covid 19 vaccine challenges what have we learned so far and what remains to be done CORD-Papers-2022-06-02 (Version 1)

Title: COVID-19 vaccine challenges: What have we learned so far and what remains to be done?
Abstract: Developing and distributing a safe and effective SARS-CoV-2 (COVID-19) vaccine has garnered immense global interest. Less than a year after COVID-19 was declared a pandemic several vaccine candidates had received emergency use authorization across a range of countries. Despite this scientific breakthrough the journey from vaccine discovery to global herd immunity against COVID-19 continues to present significant policy challenges that require a collaborative global response. We offer a framework for understanding remaining and new policy challenges for successful global vaccine campaigns against COVID-19 as well as potential solutions to address them. Decision-makers must be aware of these challenges and strategize solutions that can be implemented at scale. These include challenges around maintaining R&D incentives running clinical trials authorizations post-market surveillance manufacturing and supply global dissemination allocation uptake and clinical system adaption. Alongside these challenges financial and ethical concerns must also be addressed.
Published: 2021-03-26
Journal: Health Policy
DOI: 10.1016/j.healthpol.2021.03.013
DOI_URL: http://doi.org/10.1016/j.healthpol.2021.03.013
Author Name: Forman Rebecca
Author link: https://covid19-data.nist.gov/pid/rest/local/author/forman_rebecca
Author Name: Shah Soleil
Author link: https://covid19-data.nist.gov/pid/rest/local/author/shah_soleil
Author Name: Jeurissen Patrick
Author link: https://covid19-data.nist.gov/pid/rest/local/author/jeurissen_patrick
Author Name: Jit Mark
Author link: https://covid19-data.nist.gov/pid/rest/local/author/jit_mark
Author Name: Mossialos Elias
Author link: https://covid19-data.nist.gov/pid/rest/local/author/mossialos_elias
sha: 8969c2224fb5cf99fa12552285783c0c2a0695b6
license: no-cc
license_url: [no creative commons license associated]
source_x: Elsevier; Medline; PMC
source_x_url: https://www.elsevier.com/https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/
pubmed_id: 33820678
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/33820678
pmcid: PMC7997052
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997052
url: https://doi.org/10.1016/j.healthpol.2021.03.013 https://www.ncbi.nlm.nih.gov/pubmed/33820678/ https://www.sciencedirect.com/science/article/pii/S0168851021000853?v=s5 https://api.elsevier.com/content/article/pii/S0168851021000853
has_full_text: TRUE
Keywords Extracted from Text Content: COVID-19 COVID-19 vaccine COVID-19 vaccines dimensionsvaccine  Oxford/AstraZeneca Phase III COVID-19 vaccine politically-driven participants line People's Vaccine travelers vaccine model‖ COVID-19 Vaccine Tracker COG-UK humans Pfizer/BioNTech Phase III volunteers LMICs bodies Gavi COVID-19 AstraZeneca/Oxford Immense Figure 1 late-January Interpol AstraZeneca vaccine pre-to pit takeaways globe jab ACT respondents children male/White COVID-19 antibodies COVID-19 vaccine R&D ICMRA Oxford/AstraZeneca vaccine jabs Covaxin [3] Pfizer/BioNTech AstraZeneca/Oxford vaccine's purchased GSK vaccines pillar COVID-19 [108] COVID-19 Tools [104] ̳vaccine apartheid' [42] UK COVID-19 vaccine cargo ̳vaccine passports' vaccine jab vaccine passports firming CCEOP participants-many late-June let shelter-in-place ̳opt people UK [16] mothers residents cargo women COVID-19 vaccines HICs shoulders green light GISRS US herd virus family‖ Vaccine ̳normal data‖ jab [101 HIC JCVI half-dose individuals Gamaleya Phase III FDA one-size-fit-all candidateseven SARS-CoV-2 anti-vax donors Vaccine passports UK's Joint ̳variant-proof' vaccine pregnant women COVID-19 [65] patient six-hours OMV Cadila's ZyCoV-D CEPI persons patients EMA Vaccines vaccine productsan R&D
Extracted Text Content in Record: First 5000 Characters:Highlights  Significant global interest exists around generation of safe and effective COVID-19 vaccines.  Addressing eleven challenges (among many others) could greatly benefit COVID-19 vaccine policies.  These challenges fall under three dimensionsvaccine development, dissemination, and deployment.  Decision-makers can anticipate and recognize these challenges, and strategize solutions at scale.  Effective vaccines can add to our existing arsenal of weapons against COVID-19. Immense global interest has risen around the development and distribution of safe and effective SARS-CoV-2 (COVID- 19) vaccines. To date, multiple vaccine candidates have received authorizations for emergency use and many countries have initiated vaccination rollout efforts. Vaccines being developed, manufactured, and delivered in under a year is a notable scientific featenough so that Science Magazine named this the top breakthrough of 2020 [1] . However, from ensuring continued development of vaccine candidates, to authorizing, producing, distributing, administering, and monitoring existing ones, the COVID-19 vaccine process remains laden with policy challenges. While literature tends to explore these challenges in siloes, these issues are inherently overlapping and interdependent. As such, we offer a framework for understanding 11 of the remaining and new policy challenges related to COVID-19 vaccination efforts, and some potential solutions to address them. The framework, as illustrated in Figure 1 While several vaccines have recently gained (or are on the cusp of gaining) emergency use authorizations from countries around the world, the end of the pandemic is still a way off: many of the first generation vaccines require ultra-cold chain technology and are expensive, proving significant hurdles to global vaccination campaigns, and especially in low-and middle-income countries (LMICs); furthermore, we still do not know how long vaccines will remain effective in individuals over time; and the rise of new variants pose concern that mutations with high vaccine escape potential might emerge. As such, governments must continue to develop new vaccines and optimize their safety, effectiveness, and quality. We identified four primary challenges involved in achieving this: maintaining strong research and development incentives; running coordinated clinical trials; authorizing safe and effective vaccines efficiently and transparently; and continuing to monitor their impacts as (and after) they are deployed. Importantly, each of these challenges will require greater public engagement and intergovernmental cooperation and support in the redesign of incentives, institutions, and processes. In early December 2020, less than one year after the start of the pandemic, COVID-19 vaccines were already gaining authorizations in countries around the globe. This feat would not have been possible without the tremendous effort, collaboration, partnership, and financial support that went into the development of these products. However, even though a handful of vaccines are already being administered in countries around the world, more options on the market are necessary to vaccinate the billions and billions of people needed for herd immunity. For these first-generation vaccines, governments used both push mechanisms (i.e. direct grants to companies) and pull mechanisms (i.e. Advanced Market Commitments) to stimulate R&D without ties to quality or efficacy of eventual vaccine productsan understandable short-term solution given the situation in 2020. However, COVID-19 is unlikely to disappear soon, and we must now consider longerterm efforts. We are nowhere near the vaccine administration levels needed for global herd immunity, new variants of concern are emerging [2], and we still do not know how long current vaccines remain effective and whether yearly or other periodic boosters are necessary. Incentive structures should undergo systemic changes so that manufacturers continue to search for viable candidates. It is unlikely that all remaining and future vaccine candidates will meet efficacy thresholds for clinical trials. We have already seen the withdrawal of several candidateseven ones from major pharmaceutical developers [3] . Continued incentives are needed to maintain robust R&D efforts to ensure vaccine effectiveness, safety, and quality, and to generate second and third generation vaccines to meet the everchanging needs of populations across the globe. With the emergence of new variants, there is also a rise in interest around the development of a -universal ̳variant-proof' vaccine, able to fend off different varieties of the same virus family‖ [4] . The challenge of maintaining strong R&D incentives is bolstered by the nature of vaccine development, which presents higher costs and risk relative to other pharmaceuticals [5] . Governments and donors could consider implementing additional financing mechanisms to encourage R&D, including patent
Keywords Extracted from PMC Text: " [69] COVID-19 antibodies D's " [4 UK [16] OMV Fig. 1 Gamaleya Phase III GSK anti-vax six-hours herd male/White purchased one-size-fit-all pregnant women COVID-19 vaccine bodies travelers women COVID-19 people Oxford/AstraZeneca Phase III FDA children [9] Interpol vaccine passports COVID-19 [65] [110,111] globe ICMRA Gavi residents jab [101 firming EMA COVID-19 vaccines vaccines pillar UK's Joint vaccine People's Vaccine jab pit CCEOP participants JCVI patients vaccine products shoulders volunteers " AstraZeneca/Oxford vaccine's [10] late-June patient persons Immense SARS-CoV-2 (COVID-19) AstraZeneca vaccine US individuals [104] GISRS line COVID-19 vaccine R&D vaccine R&D politically-driven cargo COVID-19 Tools Oxford/AstraZeneca vaccine ... Vaccine passports First-mover" HICs— Pfizer/BioNTech COVID-19 [108] vaccine jab AstraZeneca/Oxford ACT [26,36] LMICs Vaccine donors Vaccines COVID-19 vaccine cargo mothers COG-UK HIC shelter-in-place green light jabs humans R&D let takeaways variant-proof Pfizer/BioNTech Phase III Covaxin CEPI UK respondents HICs half-dose 1.2–9.2 late-January
Extracted PMC Text Content in Record: First 5000 Characters:Immense global interest has risen around the development and distribution of safe and effective SARS-CoV-2 (COVID-19) vaccines. To date, multiple vaccine candidates have received authorizations for emergency use and many countries have initiated vaccination rollout efforts. Vaccines being developed, manufactured, and delivered in under a year is a notable scientific feat – enough so that Science Magazine named this the top breakthrough of 2020 [1]. However, from ensuring continued development of vaccine candidates, to authorizing, producing, distributing, administering, and monitoring existing ones, the COVID-19 vaccine process remains laden with policy challenges. While literature tends to explore these challenges in siloes, these issues are inherently overlapping and interdependent. As such, we offer a framework for understanding 11 of the remaining and new policy challenges related to COVID-19 vaccination efforts, and some potential solutions to address them. The framework, as illustrated in Fig. 1 , consists of three main 'D'-dimensions of achieving widespread global COVID-19 immunity via vaccinations. The three D's are 'development', 'dissemination', and 'deployment': ensuring the continued development of safe and effective vaccines, supplying and disseminating the vaccine around the world, and deploying the vaccine within countries. Under these dimensions, there are 11 challenges to achieving these goals: maintaining strong and sensible R&D incentives; running coordinated clinical trials; authorizing safe and effective vaccines efficiently and transparently; monitoring effectiveness during (and after) vaccine deployment; ensuring equitable vaccine access globally; manufacturing sufficient quantities and maintaining supply chain capacity; safely and securely transporting and delivering vaccines; determining fair vaccine allocation; encouraging the uptake of vaccines; ethical implications of vaccine passports and other vaccine requirements; and adapting clinical and health research systems. Financing decisions and ethical considerations will also need to be made from the start of vaccine R&D through to clinical system adaptations. As such, these are represented as cross-cutting challenges in the framework. In early December 2020, less than one year after the start of the pandemic, COVID-19 vaccines were already gaining authorizations in countries around the globe. This feat would not have been possible without the tremendous effort, collaboration, partnership, and financial support that went into the development of these products. However, even though a handful of vaccines are already being administered in countries around the world, more options on the market are necessary to vaccinate the billions and billions of people needed for herd immunity. For these first-generation vaccines, governments used both push mechanisms (i.e. direct grants to companies) and pull mechanisms (i.e. Advanced Market Commitments) to stimulate R&D without ties to quality or efficacy of eventual vaccine products – an understandable short-term solution given the situation in 2020. However, COVID-19 is unlikely to disappear soon, and we must now consider longer-term efforts. We are nowhere near the vaccine administration levels needed for global herd immunity, new variants of concern are emerging [2], and we still do not know how long current vaccines remain effective and whether yearly or other periodic boosters are necessary. Incentive structures should undergo systemic changes so that manufacturers continue to search for viable candidates. It is unlikely that all remaining and future vaccine candidates will meet efficacy thresholds for clinical trials. We have already seen the withdrawal of several candidates – even ones from major pharmaceutical developers [3]. Continued incentives are needed to maintain robust R&D efforts to ensure vaccine effectiveness, safety, and quality, and to generate second and third generation vaccines to meet the ever-changing needs of populations across the globe. With the emergence of new variants, there is also a rise in interest around the development of a "universal 'variant-proof' vaccine, able to fend off different varieties of the same virus family" [4]. The challenge of maintaining strong R&D incentives is bolstered by the nature of vaccine development, which presents higher costs and risk relative to other pharmaceuticals [5]. Governments and donors could consider implementing additional financing mechanisms to encourage R&D, including patent purchasing [6], patent pooling, and bonds [7]. The Options Market for Vaccines (OMV) model (based on the Options Market for Antibiotics model), where purchasers would make financial investments into COVID-19 vaccine R&D in exchange for reduced future prices, has been proposed as a potentially effective way to combine push and pull incentives for vaccine development in the current pandemic setting [[5,[8], [9], [10]. CEPI has already received some pol
PDF JSON Files: document_parses/pdf_json/8969c2224fb5cf99fa12552285783c0c2a0695b6.json
PMC JSON Files: document_parses/pmc_json/PMC7997052.xml.json
G_ID: covid_19_vaccine_challenges_what_have_we_learned_so_far_and_what_remains_to_be_done