Viewpoint
Abstract
In recent months genomic characterization of pandemic SARS-CoV-2 isolates identified viral variants that are less susceptible to neutralization by convalescent plasma (CP), vaccine-elicited plasma/sera, or SARS-CoV-2 monoclonal antibodies than earlier SARS-CoV-2 strains. In this Viewpoint, Casadevall et al. argue against the causal association made in some press articles between the emergence of SARS-CoV-2 variants and convalescent plasma use.
Authors
Arturo Casadevall, Jeffrey Henderson, Michael Joyner, Liise-anne Pirofski
Abstract
Authors
Shalender Bhasin
Abstract
Authors
Seth Blackshaw, Joshua R. Sanes
Abstract
Authors
Jeffrey C. Rathmell, W. Kimryn Rathmell
Abstract
Authors
Robert V. Farese Jr., Tobias C. Walther
Abstract
Limited evidence exists regarding the use of the currently approved COVID-19 mRNA vaccines (Pfizer-BioNtech BNT162b2 and Moderna mRNA-1273) during pregnancy. In this Viewpoint, Klein et al. discuss gaps in knowledge and make recommendations to incorporate age, sex, and pregnancy in the preclinical and clincal vaccine development pipeline.
Authors
Sabra L. Klein, Patrick S. Creisher, Irina Burd
Abstract
In this viewpoint, Robert Califf, former commissioner of the U.S. Food and Drug Administration, and colleagues reflect on how to approach questions about which patient treatments and strategies work, particularly in light of the tremendous pressure on the government and biomedical research enterprise to quickly develop safe, effective therapies during the SARS-CoV-2 pandemic.
Authors
Robert M. Califf, Lesley H. Curtis, Robert A. Harrington, Adrian F. Hernandez, Eric D. Peterson
Abstract
Randomized controlled trials are the preferred design for the analysis of health-related interventions. In this Viewpoint, Nigel Paneth and Michael Joyner discuss circumstances when randomized controlled trials might not be feasible and the criteria that should be used when considering applying observational data medicine.
Authors
Nigel Paneth, Michael Joyner
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