Table 6.
Mixed encoding scheme
| Tag | Title | Definition/function | Type |
|---|---|---|---|
| W | Workstreams | It groups stage-gates of the same nature and purpose | - |
| W1 | Research and development (R&D) | It comprises the activities and decisions related to vaccine R&D | Apriori cat. |
| W2 | Good manufacturing practices (GMP) | It comprises the activities and decisions related to the manufacturing preparation to meet GMP | Apriori cat. |
| W3 | Market preparation, registration, and introduction | It comprises the activities and decisions related to introducing vaccines on the market | Apriori cat. |
| W4 | Funding and Business Development | It comprises the activities and decisions related to funding and business development | Apriori cat. |
| W5 | Manufacturing | It comprises the activities and decisions related to vaccine manufacturing | Apriori cat. |
| W6 | Market monitoring | It comprises the activities related to monitoring, assessing, and prioritizing unmet global needs | Apriori cat. |
| W7 | Innovation project monitoring | It comprises the activities related to the monitoring of partnership and vaccine projects | Apriori cat. |
| W8 | Portfolio monitoring | It comprises the activities related to the monitoring of multiple vaccine projects | Apriori cat. |
| W9 | Public affairs monitoring | It comprises the activities related to the monitoring of public affairs | Apriori cat. |
| W10 | Product monitoring | It comprises the activities related to the monitoring of adverse effects | Apriori cat. |
| S | Stages | It consists of the best-practice activities needed to progress the project to the next decision point | - |
| S1 | Stakeholder unmet needs assessment | It consists of assessing unmet needs to define R&D opportunities | Cat. code |
| S2 | Scoping and preparation | It consists of scoping and preparing projects to meet R&D opportunities | Cat. code |
| S3 | Exploration and discovery | It consists of elucidating pathogenic mechanisms to identify targets and generate candidate vaccines | Cat. code |
| S4 | Early-stage preclinical | It consists of optimizing and validating candidate vaccines in simple animal models | Cat. code |
| S5 | Late-stage preclinical | It consists of testing candidate vaccines in complex animal models to assess efficacy, immunogenicity, safety, and toxicity | Cat. code |
| S6 | Clinical trial application | It consists of defining and validating clinical trial design with competent authorities | Cat. code |
| S7 | Randomized control trial (RCT) – Phase I | It involves applying the candidate vaccine to a few volunteers to test safety and dose and assess its initial ability to stimulate the immune system | Cat. code |
| S8 | Randomized control trial (RCT) – Phase II | It consists of applying the candidate vaccine to hundreds of volunteers to obtain more safety data and assess its ability to stimulate the immune system (efficacy) | Cat. code |
| S9 | Randomized control trial (RCT) – Phase III | It consists of applying the candidate vaccine to thousands of volunteers to confirm its efficacy and learn more about adverse reactions in varied groups of individuals | Cat. code |
| S10 | Chemistry, manufacturing, and control (CMC) | It consists of evaluating the facilities and infrastructure required for production, specifying the up/downstream processing platforms, and preparing quality control tests in consultation with regulatory authorities | Cat. code |
| S11 | Prepare manufacturing | It consists of adequating the existing facilities and infrastructure, as well as ensuring the necessary resources for the entire operationalization of the vaccine production chain | Cat. code |
| S12 | Market preparation | It consists of defining the market and pricing strategies | Cat. code |
| S13 | Registration | It consists of preparing and submitting the vaccine dossier to the regulatory authorities | Cat. code |
| S14 | National implementation | It consists of articulating the implementation strategy with governments and stakeholders | Cat. code |
| S15 | Market deployment | It consists of introducing the vaccine into the market on a case-by-case basis or within the context of a vaccination program | Cat. code |
| S16 | Funding | It consists of acquiring funding to support development steps, including non-dilutive financing, investors, and early revenues generated through service | Cat. code |
| S17 | Scouting | It consists of assessing the technical and market potential of relevant findings in early-stage R&D | Cat. code |
| S18 | Intellectual property (IP) protection | It consists of drafting, filing, and maintenance of patent applications | Cat. code |
| S19 | Spin-off company | It turns a subsidiary into a new and separate company to enable future partnerships | Cat. code |
| S20 | Partnering | It identifies and selects partners to improve development, production, and distribution processes | Cat. code |
| S21 | Acquisition | It consists of large vaccine companies acquiring innovations to make up their development pipeline | Cat. code |
| S22 | Manufacturing | It consists of executing the up/downstream processes, quality assurance, quality control, and compilation of batch dossiers | Cat. code |
| S23 | Global unmet needs assessment | It consists of elaborating a list of vaccine-preventable unmet needs | Cat. code |
| S24 | Demand articulation | It prioritizes unmet needs, defines articulation factors, and reviews global policy recommendations | Cat. code |
| S25 | Monitoring project | It consists of monitoring the project performance evolution | Cat. code |
| S26 | Monitoring partnership | It consists of monitoring the execution of contractual commitments made between partners | Cat. code |
| S27 | Monitoring portfolio | It consists of monitoring the performance evolution of projects running in parallel | Cat. code |
| S28 | Public affairs | It consists of monitoring public affairs | Cat. code |
| S29 | Post-market surveillance (Phase IV) | It consists of recognizing adverse events following immunizations, adequate vaccine quality, vaccination effectiveness, and gathering market and operational feasibility feedback | Cat. code |
| D, U, T | Gates (defined, undefined, and monitoring/tracking) | It consists of the points where the path forward for the next stage is agreed to | - |
| D1 | Needs prioritization | It concerns the decision of which R&D opportunities should be selected and/or prioritized | Cat. code |
| D2 | Star exploration | It concerns the decision of allocating resources for the R&D project | Cat. code |
| D3 | Lead identification | It concerns the decision to proceed to early-stage preclinical development | Cat. code |
| D4 | Candidate nomination decision | It concerns the decision of proceeding to late-stage preclinical development | Cat. code |
| D5 | Initiate clinical trials | It concerns the decision to initiate clinical trials | Cat. code |
| D6 | First-in-man | It concerns the approval by regulatory authorities to initiate clinical trials | Cat. code |
| D7 | Pre-phase II | It concerns the decision to continue to RCT Phase II | Cat. code |
| D8 | Pivotal development decision | It concerns the decision to continue to RCT Phase III | Cat. code |
| D9 | Registration decision | It concerns the decision of progressing to market preparation and registration | Cat. code |
| D10 | CMC feasibility | It concerns the decisions of acquiring equipment, inputs, and services for the adequacy of the manufacturing process | Cat. code |
| D11 | Production feasibility | It concerns the decision of upscaling manufacturing | Cat. code |
| D12 | Launch decision point | It concerns the decision to launch the vaccine on the market | Cat. code |
| D13 | Market authorization decision | It concerns the vaccine use authorization by regulatory authorities | Cat. code |
| D14 | Inclusion in the vaccination program | It concerns the decision to include the vaccine in the national immunization programs | Cat. code |
| D15 | No gate associated with S15 | - | - |
| U16 | Funding | It concerns the decision to acquire funding to support development steps | Cat. code |
| U17 | Scouting | It concerns the decisions progressing to IP protection, spin-off company, and/or partnering stages | Cat. code |
| U18 | IP protection | It concerns the decision to apply for and maintain patents in specific territories | Cat. code |
| U19 | Spin-off company | It concerns turning a subsidiary into a new and separate company | Cat. code |
| U20 | Partnering | It concerns the decision to sign licensing agreements and/or strategic partnerships | Cat. code |
| U21 | Acquisition | It concerns the decision of acquiring innovations to make up the development pipeline | Cat. code |
| U22 | Batch release | It concerns the approval by regulatory authorities of pilot batches | Cat. code |
| T23 | Global policy recommendation | It concerns the decisions of which recommendations should be included in global policies | Cat. code |
| T24 | Demand articulation | It concerns the decisions of which unmet needs should be prioritized | Cat. code |
| T25 | Monitoring project | It concerns the decisions about the continuity of the project | Cat. code |
| T26 | Monitoring partnership | It concerns the decisions about the continuity of the partnership | Cat. code |
| T27 | Monitoring portfolio | It concerns the decisions about the continuity of particular projects composing the portfolio | Cat. code |
| T28 | No gate associated with S28 | - | - |
| T29 | Post-marketing surveillance | It concerns the decisions about the continuity of the market registration | Cat. code |
| E | Enablers | It consists of the contextual factors making it possible the shift from the traditional to pandemic R&D paradigm | - |
| E1 | Global coordination | It consists of global multi-stakeholder alignment on pandemic preparedness and response initiatives | Open code |
| E2 | Ongoing vaccine R&D in preparedness for potential pandemics | It consists of continuing vaccine R&D in preparedness for possible pandemics | Open code |
| E3 | Advances in biotechnology and molecular biology | It consists of technological advances involving living systems and organisms to develop new products | Open code |
| E4 | Legal reference mechanisms | It consists of regulations in place that can support some extraordinary initiatives | Open code |
| E5 | Tailored communication | It consists of communication adapted to the audience's specific needs | Open code |
| E6 | Health literacy efforts | It consists of developing easy-to-understand basic health information and services needed to make appropriate health decisions | Open code |
| F | Driving forces | It consists of the motivators of the shift from traditional to pandemic R&D paradigm | - |
| F1 | Health, social, and economic impacts of disease | It consists of the impacts of the disease in terms of cases, hospitalizations, deaths, economic retraction, and social disparities | Open code |
| F2 | High level of community transmission | It consists of the high number of new cases and percent positivity | Open code |
| F3 | The need to rapidly develop safe and effective vaccines | It consists of the need to rapidly develop an immunizer that halts the progression of the disease | Open code |
| F4 | Flexible regulatory pathways | It refers to the flexibility in the processes related to vaccine licensing | Open code |
| F5 | Alternative financing mechanisms | It refers to the alternative ways to finance the research and development of new vaccines | Open code |
| F6 | Public–private cooperation | It refers to cooperation between public and private institutions to finance the research and development of new vaccines | Open code |
| F7 | New R&D strategies | It consists of non-traditional/innovative processes and technologies related to vaccine R&D | Open code |
| F8 | Alternative strategies for upscaling production | It refers to the alternative ways to upscale the global vaccine production capacity | Open code |
| F9 | Vaccine hesitancy | It refers to the delay in accepting or refusing vaccines despite their availability | Open code |
| I | Innovations | It relates to the elements triggering the shift from the traditional to pandemic R&D paradigm | - |
| I1 | Advanced market commitments and direct grants | It consists of binding contracts that guarantee a viable market for a product once it is successfully developed | Open code |
| I2 | Extraordinary registration and post-registration petitions | It consists of exceptional, updated criteria and procedures for handling registration petitions and post-registration changes for vaccines | Open code |
| I3 | Emergency use authorization | It consists of temporary authorization for the emergency use of candidate vaccines on an experimental basis to cope with a public health emergency of national importance | Open code |
| I4 | Extraordinary GMP certification | It consists of extraordinary and temporary criteria and procedures for GMP certification | Open code |
| I5 | Rolling submission/review | It consists of a regulatory tool used to speed up the assessment of a promising medicine during a public health emergency | Open code |
| I6 | Adaptive clinical trial design | It consists of a study that includes a prospectively planned opportunity to modify one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study | Open code |
| I7 | Nucleic acid (DNA/RNA) platform | It consists of a vaccine platform that uses genetic material from a disease-causing virus or bacterium (a pathogen) to stimulate an immune response against it | Open code |
| I8 | Recombinant viral vector platform | It consists of a fully competent viral vector backbone engineered to express an antigen from a foreign transgene | Open code |
| I9 | Partnership building | It consists of licensing agreements or strategic partnerships built to improve vaccine research, development, manufacturing, and delivery | Open code |
| I10 | Digital communication strategies | It consists of the plans and methods used to communicate using digital channels | Open code |
| M | Mechanisms | It consists of the mechanics underlying the shift from the traditional to pandemic R&D paradigm | - |
| M1 | Partial allocation of doses to low- and middle-income countries | It comprises a share of doses secured for low- and middle-income countries | Open code |
| M2 | Demand sustaining the investment in R&D | It consists of a minimum contracted demand that economically justifies the development of new vaccines | Open code |
| M3 | Immediate implementation of API-related changes | It concerns implementing API-related changes in a single stage, not requiring development and quality control tests | Open code |
| M4 | Vaccination with vaccines under emergency listing | It concerns the vaccination, on an emergency and experimental basis, without licensed vaccines | Open code |
| M5 | Remote inspection and use of existing certificates | It refers to using remote inspection or information from foreign regulatory agencies to replace in-person inspection | Open code |
| M6 | Parallelism of clinical trials | It consists of conducting the clinical development phases in parallel rather than series | Open code |
| M7 | Ultra-cold chain technology | It refers to the technology required to keep vaccines as cold as − 70 degrees Celsius | Open code |
| M8 | Manufacturing complexity | It refers to the number of degrees of freedom governing the behavior of a manufacturing system | Open code |
| M9 | Reproducibility and validation | It refers to the ability to replicate and validate the manufacturing process | Open code |
| M10 | Adaptation to new diseases | It refers to adapting existing platforms by changing the sequence encoding of the target antigen | Open code |
| M11 | Entry of new companies in the vaccine segment | It refers to the entry of other companies outside the traditional vaccine segment | Open code |
| M12 | Number of candidate vaccines | It consists of the absolute number of candidate vaccines for the same disease | Open code |
| M13 | Expansion and modernization of manufacturing technology and capacity | It refers to expanding capacity and modernizing the technology involved in vaccine production | Open code |
| M14 | Risk-sharing | It consists of sharing the risks inherent in the early stages of R&D | Open code |
| M15 | Fast-checking sites/apps | It consists of websites and applications to check vaccine and vaccination-related information in real-time | Open code |
| O | Outcomes | It refers to the positive or negative effects of the R&D paradigm shift | - |
| O1 | Inequitable distribution | It refers to the unequal distribution of vaccines among different countries | Open code |
| O2 | Licensing lead time | It consists of the time elapsed from the first document submitted to the surveillance agency until the vaccine license was granted | Open code |
| O3 | Ethical and regulatory risks | It refers to unexpected negative consequences of unethical actions or changes in laws and regulations | Open code |
| O4 | Manufacturing and logistic costs | It consists of the amount of money incurred to produce and transport vaccines | Open code |
| O5 | GMP production lead time | It consists of the time required for upscaling the production under GMP conditions | Open code |
| O6 | Clinical trials lead time | It consists of the time required to conduct phase I, II, and III clinical trials | Open code |
| O7 | Exploration and discovery lead time | It refers to the time taken from the elucidation of pathogenic mechanisms to identify targets up to the generation of candidate vaccines | Open code |
| O8 | Chance to have safe and effective vaccines | It refers to the chance of having a vaccine licensed at the end of the R&D process | Open code |
| O9 | Global production capacity | It refers to the worldwide vaccine production capacity | Open code |
| O10 | Financial risks | It refers to the risk that a business will not meet its debt repayment obligations | Open code |
| O11 | R&D lead time | It consists of the time taken from the scope and preparation of a candidate vaccine to its phase III randomized controlled trials | Open code |
| O12 | Time-to-market | It consists of the time taken from the early stages of R&D to the vaccine licensure | Open code |
| O13 | Public trust | It consists of the belief that vaccines are safe and effective | Open code |
| O14 | Vaccine uptake | It consists of a measure of how many people receive a particular vaccine | Open code |
| O15 | Disease burden | It consists of a measure of the amount of suffering caused by a particular disease | Open code |
| C | Critical incidents | It consists of remarkable events associated with the pandemic context | - |
| C1 | Outbreak of an unknown disease | It refers to official reports of a potential outbreak of an unknown disease | Open code |
| C2 | Emergence of new variants | It refers to the emergence of genetic modifications of the virus causing a pandemic disease | Open code |