About the Authors

Nadine Kaelber

Roles Investigation, Methodology

Affiliation Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Cyrus Bett

Roles Data curation, Methodology

Affiliation Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

David M. Asher

Roles Supervision, Writing – review & editing

Affiliation Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Luisa Gregori

Roles Conceptualization, Supervision, Writing – original draft

luisa.gregori@fda.hhs.gov

Affiliation Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Competing Interests

All authors work for the US FDA and all authors declare no conflict of interest.