Journal Article > Meta-AnalysisFull Text
Vaccine. 2020 February 8; Volume 38 (Issue 11); DOI:10.1016/j.vaccine.2020.02.005
Juan-Giner A, Alsalhani A, Panunzi I, Lambert V, Van Herp M, et al.
Vaccine. 2020 February 8; Volume 38 (Issue 11); DOI:10.1016/j.vaccine.2020.02.005
Measles outbreaks occur periodically in remote and difficult to reach areas in countries such as the Democratic Republic of Congo. The possibility to keep measles vaccines at temperatures outside the cold chain for a limited period prior to administration would be an advantage for organizations such as Médecins Sans Frontières, which repeatedly respond to measles outbreaks in difficult contexts.
Using stability data at 37 °C and 40 °C provided by Serum Institute of India Private Limited we applied the product release model for Extended Controlled Temperature Conditions (ECTC) to evaluate the possibility of an out of the cold chain excursion.
Measles vaccine in the lyophilized form remains above the minimum required potency at the end of the shelf-life for up to 6 days at 37 °C or for 2 days at 40 °C.
This evaluation supports the use of a monodose presentation of measles vaccine in ECTC. This could be an advantage for outbreak response in isolated and difficult to reach areas. However the operational advantages of this approach need to be established.
Using stability data at 37 °C and 40 °C provided by Serum Institute of India Private Limited we applied the product release model for Extended Controlled Temperature Conditions (ECTC) to evaluate the possibility of an out of the cold chain excursion.
Measles vaccine in the lyophilized form remains above the minimum required potency at the end of the shelf-life for up to 6 days at 37 °C or for 2 days at 40 °C.
This evaluation supports the use of a monodose presentation of measles vaccine in ECTC. This could be an advantage for outbreak response in isolated and difficult to reach areas. However the operational advantages of this approach need to be established.
Journal Article > LetterFull Text
Nat Hum Behav. 2022 January 31; Volume 6 (Issue 2); 167-167.; DOI:10.1038/s41562-022-01304-y
Prabhala A, Alsalhani A
Nat Hum Behav. 2022 January 31; Volume 6 (Issue 2); 167-167.; DOI:10.1038/s41562-022-01304-y
Other > Pre-Print
OSF Preprints. 2020 June 1; DOI:10.31219/osf.io/rdc7v
Cox V, Perrin C, Athersuch K, Martin M M, Alsalhani A
OSF Preprints. 2020 June 1; DOI:10.31219/osf.io/rdc7v
Two novel drugs, bedaquiline and delamanid, have recently become available to treat drug resistant tuberculosis (DR-TB) after many decades of little innovation in the field of DR-TB treatment. Despite evidence of improved efficacy and reduced toxicity of multi-drug regimens including the two agents, access to bedaquiline and delamanid has been very limited in many settings with a high burden of DR-TB and consistently poor treatment outcomes. Aside from regulatory, logistic, and cost barriers at country level, uptake of the novel agents was complicated by gaps in knowledge for optimal use in clinical practice after initial market approval. The main incentives of the current pharmaceutical research and development paradigm are structured around obtaining regulatory approval, which in turn requires efficacy and safety data generated by clinical trials. Recently completed and ongoing clinical trials did not answer critical questions of how to provide shorter, less toxic treatment DR-TB treatment regimens containing bedaquiline and delamanid and improve patient outcomes. Voluntary generation of evidence that is not part of this process –yet essential from a clinical or policy perspective –has been left to non-sponsor partners and researchers, often without collaborative efforts to improve post-regulatory approval access to life saving drugs. Additionally, these efforts are currently not recognized in the value chain of the research and development process, and there are no incentives to make this critical research happen in a coordinated way.
Journal Article > CommentaryFull Text
BMJ Glob Health. 2022 April 19; Volume 7 (Issue 4); e007490.; DOI:10.1136/bmjgh-2021-007490
Perrin C, Athersuch K, Elder G, Martin M, Alsalhani A
BMJ Glob Health. 2022 April 19; Volume 7 (Issue 4); e007490.; DOI:10.1136/bmjgh-2021-007490
Two drugs with novel mechanisms of action, the diarylquinoline bedaquiline and the nitroimidazole delamanid—as well as pretomanid from the same class of drugs as delamanid—have recently become available to treat drug-resistant tuberculosis (DR-TB) after many decades of little innovation in the field of DR-TB treatment. Despite evidence of improved efficacy and reduced toxicity of multidrug regimens including the two agents, access to bedaquiline and delamanid has been limited in many settings with a high burden of DR-TB and consistently poor treatment outcomes. Aside from regulatory, logistic and cost barriers at country level, uptake of the novel agents was complicated by gaps in knowledge for optimal use in clinical practice after initial market approval. The main incentives of the current pharmaceutical research and development paradigm are structured around obtaining regulatory approval, which in turn requires efficacy and safety data generated by clinical trials. Recently completed and ongoing clinical trials did not answer critical questions of how to provide shorter, less toxic treatment DR-TB treatment regimens containing bedaquiline and delamanid and improve patient outcomes. Voluntary generation of evidence that is not part of this process—yet essential from a clinical or policy perspective—has been left to non-sponsor partners and researchers, often without collaborative efforts to improve post-regulatory approval access to life-saving drugs. Additionally, these efforts are currently not recognised in the value chain of the research and development process, and there are no incentives to make this critical research happen in a coordinated way.
Journal Article > CommentaryFull Text
Lancet. 2024 April 29; Volume 403 (Issue 10439); 1825-1827.; DOI:10.1016/S0140-6736(24)00749-9
Coulborn RM, Danet C, Alsalhani A
Lancet. 2024 April 29; Volume 403 (Issue 10439); 1825-1827.; DOI:10.1016/S0140-6736(24)00749-9
Worldwide, more than 99% of the burden of measles infections and deaths affects populations in low-income and middle-income countries. Measles accounts for 3% of the global mortality of children younger than five years, constituting 90% of deaths from measles, and rubella is the main vaccine-preventable cause of birth defects. Vaccine coverage, both through routine immunisation and supplementary immunisation activities, remains below targets for measles elimination, with considerable heterogeneity between and within countries.