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. 2022 Dec 7;12(12):CD015477.
doi: 10.1002/14651858.CD015477.

Efficacy and safety of COVID-19 vaccines

Carolina Graña  1   2 , Lina Ghosn  1   2 , Theodoros Evrenoglou  2 , Alexander Jarde  1   2 , Silvia Minozzi  3 , Hanna Bergman  4 , Brian S Buckley  4 , Katrin Probyn  4 , Gemma Villanueva  4 , Nicholas Henschke  4 , Hillary Bonnet  1   2 , Rouba Assi  1   2 , Sonia Menon  1 , Melanie Marti  5 , Declan Devane  6 , Patrick Mallon  7 , Jean-Daniel Lelievre  8 , Lisa M Askie  9 , Tamara Kredo  10 , Gabriel Ferrand  1 , Mauricia Davidson  1   2 , Carolina Riveros  1   2 , David Tovey  1 , Joerg J Meerpohl  11   12 , Giacomo Grasselli  13 , Gabriel Rada  14   15 , Asbjørn Hróbjartsson  16   17 , Philippe Ravaud  1   2 , Anna Chaimani  1   2 , Isabelle Boutron  1   2
Affiliations

Efficacy and safety of COVID-19 vaccines

Carolina Graña et al. Cochrane Database Syst Rev. .

Abstract

Background: Different forms of vaccines have been developed to prevent the SARS-CoV-2 virus and subsequent COVID-19 disease. Several are in widespread use globally. OBJECTIVES: To assess the efficacy and safety of COVID-19 vaccines (as a full primary vaccination series or a booster dose) against SARS-CoV-2.

Search methods: We searched the Cochrane COVID-19 Study Register and the COVID-19 L·OVE platform (last search date 5 November 2021). We also searched the WHO International Clinical Trials Registry Platform, regulatory agency websites, and Retraction Watch.

Selection criteria: We included randomized controlled trials (RCTs) comparing COVID-19 vaccines to placebo, no vaccine, other active vaccines, or other vaccine schedules.

Data collection and analysis: We used standard Cochrane methods. We used GRADE to assess the certainty of evidence for all except immunogenicity outcomes. We synthesized data for each vaccine separately and presented summary effect estimates with 95% confidence intervals (CIs). MAIN RESULTS: We included and analyzed 41 RCTs assessing 12 different vaccines, including homologous and heterologous vaccine schedules and the effect of booster doses. Thirty-two RCTs were multicentre and five were multinational. The sample sizes of RCTs were 60 to 44,325 participants. Participants were aged: 18 years or older in 36 RCTs; 12 years or older in one RCT; 12 to 17 years in two RCTs; and three to 17 years in two RCTs. Twenty-nine RCTs provided results for individuals aged over 60 years, and three RCTs included immunocompromized patients. No trials included pregnant women. Sixteen RCTs had two-month follow-up or less, 20 RCTs had two to six months, and five RCTs had greater than six to 12 months or less. Eighteen reports were based on preplanned interim analyses. Overall risk of bias was low for all outcomes in eight RCTs, while 33 had concerns for at least one outcome. We identified 343 registered RCTs with results not yet available. This abstract reports results for the critical outcomes of confirmed symptomatic COVID-19, severe and critical COVID-19, and serious adverse events only for the 10 WHO-approved vaccines. For remaining outcomes and vaccines, see main text. The evidence for mortality was generally sparse and of low or very low certainty for all WHO-approved vaccines, except AD26.COV2.S (Janssen), which probably reduces the risk of all-cause mortality (risk ratio (RR) 0.25, 95% CI 0.09 to 0.67; 1 RCT, 43,783 participants; high-certainty evidence). Confirmed symptomatic COVID-19 High-certainty evidence found that BNT162b2 (BioNtech/Fosun Pharma/Pfizer), mRNA-1273 (ModernaTx), ChAdOx1 (Oxford/AstraZeneca), Ad26.COV2.S, BBIBP-CorV (Sinopharm-Beijing), and BBV152 (Bharat Biotect) reduce the incidence of symptomatic COVID-19 compared to placebo (vaccine efficacy (VE): BNT162b2: 97.84%, 95% CI 44.25% to 99.92%; 2 RCTs, 44,077 participants; mRNA-1273: 93.20%, 95% CI 91.06% to 94.83%; 2 RCTs, 31,632 participants; ChAdOx1: 70.23%, 95% CI 62.10% to 76.62%; 2 RCTs, 43,390 participants; Ad26.COV2.S: 66.90%, 95% CI 59.10% to 73.40%; 1 RCT, 39,058 participants; BBIBP-CorV: 78.10%, 95% CI 64.80% to 86.30%; 1 RCT, 25,463 participants; BBV152: 77.80%, 95% CI 65.20% to 86.40%; 1 RCT, 16,973 participants). Moderate-certainty evidence found that NVX-CoV2373 (Novavax) probably reduces the incidence of symptomatic COVID-19 compared to placebo (VE 82.91%, 95% CI 50.49% to 94.10%; 3 RCTs, 42,175 participants). There is low-certainty evidence for CoronaVac (Sinovac) for this outcome (VE 69.81%, 95% CI 12.27% to 89.61%; 2 RCTs, 19,852 participants). Severe or critical COVID-19 High-certainty evidence found that BNT162b2, mRNA-1273, Ad26.COV2.S, and BBV152 result in a large reduction in incidence of severe or critical disease due to COVID-19 compared to placebo (VE: BNT162b2: 95.70%, 95% CI 73.90% to 99.90%; 1 RCT, 46,077 participants; mRNA-1273: 98.20%, 95% CI 92.80% to 99.60%; 1 RCT, 28,451 participants; AD26.COV2.S: 76.30%, 95% CI 57.90% to 87.50%; 1 RCT, 39,058 participants; BBV152: 93.40%, 95% CI 57.10% to 99.80%; 1 RCT, 16,976 participants). Moderate-certainty evidence found that NVX-CoV2373 probably reduces the incidence of severe or critical COVID-19 (VE 100.00%, 95% CI 86.99% to 100.00%; 1 RCT, 25,452 participants). Two trials reported high efficacy of CoronaVac for severe or critical disease with wide CIs, but these results could not be pooled. Serious adverse events (SAEs) mRNA-1273, ChAdOx1 (Oxford-AstraZeneca)/SII-ChAdOx1 (Serum Institute of India), Ad26.COV2.S, and BBV152 probably result in little or no difference in SAEs compared to placebo (RR: mRNA-1273: 0.92, 95% CI 0.78 to 1.08; 2 RCTs, 34,072 participants; ChAdOx1/SII-ChAdOx1: 0.88, 95% CI 0.72 to 1.07; 7 RCTs, 58,182 participants; Ad26.COV2.S: 0.92, 95% CI 0.69 to 1.22; 1 RCT, 43,783 participants); BBV152: 0.65, 95% CI 0.43 to 0.97; 1 RCT, 25,928 participants). In each of these, the likely absolute difference in effects was fewer than 5/1000 participants. Evidence for SAEs is uncertain for BNT162b2, CoronaVac, BBIBP-CorV, and NVX-CoV2373 compared to placebo (RR: BNT162b2: 1.30, 95% CI 0.55 to 3.07; 2 RCTs, 46,107 participants; CoronaVac: 0.97, 95% CI 0.62 to 1.51; 4 RCTs, 23,139 participants; BBIBP-CorV: 0.76, 95% CI 0.54 to 1.06; 1 RCT, 26,924 participants; NVX-CoV2373: 0.92, 95% CI 0.74 to 1.14; 4 RCTs, 38,802 participants). For the evaluation of heterologous schedules, booster doses, and efficacy against variants of concern, see main text of review.

Authors' conclusions: Compared to placebo, most vaccines reduce, or likely reduce, the proportion of participants with confirmed symptomatic COVID-19, and for some, there is high-certainty evidence that they reduce severe or critical disease. There is probably little or no difference between most vaccines and placebo for serious adverse events. Over 300 registered RCTs are evaluating the efficacy of COVID-19 vaccines, and this review is updated regularly on the COVID-NMA platform (covid-nma.com). Implications for practice Due to the trial exclusions, these results cannot be generalized to pregnant women, individuals with a history of SARS-CoV-2 infection, or immunocompromized people. Most trials had a short follow-up and were conducted before the emergence of variants of concern. Implications for research Future research should evaluate the long-term effect of vaccines, compare different vaccines and vaccine schedules, assess vaccine efficacy and safety in specific populations, and include outcomes such as preventing long COVID-19. Ongoing evaluation of vaccine efficacy and effectiveness against emerging variants of concern is also vital.

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Conflict of interest statement

Carolina Graña: none known.

Lina Ghosn: none known.

Theodoros Evrenoglou: none known.

Alexander Jarde: none known.

Silvia Minozzi: no relevant interests; Joint Co‐ordinating Editor and Method editor of the Drugs and Alcohol Group.

Hanna Bergman: Cochrane Response – consultant; WHO – grant/contract (Cochrane Response was commissioned by the WHO to perform review tasks that contribute to this publication).

Brian Buckley: none known.

Katrin Probyn: Cochrane Response – consultant; WHO – consultant (Cochrane Response was commissioned to perform review tasks that contribute to this publication).

Gemma Villanueva: Cochrane Response – employment (Cochrane Response has been commissioned by WHO to perform parts of this systematic review).

Nicholas Henschke: Cochrane Response – consultant; WHO – consultant (Cochrane Response was commissioned by the WHO to perform review tasks that contributed to this publication).

Hillary Bonnet: none known.

Rouba Assi: none known.

Sonia Menon: P95 – consultant.

Melanie Marti: no relevant interests; Medical Officer at WHO.

Declan Devane: Health Research Board (HRB) – grant/contract; registered nurse and registered midwife but no longer in clinical practice; Editor, Cochrane Pregnancy and Childbirth Group.

Patrick Mallon: AstraZeneca – Advisory Board; spoken of vaccine effectiveness to media (print, online, and live); works as a consultant in a hospital that provides vaccinations; employed by St Vincent's University Hospital.

Jean‐Daniel Lelievre: no relevant interests; published numerous interviews in the national press on the subject of COVID vaccination; Head of the Department of Infectious Diseases and Clinical Immunology CHU Henri Mondor APHP, Créteil; WHO (IVRI‐AC): expert Vaccelarate (European project on COVID19 Vaccine): head of WP; involved with COVICOMPARE P et M Studies (APHP, INSERM) (public fundings).

Lisa Askie: no relevant interests; Co‐convenor, Cochrane Prospective Meta‐analysis Methods Group.

Tamara Kredo: no relevant interests; Medical Officer in an Infectious Diseases Clinic at Tygerberg Hospital, Stellenbosch University.

Gabriel Ferrand: none known.

Mauricia Davidson: none known.

Carolina Riveros: no relevant interests; works as an epidemiologist.

David Tovey: no relevant interests; Emeritus Editor in Chief, Feedback Editors for 2 Cochrane review groups.

Joerg J Meerpohl: no relevant interests; member of the German Standing Vaccination Committee (STIKO).

Giacomo Grasselli: Pfizer – speaking engagement.

Gabriel Rada: none known.

Asbjørn Hróbjartsson: no relevant interests; Cochrane Methodology Review Group Editor.

Philippe Ravaud: no relevant interests; involved with Mariette CORIMUNO‐19 Collaborative 2021, the Ministry of Health, Programme Hospitalier de Recherche Clinique, Foundation for Medical Research, and AP‐HP Foundation.

Anna Chaimani: none known.

Isabelle Boutron: no relevant interests; member of Cochrane Editorial Board.

Figures

1
1
Network graph. The size of the nodes is proportional to the number of participants randomized and the thickness of the lines to the number of studies in each comparison.
2
2
PRISMA flow diagram of included randomized controlled trials (RCTs) (last search date 5 November 2021). COVID‐NMA is a living systematic review of all trials assessing treatment and preventive interventions for COVID‐19 (Boutron 2020a). This review is a subreview of the COVID‐NMA. FDA: Food and Drug Administration; ICTRP: World Health Organization (WHO) International Clinical Trials Registry Platform.
3
3
Analysis 1.1.2: RNA‐based vaccine. Outcome: confirmed symptomatic COVID‐19 after complete vaccination. Ali 2021 included only participants 3 to 17 years of age. Frenck 2021 included only participants 12 to 15 years of age.
4
4
Analysis 1.1.3: RNA‐based vaccine. Outcome: severe or critical COVID‐19 after complete vaccination. *Thomas 2021 reports pooled results including adults' participants from Thomas 2021 and adolescent participants from Frenck 2021.
5
5
Analysis 1.1.4: RNA‐based vaccine. Outcome: all‐cause mortality. Ali 2021 included only participants 3 to 17 years of age. Frenck 2021 included only participants 12 to 15 years of age.
6
6
Analysis 1.1.5: RNA‐based vaccine. Outcome: serious adverse events (SAEs). Ali 2021 included only participants 3 to 17 years of age. Frenck 2021 included only participants 12 to 15 years of age.
7
7
Analysis 1.1.7: RNA‐based vaccine. Outcome: any adverse event (AE). Ali 2021 included only participants 3 to 17 years of age. Frenck 2021 included only participants 12 to 15 years of age.
8
8
Analysis 1.1.1: RNA‐based vaccine. Outcome: confirmed SARS‐CoV‐2 infection after complete vaccination. Ali 2021 included only participants 3 to 17 years of age.
9
9
Analysis 1.1.6: RNA‐based vaccine. Outcome: systemic reactogenicity events. Ali 2021 included only participants 3 to 17 years of age.
10
10
Analysis 1.1.8: RNA‐based vaccine. Outcome: local reactogenicity events. Ali 2021 included only participants 3 to 17 years of age.
11
11
Analysis 2.1.1: Non‐replicating viral vector vaccine. Outcome: confirmed SARS‐CoV‐2 infection after complete vaccination. Voysey 2021a: data pooled from four trials.
12
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Analysis 2.1.2: non‐replicating viral vector vaccine. Outcome: confirmed symptomatic COVID‐19 after complete vaccination. Voysey 2021a: data pooled from four trials.
13
13
Analysis 2.1.4: non‐replicating viral vector vaccine. Outcome: all‐cause mortality. In Kulkarni 2021, the control arm received adjuvant. Voysey 2021a: data pooled from four trials.
14
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Analysis 2.1.5: non‐replicating viral vector vaccine. Outcome: serious adverse events (SAEs). In Kulkarni 2021, the control arm received adjuvant. Voysey 2021a: data pooled from four trials.
15
15
Analysis 2.1.6: non‐replicating viral vector vaccine. Outcome: systemic reactogenicity events.
16
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Analysis 2.1.7: non‐replicating viral vector vaccine. Outcome: any adverse event (AE). In Kulkarni 2021, the control arm received adjuvant. Voysey 2021a merged results from four different trials where three used quadrivalent meningococcal conjugate vaccine as placebo and one trial used normal saline.
17
17
Analysis 2.1.8: non‐replicating viral vector vaccine. Outcome: local reactogenicity events.
18
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Analysis 2.2.1: serum Institute of India/Astra Zeneca+University of Oxford – SII‐ChAdOx1 versus University of Oxford – ChAdOx1. Outcome: all‐cause mortality.
19
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Analysis 2.2.2: SII‐ChAdOx1 versus ChAdOx1. Outcome: serious adverse events (SAEs).
20
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Analysis 2.2.3: SII‐ChAdOx1 versus ChAdOx1. Outcome: systemic reactogenicity events.
21
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Analysis 2.2.4: SII‐ChAdOx1 versus ChAdOx1. Outcome: any adverse event (AE).
22
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Analysis 2.2.5: SII‐ChAdOx1 versus ChAdOx1. Outcome: local reactogenicity events.
23
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Analysis 2.1.3: non‐replicating viral vector vaccine. Outcome: severe or critical COVID‐19 after complete vaccination.
24
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Analysis 3.1.2: inactivated virus vaccine. Outcome: confirmed symptomatic COVID‐19 after complete vaccination. Al Kaabi 2021.1 and Al Kaabi N 2021.2 refers to two different comparisons from the same report (Al Kaabi 2021).
25
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Analysis 3.1.3: inactivated virus vaccine. Outcome: severe or critical COVID‐19 after complete vaccination.
26
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Analysis 3.1.4: inactivated virus vaccine. Outcome: all‐cause mortality. Al Kaabi 2021.1 and Al Kaabi N 2021.2 refers to two different comparisons from the same report (Al Kaabi 2021).
27
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Analysis 3.1.5: inactivated virus vaccine. Outcome: serious adverse events (SAEs). Han 2021 included only participants 3 to 17 years of age. Wu 2021a included only participants 60 years of age and older. Wu 2021a reports data for phase 1 and 2. Al Kaabi 2021.1 and Al Kaabi N 2021.2 refer to two different comparisons from the same report (Al Kaabi 2021).
28
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Analysis 3.1.6: inactivated virus vaccine. Outcome: systemic reactogenicity events. Xia S 2021 included only participants 3 to 17 years of age (Xia 2021). Wu Z 2021 included only participants 60 years of age and older (Wu 2021a). Wu Z 2021 reports data for phase 2 (Wu 2021a). Al Kaabi 2021.1 and Al Kaabi N 2021.2 refer to two different comparisons from the same report (Al Kaabi 2021). Zhang 2020.1 and Zhang 2020.2 refers to two different comparisons from the same report (Zhang 2021).
29
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Analysis 3.1.7: inactivated virus vaccine. Outcome: any adverse event (AE). Han B 2021 and Xia 2021 included only participants 3 to 17 years of age (Han 2021; Xia 2021). Wu Z 2021 included only participants 60 years of age and older (Wu 2021a). Wu Z 2021 reports data for phase 1 and 2 (Wu 2021a), Al Kaabi 2021.1 and Al Kaabi N 2021.2 refer to two different comparisons from the same report (Al Kaabi 2021). Zhang 2020.1 and Zhang 2020.2 refers to two different comparisons from the same report (Zhang 2021).
30
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Analysis 3.1.8: inactivated virus vaccine. Outcome: local reactogenicity events. Xia S 2021 included only participants 3 to 17 years of age (Xia 2021). Wu Z 2021 included only participants 60 years of age and older (Wu 2021a). Wu Z 2021 reports data for phase 2 (Wu 2021a). Al Kaabi 2021.1 and Al Kaabi N 2021.2 refer to two different comparisons from the same report (Al Kaabi 2021). Zhang 2020.1 and Zhang 2020.2 refers to two different comparisons from the same report (Zhang 2021).
31
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Analysis 3.1.1: inactivated virus vaccine. Outcome: confirmed SARS‐CoV‐2 infection after complete vaccination. Al Kaabi 2021.1 and Al Kaabi N 2021.2 refer to two different comparisons from the same report (Al Kaabi 2021).
32
32
Analysis 4.1.1: protein subunit vaccine. Outcome: confirmed symptomatic COVID‐19 after complete vaccination.
33
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Analysis 4.1.2: protein subunit vaccine. Outcome: severe or critical COVID‐19 after complete vaccination.
34
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Analysis 4.1.3: protein subunit vaccine. Outcome: all‐cause mortality.
35
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Analysis 4.1.4: protein subunit vaccine. Outcome: serious adverse events (SAEs).
36
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Analysis 4.1.5: protein subunit vaccine. Outcome: systemic reactogenicity events.
37
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Analysis 4.1.6: protein subunit vaccine. Outcome: any adverse event (AE).
38
38
Analysis 4.1.7 Protein subunit vaccine. Outcome: local reactogenicity events
39
39
Analysis 5.1.1: heterologous vaccination scheme versus homologous vaccination scheme. Outcome: serious adverse events (SAEs). Liu X 2021.1 and Liu X 2021.2 are different comparisons for the same report (Liu 2021).
40
40
Analysis 5.1.2: heterologous vaccination scheme versus homologous vaccination scheme. Outcome: systemic reactogenicity events.
41
41
Analysis 5.1.3: heterologous vaccination scheme versus homologous vaccination scheme. Outcome: any adverse event (AE). Liu 2021 included only participants 50 years of age or older. Liu X 2021.1 and Liu X 2021.2 are different comparisons for the same report (Liu 2021).
42
42
Analysis 5.1.4: heterologous vaccination scheme versus homologous vaccination scheme. Outcome: local reactogenicity events.
43
43
Analysis 6.1.2: booster versus placebo/no booster. Outcome: systemic reactogenicity events.
44
44
Analysis 6.1.3: booster versus placebo/no booster. Outcome: local reactogenicity events.
45
45
Analysis 6.1.1: booster versus placebo/no booster. Outcome: all‐cause mortality.
46
46
Analysis 6.2.4: homologous booster versus heterologous booster. Outcome: local reactogenicity events. Bonelli 2021 included only participants under current Rituximab therapy.
47
47
Analysis 6.2.2: homologous booster versus heterologous booster. Outcome: systemic reactogenicity events.
48
48
Analysis 6.2.1: homologous booster versus heterologous booster. Outcome: serious adverse events.
49
49
Analysis 6.2.3: homologous booster versus heterologous booster. Outcome: any adverse event.
50
50
Analysis 7.1.1: variant‐Alpha. Outcome: confirmed symptomatic COVID‐19 after complete vaccination.
51
51
Analysis 7.2.1: variant‐Beta. Outcome: confirmed symptomatic COVID‐19 after complete vaccination.
52
52
Analysis 7.3.1: variant‐Gamma. Outcome: confirmed symptomatic COVID‐19 after complete vaccination.
53
53
Analysis 7.4.1: variant‐Delta. Outcome: confirmed symptomatic COVID‐19 after complete vaccination.
54
54
Analysis 8.1: follow‐up. RNA‐based vaccine. Outcome: confirmed symptomatic COVID‐19 after complete vaccination.
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References

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    1. Fadlyana E, Rusmil K, Tarigan R, Rahmadi AR, Prodjosoewojo S, Sofiatin Y, et al. A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: an interim analysis in Indonesia. Vaccine 2021;39(44):6520-8. - PMC - PubMed
Falsey 2021 {published data only}
    1. Falsey AR, Sobieszczyk ME, Hirsch I, Sproule S, Robb ML, Corey L, et al. Phase 3 safety and efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 vaccine. New England Journal of Medicine 2021;385(25):2348-60. - PMC - PubMed
Formica 2021 {published data only}
    1. Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, et al. Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: a phase 2 randomized placebo-controlled trial. PLOS Medicine 2021;18(10):e1003769. - PMC - PubMed
    1. Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, et al. Evaluation of a SARS-CoV-2 vaccine NVX-CoV2373 in younger and older adults. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.02.26.21252482] - DOI - PMC - PubMed
Frenck 2021 {published data only}
    1. Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, et al. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. New England Journal of Medicine 2021;385(3):239-50. - PMC - PubMed
Guo 2021 {published data only}
    1. Guo W, Duan K, Zhang Y, Yuan Z, Zhang YB, Wang Z, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 1/2 trial. eClinicalMedicine 2021;38:101010. - PMC - PubMed
Hall 2021 {published data only}
    1. Hall VG, Ferreira VH, Ku T, Ierullo M, Majchrzak-Kita B, Chaparro C, et al. Randomized trial of a third dose of mRNA-1273 vaccine in transplant recipients. New England Journal of Medicine 2021;385(13):1244-6. - PMC - PubMed
Han 2021 {published data only}
    1. Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomized, controlled, phase 1/2 clinical trial. Lancet Infectious Diseases 2021;21(12):1645-53. - PMC - PubMed
Heath 2021 {published data only}
    1. Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al. Safety and efficacy of NVX-CoV2373 Covid-19 vaccine. New England Journal of Medicine 2021;385(13):1172-83. - PMC - PubMed
    1. Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, et al . Efficacy of the NVX-CoV2373 Covid-19 vaccine against the B. 1.1.7 variant. medRxiv 2021 [Preprint].
Keech 2020 {published data only}
    1. Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. New England Journal of Medicine 2020;383:2320-32. - PMC - PubMed
Kremsner 2021 {published data only}
    1. Kremsner PG, Ahuad Guerrero RA, Arana-Arri E, Aroca Martinez GJ, Bonten M, Chandler R, et al. Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate: results from Herald, a phase 2b/3, randomized, observer-blinded, placebo-controlled clinical trial in ten countries in Europe and Latin America. SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3911826] - DOI - PMC - PubMed
Kulkarni 2021 {published data only}
    1. Kulkarni PS, Padmapriyadarsini C, Vekemans J, Bavdekar A, Gupta M, Kulkarni P, et al. A phase 2/3, observer-blind, randomized, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCOV-19 (COVID-19 vaccine) in adults in India. eClinicalMedicine 2021;42:101218. - PMC - PubMed
Li 2021a {published data only}
    1. Li J, Hou L, Guo X, Jin P, Wu S, Zhu J, et al. Heterologous prime-boost immunization with CoronaVac and Convidecia. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.03.21263062] - DOI
Liu 2021 {published data only}
    1. Liu X, Shaw RH, Stuart AS, Greenland M, Aley PK, Andrews NJ, et al. Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomized, non-inferiority trial. Lancet 2021;398(10303):856-69. - PMC - PubMed
    1. Liu X, Shaw RH, Stuart AS, Greenland M, Aley PK, Andrews NJ, et al. Safety and immunogenicity report from the Com-COV Study – a single-blind randomized non-inferiority trial comparing heterologous and homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine. SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3874014] - DOI - PMC - PubMed
Logunov 2021 {published data only}
    1. Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomized controlled phase 3 trial in Russia. Lancet 2021;397(10275):671-81. - PMC - PubMed
Madhi 2021a {published data only}
    1. Madhi SA, Koen AL, Izu A, Fairlie L, Cutland CL, Baillie V, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 in people living with and without HIV in South Africa: an interim analysis of a randomized, double-blind, placebo-controlled, phase 1B/2A trial. Lancet HIV 2021;8(9):e568-80. - PMC - PubMed
Madhi 2021b {published data only}
    1. Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, et al. Efficacy of the ChAdOx1 nCoV-19 Covid-19 vaccine against the B.1.351 variant. New England Journal of Medicine 2021;384(20):1885-98. - PMC - PubMed
Mok 2021 {published data only}
    1. Mok C, Cheng S, Chen C, Yiu K, Chan TO, Lai KC, et al. A RCT of a third dose CoronaVac or BNT162b2 vaccine in adults with two doses of CoronaVac. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.11.02.21265843] - DOI
Palacios 2020 {published data only}
    1. Palacios R, Patiño EG, Oliveira Piorelli R, Conde MT, Batista AP, Zeng G, et al. Double-blind, randomized, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of treating healthcare professionals with the adsorbed COVID-19 (inactivated) vaccine manufactured by Sinovac – PROFISCOV: a structured summary of a study protocol for a randomized controlled trial. Trials 2020;21(1):853. - PMC - PubMed
Sablerolles 2021 {published data only}
    1. Sablerolles RS, Rietdijk WJ, Goorhuis A, Postma DF, Visser LG, Geers D, et al. Immunogenicity and reactogenicity of booster vaccinations after Ad26.COV2.S priming. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.18.21264979] - DOI
Sadoff 2021a {published data only}
    1. Food and Drug Administration. Vaccines and related biological products Advisory Committee Meeting; February 26, 2021; FDA briefing document: Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. www.fda.gov/media/146217/download (accessed prior to 1 November 2022).
    1. Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM, et al. Interim results of a Phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine. New England Journal of Medicine 2021;384(19):1824-35. - PMC - PubMed
    1. Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, Groot AM, et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.09.23.20199604] - DOI
Sadoff 2021b {published data only}
    1. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, et al. Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19. New England Journal of Medicine 2021;384(23):2187-201. - PMC - PubMed
Shinde 2021 {published data only}
    1. Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al. Efficacy of NVX-CoV2373 Covid-19 vaccine against the B.1.351 variant. New England Journal of Medicine 2021;384(20):1899-909. - PMC - PubMed
    1. Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al. Preliminary efficacy of the NVX-CoV2373 Covid-19 vaccine against the B.1.351 variant. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.02.25.21252477] - DOI - PMC - PubMed
Tanriover 2021 {published data only}
    1. Tanriover MD, Doğanay HL, Akova M, Güner HR, Azap A, Akhan S, et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomized, placebo-controlled, phase 3 trial in Turkey. Lancet 2021;398(10296):213-22. - PMC - PubMed
Thomas 2021 {published data only}
    1. Food and Drug Administration. Vaccines and related biological products Advisory Committee Meeting; December 10, 2020; FDA briefing document: Pfizer-BioNTech COVID-19 vaccine. www.fda.gov/media/144245/download (accessed prior to 1 November 2022).
    1. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine 2020;383(27):2603-15. - PMC - PubMed
    1. Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. New England Journal of Medicine 2021;385(19):1761-773. - PMC - PubMed
    1. Thomas SJ, Moreira ED Jr, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Six month safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.28.21261159] - DOI - PMC - PubMed
Toledo‐Romani 2021 {published data only}
    1. Toledo-Romani ME, Garcia-Carmenate M, Silva-Valenzuela C, Baldoquin-Rodriguez W, Martínez-Pérez M, Rodríguez-González M, et al. Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-PLUS: double-blind, randomized, placebo-controlled phase 3 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.31.21265703] - DOI - PMC - PubMed
Voysey 2021a {published data only}
    1. Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomized controlled trial. Lancet 2020;396(10249):467-78. [PMID: ] - PMC - PubMed
    1. Voysey M, Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized controlled trials in Brazil, South Africa, and the UK. Lancet 2021;397(10269):99-111. [PMID: ] - PMC - PubMed
Walsh 2020 {published data only}
    1. Walsh EE, Frenck R, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. RNA-based COVID-19 vaccine BNT162b2 selected for a pivotal efficacy study. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.08.17.20176651] - DOI
    1. Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. New England Journal of Medicine 2020;383(25):2439-50. - PMC - PubMed
Wu 2021a {published data only}
    1. Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infectious Diseases 2021;21(6):803-12. - PMC - PubMed
Xia 2020 {published data only}
    1. Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, et al. Effect of an inactivated vaccine against SARS-CoV-2 on safety and immunogenicity outcomes: interim analysis of 2 randomized clinical trials. JAMA 2020;324(10):951-60. - PMC - PubMed
    1. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomized, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infectious Diseases 2020;21(1):39-51. - PMC - PubMed
Xia 2021 {published data only}
    1. Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, et al. Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomized, double-blind, controlled, phase 1/2 trial. Lancet Infectious Diseases 2021;22(2):196-208. - PMC - PubMed
Zhang 2021 {published data only}
    1. Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infectious Diseases 2021;21(2):181-92. - PMC - PubMed

References to studies excluded from this review

Baden 2021 {published data only}
    1. Baden LR, El Sahly HM, Essink B, Follmann D, Neuzil KM, August A, et al. Covid-19 in the phase 3 trial of mRNA-1273 during the Delta-variant surge. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.17.21263624] - DOI - PMC - PubMed
Barrett 2021 {published data only}
    1. Barrett JR, Belij-Rammerstorfer S, Dold C, Ewer KJ, Folegatti PM, Gilbride C, et al. Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses. Nature Medicine 2021;27(2):279-88. - PubMed
Ewer 2021 {published data only}
    1. Ewer KJ, Barrett JR, Belij-Rammerstorfer S, Sharpe H, Makinson R, Morter R, et al. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nature Medicine 2021;27(2):270-8. - PubMed
Flaxman 2021 {published data only}
    1. Flaxman A, Marchevsky NG, Jenkin D, Aboagye J, Aley PK, Angus B, et al. Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomized controlled trials (COV001 and COV002). Lancet 2021;398(10304):981-90. - PMC - PubMed
Hsieh 2021 {published data only}
    1. Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, et al. Safety and immunogenicity of a recombinant stabilized prefusion SARS-CoV-2 spike protein vaccine (MVC-COV1901) adjuvanted with CpG 1018 and aluminum hydroxide in healthy adults: a phase 1, dose-escalation study. eClinicalMedicine 2021;38:100989. - PMC - PubMed
Irfan 2021 {published data only}
    1. Irfan N, Chagla Z. In South Africa, a 2-dose Oxford/AZ vaccine did not prevent mild to moderate COVID-19 (cases mainly B.1.351 variant). Annals of Internal Medicine 2021;174(5):JC50. - PubMed
Lazarus 2021 {published data only}
    1. Lazarus R, Baos S, Cappel-Porter H, Carson-Stevens A, Clout M, Culliford L, et al. The safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults: a phase IV, multicentre randomized controlled trial with blinding (ComFluCOV). SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3931758] - DOI - PMC - PubMed
Patamatamkul 2021 {published data only}
    1. Patamatamkul S, Thammawat S, Buranrat B. Induction of robust neutralizing antibodies against the COVID-19 Delta variant with ChAdOx1 nCoV-19 or BNT162b2 as a booster following a primary vaccination series with CoronaVac. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.25.21264099] - DOI
Ward 2021a {published data only}
    1. Ward BJ, Séguin A, Couillard J, Trépanier S, Landry N. Phase III: randomized observer-blind trial to evaluate lot-to-lot consistency of a new plant-derived quadrivalent virus like particle influenza vaccine in adults 18-49 years of age. Vaccine 2021;39(10):1528-33. - PubMed
Wu 2021b {published data only}
    1. Wu K, Choi A, Koch M, Ma LZ, Hill A, Nunna N, et al. Preliminary analysis of safety and immunogenicity of a SARS-CoV-2 variant vaccine booster. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.05.21256716] - DOI - PMC - PubMed
Zdanowski 2021 {published data only}
    1. Zdanowski W, Waśniewski T. Evaluation of SARS-CoV-2 spike protein antibody titers in cord blood after COVID-19 vaccination during pregnancy in Polish healthcare workers: preliminary results. Vaccines 2021;9(6):675. - PMC - PubMed

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