Regulatory agilities impacting review timelines for Pfizer/BioNTech's BNT162b2 mRNA COVID-19 vaccine: a retrospective study.

Patel, Prisha; Macdonald, Judith C; Boobalan, Jayanthi; Marsden, Matthew; Rizzi, Ruben; Zenon, Marianne; Ren, Jinma; Chu, Haitao; Cappelleri, Joseph C; Roychoudhury, Satrajit; O'Brien, Julie; Izaki-Lee, Konoha; Boyce, Donna.

Afiliação

Patel P; International Regulatory Science and Policy, Pfizer, Tadworth, United Kingdom.
Macdonald JC; International Regulatory Science and Policy, Pfizer, Tadworth, United Kingdom.
Boobalan J; International Regulatory Science and Policy, Pfizer, Kuala Lumpur, Malaysia.
Marsden M; Global Regulatory Sciences, Pfizer, Tadworth, United Kingdom.
Rizzi R; BioNTech SE, Mainz, Germany.
Zenon M; International Regulatory Science and Policy, Pfizer, Johannesburg, South Africa.
Ren J; Statistical Research and Data Science Center, Pfizer, Collegeville, PA, United States.
Chu H; Statistical Research and Data Science Center, Pfizer, Groton, CT, United States.
Cappelleri JC; Statistical Research and Data Science Center, Pfizer, Groton, CT, United States.
Roychoudhury S; Statistical Research and Data Science Center, Pfizer, Collegeville, PA, United States.
O'Brien J; International Regulatory Science and Policy, Pfizer, Dublin, Ireland.
Izaki-Lee K; International Regulatory Science and Policy, Pfizer, Tadworth, United Kingdom.
Boyce D; School of Physiology, Pharmacology and Neuroscience, University of Bristol, Bristol, United Kingdom.