Covid-19 living Data

COVID-19 vaccine effectiveness
(Randomized evidence)

Methods

Latest news:Last search date July 30, 2023. No further screening is planned after this date.
Results of booster studies are available in the tables below Last search date for included studies is April 18, 2023. A list of studies included between april 19 and July 30 2023 but not extracted are detailed on here .

As of December 14, 2022, the COVID-NMA revised its protocol and discontinued the inclusion of prime vaccination trials in its analysis. The analysis presented on this page for prime vaccines compared to placebo or other vaccines includes trials that were identified and included up to December 14, 2022. A list of studies that were eligible up to this date but not extracted is provided in detail here .

The vaccine review "Efficacy and safety of COVID‐19 vaccines" included 41 preprints and published trials of 12 different COVID-19 used as prime vaccination and that were published before 5 November 2021.

meta-COVID

Perform your own analysis using COVID-NMA data for prime vaccination (last search date 14/12/2022), create and download your forest plots by clicking below:

COVID-19 PRIME VACCINATION: Last search date December 14, 2022.

Vaccine efficacy and safety for vaccine vs placebo / no vaccine (forest plots)

Vaccine efficacy and safety for vaccine vs vaccine (forest plots)

Vaccine efficacy, immunogenicity and safety of heterologous vs homologous vaccination (tables)

Reference	Intervention 1	Intervention 2	Follow up months	Participants	r1/N1	r2/N2	RR [95% CI]	Risk of bias
	A	B	C	D	E	Overall
Toledo-Romani ME, 2022 b	FINLAY-FR-2-25 mcg +FR-1-50 mcg	Placebo	*	Adults	0 / 13828	6 / 12486	100.0 [*, 100]

Efficacy
Severe or critical COVID-19 after complete vaccination
Confirmed symptomatic COVID-19 after complete vaccination

Reference	Intervention 1	Intervention 2	Follow up months	Participants	r1/N1	r2/N2	VE [95% CI]	Risk of bias
	A	B	C	D	E	Overall
Toledo-Romani ME, 2022 b	FINLAY-FR-2-25 mcg +FR-1-50 mcg	Placebo	*	Adults	NR	NR	92.0 [80.4, 96.7]

Immunogenicity
Geometric mean titre specific antibodies

Reference	Intervention 1	Intervention 2	Follow up days	Participants	GMT1(N1)	GMT2(N2)	GMR [95% CI]	Evaluated by	Risk of bias
									A	B	C	D	E	Overall
Janssen C, 2022	1 dose BNT162b2/1 dose mRNA-1273	2 doses BNT162b2	28	Adults	3,706 (96)	2,698 (94)	1.37 [1.10, 1.72]	ELISA
Janssen C, 2022	1 dose mRNA-1273 /1 dose BNT162b2	2 doses mRNA-1273	28	Adults	2,690 (103)	3,995 (97)	0.67 [0.55, 0.82]	ELISA
Puthanakit T, 2022 a	CoronaVac followed by BNT162b2 30 at 6week interva	CoronaVac followed by BNT162b2 30 at 3week interva	21	Adolescents	112 (20)	77 (20)	1.28 [1.09, 1.51]	ELISA
Puthanakit T, 2022 a	CoronaVac followed by BNT162b2 20 at 3week interva	CoronaVac followed by BNT162b2 30 at 3week interva	21	Adolescents	84 (17)	77 (20)	0.95 [0.80, 1.13]	ELISA
Puthanakit T, 2022 a	CoronaVac followed by BNT162b2 20 at 6week interva	CoronaVac followed by BNT162b2 30 at 3week interva	21	Adolescents	74 (19)	77 (20)	1.10 [0.94, 1.30]	ELISA
Chen C, 2022	1 dose ChAdOx1 / 1 dose MVC-COV1901	ChAdOx1	10	Healthy adults	8 (50)	5 (50)	1.5 [1.2, 1.9]	ELISA
Li J, 2022	1 dose CoronaVac / 1 dose Ad5-vectored	2 doses CoronaVac	14	Healthy adults	942 (51)	154 (50)	6.11 [3.90, 9.57]	ELISA

N1: Number of patients analyzed in intervention 1; N2: Number of patients analyzed in intervention 2; GMT1: Geometric mean titre for intervention 1; GMT2: Geometric mean titre for intervention 2

Geometric mean titre neutralizing antibodies

Reference	Intervention 1	Intervention 2	Follow up days	Participants	GMT1(N1)	GMT2(N2)	GMR [95% CI]	Evaluated by	Risk of bias
									A	B	C	D	E	Overall
Janssen C, 2022	1 dose BNT162b2/1 dose mRNA-1273	2 doses BNT162b2	28	Adults	523 (96)	396 (94)	1.31 [1.02, 1.69]	CPE (cytopathic effect)-based virus neutralization test (VNT)
Chen C, 2022	1 dose ChAdOx1 / 1 dose MVC-COV1901	ChAdOx1	10	Healthy adults	202 (50)	78 (50)	2.6 [1.7, 4.0]	Plaque reduction neutralization
Li J, 2022	1 dose CoronaVac / 1 dose Ad5-vectored	2 doses CoronaVac	14	Healthy adults	54 (51)	13 (50)	4.3 [2.5, 7.3]	CPE-based microneutralization assay-wild-type
Jin P, 2022 b	CoronaVac/Ad5-nCoV	CoronaVac	14	Elderly	71 (48)	9 (47)	7.62 [4.44, 13.1]	Microneutralization assay

N1: Number of patients analyzed in intervention 1; N2: Number of patients analyzed in intervention 2; GMT1: Geometric mean titre for intervention 1; GMT2: Geometric mean titre for intervention 2

Safety
Serious adverse events

Reference	Intervention 1	Intervention 2	Follow up months	Participants	r1/N1	r2/N2	RR [95% CI]	Risk of bias
								A	B	C	D	E	Overall
Macchia A, 2022	Gam-COVID-Vac rAd26-S	Gam-COVID-Vac rAd26-S/BBIBP-CorV	1	Adults	0 / 87	0 / 65	NR
Stuart A, 2021 a	1 dose ChAdOx1 followed by 1 dose NVX-CoV2373	2 doses ChAdOx1	NR	Older adults	1 / 179	3 / 180	0.34 [0.04 - 3.19]
Stuart A, 2021 a	1 dose ChAdOx1 followed by 1 dose mRNA-1273	2 doses ChAdOx1	NR	Older adults	3 / 181	3 / 180	0.99 [0.2 - 4.86]
Stuart A, 2021 b	1 dose BNT162b2 followed by 1 dose NVX-CoV2373	2 doses BNT162b2	NR	Older adults	3 / 180	2 / 175	1.46 [0.25 - 8.62]
Stuart A, 2021 b	1 dose BNT162b2 followed by 1 dose mRNA-1273	2 doses BNT162b2	NR	Older adults	3 / 177	2 / 175	1.48 [0.25 - 8.77]
Janssen C, 2022	1 dose BNT162b2/1 dose mRNA-1273	2 doses BNT162b2	0.9	Adults	0 / 102	0 / 101	NR
Janssen C, 2022	1 dose mRNA-1273 /1 dose BNT162b2	2 doses mRNA-1273	0.9	Adults	0 / 106	0 / 105	NR
Liu X, 2022	1 dose ChAdOx1/ 1 dose BNT162b2	2 doses ChAdOx1	8.3	Adults	2 / 114	1 / 115	2.02 [0.19 - 21.94]
Liu X, 2022	1 dose BNT162b2 /1 dose ChAdOx1	2 doses BNT162b2	8.3	Adults	2 / 115	1 / 119	2.07 [0.19 - 22.51]
Bánki Z, 2022	1 dose ChAdOx1/ 1 dose BNT162b2	ChAdOx1	1	Healthy adults	1 / 114	0 / 108	2.84 [0.12 - 69.03]
Chen C, 2022	1 dose ChAdOx1 / 1 dose MVC-COV1901	ChAdOx1	0.9	Healthy adults	0 / 50	0 / 50	NR
Li J, 2022	1 dose CoronaVac / 1 dose Ad5-vectored	2 doses CoronaVac	1	Healthy adults	0 / 51	0 / 50	NR
Jin P, 2022 b	CoronaVac/Ad5-nCoV	CoronaVac	6	Elderly	1 / 50	2 / 50	0.5 [0.05 - 5.33]
Niyomnaitham S, 2022 a	CoronaVac/ChAdOx1	BNT162b2	2.8	Adults	0 / 30	0 / 26	NR
Niyomnaitham S, 2022 a	CoronaVac/BNT162b2	BNT162b2	2.8	Adults	0 / 30	0 / 26	NR
Niyomnaitham S, 2022 a	ChAdOx1/CoronaVac	BNT162b2	2.8	Adults	0 / 29	0 / 26	NR
Niyomnaitham S, 2022 a	ChAdOx1/BNT162b2	BNT162b2	2.8	Adults	0 / 26	0 / 26	NR
Niyomnaitham S, 2022 a	BNT162b2/CoronaVac	BNT162b2	2.8	Adults	0 / 29	0 / 26	NR
Niyomnaitham S, 2022 a	BNT162b2+ChAdOx1	BNT162b2	2.8	Adults	0 / 30	0 / 26	NR
Toledo-Romani ME, 2022 b	FINLAY-FR-2-25 mcg +FR-1-50 mcg	Placebo	2.7	Adults	1 / 14677	3 / 14675	0.33 [0.03 - 3.2]

r1: Number of events in intervention 1, r2: Number of events in intervention 2, N1: Number of patients analyzed in intervention 1; N2: Number of patients analyzed in intervention 2.

All-cause mortality

Reference	Intervention 1	Intervention 2	Follow up months	Participants	r1/N1	r2/N2	RR [95% CI]
	A	B	C	D	E	Overall
Chen C, 2022	1 dose ChAdOx1 / 1 dose MVC-COV1901	ChAdOx1	0.9	Healthy adults	0 / 50	0 / 50	NR
Toledo-Romani ME, 2022 b	FINLAY-FR-2-25 mcg +FR-1-50 mcg	Placebo	5.4	Adults	11 / 13883	24 / 14303	0.47 [0.23 - 0.96]

Vaccine efficacy and safety against variants of concern (forest plots)

Trials reports under extraction

In addition to the below included trials, we have included and presently extracting 12 new vaccine randomized trials

Description of primary studies

In this table, we report the main characteristics of the COVID-19 vaccine candidates from RCTs identified, in addition to the overall risk of bias assessment.

For prime vaccination, early phase trials were extracted only when the dose has been selected. Results from phase 1-2 studies are included in forest plots for the chosen vaccine dose and schedule only. List of early phases included but not extracted are detailed on here .

Search studies

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Trial	Type	Comparisons		Design	Participants	Sample size	Overall risk of bias Highest assessment	Full description
		Intervention 1	Intervention 2
CTRI/2022/01/039366 Biological E Limited Thuluva S, medRxiv, 2023 b Full text Commentary	Protein subunit	BBV152/Boost BECOV2	BBV152/Boost Placebo	RCT Phase 3	Adults including elderly and co-morbidities in 7 centres in India.	N= 208	Low Details	Full description
NCT05249816 Novavax, Inc Toback S, medRxiv, 2023 Full text Commentary	Heterologous booster	2 or 3 doses of BBIBP-CorV/Boost NVX-CoV2373	2 or 3 doses of BBIBP-CorV/Boost BBIBP-CorV	RCT Phase 3	Healthy adult volunteers who had received a complete 2 doses series of BBIBP-CorV vaccine with or without a a third dose booster of BBIBP-CorV vaccine in 2 centres in UAE	N= 1000	Some concerns Details	Full description
NCT05204589 Institute of Biotechnology (Beijing, China); CanSino Biologics Li X, SSRN, 2023 Full text Commentary	Heterologous vaccination scheme	Any inactivated COVID-19 vaccine/Boost aerosolized Ad5-nCoV	Any inactivated COVID-19 vaccine/Boost homologous	RCT Phase 3	Healthy adults with no history of COVID-19 in multiple centres in China.	N= 420	Some concerns Details	Full description
ChiCTR2100051391 Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Xia N, Research Square, 2023 Full text Commentary	Heterologous booster	Any COVID-19 vaccine/Boost dNS1-RBD	Any COVID-19 vaccine/Boost Placebo	RCT Phase 3	Adultsincluding healthy and mild stable co-morbidities without prior COVID-19 history in 33 centres in Philippines, South Africa, Colombia and Vietnam	N= 17210	Some concerns Details	Full description
CTRI/2022/04/042017 Novavax; Bharat Biotech Kulkarni P , Research Square, 2023 b Full text Commentary	Heterologous booster	BBV152/Boost SII-NVX-CoV2373	BBV152 Booster	RCT Phase 3	Adults including elderly and controlled co-morbidities, primed with viral vector and inactivated vaccines, with no history of COVID-19 in 8 centres in India.	N= 186	Some concerns Details	Full description
CTRI/2022/04/042017 Novavax Kulkarni P, Research Square, 2023 a Full text Commentary	Heterologous booster	ChAdOx1/Boost SII-NVX-CoV2373	ChAdOx1 /Boost ChAdOx1	RCT Phase 3	Adults including elderly and controlled co-morbidities,primed with viral vector and inactivated vaccines, with no history of COVID-19 in 8 centres in India.	N= 186	Some concerns Details	Full description
CTRI/2022/01/039366 Biological E Limited Thuluva S, medRxiv, 2023 a Full text Commentary	Heterologous vaccination scheme	ChAdOx1/Boost BECOV2	ChadOx1/boostPlacebo	RCT Phase 3	Adults including elderly and co-morbidities in 7 centres in India.	N= 208	Low Details	Full description
jRCT2051210164 VLP Therapeutics Japan; Pfizer/BioNTech + Fosun Pharma Akahata W, SSRN, 2023 a Full text Full text Commentary Commentary	saRNA based vaccine	BNT162b2/Boost VLPCOV-01 0.3 mcg BNT162b2/Boost VLPCOV-01 1 mcg BNT162b2/Boost VLPCOV-01 3 mcg	BNT162b2/boostBNT	RCT Phase 1	Healthy adults, 18 to 55 years of age, SARS-CoV-2 infection-free in a single centre in Japan.	N= 46	Some concerns Details	Full description
jRCT2051210164 VLP Therapeutics Japan; Pfizer/BioNTech + Fosun Pharma Akahata W , SSRN, 2023 b Full text Full text Commentary Commentary	saRNA based vaccine	BNT162b2/Boost VLPCOV-01 0.3 mcg BNT162b2/Boost VLPCOV-01 1 mcg BNT162b2/Boost VLPCOV-01 3 mcg	BNT162b2/boostBNT	RCT Phase 1	Healthy adults, ≥65 years years of age, SARS-CoV-2 infection-free in a single centre in Japan.	N= 46	Some concerns Details	Full description
NCT05583357 Livzon Pharmaceutical Group Inc He Q, J. Clin. Med., 2022 a Full text Commentary	Protein subunit	Any inactivated COVID-19 vaccine/Boost inactivated COVID-19 vaccine/Boost V-01D-351	Any inactivated COVID-19 vaccine/Boost inactivated COVID-19 vaccine/Boost CoronaVac	RCT Phase 1	Healthy adults with no history of SARS-CoV-2 infection and 3 doses of CoronaVac or BBIBP-CorV in one centre in China	N= 20	Some concerns Details	Full description

Bennett C, medRxiv, 2023	Immunogenicity and safety of heterologous Omicron BA.1 and bivalent SARS-CoV-2 recombinant spike protein booster vaccines: a phase 3, randomized, clinical trial
Chaudhary A, Vaccine, 2023	Characterization of immune responses to two and three doses of the adenoviral vectored vaccine ChAdOx1 nCov-19 and the whole virion inactivated vaccine BBV152 in a mix-and-match study in India.
Costa Clemens SA, Hum Vaccin Immunother, 2023	Immunogenicity, safety and reactogenicity of heterologous (third dose) booster vaccination with a full or fractional dose of two different COVID-19 vaccines: A phase 4, single-blind, randomized controlled trial in adults
Gui,EBioMedicine, 2023	Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trial
Hannawi S, Nat Commun, 2023	Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men.
Huang T, The Lancet, 2023	Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label,
Liu X, journal of infection, 2023 a	"Persistence of immune responses after heterologous and homologous third COVID-19 vaccine dose schedules in the UK: eight-month analyses of the COV-BOOST trial."
Nolan T, Lancet, 2023	Interim Results from a Phase I Trial of Novel SARS-CoV-2 Beta Variant Receptor-Binding Domain Recombinant Protein and mRNA Vaccines as a 4th Dose Booster
Oda Y, medRxiv, 2023	Booster dose of self-amplifying SARS-CoV-2 RNA vaccine vs. mRNA vaccine: a phase 3 comparison of ARCT-154 with Comirnaty
Roa CC, J Infect Dis, 2023	Superior boosting of neutralizing titers against Omicron SARS-CoV-2 variants by heterologous SCB-2019 vaccine vs a homologous booster in CoronaVac-primed adults
Tan NH, Lancet inf dis, 2023	Immunogenicity of bivalent omicron (BA.1) booster vaccination after different priming regimens in health-care workers in the Netherlands (SWITCH ON): results from the direct boost group of an open-label, multicentre, randomised controlled t
Wu J-D, Lancet Infect Dis, 2023	Safety, immunogenicity, and efficacy of the mRNA vaccine CS-2034 as a heterologous booster versus homologous booster with BBIBP-CorV in adults aged â‰¥18 years: a randomised, double-blind, phase 2b trial.

COVID-19 vaccine effectiveness(Randomized evidence)