PD195 Variation In Decision-Making And Market Access Routes For Vaccines: Insights From Seven Countries
Bibliographic record
Abstract
Introduction Quick and equitable market access to vaccines is a global priority. However, market access routes for vaccines are complex and differ from those for pharmaceuticals. Furthermore, there is variation in decision-making between countries due to local requirements. This work aimed to increase awareness of the key elements of these pathways and the stakeholders involved in European Union (EU) and non-EU countries. Methods Pragmatic desk-based research was undertaken in November 2023 to explore key elements of the market access pathways for vaccines and how these differ between countries. Specifically, the countries of interest were Canada, England, France, Germany, Italy, Spain, and the USA. Where available, information was extracted about the key stages and stakeholders involved in the decision-making pathway as well as details about any post-licensing monitoring, the value assessment framework used, vaccine pricing, and the procurement process. In addition, examples of barriers to vaccine access were extracted. The key findings and between-country differences were summarized narratively. Results National Immunization Technical Advisory Groups (NITAGs) were key stakeholders in all countries explored and had varying roles. The evidence requirements differed among countries, such as Germany’s requirement for economic and epidemiological modeling. The Vaccine Monitoring Platform coordinates studies for post-authorization monitoring of vaccines across EU countries. However, England is not part of this network and uses a national agency instead. Vaccine procurement and pricing also differed (e.g., France uses individual reimbursement, England uses national tendering, and Canada uses regional tendering). There was variation in vaccine pricing within the USA, depending on the healthcare provider. Barriers to vaccine access were well reported. Conclusions These results can influence the market access strategy of vaccine developers to ensure rapid and equitable vaccine access across countries. Several between-country differences in vaccine market access routes were identified; for example, the role of NITAGs, evidence requirements, and post-licensing monitoring processes. Barriers to vaccine access have been reported in the literature, with some organizations providing recommendations to overcome these.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.020 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.001 | 0.004 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".