Moderna, Pfizer Protocols May Make COVID Vaccines Hard to Compare

▤ Summary

“Both trials appeared to be well designed,” based on publicly available information, said Ira Longini, co-director of the Center for Statistics and Quantitative Infectious Diseases Emerging Pathogens Institute at the University of Florida. The agency guidance says trials “need not screen for or exclude participants with history or laboratory evidence of prior SARS-CoV-2 infection.” Moderna is the first of the four confirmed companies that are part of the US government’s Operation Warp Speed project to quickly advance coronavirus vaccines. At a meeting of the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices on 29 July, Julie Ledgerwood, deputy director and chief medical office of the vaccine research center at the National Institute of Allergy and Infectious Diseases, described the Warp Speed trial approach as “semi-independent harmonized trials” which will include collaborating labs on issues like defining COVID infections and T-cell responses. Other shared principles of the OWS trials include the primary endpoint of prevention of symptomatic COVID-19 disease, virologic confirmation, and a common data safety monitoring board managed by the NIAID. In older adults (65-85 years of age), two 30 µg doses, spaced three weeks apart, the vaccine candidate elicited a neutralizing antibody geometric mean titer (GMT) higher than that in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

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