Dataset Information

Developing-country vaccine manufacturers' technical capabilities can make a difference in global immunization.

ABSTRACT: Members of the Developing Countries Vaccine Manufacturers' Network (DCVMN) have been actively engaged in the development of COVID-19 vaccine candidates. According to the WHO COVID-19 vaccine landscape updated on 29 December 2020, 18 member manufacturers had vaccines in preclinical or clinical trials, including three members with candidates in Phase III trials. Once successful candidates have been identified there will be a need for large scale vaccine manufacturing and supply, in which DCVMN member manufacturers can play a key role. In an internal survey in 2019, DCVMN members reported the capability to supply over 3.5 billion vaccine doses annually, and the provision of over 50 distinct vaccines to 170 countries. To describe the capabilities of DCVMN member manufacturers more precisely, a 121-question survey was circulated to 41 Network members. The survey assessed the manufacturers' capabilities in utilizing various technology platforms, cell cultures and filling technologies, in addition to their capacities for manufacturing drug products. The survey also evaluated manufacturers' preparedness to dedicate existing capacities to COVID-19 vaccine production. Results revealed that sampled manufacturers have strong capabilities for manufacturing vaccines based on recombinant technologies, particularly with mammalian cells, and microbial and yeast expression systems. Capabilities in utilizing cell cultures were distributed across multiple cell types, however manufacturing capacities with Vero and CHO cells were prominent. Formulating and filling findings illustrated further large-scale capabilities of Network members. Sampled manufacturers reported that over 50% of their capacity for vaccine manufacturing could be dedicated to COVID-19 vaccine production.

SUBMITTER: Hayman B

PROVIDER: S-EPMC8330991 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundPublic trust in immunization is an increasingly important global health issue. Losses in confidence in vaccines and immunization programmes can lead to vaccine reluctance and refusal, risking disease outbreaks and challenging immunization goals in high- and low-income settings. National and international immunization stakeholders have called for better monitoring of vaccine confidence to identify emerging concerns before they evolve into vaccine confidence crises.MethodsWe perform a large-scale, data-driven study on worldwide attitudes to immunizations. This survey - which we believe represents the largest survey on confidence in immunization to date - examines perceptions of vaccine importance, safety, effectiveness, and religious compatibility among 65,819 individuals across 67 countries. Hierarchical models are employed to probe relationships between individual- and country-level socio-economic factors and vaccine attitudes obtained through the four-question, Likert-scale survey.FindingsOverall sentiment towards vaccinations is positive across all 67 countries, however there is wide variability between countries and across world regions. Vaccine-safety related sentiment is particularly negative in the European region, which has seven of the ten least confident countries, with 41% of respondents in France and 36% of respondents in Bosnia & Herzegovina reporting that they disagree that vaccines are safe (compared to a global average of 13%). The oldest age group (65+) and Roman Catholics (amongst all faiths surveyed) are associated with positive views on vaccine sentiment, while the Western Pacific region reported the highest level of religious incompatibility with vaccines. Countries with high levels of schooling and good access to health services are associated with lower rates of positive sentiment, pointing to an emerging inverse relationship between vaccine sentiments and socio-economic status.ConclusionsRegular monitoring of vaccine attitudes - coupled with monitoring of local immunization rates - at the national and sub-national levels can identify populations with declining confidence and acceptance. These populations should be prioritized to further investigate the drivers of negative sentiment and to inform appropriate interventions to prevent adverse public health outcomes.

Project description:Standardized case definitions strengthen post-marketing safety surveillance of new vaccines by improving generated data, interpretation and comparability across surveillance systems. The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project developed standardized case definitions for 21 key obstetric and neonatal terms following the Brighton Collaboration (BC) methodology. In this prospective cohort study, we assessed the applicability of GAIA definitions for maternal immunization exposure and for low birth weight (LBW), preterm birth, small for gestational age (SGA), stillbirth, neonatal death, neonatal infection, and congenital microcephaly. We identified the missing data elements that prevented identified cases and exposures from meeting the case definition (level 1-3 of BC diagnostic certainty). Over a one-year period (2019-2020), all births occurring in 21 sites (mostly secondary and tertiary hospitals) in 6 Low Middle Income Countries and 1 High Income Country were recorded and the 7 perinatal and neonatal outcome cases were identified from routine medical records. Up to 100 cases per outcome were recruited sequentially from each site. Most cases recruited for LBW, preterm birth and neonatal death met the GAIA case definitions. Birth weight, a key parameter for all three outcomes, was routinely recorded at all sites. The definitions for SGA, stillbirth, neonatal infection (particularly meningitis and respiratory infection) and congenital microcephaly were found to be less applicable. The main barrier to obtaining higher levels of diagnostic certainty was the lack of sonographic documentation of gestational age in first or second trimester. The definition for maternal immunization exposure was applicable, however, the highest level of diagnostic certainty was only reached at two sites. Improved documentation of maternal immunization will be important for vaccine safety studies. Following the field-testing of these 8 GAIA definitions, several improvements are suggested that may lead to their easier implementation, increased standardization and hence comparison across studies.

Dataset Information

Developing-country vaccine manufacturers' technical capabilities can make a difference in global immunization.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets