Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers

Dellepiane, Nora; Pagliusi, Sonia; Akut, Prashant; Comellas, Sebastian; Clercq, Norbert De; Ghadge, S. N.; Gastineau, Thierry; McGoldrick, Mic; Nurnaeni, Ida; Scheppler, Lorenz

doi:10.1016/j.jvacx.2020.100075

Cited by 7 publications

(6 citation statements)

References 7 publications

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“…Regulatory filings and limited capabilities to expand markets were recognized slightly more frequently by respondents as important challenges for improved vaccines than novel vaccines ( Fig. 3 ) due to the lack of predictability of timelines for regulatory review and approval of post-approval changes of existing products [18] , while new product registrations bring new markets, and thus may be more attractive for manufacturers to engage in. These two factors – expand markets and regulatory filings - likely go hand in hand considering the rigorous regulatory processes that must be completed before a vaccine can be supplied outside the domestic market [12] .…”

Section: Resultsmentioning

confidence: 99%

“…These two factors – expand markets and regulatory filings - likely go hand in hand considering the rigorous regulatory processes that must be completed before a vaccine can be supplied outside the domestic market [12] . Even for WHO prequalified vaccines, the final step of achieving local licensure in a broad range of countries can often be a challenge for DCVMs due to divergent regulatory pathways and country-specific requirements [18] , [19] . Regulatory convergence globally would notably remove this barrier [19] .…”

Section: Resultsmentioning

confidence: 99%

“…Regulatory convergence globally would notably remove this barrier [19] . Despite some global efforts (e.g., WHO collaborative registration procedure (CRP) 2 ) challenges with CRP adoption in countries remain [18] , [20] .…”

Section: Resultsmentioning

confidence: 99%

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Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities

Hayman

Bowles

Evans

et al. 2021

Vaccine

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities

Hayman

Bowles

Evans

et al. 2021

Vaccine

Self Cite

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“… Confirmation of the clinical studies matches the results [ 37 ] Manufacturing and research facilities routine departmental inspections. Annual product analysis Process regulation Post licence modification To ensure the population goals for the intended use of the vaccine are correct [ 38 ] Licensing can improve the process. To take advantage of more modern manufacturing methods Important transition changes should be carefully assessed …”

Section: Vaccination Processmentioning

confidence: 99%

COVID-19 pandemics Stage II – Energy and environmental impacts of vaccination

Klemeš

Jiang

Fan

et al. 2021

Renewable and Sustainable Energy Reviews

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The COVID-19 pandemic developed the severest public health event in recent history. The first stage for defence has already been documented. This paper moves forward to contribute to the second stage for offensive by assessing the energy and environmental impacts related to vaccination. The vaccination campaign is a multidisciplinary topic incorporating policies, population behaviour, planning, manufacturing, materials supporting, cold-chain logistics and waste treatment. The vaccination for pandemic control in the current phase is prioritised over other decisions, including energy and environmental issues. This study documents that vaccination should be implemented in maximum sustainable ways. The energy and related emissions of a single vaccination are not massive; however, the vast numbers related to the worldwide production, logistics, disinfection, implementation and waste treatment are reaching significant figures. The preliminary assessment indicates that the energy is at the scale of ~1.08 × 10 10 kWh and related emissions of ~5.13 × 10 12 gCO 2eq when embedding for the envisaged 1.56 × 10 10 vaccine doses. The cold supply chain is estimated to constitute 69.8% of energy consumption of the vaccination life cycle, with an interval of 26–99% depending on haul distance. A sustainable supply chain model that responds to an emergency arrangement, considering equality as well, should be emphasised to mitigate vaccination's environmental footprint. This effort plays a critical role in preparing for future pandemics, both environmentally and socially. Research in exploring sustainable single-use or reusable materials is also suggested to be a part of the plans. Diversified options could offer higher flexibility in mitigating environmental footprint even during the emergency and minimise the potential impact of material disruption or dependency.

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“…Chemistry, Manufacturing, and Controls (CMC) changes in medicinal products are inevitable regardless of their type, category, or characteristics. They can be observed in the form of a technological transfer to the final manufacturer of the products during the developmental phase, changing technical needs due to new findings during the product lifecycle, and continuous improvement in the manufacturing processes and product characteristics ( 1 ).…”

Section: Introductionmentioning

confidence: 99%

A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines

Rodriguez

Lucia²

2021

Front. Med.

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In recent years, post-approval changes (PACs) for medicinal products have increased faster than the national regulatory agencies can attend to without causing any negative impact. This study presents a proposal for regulatory management based on our analysis of the data available from the national regulatory agencies of Latin America on the total post-approval changes evaluated, and the time spent in the process. A retrospective search on the official websites of competent national regulatory authorities (NRAs) of 14 Latin American countries (México, Guatemala, Nicaragua, Honduras, El Salvador, Panamá, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Argentina, Chile and Brazil) was conducted to collect data on post-approval changes in the last 4–6 years, up to January 2021. The NRAs considered were Brazil, México, Colombia, and Costa Rica. Our analysis was focused on the post-approval changes that required approval before implementation, those that were submitted, and those that were submitted and approved for small molecules, biologics, and biotechnological products. The results indicated differences in the regulatory processes and procedures applied by the different agencies. We also found that the implementation of the PACs was directly impacted by limited resources, which puts the medication supply for chronic treatments at risk resulting in serious consequences for patients. For local decision-making, Latin American NRAs should implement regulatory pathways already made by regulatory agencies included in the World Health Organization Listed Authorities on PAC approval to optimize their resources and to ensure the continuity of medicine supply for their patients.

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Alignment in post-approval changes (PAC) guidelines in emerging countries may increase timely access to vaccines: An illustrative assessment by manufacturers

Cited by 7 publications

References 7 publications

Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities

Advancing innovation for vaccine manufacturers from developing countries: Prioritization, barriers, opportunities

COVID-19 pandemics Stage II – Energy and environmental impacts of vaccination

A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines

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