Covid-19 Vaccine TrialsAnisa Rowhani-Farid2023-09-04T00:38:03-04:00

Pfizer BNT162b2 mRNA vaccine

Registration	NCT04368728, n=43,998; 12-85y	NCT04713553; n=1,530; 12-50y	NCT04816643; n=4,644; 6m-11y
Pre-study documents
Statistical Analysis Plan (SAP)	SAP	Not available	SAP (original & amendment 4)
Protocol	Protocol	Not available	Protocol (original & amendment 4)
Case Report Forms (CRFs)	Blank CRF	Not available	Not available
Post-study documents
Press releases	Nov 9, 2020, March 31, 2021, Apr 1, 2021	No	Sep 20, 2021
Publications	Walsh 2020 NEJM (phase 1) Polack 2020 NEJM (16+ years, EUA) Thomas 2021 NEJM (16+ years, BLA) Frenck 2021 NEJM (12-15 years)	N/A: trial ongoing	Walter 2021 NEJM (5-11 years)
Clinical Study Report	CSR	N/A: trial ongoing	Not available
Other	Other	N/A: trial ongoing	Not available
Individual Participant Data (IPD)	Not available	N/A: trial ongoing	Not available
Documents made available by regulators	The RIAT Support Center recommends Health Canada and the European Medicines Agency as the two leading regulatory bodies providing access to the largest number of regulatory documents in English. The Japanese PMDA is the only regulator routinely publishing non-clinical data. US FDA Main webpage for Pfizer-BioNTech vaccine Main webpage for Comirnaty Dec 11, 2020 EUA review memorandum for 16+ years old (57 pages) May 10, 2021 EUA review memorandum for 12-15 year olds (43 pages) Oct 6, 2021 EUA review memorandum for 5-11 year olds (47 pages) Nov 8, 2021 Summary Basis for Regulatory Action – Comirnaty Aug 23, 2021 Comirnaty BLA approval “action package” (medical, statistical, and other discipline reviews, letters, and related documents) US FDA Advisory Committee (VRBPAC) meeting materials Dec 10, 2020 FDA briefing document for 16+ year old EUA application (53 pages) Dec 10, 2020 Pfizer briefing document for 16+ year old EUA application (92 pages) Sep 17, 2021 VRBPAC meeting on Pfizer booster application for 16+ year olds (main page, video, agenda, roster, no transcript available) UK MHRA Main webpage for Pfizer-BioNTech vaccine Public assessment report (51 pages) Australia TGA Main webpage for Pfizer-BioNTech vaccine Public assessment report (42 pages) EU EMA Main webpage for Pfizer-BioNTech vaccine Public assessment report (140 pages) Clinical information (6990 pages) Health Canada Main webpage Summary basis of decision (63 pages) Clinical information (>6000 pages) Japan PMDA Main webpage (English, Japanese) Feb 14, 2021 Public assessment report (English; 85 pages) Clinical and non-clinical information (Japanese/English; 1239 pages) WHO Main webpage Jan 14, 2021 Background document to the WHO interim recommendations (44 pages)

Moderna mRNA-1273 vaccine

Registration	NCT04470427; n=30,420; ≥18y	NCT04811664; n=37,500; 18-26y	NCT04796896; n=6,750; 6m- 12y
Regulatory Docs	The RIAT Support Center recommends Health Canada and the European Medicines Agency as the two leading regulatory bodies providing access to the largest number of regulatory documents in English. The Japanese PMDA is the only regulator routinely publishing non-clinical data. USA FDA: main webpage, Emergency Use Authorization 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)
Pre-study documents
SAP	SAP	None	None
Protocol	Protocol	None	None
CRF	None	None	None
Post-study documents
Press release	Press release	No	No
Publication	Pub	N/A: trial ongoing	N/A: trial ongoing
CSR	No	N/A: trial ongoing	N/A: trial ongoing
Other	Other	N/A: trial ongoing	N/A: trial ongoing
IPD	No	N/A: trial ongoing	N/A: trial ongoing

Oxford/AstraZeneca ChAdOx1 vaccine

Registration	ISRCTN89951424; n=10,300; ≥18y	NCT04400838; n=12,390; ≥18y	ISRCTN15638344; n=300; 6-17y	NCT	NCT
Regulatory Docs	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 (120 pages), clinical and non-clinical information (1134 pages) WHO: main webpage, Background document to the WHO interim recommendations (56 pages)
Pre-study documents
SAP	None	None	None
Protocol	Protocol	Protocol	None
CRF	None	None	None
Post-study documents
Press release	Press release	Press release	No
Publication	Pub 1, 2	Pub 1, 2	N/A: trial ongoing
CSR	No	No	N/A: trial ongoing
Other	No	No	N/A: trial ongoing
IPD	No	No	N/A: trial ongoing

Janssen (Johnson & Johnson) Ad26.COV2.S vaccine

Registration	NCT04505722; n=44,325; ≥18y	NCT04535453; n=1,210; 12-55, ≥65y	NCT04614948; n=30,000; ≥18y	NCT	NCT
Regulatory Docs	USA FDA: main webpage, Emergency Use Authorization 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)
Pre-study documents
SAP	SAP	None	None
Protocol	Protocol	Protocol	Protocol
CRF	Blank ICF	None	No
Post-study documents
Press release	Press release	Press release	No
Publication	Sadoff et al. 2021 (Interim analysis) Sadoff et al. 2022 (final analysis of efficacy)	No	N/A: trial ongoing
CSR	No	No	N/A: trial ongoing
Other	No	No	N/A: trial ongoing
IPD	No	No	N/A: trial ongoing

Novavax SARS-CoV-2 rS/Matrix-M1 Adjuvanted vaccine

Registration	NCT04611802; n=30,000; ≥18y	NCT04368988; n=1,419; 18-84y	NCT04583995; n=15,187; 18-84y
Regulatory Docs	None
Pre-study documents
SAP	None	SAP	SAP
Protocol	Protocol v1 and v9, v10	Protocol	Protocol
CRF	None	None	No
Post-study documents
Press release	1, 2	Press release	Press release
Publication	Dunkle 2021 (preprint) Dunkle 2021 (NEJM)	N/A: trial ongoing	Pub
CSR	N/A	N/A: trial ongoing	No
Other	N/A	N/A: trial ongoing	No
IPD	N/A	N/A: trial ongoing	No

Gamaleya Research Institute Sputnik V / Gam-COVID-Vac vaccine

Registration	NCT04530396; n=33,758; ≥18y	NCT04741061; n=6,000; ≥18y	NCT04642339; n=2,000; ≥18y	NCT	NCT
Regulatory Docs	None
Pre-study documents
SAP	None	None	None
Protocol	None	None	None
CRF	None	None	No
Post-study documents
Press release	Press release	No	No
Publication	Pub	N/A: trial ongoing	N/A: trial ongoing
CSR	No	N/A: trial ongoing	N/A: trial ongoing
Other	No	N/A: trial ongoing	N/A: trial ongoing
IPD	No	N/A: trial ongoing	N/A: trial ongoing

Sinopharm (BIBP)

Registration	ChiCTR2000032459; n=2,128; ≥3y	NCT04510207; n=45,000; ≥18y	NCT04612972; n=12,000; ≥18y	NCT	NCT
Regulatory Docs	None
Pre-study documents
SAP	None	SAP	None
Protocol	None	Protocol	None
CRF	None	None	None
Post-study documents
Press release	No	No	No
Publication	Pub	Pub	N/A: trial ongoing
CSR	No	No	N/A: trial ongoing
Other	No	No	N/A: trial ongoing
IPD	No	No	N/A: trial ongoing

Sinovac (CoronaVac)

Registration	NCT04456595; n=12,688; ≥18y	NCT04551547; n=552; 3-17y	NCT04582344; n=13,000; 18-59y	NCT	NCT
Regulatory Docs	None
Pre-study documents
SAP	None	None	None
Protocol	Protocol	None	Protocol
CRF	None	None	None
Post-study documents
Press release	Press release	No	Press release
Publication	Pub	Pub	No
CSR	No	No	No
Other	No	No	No
IPD	No	No	No