Table 3

Availability of regulatory reviews and additional data for COVID-19 vaccines

Manufacturer	Regulatory reviews and additional data
Pfizer	USA FDA: main webpage, Emergency Use Authorisation review memorandum (57 pages), EUA review memorandum for 12–15 year olds (43 pages), advisory committee briefing documents (FDA, Pfizer) UK MHRA: main webpage, public assessment report (51 pages) AUS TGA: main webpage, public assessment report (42 pages) EU EMA: main webpage, public assessment report (140 pages), clinical information (6990 pages) Canada HC: main webpage, summary basis of decision (63 pages), clinical information (5910 pages) Japan PMDA: main webpage (English, Japanese), public assessment reportok (74 pages), clinical and non-clinical information (1239 pages) WHO: main webpage, background document to the WHO interim recommendations (44 pages)
Moderna	USA FDA: main webpage, Emergency Use Authorisation review memorandum (61 pages), advisory committee meeting briefing documents (FDA, Moderna) UK MHRA: main webpage, public assessment report (7 pages) EU EMA: main webpage, public assessment report (169 pages), clinical information (6095 pages) Canada HC: main webpage, summary basis of decision (61 pages), clinical information (6095 pages) Japan PMDA: main webpage (English, Japanese), public assessment report (74 pages), clinical and non-clinical information (542 pages) WHO: main webpage, background document to the WHO interim recommendations (41 pages)
Oxford/AZ	UK MHRA: main webpage, public assessment report (58 pages) AUS TGA: main webpage, public assessment report (49 pages) EU EMA: main webpage, public assessment report (181 pages) Canada HC: main webpage, summary basis of decision (66 pages) Japan PMDA: main webpage (English, Japanese), public assessment report (122 pages), clinical and non-clinical information (1134 pages) WHO: main webpage, background document to the WHO interim recommendations (56 pages)
Janssen	USA FDA: main webpage, Emergency Use Authorisation review memorandum (69 pages), advisory committee meeting briefing documents (FDA, Janssen) UK MHRA: main webpage, public assessment report (11 pages) EU EMA: main webpage, public assessment report (218 pages) Canada HC: main webpage, summary basis of decision (60 pages) WHO: main webpage, background document to the WHO interim recommendations (54 pages)
Novavax	None
Gamaleya Research Institute	None
Sinopharm	WHO: main webpage, background document to the WHO interim recommendations (23 pages)
Sinovac	WHO: main webpage, background document to the WHO interim recommendations (30 pages)

Data current as of 27 June 2021.
Regulatory agencies for each country.: USA FDA; UK MHRA; Canada HC; Japan PDMA; International/non-country entity WHO.
AUS, Australia; EMA, European Medicines Agency; EU, European Union; FDA, Food and Drug Administration; HC, Heath Canada; MHRA, Medicines and Healthcare products Regulatory Agency; PMDA, Pharmaceuticals and Medical Devices Agency; TGA, Therapeutic Goods Administration; USA, United States of America; WHO, World Health Organization.