: the race to rollout antibody-based Covid-19 drugs,” Quartz, 8 April 2020, available online at https://qz.com/1835197/pharma-companies-race-to-roll-out-antibody-based-covid-19-drugs/
- ^ Nick Taylor, “Lilly: Maximizing manufacturing capacity is key to COVID-19 antibody strategy,” BioPharma Reporter, 4 August 2020, available online at https://www.biopharma-reporter.com/Article/2020/08/04/Lilly-Maximizing-manufacturing-capacity-is-key-to-COVID-19-antibody-strategy?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright.
- ^ Regeneron, “Regeneron’s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalised Covid-19 patients,” company website, 29 September 2020, available online at https://investor.regeneron.com/news-releases/news-release-details/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and
- ^ Ibid.
- ^ Ibid.
- ^ Jane Byrne, “Trump administration funding phase III on AZ monoclonal antibody therapy,” BIoPharma Reporter, 12 October 2020, available online at https://www.biopharma-reporter.com/Article/2020/10/12/Trump-administration-funding-Phase-3-studies-on-AZ-monoclonal-antibody-therapy
- ^ AstraZeneca, “Two trials of AZD7442 will enrol over 6,000 adults for the prevention of COVID-19 with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections,” AstraZeneca website, 9 October 2020, available online at https://www.astrazeneca.com/media-centre/press-releases/2020/covid-19-long-acting-antibody-laab-combination-azd7442-rapidly-advances-into-phase-iii-clinical-trials.html
- ^ Press release, “UK government secures new Covid-19 vaccines and backs global clinical trial,” 14 August 2020, available online at https://www.gov.uk/government/news/uk-government-secures-new-covid-19-vaccines-and-backs-global-clinical-trial “ . . . [A] deal with AstraZeneca will provide the UK with access to treatments containing COVID-19 neutralising antibodies to protect those who cannot receive vaccines, such as cancer and immunocompromised patients.”
- ^ Nick Taylor, op. cit.
- ^ “The Alliance, formed by CSL Behring and Takeda, also includes the leading-edge expertise of founding members Biotest, BPL, LFB, and Octapharma, along with additional industry members ADMA Biologics, BioPharma Plasma, GC Pharma, Liminal BioSciences, National Bioproducts Institute and Sanquin. The Bill & Melinda Gates Foundation is providing advisory support. Microsoft is providing technology including the Alliance website and the Plasma Bot for donor recruitment. Organizations including Pall and Uber Health are also making contributions to the CoVIg-19 Plasma Alliance. Experts from the Alliance are collaborating across key aspects such as plasma collection, clinical trial development, and product manufacturing.” Takeda press release, “First enrolled patient in NIH phase III trial to evaluate potential Covid-19 hyperimmune medicine,” Takeda website, 8 October 2020, available online at https://www.takeda.com/newsroom/newsreleases/2020/first-patient-enrolled-in-nih-phase-3-trial-to-evaluate-potential-covid-19-hyperimmune-medicine/
- ^ Ibid.
- ^ Angus Liu, op. cit. See also, Michael Erman, “Takeda group begins manufacturing Covid-19 plasma treatment ahead of approval,” Reuters, 12 October 2020, available online at https://uk.reuters.com/article/us-health-coronavirus-takeda/takeda-group-begins-manufacturing-covid-19-plasma-treatment-ahead-of-approval-idUKKBN26X2MW
- ^ Beth Pathak, “Convalescent plasma in the management of moderate Covid in adults,” BMJ 22 October 2020, available online at https://www.bmj.com/content/371/bmj.m4072. See also, Linda Geddes, “Covid 19 blood plasma therapy has limited effect, study finds,” The Guardian, 23 October 2020, available online at https://www.theguardian.com/world/2020/oct/23/covid-19-blood-plasma-therapy-has-limited-effect-study-finds
- ^ Victoria Rees, “Celltrion Covid-19 antibody treatment to enter phase III trial,” European Pharmaceutical Review, 14 October 2020, available online at https://www.europeanpharmaceuticalreview.com/news/130168/celltrion-covid-19-antibody-treatment-to-enter-phase-iii-trial/
- ^ Lucy Parson, “Celltrion launches Phase III trial of Covid-19 mAB,” PMLiVE, 14 October 2020, available online at http://www.pmlive.com/pharma_news/celltrion_launches_phase_3_trial_of_covid-19_mab_1353076
- ^ Doug Quarry, “International SOS weekly scientific update focusing on treatment, immunity, and vaccine development,” 9 October 2020, available online at file:///C:/Users/ethorne/Downloads/INTERNATIONAL%20SOS%20WEEKLY%20SCIENTIFIC%20UPDATE%209%20OCTOBER%202020.pdf
- ^ Vir Biotechnology and GSK start Phase II/III study of Covid antibody treatment,” GSK website, 31 August 2020, available online at https://www.gsk.com/en-gb/media/press-releases/vir-biotechnology-and-gsk-start-phase-23-study-of-covid-19-antibody-treatment/
- ^ Lucy Parsons, “GSK and Vir Biotech expand phase 3 COVID-19 antibody study,” PMLiVE, 7 October 2020, available online at https://www.pmlive.com/pharma_news/gsk_and_vir_biotech_expand_phase_3_covid-19_antibody_study_1352654
- ^ Kyle Blankenship, “Amid Regeneron’s emergency use bid, former FDA chiefs says US ‘too late’ on mass manufacture of Covid-19 antibodies,” Fierce Pharma, 12 October 2020, available online at https://www.fiercepharma.com/manufacturing/amid-regeneron-s-emergency-use-bid-former-fda-chief-says-u-s-too-late-mass
- ^ Kyle Blankenship, op. cit.
- ^ Ibid. See also Regeneron press release, “Regeneron and Roche collaborate to significantly increase global supply of REGN-COV2 investigational antibody cocktail for Covid-19,” company website, 19 August 2020, available online at https://investor.regeneron.com/index.php/news-releases/news-release-details/regeneron-and-roche-collaborate-significantly-increase-global
- ^ Regeneron press release, ibid.
- ^ Kyle Blankenship, “Eli Lilly, Amgen join forces to scale production of Covid-19 antibody cocktails, Fierce Pharma, 17 September 2020, available online at https://www.fiercepharma.com/manufacturing/eli-lilly-amgen-join-forces-to-scale-production-covid-19-antibody-cocktails
- ^ Kyle Blankenship, op. cit., “Amid Regeneron’s emergency use bid,”
- ^ Kyle Blankenship, “Eli Lilly taps Fujifilm to chip in on Covid-19 antibody manufacturing as it awaits FDA emergency use decision,” Fierce Pharma, 13 October 2020, available online at https://www.fiercepharma.com/manufacturing/eli-lilly-taps-fujifilm-to-chip-covid-19-antibody-cocktail-manufacturing
- ^ Ibid.
- ^ Kyle Blankenship, op. cit., “Eli Lilly, Amgen join forces to scale production of Covid-19 antibody cocktails,”
- ^ Duke University’s Margolis Center for Health Policy, “Covid 19 manufacturing for monoclonal antibodies,” 20 June 2020, available online at https://healthpolicy.duke.edu/sites/default/files/2020-06/Issue%20Brief%20-%20COVID-19%20Manufacturing%20of%20Monoclonal%20Antibodies.pdf, pp. 2-3.
- ^ Wellcome, “Report summary: expanding access to monoclonal antibody-based products: a global call to action,” 10 August 2020, available online at https://wellcome.org/reports/expanding-access-monoclonal-antibodies#main
- ^ Duke University’s Margolis Center for Health Policy, op. cit., p.3.
- ^ Ibid, p. 3.
- ^ Ibid., p. 3.
- ^ Ibid., p.3.
- ^ Kyle Blankenship, “AstraZeneca, Samsung reach $331 million biologics manufacturing deal amid Korean CMO’s expansion push,” Fierce Pharma, 22 September 2020, available online at https://www.fiercepharma.com/manufacturing/astrazeneca-samsung-reach-331m-supply-deal-for-biologics-manufacturing
- ^ Kyle Blankenship, “Samsung Biologics plots $2 billion ‘super plant’ as Covid sends sales through the roof,” Fierce Pharma, 11 August 2020, available online at https://www.fiercepharma.com/manufacturing/samsung-biologics-plots-2b-super-plant-as-covid-19-sends-sales-through-roof
- ^ Kyle Blankenship, “AstraZeneca, Samsung reach $331 million biologics manufacturing deal,” op. cit..
- ^ Ibid., p. 4.
- ^ Ibid., p. 4.
- ^ Ibid., p. 4.
- ^ Wellcome, IAVI, Expanding Access to Monoclonal Antibody-Based Products: A Call to Action, available online at https://wellcome.org/sites/default/files/expanding-access-to-monoclonal-antibody-based-products.pdf
- ^ Ibid.
- ^ Ibid.
- ^ Ibid.
- ^ Ibid, pp. 20-21.
- ^ Ibid., p. 22.
- ^ Ibid., pp. 47-48.
- ^ ACT Accelerator Therapeutics Partnership, “Covid-19 therapeutics investment case,” p. 1, available online at https://unitaid.org/assets/Therapeutics-Partnership-Investment-Case.pdf
- ^ Tim McDonnell, op. cit.
- ^ Tracker is taken from “Covid-19 therapeutics tracker,” Regulatory Focus, updated 21 August 2020, available at https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker”