Efficacy and safety of COVID-19 vaccines

Carolina Graña, Lina Ghosn, Theodoros Evrenoglou, Alexander Jarde, Silvia Minozzi, Hanna Bergman, Brian S Buckley, Katrin Probyn, Gemma Villanueva, Nicholas Henschke, Hillary Bonnet, Rouba Assi, Sonia Menon, Melanie Marti, Declan Devane, Patrick Mallon, Jean-Daniel Lelievre, Lisa M Askie, Tamara Kredo, Gabriel Ferrand, Mauricia Davidson, Carolina Riveros, David Tovey, Joerg J Meerpohl, Giacomo Grasselli, Gabriel Rada, Asbjørn Hróbjartsson, Philippe Ravaud, Anna Chaimani, Isabelle Boutron, Carolina Graña, Lina Ghosn, Theodoros Evrenoglou, Alexander Jarde, Silvia Minozzi, Hanna Bergman, Brian S Buckley, Katrin Probyn, Gemma Villanueva, Nicholas Henschke, Hillary Bonnet, Rouba Assi, Sonia Menon, Melanie Marti, Declan Devane, Patrick Mallon, Jean-Daniel Lelievre, Lisa M Askie, Tamara Kredo, Gabriel Ferrand, Mauricia Davidson, Carolina Riveros, David Tovey, Joerg J Meerpohl, Giacomo Grasselli, Gabriel Rada, Asbjørn Hróbjartsson, Philippe Ravaud, Anna Chaimani, Isabelle Boutron

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.

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.

Copyright © 2022 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.

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
12
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
14
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
16
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
18
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
19
Analysis 2.2.2: SII‐ChAdOx1 versus ChAdOx1. Outcome: serious adverse events (SAEs).
20
20
Analysis 2.2.3: SII‐ChAdOx1 versus ChAdOx1. Outcome: systemic reactogenicity events.
21
21
Analysis 2.2.4: SII‐ChAdOx1 versus ChAdOx1. Outcome: any adverse event (AE).
22
22
Analysis 2.2.5: SII‐ChAdOx1 versus ChAdOx1. Outcome: local reactogenicity events.
23
23
Analysis 2.1.3: non‐replicating viral vector vaccine. Outcome: severe or critical COVID‐19 after complete vaccination.
24
24
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
25
Analysis 3.1.3: inactivated virus vaccine. Outcome: severe or critical COVID‐19 after complete vaccination.
26
26
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
27
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
28
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
29
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
30
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
31
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
33
Analysis 4.1.2: protein subunit vaccine. Outcome: severe or critical COVID‐19 after complete vaccination.
34
34
Analysis 4.1.3: protein subunit vaccine. Outcome: all‐cause mortality.
35
35
Analysis 4.1.4: protein subunit vaccine. Outcome: serious adverse events (SAEs).
36
36
Analysis 4.1.5: protein subunit vaccine. Outcome: systemic reactogenicity events.
37
37
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.

References

References to studies included in this review Ali 2021 {published data only}

    1. Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, et al. Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. New England Journal of Medicine 2021;385(24):2241-51.
Al Kaabi 2021 {published data only}
    1. Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, et al. Effect of 2 inactivated SARS-CoV-2 vaccines on symptomatic COVID-19 infection in adults: a randomized clinical trial. JAMA 2021;326(1):35-45.
Asano 2022 {published data only}
    1. Asano M, Okada H, Itoh Y, Hirata H, Ishikawa K, Yoshida E, et al. Immunogenicity and safety of AZD1222 (ChAdOx1 nCoV-19) against SARS-CoV-2 in Japan: a double-blind, randomized controlled phase 1/2 trial. International Journal of Infectious Diseases 2022;114:165-74.
Bonelli 2021 {published data only}
    1. Bonelli M, Mrak D, Tobudic S, Sieghart D, Koblischke M, Mandl P, et al. Additional heterologous versus homologous booster vaccination in immunosuppressed patients without SARS-CoV-2 antibody seroconversion after primary mRNA vaccination: a randomized controlled trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.05.21263125]
Bueno 2021 {published data only}
    1. Bueno SM, Abarca K, González PA, Gálvez NM, Soto JA, Duarte LF, et al. Interim report: safety and immunogenicity of an inactivated vaccine against SARS-CoV-2 in healthy Chilean adults in a phase 3 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.03.31.21254494]
    1. Bueno SM, Abarca K, González PA, Gálvez NM, Soto JA, Duarte LF, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in a subgroup of healthy adults in Chile. Clinical Infectious Diseases 2021 Sep 19 [Epub ahead of print]. [DOI: 10.1093/cid/ciab823]
Clemens 2021 {published data only}
    1. Clemens SA, Folegatti PM, Emary KR, Weckx LY, Ratcliff J, Bibi S, et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 lineages circulating in Brazil. Nature Communications 2021;12(1):5861.
Dunkle 2021 {published data only}
    1. Dunkle LM, Kotloff KL, Gay CL, Áñez G, Adelglass JM, Barrat Hernández AQ, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.05.21264567]
Ella 2021a {published data only}
    1. Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, et al. A Phase 1: safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.12.11.20210419]
    1. Ella R, Vadrevu KM, Jogdand H, Prasad S, Reddy S, Sarangi V, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomized, phase 1 trial. Lancet Infectious Diseases 2021;21(5):637-46.
Ella 2021b {published data only}
    1. Ella R, Reddy S, Blackwelder W, Potdar V, Yadav P, Sarangi V, et al. Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a double-blind, randomized, controlled phase 3 trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.06.30.21259439]
El Sahly 2021 {published data only}
    1. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. New England Journal of Medicine 2021;384(5):403-16.
    1. El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, et al. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. New England Journal of Medicine 2021;385(19):1774-85.
    1. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee Meeting; December 17, 2020; FDA Briefing Document: Moderna COVID-19 vaccine. (accessed prior to 1 November 2022).
Emary 2021 {published data only}
    1. Emary KR, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomized controlled trial. Lancet 2021;397(10282):1351-62.
Fadlyana 2021 {published data only}
    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.
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.
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.
    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]
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.
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.
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.
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.
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.
    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.
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]
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.
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]
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.
    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]
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.
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.
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.
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]
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.
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]
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. (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.
    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]
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.
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.
    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]
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.
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. (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.
    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.
    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]
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]
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: ]
    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: ]
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]
    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.
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.
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.
    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.
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.
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.
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]
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.
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.
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.
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.
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.
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]
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]
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.
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]
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.
Additional references Abbasi 2020
    1. Abbasi J. COVID-19 and mRNA vaccines – first large test for a new approach. JAMA 2020;324(12):1125-7.
Angkasekwinai 2022
    1. Angkasekwinai N, Sewatanon J, Niyomnaitham S, Phumiamorn S, Sukapirom K, Sapsutthipas S, et al. Comparison of safety and immunogenicity of CoronaVac and ChAdOx1 against the SARS-CoV-2 circulating variants of concern (Alpha, Delta, Beta) in Thai healthcare workers. Vaccine X 2022;10:100153.
Attaway 2021
    1. Attaway AH, Scheraga RG, Bhimraj A, Biehl M, Hatipoğlu U. Severe Covid-19 pneumonia: pathogenesis and clinical management. BMJ 2021;372:n436.
Baden 2021
    1. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. New England Journal of Medicine 2021;384(5):403-16.
Balduzzi 2019
    1. Balduzzi S, Rücker G, Schwarzer G. How to perform a meta-analysis with R: a practical tutorial. Evidence-Based Mental Health 2019;22:153-60.
Borobia 2021
    1. Borobia AM, Carcas AJ, Pérez-Olmeda M, Castaño L, Bertran MJ, García-Pérez J, et al. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet 2021;398(10295):121-30.
Boutron 2020a
    1. Boutron I, Chaimani A, Meerpohl JJ, Hróbjartsson A, Devane D, Rada G, et al. The COVID-NMA Project: building an evidence ecosystem for the COVID-19 pandemic. Annals of Internal Medicine 2020;173(12):1015-7.
Boutron 2020b
    1. Boutron I, Chaimani A, Meerpohl JJ, Hróbjartsson A, Devane D, Rada G, et al. Interventions for preventing and treating COVID-19: protocol for a living mapping of research and a living systematic review. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No: CD013769. [DOI: 10.1002/14651858.CD013769]
Bucci 2021
    1. Bucci EM, Berkhof J, Gillibert A, Gopalakrishna G, Calogero RA, Bouter LM, et al. Data discrepancies and substandard reporting of interim data of Sputnik V phase 3 trial. Lancet 2021;397(10288):1881-3.
Bueno 2021
    1. Bueno SM, Abarca K, González PA, Gálvez NM, Soto JA, Duarte LF, et al. Interim report: safety and immunogenicity of an inactivated vaccine against SARS-CoV-2 in healthy Chilean adults in a phase 3 clinical trial. medRxiv 2021 [Preprint].
Cabanac 2021
    1. Cabanac G, Oikonomidi T, Boutron I. Day-to-day discovery of preprint-publication links. Scientometrics 2021;126(6):5285-304.
Castagneto Gissey 2021
    1. Castagneto Gissey L, Panunzi S, Maltese S, Russo MF, Angelini G, De Gaetano A, et al. Living systematic meta-analysis of COVID-19 vaccines and dose allocation strategies. SSRN 2021 [Preprint]. [DOI: 10.2139/ssrn.3827806]
CDC 2021
    1. Centers for Disease Control and Prevention. Understanding mRNA COVID-19 vaccines. (accessed prior to 1 November 2022).
Chaimani 2013
    1. Chaimani A, Higgins JP, Mavridis D, Spyridonos P, Salanti G. Graphical tools for network meta-analysis in STATA. PLOS One 2013;8 (10):e76654.
Chaimani 2015
    1. Chaimani A, Salanti G. Visualizing assumptions and results in network meta-analysis: the Network Graphs Package. Stata Journal 2015;15(4):905-50.
Chaimani 2022
    1. Chaimani A, Caldwell DM, Li T, Higgins JP, Salanti G. Chapter 11: Undertaking network meta-analyses. In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.3 (updated February 2022). Cochrane, 2022. Available from .
Chappell 2021
    1. Chappell KJ, Mordant FL, Li Z, Wijesundara DK, Ellenberg P, Lackenby JA, et al. Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infectious Diseases 2021;21(10):1383-94.
Che 2021
    1. Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, et al. Randomized, double-blinded, placebo-controlled Phase 2 trial of an inactivated severe acute respiratory syndrome coronavirus 2 vaccine in healthy adults. Clinical Infectious Diseases 2021;73(11):e3949-55.
Chu 2021
    1. Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, et al. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine 2021;39(20):2791-9.
Dal‐Ré 2021a
    1. Dal-Ré R, Bekker LG, Gluud C, Holm S, Jha V, Poland GA, et al. Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities. Lancet Infectious Diseases 2021;21(11):e342-7.
Dal‐Ré 2021b
    1. Dal-Ré R, Orenstein W, Caplan AL. Being fair to participants in placebo-controlled COVID-19 vaccine trials. Nature Medicine 2021;27(6):938.
DeZure 2016
    1. DeZure AD, Berkowitz NM, Graham BS, Ledgerwood JE. Whole-inactivated and virus-like particle vaccine strategies for chikungunya virus. Journal of Infectious Diseases 2016;214(Suppl 5):S497-9.
Dias 2010
    1. Dias S, Welton NJ, Caldwell DM, Ades AE. Checking consistency in mixed treatment comparison meta-analysis. Statistics in Medicine 2010;29(7-8):932-44.
Dong 2020
    1. Dong Y, Dai T, Wei Y, Zhang L, Zheng M, Zhou F. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduction and Targeted Therapy 2020;5(1):237.
Egger 1997
    1. Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34.
Ella 2020b
    1. Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, et al. Safety and immunogenicity clinical trial of an inactivated SARS-CoV-2 vaccine, BBV152 (a phase 2, double-blind, randomised controlled trial) and the persistence of immune responses from a phase 1 follow-up report. medRxiv 2020 [Preprint]. [DOI: 10.1101/2020.12.21.20248643]
Ella 2021a
    1. Ella R, Reddy S, Jogdand H, Sarangi V, Ganneru B, Prasad S, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomized, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomized phase 1 trial. Lancet Infectious Diseases 2021;21(7):950-61.
Enjuanes 2016
    1. Enjuanes L, Zuñiga S, Castaño-Rodriguez C, Gutierrez-Alvarez J, Canton J, Sola I. Molecular basis of coronavirus virulence and vaccine development. Advances in Virus Research 2016;96:245-86.
Epistemonikos
    1. Epistemonikos. Epistemonikos L·OVE COVID-19 platform. Available at .
FDA 2020a
    1. Food and Drug Administration. Development and licensure of vaccines to prevent COVID-19. Guidance for industry; June 2020. (accessed prior to 1 November 2022).
FDA 2020b
    1. Food and Drug Administration. FDA Briefing Document Moderna COVID-19 Vaccine. Vaccines and Related Biological Products Advisory Committee Meeting December 17, 2020. (accessed prior to 1 November 2022).
FDA 2020c
    1. Food and Drug Administration. FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine. Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020. (accessed prior to 1 November 2022).
FDA 2021
    1. Food and Drug Administration. FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Vaccines and Related Biological Products Advisory Committee Meeting February 26, 2021. (accessed prior to 1 November 2022).
Feikin 2022
    1. Feikin DR, Higdon MM, Abu-Raddad LJ, Andrews N, Araos R, Goldberg Y, et al. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression. Lancet 2022;399(10328):924-44.
Feng 2021
    1. Feng Y, Chen J, Yao T, Chang Y, Li X, Xing R, et al. Safety and Immunogenicity of Inactivated SARS-CoV-2 vaccine in high-risk occupational population: a randomized, parallel, controlled clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.08.06.21261696]
Folegatti 2020
    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, randomised controlled trial. Lancet 2020;396:467-78.
Formica 2021
    1. Formica N, Mallory R, Albert G, Robinson M, Plested JS, Cho I, et al, the 2019nCoV-101 Study Group. Evaluation of a SARS-CoV-2 vaccine NVX-CoV2373 in younger and older adults. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.02.26.21252482]
Fuenmayor 2017
    1. Fuenmayor J, Gòdia F, Cervera L. Production of virus-like particles for vaccines. New Biotechnology 2017;39(Pt B):174-80.
Gavi 2020
    1. Gavi. What are viral vector-based vaccines and how could they be used against COVID-19? (accessed prior to 1 November 2022).
Gobeil 2021
    1. Gobeil P, Pillet S, Séguin A, Boulay I, Mahmood A, Vinh DC, et al. Interim report of a Phase 2 randomized trial of a plant-produced virus-like particle vaccine for Covid-19 in healthy adults aged 18-64 and older adults aged 65 and older. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.14.21257248]
Goepfert 2021
    1. Goepfert PA, Fu B, Chabanon AL, Bonaparte MI, Davis MG, Essink BJ, et al. Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study. Lancet Infectious Diseases 2021;21(9):1257-70.
GRADEpro GDT [Computer program]
    1. McMaster University (developed by Evidence Prime) GRADEpro GDT. Version accessed 6 December 2021. Hamilton (ON): McMaster University (developed by Evidence Prime). Available at .
Guyatt 2011
    1. Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, et al. GRADE guidelines 6. Rating the quality of evidence – imprecision. Journal of Clinical Epidemiology 2011;64(12):1283-93.
Harder 2021
    1. Harder T, Koch J, Vygen-Bonnet S, Kulper-Schiek W, Pilic A, Reda S, et al. Efficacy and effectiveness of COVID-19 vaccines against SARS-CoV-2 infection: interim results of a living systematic review, 1 January to 14 May 2021. Eurosurveillance 2021;26(28):2100563.
Hayawi 2021
    1. Hayawi K, Shahriar S, Serhani MA, Alashwal H, Masud MM. Vaccine versus variants (3Vs): are the COVID-19 vaccines effective against the variants? A systematic review. Vaccines 2021;9(11):1305.
Heath 2021
    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]. [DOI: 10.1101/2021.05.13.21256639]
Higdon 2021
    1. Higdon MM, Wahl B, Jones CB, Rosen JG, Truelove SA, Baidya A, et al. A systematic review of COVID-19 vaccine efficacy and effectiveness against SARS-CoV-2 infection and disease. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.17.21263549]
Higgins 2021
    1. Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.2 (updated February 2021). Cochrane, 2021. Available from .
Hobernik 2018
    1. Hobernik D, Bros M. DNA vaccines – how far from clinical use? International Journal of Molecular Sciences 2018;19(11):3605.
Hultcrantz 2017
    1. Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, et al. The GRADE Working Group clarifies the construct of certainty of evidence. Journal of Clinical Epidemiology 2017;87:4-13.
Kirkham 2018
    1. Kirkham JJ, Altman DG, Chan AW, Gamble C, Dwan KM, Williamson PR. Outcome reporting bias in trials: a methodological approach for assessment and adjustment in systematic reviews. BMJ 2018;362:k3802.
Korang 2022
    1. Korang SK, Rohden E, Veroniki AA, Ong G, Ngalamika O, Siddiqui F, et al. Vaccines to prevent COVID-19: a living systematic review with trial sequential analysis and network meta-analysis of randomized clinical trials. PLOS One 2022;17(1):e0260733.
Kow 2022
    1. Kow CS, Ramachandram DS, Hasan SS. The effectiveness of mRNA-1273 vaccine against COVID-19 caused by Delta variant: a systematic review and meta-analysis. Journal of Medical Virology 2022;94(5):2269-74.
Lazarus 2021
    1. Lazarus R, Taucher C, Brown C, Čorbic I, Danon L, Dubischar K, et al. Immunogenicity and safety of inactivated whole virion Coronavirus vaccine with CpG (VLA2001) in healthy adults aged 18 to 55: a randomised phase 1 /2 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.08.13.21262021]
Li 2021b
    1. Li J, Hui A, Zhang X, Yang Y, Tang R, Ye H, et al. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nature Medicine 2021;27(6):1062-70.
Li 2021c
    1. Li M, Yang J, Wang L, Wu Q, Wu Z, Zheng W, et al. A booster dose is immunogenic and will be needed for older adults who have completed two doses vaccination with CoronaVac: a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.08.03.21261544]
Liu 2021
    1. Liu X, Shaw RH, Stuart AS, Greenland M, Dinesh T, Provstgaard-Morys S, et al. Safety and immunogenicity report from the com-COV study – a single-blind randomised non-inferiority trial comparing heterologous and homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine. SSRN 2021 [Preprint].
Low 2021
    1. Low JG, Alwis R, Chen S, Kalimuddin S, Leong YA, Mah TK, et al. A phase 1/2 randomized, double-blinded, placebo controlled ascending dose trial to assess the safety, tolerability and immunogenicity of ARCT-021 in healthy adults. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.01.21259831]
Lv 2021
    1. Lv M, Luo X, Shen Q, Lei R, Liu X, Liu E, et al. Safety, immunogenicity, and efficacy of COVID-19 vaccines in children and adolescents: a systematic review. Vaccines 2021;9(10):1102.
Madhi 2021
    1. Madhi SA, Koen AL, Fairlie L, Cutland CL, Baillie V, Padayachee SD, et al. ChAdOx1 nCoV-19 (AZD1222) vaccine in people living with and without HIV. Research Square 2021 [Preprint]. [DOI: 10.21203/-322470/v1]
Makris 2021
    1. Makris M, Pavord S, Lester W, Scully M, Hunt B. Vaccine-induced immune thrombocytopenia and thrombosis (VITT). Research and Practice in Thrombosis and Haemostasis 2021;5(5):e12529.
Mammen 2021
    1. Mammen MP Jr, Tebas P, Agnes J, Giffear M, Kraynyak KA, Blackwood E, et al. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: a preliminary report of a randomized, blinded, placebo-controlled, Phase 2 clinical trial in adults at high risk of viral exposure. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.05.07.21256652]
Marshall 2020
    1. Marshall JC, Murthy S, Diaz J, Adhikari NK, Angus DC, Arabi YM, et al. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infectious Diseases 2020;20(8):e192-7.
Mavridis 2014
    1. Mavridis D, Welton NJ, Sutton A, Salanti G. A selection model for accounting for publication bias in a full network meta-analysis. Statistics in Medicine 2014;33(30):5399-412.
Meng 2021b
    1. Meng FY, Gao F, Jia SY, Wu XH, Li JX, Guo XL, et al. Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials. Signal Transduction and Targeted Therapy 2021;6(1):271.
Mortola 2004
    1. Mortola E, Roy P. Efficient assembly and release of SARS coronavirus-like particles by a heterologous expression system. FEBS Letters 2004;576(1-2):174-8.
Mulligan 2020
    1. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 2020;586(7830):589-93.
Nguyen 2021
    1. Nguyen TP, Do Q, Phan LT, Dinh DV, Khong H, Hoang LV, et al. Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.22.21260942]
Nikolakopoulou 2020
    1. Nikolakopoulou A, Higgins JP, Papakonstantinou T, Chaimani A, Del Giovane C, Egger M, et al. CINeMA: an approach for assessing confidence in the results of a network meta-analysis. PLOS Medicine 2020;17 (4):e1003082.
Oikonomidi 2020
    1. Oikonomidi T, Boutron I, Pierre O, Cabanac G, Ravaud P, COVID-19 NMA Consortium. Changes in evidence for studies assessing interventions for COVID-19 reported in preprints: meta-research study. BMC Medicine 2020;18(1):402.
Ostrowski 2021
    1. Ostrowski SR, Søgaard OS, Tolstrup M, Stærke NB, Lundgren J, Østergaard L, et al. Inflammation and platelet activation after COVID-19 vaccines – possible mechanisms behind vaccine-induced immune thrombocytopenia and thrombosis. Frontiers in Immunology 2021;12:779453.
Ouzzani 2016
    1. Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyanv – a web and mobile app for systematic reviews. Systematic Reviews 2016;5(1):210.
Oxford Vaccine Group 2020
    1. Oxford Vaccine Group. Vaccine Knowledge Project: independent information about vaccines and infectious diseases. (accessed prior to 1 November 2022).
Page 2021
    1. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.
Pajon 2021
    1. Pajon R, Paila YD, Girard B, Dixon G, Kacena K, Baden LR, et al. Initial analysis of viral dynamics and circulating viral variants during the mRNA-1273 Phase 3 COVE trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.28.21264252]
Pan 2021a
    1. Pan HX, Liu JK, Huang BY, Li GF, Chang XY, Liu YF, et al. Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine (KCONVAC) in healthy adults: two randomized, double-blind, and placebo-controlled Phase 1/2 clinical trials. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.04.07.21253850]
Pan 2021b
    1. Pan HX, Wu QH, Zeng G, Yang J, Jiang DY, Deng XW, et al. Immunogenicity and safety of a third dose, and immune persistence of CoronaVac vaccine in healthy adults aged 18–59 years: interim results from a double-blind, randomized, placebo-controlled phase 2 clinical trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.23.21261026]
Pérez‐Rodríguez 2021
    1. Pérez-Rodríguez S, la Caridad Rodríguez-González M, Ochoa-Azze R, Climent-Ruiz Y, Alberto González-Delgado C, Paredes-Moreno B, et al. A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: safety, reactogenicity and immunogenicity. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.04.21264522]
Pitisuttithum 2021
    1. Pitisuttithum P, Luvira V, Lawpoolsri S, Muangnoicharoen S, Kamolratanakul S, Sivakorn C, et al. Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: interim results of a randomised, placebo-controlled, Phase 1/2 trial. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.17.21263758]
Polack 2020
    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.
Pollard 2021
    1. Pollard AJ, Bijker EM. A guide to vaccinology: from basic principles to new developments. Nature Reviews Immunology 2021;21(2):83-100.
Pu 2021
    1. Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, et al. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18–59 years: a phase I randomized, double-blinded, controlled trial. Vaccine 2021;39(20):2746-54.
Qiao 2020
    1. Qiao J. What are the risks of COVID-19 infection in pregnant women? Lancet 2020;395(10226):760-2.
Ramasamy 2020
    1. Ramasamy MN, Minassian AM, Ewer KJ, Flaxman AL, Folegatti PM, Owens DR, et al. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomized, controlled, phase 2/3 trial. Lancet 2020;396(10267):1979-93.
Richmond 2021
    1. Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, et al. Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomized, double-blind, placebo-controlled trial. Lancet 2021;397(10275):682-94.
Riley 2011
    1. Riley RD, Higgins JP, Deeks JJ. Interpretation of random effects meta-analyses. BMJ 2011;342:d549.
Rizk 2021
    1. Rizk JG, Gupta A, Sardar P, Henry BM, Lewin JC, Lippi G, et al. Clinical characteristics and pharmacological management of COVID-19 vaccine-induced immune thrombotic thrombocytopenia with cerebral venous sinus thrombosis: a review. JAMA Cardiology 2021;6(12):1451-60.
Roozen 2021
    1. Roozen GV, Prins ML, Binnendijk R, den Hartog G, Kuiper VP, Prins C, et al. Tolerability, safety and immunogenicity of intradermal delivery of a fractional dose mRNA-1273 SARS-CoV-2 vaccine in healthy adults as a dose sparing strategy. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.07.27.21261116]
Roper 2009
    1. Roper RL, Rehm KE. SARS vaccines: where are we? Expert Review of Vaccines 2009;8(7):887-98.
Rotshild 2021
    1. Rotshild V, Hirsh-Raccah B, Miskin I, Muszkat M, Matok I. Comparing the clinical efficacy of COVID-19 vaccines: a systematic review and network meta-analysis. Scientific Reports 2021;11(1):22777.
Rubin 2013
    1. Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromized host. Clinical Infectious Diseases 2013;58(3):e44-e100.
Rucker 2013
    1. Rucker G, Schwarzer G, Rücker G, Schwarzer G, Krahn U, König J. Network meta-analysis using frequentist methods – package netmeta. cran.r– (accessed prior to 1 November 2022).
Ryzhikov 2021
    1. Ryzhikov AB, Ryzhikov ЕА, Bogryantseva MP, Usova SV, Danilenko ED, Nechaeva EA, et al. A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the "EpiVacCorona" vaccine for the prevention of COVID-19. Russian Journal of Infection and Immunity 2021;11(2):283-96.
Sadoff 2020c
    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].
Salanti 2011
    1. Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. Journal of Clinical Epidemiology 2011;64(2):163-7.
Schünemann 2021
    1. Schünemann HJ, Higgins JP, Vist GE, Glasziou P, Akl EA, Skoetz N, et al. Chapter 14: Completing 'Summary of findings' tables and grading the certainty of the evidence. In: Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 6.2 (updated February 2021). Cochrane, 2021. Available from .
Sharifian‐Dorche 2021
    1. Sharifian-Dorche M, Bahmanyar M, Sharifian-Dorche A, Mohammadi P, Nomovi M, Mowla A. Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis post COVID-19 vaccination; a systematic review. Journal of the Neurological Sciences 2021;428:117607.
Shinde 2021
    1. Shinde V, Bhikha S, Hoosain Z, Archary M, Bhorat Q, Fairlie L, et al, for the 2019nCoV-501 Study Group. Preliminary efficacy of the NVX-CoV2373 Covid-19 vaccine against the B.1.351 variant. medRxiv 2021 [Preprint].
Shu 2021
    1. Shu YJ, He JF, Pei RJ, He P, Huang ZH, Chen SM, et al. Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial. Chinese Medical Journal 2021;134(16):1967-76.
Sridhar 2021
    1. Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, et al. Safety and immunogenicity of a SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in healthy adults: interim findings from a phase 2, randomised, dose-finding, multi-centre study. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.10.08.21264302]
Stephenson 2021
    1. Stephenson KE, Le Gars M, Sadoff J, Groot AM, Heerwegh D, Truyers C, et al. Immunogenicity of the Ad26.COV2.S vaccine for COVID-19. JAMA 2021;325(15):1535-44.
Sterne 2019
    1. Sterne JA, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomized trials. BMJ 2019;366:l4898.
Thomas 2021
    1. Thomas SJ, Moreira ED, 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].
Turner 2012
    1. Turner RM, Davey J, Clarke MJ, Thompson SG, Higgins JP. Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane Database of Systematic Reviews. International Journal of Epidemiology 2012;41(3):818-27.
van Riel 2020
    1. Riel D, Wit E. Next-generation vaccine platforms for COVID-19. Nature Materials 2020;19(8):810-2.
Viechtbauer 2010
    1. Viechtbauer W. Conducting meta-analyses in R with the metafor package. Journal of Statistical Software 2010;36(3):1-48.
Voysey 2021b
    1. Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomized trials. Lancet 2021;397(10277):881-91.
Walsh 2021
    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 2021 [Preprint].
Ward 2021b
    1. Ward BJ, Gobeil P, Séguin A, Atkins J, Boulay I, Charbonneau PY, et al. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nature Medicine 2021;27(6):1071-8.
White 2008
    1. White IR, Higgins JP, Wood AM. Allowing for uncertainty due to missing data in meta-analysis – part 1: two-stage methods. Statistics in Medicine 2008;27(5):711-27.
WHO 2020a
    1. World Health Organization. Coronavirus disease 2019 (COVID-19). Situation report – 51. (accessed prior to 1 November 2022).
WHO 2020b
    1. World Health Organization. Considerations for evaluation of COVID19 vaccines. Points to consider for manufacturers of COVID-19 vaccines. Version 24 September 2020. (accessed prior to 1 November 2022).
WHO 2020c
    1. World Health Organization. WHO target product profiles for COVID-19 vaccines. Version 3 – 29 April 2020. (accessed prior to 1 November 2022).
WHO 2022a
    1. World Health Organization. Tracking SARS-CoV-2 variants. (accessed prior to 1 November 2022).
WHO 2022b
    1. World Health Organization. COVID-19 vaccine tracker and landscape. (accessed prior to 1 November 2022).
WHO Ad Hoc Expert Group 2021
    1. WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation. Placebo-controlled trials of covid-19 vaccines – why we still need them. New England Journal of Medicine 2021;384:e2. [DOI: 10.1056/NEJMp2033538]
Worldometer 2022
    1. Worldometer. COVID-19 coronavirus pandemic. (accessed prior to 1 November 2022).
Wu 2021c
    1. Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, et al. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infectious Diseases 2021;21(12):1654-64.
Xia 2020
    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.
Yang 2021
    1. Yang S, Li Y, Dai L, Wang J, He P, Li C, et al. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomized, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infectious Diseases 2021;21(8):1107-19.
Yepes‐Nuñez 2019
    1. Yepes-Nuñez JJ, Li SA, Guyatt G, Jack SM, Brozek JL, Beyene J, et al. Development of the summary of findings table for network meta-analysis. Journal of Clinical Epidemiology 2019;115:1-13.
Zakarya 2021
    1. Zakarya K, Kutumbetov L, Orynbayev M, Abduraimov Y, Sultankulova K, Kassenov M, et al. A single-centre, randomized, single-blind, placebo-controlled phase 1 and an open-label phase 2 clinical trials with a 6 months follow-up in Kazakhstan. EClinicalMedicine 2021;39:101078.
Zeng 2021a
    1. Zeng L, Brignardello-Petersen R, Hultcrantz M, Siemieniuk RA, Santesso N, Traversy G, et al. GRADE guidelines 32: GRADE offers guidance on choosing targets of GRADE certainty of evidence ratings. Journal of Clinical Epidemiology 2021;137:163-75.
Zeng 2021b
    1. Zeng B, Gao L, Zhou Q, Yu K, Sun F. Effectiveness of COVID-19 vaccines against SARS-CoV-2 variants of concern: a systematic review and meta-analysis. medRxiv 2021 [Preprint]. [DOI: 10.1101/2021.09.23.21264048]
Zhang 2021b
    1. Zhang J, Hu Z, He J, Liao Y, Li Y, Pei R, et al. Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial. Emerging Microbes & Infections 2021;10(1):1589-97.
Zhu 2020
    1. Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, et al. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 2 trial. Lancet 2020;396(10249):479-88.
Zhu 2021a
    1. Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, et al. Safety and immunogenicity of a recombinant adenovirus type-5-vectored COVID-19 vaccine with a homologous prime-boost regimen in healthy participants aged 6 years and above: a randomized, double-blind, placebo-controlled, phase 2b trial. Clinical Infectious Diseases 2022;75(1):e783-91. [DOI: 10.1093/cid/ciab845]
Zhu 2022
    1. Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, et al. Safety and immunogenicity of a recombinant adenovirus type-5-vectored COVID-19 vaccine with a homologous prime-boost regimen in healthy participants aged 6 years and above: a randomized, double-blind, placebo-controlled, phase 2b trial. Clinical Infectious Diseases 2022;75(1):e783-91.
References to other published versions of this review Grana 2021
    1. Grana C, Ghosn L, Boutron I. Efficacy and safety of COVID-19 vaccines: a systematic review and meta-analysis. PROSPERO 2021 CRD42021271897. (accessed prior to 1 November 2022).

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다