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, 2021Apr 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

US FDA Advisory Committee (VRBPAC) meeting materials

UK MHRA

Australia TGA

EU EMA

Health Canada

Japan PMDA

WHO

Moderna mRNA-1273 vaccine

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)

Registration NCT04470427; n=30,420; ≥18y NCT04811664; n=37,500; 18-26y NCT04796896; n=6,750; 6m- 12y
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