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 ===== Emergency Use Authorization ===== ===== Emergency Use Authorization =====
-{{ ::covid_jab_eua_contract_-_stop_transmission.png?800|}}+
 ==== USA - FDA ==== ==== USA - FDA ====
 Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum
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 +{{ ::covid_jab_eua_contract_-_stop_transmission.png?800|}}
  
 Identifying Information Identifying Information
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 === Review Team ===  === Review Team === 
 [[:Ramachandra Naik]], Ph.D., Chair, OVRR/DVRPA; [[:Ramachandra Naik]], Ph.D., Chair, OVRR/DVRPA;
 +
 CAPT [:Michael Smith]], Ph.D., Regulatory Project Manager, OVRR/DVRPA; CAPT [:Michael Smith]], Ph.D., Regulatory Project Manager, OVRR/DVRPA;
-[:Susan Wollersheim]], M.D., Clinical reviewer, OVRR/DVRPA; + 
-[:Nabil Al-Humadi]], Ph.D., Toxicology reviewer, OVRR/DVRPA; +[[:Susan Wollersheim]], M.D., Clinical reviewer, OVRR/DVRPA; 
-[:Lei Huang]], Ph.D., Biostatistics reviewer, OBE/DB; + 
-[:Haruhiko Murata]], Ph.D., CMC/Product reviewer, OVRR/DVP; +[[:Nabil Al-Humadi]], Ph.D., Toxicology reviewer, OVRR/DVRPA; 
-[:Xiao Wang]], Ph.D., CMC/Product reviewer, OVRR/DVP; + 
-[:Laura Fontan]], Ph.D., CMC/Facility reviewer; OCBQ/DMPQ; +[[:Lei Huang]], Ph.D., Biostatistics reviewer, OBE/DB; 
-[:Kathleen Jones]], Ph.D., CMC/Facility reviewer, OCBQ/DMPQ; + 
-[:Kerry Welsh]], M.D., Pharmacovigilance reviewer, OBE/DE; +[[:Haruhiko Murata]], Ph.D., CMC/Product reviewer, OVRR/DVP; 
-[:Narayan Nair]], M.D., Pharmacovigilance reviewer, OBE/DE; + 
-[:Brenda Baldwin]], Ph.D., Data Integrity reviewer, OVRR/DVRPA; +[[:Xiao Wang]], Ph.D., CMC/Product reviewer, OVRR/DVP; 
-[:Bhanumathi Kannan]], Ph.D., BIMO reviewer, OCBQ/DIS/BMB; + 
-[:Oluchi Elekwachi]], Ph.D., Labeling reviewer, OCBQ/DCM/APLB+[[:Laura Fontan]], Ph.D., CMC/Facility reviewer; OCBQ/DMPQ; 
 + 
 +[[:Kathleen Jones]], Ph.D., CMC/Facility reviewer, OCBQ/DMPQ; 
 + 
 +[[:Kerry Welsh]], M.D., Pharmacovigilance reviewer, OBE/DE; 
 + 
 +[[:Narayan Nair]], M.D., Pharmacovigilance reviewer, OBE/DE; 
 + 
 +[[:Brenda Baldwin]], Ph.D., Data Integrity reviewer, OVRR/DVRPA; 
 + 
 +[[:Bhanumathi Kannan]], Ph.D., BIMO reviewer, OCBQ/DIS/BMB; 
 + 
 +[[:Oluchi Elekwachi]], Ph.D., Labeling reviewer, OCBQ/DCM/APLB
  
 === Review Completion Date December 11, 2020 === === Review Completion Date December 11, 2020 ===
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 === Intended Use for EUA Active immunization to prevent coronavirus disease 2019 ===  === Intended Use for EUA Active immunization to prevent coronavirus disease 2019 === 
 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)  (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) 
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 Intended Population Individuals 16 years of age and older Intended Population Individuals 16 years of age and older
  
 ((https://web.archive.org/web/20201217133250/https://www.fda.gov/media/144416/download)) ((https://web.archive.org/web/20201217133250/https://www.fda.gov/media/144416/download))
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