The Quint has found that that the same Bhopal hospital that had earlier been reported as having committed ethical breaches during COVID-19 vaccine trials has also violated the protocols set down by Bharat Biotech for phase 3 trials of its Covaxin candidate vaccine.
In addition to already reported violations of the New Drug and Clinical Trial Rules 2019 (NDCT 2019), the People’s Hospital also violated these protocols to a degree that renders data from this section of trials “untrustworthy,” notes Pulla.
The hospital is one among 26 trial sites for Covaxin and had signed on more than 1,700 participants. The protocol violation also jeopardises Bharat Biotech’s understanding of the efficacy and safety of its COVID-19 vaccine.
14.
Rigby RA, Stasinopoulos DM. Generalized additive models for location, scale and shape.
J R Stat Soc Ser C Appl Stat. 2005;54(3):507-554. doi:10.1111/j.1467-9876.2005.00510.xGoogle ScholarCrossref
15.
R: A Language and Environment for Statistical Computing v. 3.5. 1. R Foundation for Statistical Computing; 2019.
16.
Vaduganathan M, Vardeny O, Michel T, et al. Renin–angiotensin–aldosterone system inhibitors in patients with Covid-19.
17.
Imai Y, Kuba K, Rao S, et al. Angiotensin-converting enzyme 2 protects from severe acute lung failure.
18.
Reynolds HR, Adhikari S, Pulgarin C, et al. Renin–angiotensin–aldosterone system inhibitors and risk of Covid-19.
19.
Mancia G, Rea F, Ludergnani M,
Research Article
Birth weight, growth, nutritional status and mortality of infants from Lambaréné and Fougamou in Gabon in their first year of life
Rella Zoleko-Manego, Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Validation, Visualization, Writing – original draft, Writing – review & editing
Affiliations Centre de Recherches Médicales de Lambaréné (CERMEL), Lambaréné, Gabon, Institut für Tropenmedizin, Universität Tübingen, Tübingen, Germany, Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Roles Formal analysis, Writing – original draft, Writing – review & editing
Affiliation Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University
Negotiating for the fair treatment of study participants and benefit sharing before a study commences does not constitute an unfair inducement. It is an ethical imperative.
SA Covid-19 vaccine trials âhold key lessonsâ for future partnerships
By The Conversation
By Keymanthri Moodley and Theresa Rossouw
Covid-19 vaccine supplies are available in various parts of the world. But itâs clear that distribution is not symmetrical.
High-income countries have access to disproportionate quantities of limited supplies.
Vaccine nationalism, stockpiling and profit-driven strategies of global pharmaceutical manufacturers have shown up global health inequities.
More than 100 million doses of Covid-19 vaccines have been administered globally to date. Only about 200 000 (0.2%) have been in Africa.
South Africa is one of the first countries in sub-Saharan Africa to procure vaccines. The country has some of the highest reported cases of Covid-19 in the region. But, despite hosting a clinical trial of the AstraZeneca vaccine, South Africa was unable to secure a fair pricing agreement.